for 266th... · Web viewMr.Khalid Javed, representative of Director, Drugs Testing Laboratory, Peshawar attended the meeting on 07.02.2016. Zaheer-ud-Din M. Babar (Deputy Director

Minutes for 266th Meeting Registration Board held on 06-07th February, 2017.

Item No. Detail of Item Page No(s)

Item No.I Confirmation for minutes of 265th Registration Board meeting 04

Item No.II Medical Device & Medicated Cosmetics 05 – 95

Item No.III Pharmacy Services Division 96 – 100

Item No.IV Pharmaceutical Evaluation & Registration Division 101 – 168

Item No.V Biological Drugs Division 169 – 219

Item No.VI Quality Assurance & Laboratory Testing 220 – 231

Item No.VII Additional Agenda

A. Medical Device & Medicated Cosmetics Division

B. Biological Division

C. Pharmaceutical Evaluation & Registration Division

D. Quality Assurance & Lab. Testing Division

232 – 246

247 – 249

250 – 253

254 – 256

Minutes for 266th Meeting of Registration Board. 1

266th meeting of Registration Board was held on 06-07th February, 2017 in the

Committee Room, Drug Regulatory Authority of Pakistan, G-9/4, Islamabad. The meeting

was chaired by Mr. Ghulam Rasool Dutani, Director, Pharmaceutical Evaluation &

Registration Division, DRAP. The meeting started with recitation of the Holy Verses. The

meeting was attended by the following:-

1. Maj.Gen.Dr. Tahir Mukhtar SyedCommandant AFIRM / Head Department of Medicine, Army Medical College

Member

2. Prof.Dr.Ghulam Sarwar, Dean, Faculty of Pharmacy, Jinnah Women University, Karachi

Member

3. Dr.Qurban Ali, Director General National Veterinary Laboratory, Islamabad.

Member

4. Mr.Aslam Shah, Senior Manager Pharmacy, Indus Hospital, Karachi

Member

5. Jam Muhammad AslamAssistant Draftsman-II, Ministry of Law & Justice

Member

6. Mr.Ammar LateefRepresentative IPO

Member

7. Dr.Amanullah KhanDirector, Drugs Testing Laboratory, QuettaGovernment of Baluchistan

Member

8. Dr. Muhammad Saleem ButtDirector, Drugs Testing Laboratory, RawalpindiGovernment of Punjab.

Member

9. Mr.Khalid JavedRepresentative of Director, Drugs Testing Laboratory, Peshawar, Government of Khyber Pakhtunkhwa

Member

10. Dr.Noor-us-SabaDirector, Biological Drugs Division, DRAP

Member

11. Ms.Tehreem Sara,Additional Director, Representative of Medical Device Division, DRAP

Member

12. Dr.Abdur RasheedAdditional Director, QA&LT Division, DRAPRepresentative of QA&LT Division

Member

13. Dr. Obaidullah, Additional Director (Reg.I) Secretary

Mr.Khalid Javed, representative of Director, Drugs Testing Laboratory, Peshawar

attended the meeting on 07.02.2016.

Zaheer-ud-Din M. Babar (Deputy Director R.I/R IV), Abdullah (Deputy Director,

PEC, R V/ Incharge, PEC), Babar Khan (Assistant Director RIII), Abdul Mughees (Assistant

Director RII), Ms.Sana Kanwal (Assistant Director RV) and Assistant Directors,


Pharmaceutical Evaluation Cell, Medical Device Division, Biological Drugs Division,

Quality Assurance & Lab testing assisted relevant Director with agenda.

Mr. Khalid Muneer, Akbar Siddique, Nadeem Hussain Alamgeer, Dr.Zafar Hashmi

and Shahzad Hussain attended the meeting as observer on behalf of PPMA, Pharma Bureau

and PCDA respectively.

Brig (R) Prof.Dr.Qaiser Khan, Head Department of Cardiology attended meeting as

technical expert during consideration of cases pertaining to Medical Device Division as

decided by National consultative meeting held on 03.02.2017.


Item No.I: Confirmation of minutes of 265th meeting Registration Board.

265th meeting of Registration Board was held on 24-25th January, 2016. Draft minutes

were circulated to members (who attended the meeting) on 02.02.2017 with the request to

forward their comments (if any) within 05 days.

Members were again requested on 04.02.2016 to forward comments (if any) on Item

No.V: Additional Agenda Item; Case No. C: Medical devices & Medicated Cosmetics by

05.02.2016 to enable concerned Division to proceed further. This urgent processing was

requested in view of HR case No.623-P/2017 in the Supreme Court of Pakistan.

No comments have been received yet.

Decision: Registration Board approved minutes for 265th meeting.


Item No.II: Medical Device & Medicated Cosmetics.

Case No.01: Deferred Applications for Registration of Medical Devices for Import.

Registration Board was apprised that keeping in view directions of Honorable

Supreme Court of Pakistan in HR Case 623-P/2017, a consultative meeting on issues retalted

to registration, use and pricing of medical devices was held on 3 rd February, 2017 under the

Chairmanship of Secretary, Ministry of NHSR&C / Chairmain Policy Board. Following

recommendations were agreed unanimously in order to facilitate the registration and use of

medical devices registered as drug.

(i) Registration Board meetings shall be conducted with short intervals for consideration of the applications of medical devices declared as drug, and ensure quick disposal of pending as well as fresh applications and increase supply of registered products. For this purpose two urgent meetings i.e. on 6 th-7th February and 20th-21st February have already been convened and wide publicity through Press Advertisement has also been ensured.

(ii) Two cardiologists shall be taken as observer members to attend the forthcoming meetings of Registration Board for the agenda of cardiac devices. Secretary NHSR&C in consultation with Maj Gen (R) Prof Azher Kiyani will propose the names. These observers shall provide clinical input.

(iii) Registration process of these products shall be made speedy and Registration Board be advised to accept original required documents (without the condition of embassy attestation) at the time of issuance of registration certificate with an Affidavit on stamp paper that the documents furnished are original and that Embassy attested documents and certificates (where applicable) shall be provided by the firm to DRAP within 6 months. Furthermore, similarly the Authorization letter/sole agency agreement and Credentials of manufacturer shall be accepted in original (without notarization) at the time of issuance of registration certificate with an Affidavit on stamp paper that the documents are original and that notarized copies of these shall be provided to DRAP within 2 months.

Secretary, NHSR&C / Chairmain Policy Board in a meeting held on 07.02.2016 with

officers of Medical Device Division, Secretary Registration Board and CEO, DRAP clarified

applicant shall submit original documents i.e. free sale certificates and authorization letter /

sole agency agreement and credentials of manufacturer abroad (as recorded in point iii/

above) before consideration by Registration Board along with an affidavit as recorded above.

Registration Board deliberated the matter in detail and decided that in order to

expedite the registration application of the medical devices declared as drug (disposable

syringe, disposable set for collection or transfusion of blood or giving any infusion, stents,

catheters, cannula, auto disposable syring or butterfly needle). Following criteria / parameters

shall be considered for the approval of medical devices placed before the Registration Board.

i. Registration Board agreed that applicant shall provide original Free slae certificate (without embassy attestation) before consideration by the Board with an Affidavit (to


be signed by owner of the company / applicant / authorized person) on stamp paper that the documents furnished are original and that embassy attested Free Sale certificates shall be provided by the firm to DRAP within 6 months. Registration letter shall be issued with the condition that applicant will provide aforementioned document in 6 months time and in case of non compliance to this condition, the Registration Board shall revoke its registration certificate.

ii. Applicant shall provide Authorization letter/sole agency agreement and credentials of manufacturer abroad in original (without notarization) before consideration by Registration Board with an affidavit on stamp paper that the documents are original and that notarized copies of these documents shall be provided to DRAP within 2 months. Registration letter shall be issued with the condition that applicant will provide aforementioned document in 2 months time and in case of non compliance to this condition, the Registration Board shall revoke its registration certificate.

iii. The products approved (having Free Sale Certificate) by regulatory authorties of reference countries (as approved by the Registration Board in 249th meeting viz.USFDA, Health Canada, EMA, TGA Australia, PMDA Japan, United Kingdom, Germany, France, Switzerland, Netherlands, Austria, Denmark, Sweden and Norway or drugs registered in atleast three European Union counties), will be considered as benchmark to certify the safety, efficacy and quality of these medical devices declared as drug.

iv. For assigning shelf life to the product, applicant shall either provide document confirming shelf life of the product by regulatory authority of country of origin or stability data conducted by the manufacturer of the product for consideration of Registration Board.

v. Registration Board was apprised that in some cases more than one authorization letter/ sole agency agreement has been granted by the manufacturer / licence holder / distributors for the same product of same manufacturing site but with different or same brand names. Registration Board deliberated and decided that in such cases sole agency agreement of manufacturer shall be considered for the grant of registration of the product.

vi. Approved products are subject to compliance of Import Policy for Finished Drugs.

vii. Registration Board decided that registration letters for already approved medical devices declared as drugs shall be processed on same principals for free sale certificate, sole agency agreement, authorization letter as decided in instant meeting.

viii. As most of the applications are pending since long, and applicants have been informed about the shortcomings of their application. However, Registration Board decided to give final letter to all applicants for rectification of shortcoming within 7 days from the date of issuance of letter. Accordingly, cases will be placed before Registration Board for decision in its forthcoming meeting on 20-21st February, 2017.

ix. In order to expedite registration process and thorough evaluation applications of medical devices declared as drug, Registration Board constituted an evaluation cell for scrutinization of registration applications of cardiac stents, catheters and cannulas. Recommendations of the committee shall be placed Registration Board for its consideration and further decision. Composition of the evaluation cell is as under:S.No Designation Status

1. Director, Medical Devices Chairman & Convenier

2. Respective officers of Medical Device Division Members


3. 02 nominees of concerned professional medical associations

Technical expert

For cardiac stents, catheters and cannulas, one nominee each of Cardiologist Socities and Pakistan Society of Interventional Cardiologists and one expert each from Cardiology Department PIMS and Rawalpindi Institute of Cardiology, Rawalpindi shall attend meeting as technical experts.

A) Stents.

S. No.

Name of Importer and Manufacture/

Exporter.

Name of Medical Device

Price &

Pack size

Shelf life

Remarks Decision

1. M/s ACP Systems,13, Naval Fleet Club, Iqbal (S.J) Shaheed Road Karachi.

Manufactured by:M/s Medtronic Ireland, Parkmore Business Park West, Galway Ireland.

Resolute Integrity (DES) Coronary Stent

Cobalt Chromium Alloy Stent coated with Zotarolimus (Rapamycin analog)

(As per FSC)

Decontrolled till policy decision by Policy Board/ Federal Govt.

1’s

24 mont

hs

Applied on03-08-2012Differential fee not depositedLetter issued on23-10-2012. Reminder issued on 20-1-2017.

Deferred for rectification of following shortcomings:a. Differential fee

PKR.35,000/-,b. Clarification as product

is already registered with same brand name but different manufacturer.

c. Original and valid Free Sale Certificate as decided above by Registration Board.

d. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.

e. Clinical data, if any,f. Approval of shelf life

from regulatory authority or Stability data to support claimed shelf life.

g. OrigInal Credentials of manufacture as decided above by Registration Board.

h. Copy Valid Drug Sale License.


Manufactured by:M/s Medtronic Ireland,

Integrity BMS Coronary Stent

Cobalt Chromium Alloy Stent

(As per FSC)

Decontrolled till policy decision by Policy Board/ Federal Government

24 mont

hs

Applied on 03-08-2012Differential fee not depositedLetter Issued on 23-10-2012.Reminder issued on


PKR.35,000/-,b. Clarification as Product

already registered with same brand name but different manufacturer.

c. Original Free Sale Certificate as decided above by Registration Board.


Parkmore Business Park West, Galway Ireland.

Applied on03-08-2012

1’s

20-1-2017. d. Original authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.



g. Original Credentials of manufacture as decided above by Registration Board.

h. Copy Valid Drug Sale License,


Manufactured by:

M/s Medtronic Ireland, Parkmore Business Park West, Galway Ireland.

Endeavor Sprint (DES) Coronary Stent

Cobalt Alloy Stent coated with Zotarolimus (Rapamycin analog)

(As per FSC)


1’s

24 mont

hs

Applied on 03-08-2012Differential fee not depositedLetter Issued on 23-10-2012.Reminder issued on 20-1-2017.


PKR.35,000/b. Clarification as Product

already registered with same brand name but different manufacturer.


d. Original authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.



g. Original Credentials of manufacture as decided above by Registration Board.

h. Copy Valid Drug Sale License, `

4. M/s Claris Medical, 54-A, Street 5, Sector F-8/3, Islamabad.

Manufactured by:M/s Biotronic

Orsiro Drug Eluting Coronary Stent

(Sirolimous)

(As per FSC)

Decontrolled till policy decision by Policy Board/ Federa

Not mentioned.

Applied on 10-12-2012Letter Issued on 14-4-2013. Reminder issued on2-3-2015.


PKR.35,000/-,b. Clarification as

different manufacturing site.

c. Original Free Sale Certificate as decided


AG Ackerstrasse 6, 8180 Bulach, Switzerland. Contract Medical International GmbHLauensteiner Strasse 37, 01277 Dresden, Germany.Applied on10-12-2012

l Government

1’s

Final reminder issued on 20-1-2017.

above by Registration Board.


e. Original Credentials of manufacture as decided above by Registration Board.

f. Copy Valid Drug Sale License.

5. M/s Claris Medical, 54-A, Street 5, Sector F-8/3, Islamabad. /Manufactured by:M/s Biotronic AG Ackerstrasse 6, 8180 Bulach, Switzerland. Contract Medical International GmbHLauensteiner Strasse 37, 01277 Dresden, Germany.

Applied on10-12-2012

PRO Kinetic Energy Coronary Stents.

(As per FSC)

Decontrolled till policy decision by Policy Board/ Federal Govt.1’s

Not mentioned.

Applied on 10-12-2012Letter Issued on 14-4-2013.Reminder issued on2-3-2015.Final reminder issued on 20-1-2017



different manufacturing site.





6. M/s. Trans Angio System, 507 Progressive square, P.E.C.H.S, Block-6, Shahra-e-Faisal Karachi-75400

Manufactured by:M/s Translumina GmbH, Neue

Yukon ® CC Stent SystemSizes and product codes as per FSC


1’s

03 years

Applied on 12-4-2011Letter for deficiencies issued on 23-10-2012Reminder issued on4-3-2015.Final reminder issued on6-10-2016

Deferred for rectification of following shortcomings:a. Original Free Sale

Certificate as decided above by Registration Board.

b. Original authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.

c. Original Credentials of manufacture as decided above by Registration Board.


Rottenburger Strabe 50, 72379, Hechingen, Germany.

Applied on12-4-2011

d. Clinical data, if any.e. Approval of shelf life


7. M/s. TM Marketing, 9/SB-2 Miran Muhammad Shah Road, K.D.A Scheme#1 Karachi.

Manufactured by:M/s. ClearStream Technologies Ltd., Moyne Upper, Enniscorthy Co. Wexford, Ireland.

Applied on18-4-2011

ClearFlex-X Coronary Stent

(As per FSC)


1’s

03 years

Applied on 18-4-2011Letter for deficiencies issued on26-9-2012Reminder issued on4-3-2015.Final reminder issued on6-10-2016

Deferred for rectification of following shortcomings:a. Differential Fee

PKR.35,000/-.b. Original Free Sale


c. Original authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.

d. Original Credentials of manufacture as decided above by Registration Board.

e. Clinical data, if any.f. Approval of shelf life


g. Copy of valid drug sale licence.


Manufactured byM/s. ClearStream Technologies Ltd., Moyne Upper, Enniscorthy Co. Wexford, Ireland.

SatinFlex Coronary Stent

(As per FSC)


03 years

Applied on18-4-2011Letter for deficiencies issued on26-9-2012Reminder issued on4-3-2015.Final reminder issued on6-10-2016







from regulatory authority or Stability data to support claimed


shelf life.g. Copy of Valid Drug

Sale Licence.9. M/s. Maxims

Medical,534-H-Block, Phase-5,Street no-13, Defence, DHA, Lahore.

Responsible Manufacturer:M/s. Abbott Vascular, 3200, Lakeside Drive, Santa Clara, California CA 95054, USA.

Manufacturing Site:M/s Abbott Vascular, Belgium.

Multilink 8 Coronary Stent

(As per FSC)


02 years

Applied on23-4-2011Letter Issued on 23-10-2012Reminder issued on7-10-2016.




c. Copy of Valid Drug Sale Licence.



f. Clinical data, if any.g. Approval of shelf life


10. M/s. Maxims Medical,534-H-Block, Phase-5,Street No-13, Defence, DHA, Lahore.Responsible Manufacturer:M/s. Abbott Vascular, 3200, Lakeside Drive, Santa Clara, California CA 95054, USA.Manufacturing Site:M/s. Abbott Vascular, Instruments Deutsuhland, GmbH, Rudolf-diesel-dtrabe 29, 72414, Rangendingen,

JO Stent Graft Master

(As per FSC)


1’s

02 years

Applied on23-4-2011.Letter Issued on 23-10-2012Reminder issued on7-10-2016.








g. Copy of Valid Drug Sale Licence.


Germany.11. M/s Maxims

Medical,534-H-Block, Phase-5, St.No-13, DHA, Lahore.Responsible Manufacturer:M/s Abbott Vascular, 3200, Lakeside Drive, Santa Clara, California CA 95054, USA.Manufacturing Site:M/s. Abbott Vascular, Instruments Deutsuhland, GmbH, Rudolf-diesel-dtrabe 29, 72414, Rangendingen, Germany.

Flex Master F1 Coronary Stent

(As per FSC)


1’s

02 years

Authorization letter/sole agency agreement issued by Indian region.Applied on23-4-2011Letter for deficiencies issued on23-10-2012

Reminder issued on7-10-2016.


PKR.35,000/-.b. Original and valid Free

Sale Certificate as decided above by Registration Board.

c. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.


e. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.

f. Copy of Valid Drug Sale Licence.

g. Clinical data, if any.

12. M/s. Stents Specialties, 47 kahuta triangle industrial area, Islamabad.Manufactured by:

M/s. Plasmachem GmBH, alte gaertnerei 22-55128mainz,Germany

SupplierM/s. Mack & Co.GmBH, Bahnhofstrasse, 27356,ROTENBURG, Germany

Bio Diamond Delivery System (Coronary pre-mounted Stent)

(As per FSC)


2 years

Applied on23-6-2011.Letter Issued on 13-9-2012.Reminder issued on20-1-2017.


PKR.35,000/-.b. Original and valid Free






g. Clinical data, if any.13. M/s. Stents

Specialties, 47 Bio Diamond mF12 Stent

Decontrolled

2 years

Applied on

Deferred for rectification of following shortcomings:


kahuta triangle industrial area, Islamabad.

Manufactured by:M/s Plasmachem Gmbh, alte gaertnerei 22-55128 mainz,Germany

SupplierM/s. Mack & Co.GMBH, BahnhofstrTTasse, 27356,ROTENBURG,Germany

(12mm)

(As per FSC)

till policy decision by Policy Board/ Federal Govt.1’s

27-6-2011.Letter Issued on 13-9-2012.No reply received till date.Reminder issued on20-1-2017.

a. Differential Fee PKR.35,000/-.

b. Original and valid Free Sale Certificate as decided above by Registration Board.





g. Clinical data, if any.14. M/s Intek

Corporation, # 30,1st Floor, Al-Amin Plaza, The Mall, Rawalpindi.Legal manufacturer:M/S Terumo Corporation. 44-1,2 Chome, Hatagya, Shibuya-Ka, Tokyo 151-0072, JapanActual Manufacturer:M/s Ashitaka Factory of Terumo Corporation, 150, Maimaigi-cho, Fujinomiya city, Shizuoka Prefecture 418-0015, Japan.

Tsunami ® Gold Coronary Stent System

(As per FSC)


36 mont

hs

Application date 27.3.2013.Letter issued on 14.10.2013. Reminder issued on 19-1-2017.

Deferred for rectification of following shortcomings:a. Original and valid Free


15. M/s Interex Company,195 Block 7/8 KMCHS

CP Stent (Bare & Covered)

Decontrolled till policy

Not mentioned

in

Applied on 24-9-2013.Letter

Deferred for rectification of following shortcomings:a. Clarification as two

Different Products


Justice Inamullah Road, KarachiManufactured by:

1. M/s.NuMed, Inc 2880 Main Street, Hopkinton, NY, 12965, USA.

2. M/s.NuMed Canada, Inc 45 Second Street West, Cornwall, Ontario K6J1G3, Canada.

(Sizes as per FSC)

decision by Policy Board/ Federal Government

1’s

form 5-A.

issued on 6.6.2014.Reminder issued on 20-1-2017.

applied in one Application.



d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.

e. Clinical data, if any.

16. M/s Hakimsons (Pvt) Ltd, Hakimsons House, A/56/S.I.T.E. Manghopir Pir Road, Karachi.Manufactured by:M/s Life Vascular Devices Biotech, S.L., C.I.F. B-65405169, Cami de Ca n’Ubach, 11 (pol. IND. Les Fallulles), 08620 SANT VICENC, DELS HORTS, Barcelona, Spain.

Architect CoCr Coronary Stent System

(Codes and Sizes as per Free Sale Certificate)


1’s

3 years.

Applied on9-1-2014Letter Issued. Reminder issued on2-3-2015Final reminder issued on18-1-2017.Letter Issued3-2-2017

Deferred for rectification of following shortcomings:a. Original and valid

authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.

b. Original Credentials of manufacture as decided above by Registration Board.

17. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons, Amangarh, Nowshera,

Synergy TM

Monorail TM

Everolius Eluting Platinum Chromium Coronary Stent System

Decontrolled till policy decision by Policy Board/

18 mont

h

Applied on11-9-2014Letter issued on 12.2.2015.

Approved as per Import Policy for Finished Drugs.


Legal Manufacturer:M/s. Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 017603-1537.USA.Manufacturing Site:M/s. Boston Scientific Ireland Ltd, Ballybrit Business Park, Galway, Ireland.

Codes and sizes as per Free Sale Certificate.

Federal Govt.

1’s

18. M/s. Health Tec,10-B, Street No.24, Valley Road, Westrige-I Rawalpindi.Legal Manufacturer:M/s Cardionovum Sp. Z.o.o., Panska Str.73,00-834 Warsaw, Poland.Coating manufacturer: DOT GmBH, Charles Darwin-Ring1a, 18059 Rostock, Germany.Assembling of Finished products:Arthesys S.A.20 Rue Traversiere, 92230GENNEVILLIERS, France.

Xlimus Sirolimus Eluting Coronary Stent System

(As per FSC)


1’s

2 years

Applied on27-8-2015Letter issued on 25.11.2015Reminder issued on19-1-2017.

Deferred for rectification of following shortcomings:a. Clarification as status

of impurities in conclusion of stability study.

19. M/s. Ferozsons Laboratories, P.O. Ferozsons,

Rebel TM

Monorail TM

PtCr Coronary Stent System

Decontrolled till policy decisio

3 years

Applied on17-9-2015Letter Issued on


Sale Certificate as decided above by


Amangarh, Nowshera,Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way. Marlborough, MA, USA 01752.Manufacturing Site:M/s. Boston Scientific Corporation, Maple Grove & plymouth, MN 55311, USA.

(As per FSC)

n by Policy Board/ Federal Government

1’s

9-8-2016. Registration Board.b. Clarificaiton as status

of export only on copy of Free Sale Certificate.


d. OrigInal Credentials of manufacture as decided above by Registration Board.

20. M/s Genus,220, D.M.C.H.S, Block-3 Sirajuddaula Road, Karachi.

Manufactured By:M/s Umbra Medical Products, Inc, 8930 East Roan Lane, Inverness, Florida 34450 USA.

Silver Stent-CC Cobalt Chromium Drug Eluting Stent

Product codes as per Free Sale Certificate.

Decontrolled till policy decision by the Policy Board/Federal Government

1’s

2 years

Applied on 4-11-2015Letter Issued on 11-8-2016.Reminder issued on 18-1-2017Letter issued on 3-2-2017Following shortcomings:

1. Outline of Method of Manufacturing.2. Last Inspection report3. Free Sale Certificate of USFDA provided but not embassy attested.

Approved as per Import Policy for Finished Drugs and as per decision of Registration Board regarding Free Sale Certificate.

21. M/s Genus,220,

Affinity CC Cobalt

Decontrolled

2 years

Applied on

Approved as per Import Policy for Finished Drugs


D.M.C.H.S, Block-3 Sirajuddaula Road, Karachi.Manufactured By:M/s Umbra Medical Products, Inc, 8930 East Roan Lane, Inverness, Florida 34450 USA.

Chromium Sirolimus Eluting Stent.


till policy decision by the Policy Board /Federal Govt.1’s

4-11-2015Letter Issued on 11-8-2016.Reminder issued on 18-1-2017Letter issued on3-2-2017

and as per decision of Registration Board regarding Free Sale Certificate.

22. M/s Digital Imaging Systems, 121, Habitat Apartment, Ghaus-ul-Azam Road, Shadman II,,Lahore /Responsible Manufacturer:M/s Abbott Vascular, 3200 Lakeside Drive, Santa Clara, California 95054, USA.

Manufacturing Site:M/s Abbott Vascular, Cashel Road, Clonmel, County Tipperary, Ireland.

Xience Alpine Stent

(Codes and sizes as per Free Sale Certificate).


1’s

02 years

Applied on 3-12-2015Letter Issued on 17-1-2017.



b. OrigInal Credentials of manufacture as decided above by Registration Board.

23. M/s Cardevo International (Pvt) Ltd, Office No.120, 4th Floor, Main Boulevard Mega Tower, Gulberg-II, Lahore.Manufactured By:M/s Accura Medizintechnik GmbH, Max-Planck-

Accura Decent S Sirolimus- Eluting Coronary Stent SystemProduct codes and sizes as per Free Sale Certificate.

.


1’s

12 mont

hs

Applied on2-2-2016Letter sent on20-1-2017Reminder issued on3-2-2017

Deferred for rectification of following shortcomings:a. Clarification of Brand

Name requested and Change of Product name from Itrix II to decent S and manufacturer of the product.

b. Clarification of address of applicant is different on credentials, Form-5A,Drug sale Licence and letter of authorization


Str.33, 61184, Karben, Germany.



24. M/s Digital Imaging Systems, 121, Habitats Apartments, Shadman-II, Ghaus-ul-Azam Road, Lahore/Legal Manufacturer :M/s Abbott Vascular, 3200 Lakeside Drive, Santa Clara, California 95054, USA.Manufacturing Site:M/s Abbott Vascular, Cashel Road, Clonmel, County Tipperary, Ireland.

Multilink 8 Coronary Stent System

Product and codes as per Free Sale Certificate.


1’s

2 years

Applied on16-3-2016Letter sent on 20-1-2017

Deferred for rectification of following shortcomings:c. Original and valid



25. M/s. Life Cares, M-20 Falaknaz Plaza, Shahra-e-Faisal, Karachi.Manufactured byM/s. Scitech Products Medicos Ltda, Sao Paolo Brazil.

Drug Eluting Stents Inspiron

Stent Length (mm): 13, 16, 19, 23, 29, 33,38.

Stent Dia (mm)2.5, 2.75, 3.0, 3.5.


1’s

2 years

Applied on 4-4-2016Letter sent on19-1-2017

Deferred for rectification of following shortcomings:a. Application on the

prescribed Form.5-Ab. Original and valid Free



d. Clinical data, if any,e. Approval of shelf life


f. OrigInal Credentials of


manufacture as decided above by Registration Board.

g. Copy Valid Drug Sale License,

h. Manufacturing and analytical procedure.

26. M/s. Life Cares, M-20 Falaknaz Plaza, Shahra-e-Faisal, Karachi.Manufactured byM/s. Scitech Products Medicos Ltda, Sao Paolo Brazil

Bare Metal Stent Cronus (Chromium Cobalt)

Stent Length (mm): 13, 16, 19, 23, 29, 33,38.

Stent Dia (mm)2.5, 2.75, 3.0, 3.5.


1’s

2 years

Applied on 4-4-2016Letter issued on20-1-2017

Deferred for rectification of following shortcomings:a. Application on the

prescribed Form.5-Ab. Original and valid Free





f. OrigInal Credentials of manufacture as decided above by Registration Board.


h. Manufacturing and analytical procedure.

27. M/s. Promed International, CB-6349 Amarpak Plaza, Jhelum Road, Rawalpindi.Legal Manufacturer:M/s Biosensors Europe SA, Rue De Lausanne 29, 1110 Morges, Switzerland.Manufacturing Site:M/s Biosensors Interventional Technologies

Axxess TM

Drug Coated Coronary Bifurcation Stent System.Product sizes and codes as per FSC


1’s

24 mont

hs

Applied on20-4-2016Letter issued on 18-1-2017



b. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.

c. Clinical data, if any,d. Approval of shelf life




Pte Ltd, 36 Jalan Tukang, Singapore 619266, Singapore.Sterilization Sites:

i. BGS-Beta-Gamma-Service GmbH & Co Kg, Fritz-Kotz-Strasse 16, 51674 Wieth, Germany.

ii. Electron Beam Sdn, Bhd, Lot 7, Jalan Sungai Pinang 4/3, Taman Perindustrian Pulau Indah (Fasa 2), 42920 Port Klang, Selagnor, Malaysia.

f. Copy Valid Drug Sale License,

28. M/s. ACP System,13-23, Naval Fleet Club, Iqbal (S.J) Shaheed Road,Karachi.Legal Manufacturer:M/s Medtronic, Inc. 710 Medtronic Parkway NE Minneapolis, MN 55432, USA.Manufacturing Site:M/s Medtronic Ireland, Parkmore Business Park West Galway, Ireland.

Driver Sprint Rapid Exchange Coronary Stent System

(As per FSC of Ireland)


1’s

2 years




29. M/s. Maxims Medical, 534

Amazonia SIR Drug

Decontrolled

2 years

Applied on 7-6-



H Block, St. No.13, Phase-5,DHA, Lahore.Manufactured by:M/s Minvasys, 7, rue du Fosse Blanc-92230, Gennevilliers France.

Eluting Stent

Stent Length (mm):8, 12, 16, 20, 24, 28, 32, 36, 40.

Stent Dia (mm)2.25, 2.50, 2.75, 3.00, 3.50, 4.00. (As per FSC)

till policy decision by Policy Board/ Federal Government

1’s

2016Letter issued on 19.1.2017

a. Original and valid Free Sale Certificate as decided above by Registration Board.



from regulatory authority or brnaad specific stability data to support claimed shelf life.

e. OrigInal Credentials of manufacture as decided above by Registration Board.

30. M/s Bio Medics Medical System, F-597, F-Block, Satellite Town, Rawalpindi.Manufactured By:M/s Alco Advanced Lightweight Constructions GmbH, Am Borsigturm 50, 13507, Berlin, Germany.

OSIRA CR ® L 605 Cobalt Chromium Rapamycin Eluting Coronary Stent.

Stent Dia (mm): 2.5, 2.75, 3.0, 3.5.Stent Length (mm): 8, 12, 16, 20, 24, 28, 32, 38, 42.(As per FSC)

Decontrolled till policy decision by the Policy Board/ Federal Govt.

1’s

18 mont

hs

Applied on1-4-2016Letter issued on19-1-2017.

(The firm given undertaken that they need one-month time period to fulfill deficiencies/documents required for registration.)

Deferred for rectification of following shortcomings:a. OrigInal Credentials of





31. M/s Bio Medics Medical System, F-597, F-Block, Satellite Town, Rawalpindi.

Manufactured By:M/s Alco Advanced Lightweight

OSIRA R4 ® 3l6 LVM(Rapamycin Eluting Coronary Stent)

Stent Inner Dia (mm): 2.5, 2.75, 3.0, 3.5, 4.0.Stent Length (mm): 8, 12, 16, 20, 24,

Decontrolled till policy decision by the Policy Board/ Federal Government

18 mont

hs

Applied on 7-4-2016Letter issued on 19.1.2017. (The firm given undertaken that they need one-month time period to



b. Clinical data, if any,c. Approval of shelf life


d. OrigInal Credentials of manufacture as decided


Constructions GmbH, Am Borsigturm 50, 13507, Berlin, Germany.

28, 32, 38, 42.(As per FSC)

1’s fulfill deficiencies/documents required for registration.)


32. M/s SLT Saving Life Technologies, 126-H, Model Town, Lahore.Manufactured by:M/s Eucatech AG, Rebgartenweg 27, 79567 Weil and Rhein/ Germany.

EUCALIMUSSirolimus Eluting Stent System

Sizes and codes as per Free Sale Certificate.

Decontrolled till policy decision by the Policy Board/ Federal Government1’s

24 mont

hs

Deferred for provision of following documents/ information:Stents from same source already registered with M/s Radiant Devices Biomedical Pvt. Lahore.Principal manufacturer has issued embassy attested letter of cancellation to previous agent and inform that previous agent is not allowed to sell any their products in Pakistan.

Registration Board deferred and decided to Showcause to M/s Radient Devices for explaination in next meeting in this regard and following shortcomings.a. Original and valid


b. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.

33. M/s Promed International, CB-6349 Amar Pak Plaza, Jhelum Road,Rawalpindi.Legal

BioMatrix Alpha TM

Drug Eluting Coronary Stent System

Codes and sizes as per

Decontrolled till policy decision by the Policy

12 mont

hs

Applied on 17-11-2016Letter issued on20-1-2017Further deficiencie




Manufacturer:M/s Biosnsor Europe SA, Rue De Lausanne 29, 1110 Morges, Switzerland.Manufacturing Site:M/s Biosensors Interventional Technologies Pte Ltd, 36 Jalan Tukang, Singapore 619266, Singapore.Sterilization Site:1. BGS-Beta-Gamma-Service GmbH & Co Kg, Fritz-Kotz-Strasse 16, 51674 Wieth, Germany.

2. Electron Beam Sdn, Bhd, Lot 7, Jalan Sungai Pinang 4/3, Taman Perindustrian Pulau Indah (Fasa 2), 42920 Port Klang, Selagnor, Malaysia.

FSC. Board/ Federal Govt.

1’s

s communicated on 02.02.2017


34. M/s. SES Associates, 61 Bank Square Market, Model town, Lahore

Manufactured by:M/s. QualiMed GmbH, BoschstraBe 16, D-21423, Winsen,

UNA TM

Stent Delivery System (Stainless Steel Coronary Stent)

Stent Length (mm): 10, 14, 18, 24, 28, 34, 38.

Balloon Dia


1’s

2 years in 5-

A3

years Shelf life

report

Applied on 14-6-2011.Letter issued 23-10-2012.Reminder issued on 20-1-2017.Letter issued on 03.2.2017




c. Clinical Data, if any.d. Valid copy of Drug

Sale Licence.e. Approval of shelf life

from regulatory


Germany. (mm): 2.00, 2.25, 2.50, 2.75, 3.00, 3.25, 3.50, 4.00.(As per FSC)

authority or Stability data to support claimed shelf life.

f. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.

35. M/s. SES Associates,61-Bank Square Market, Model Town, Lahore.

Manufactured by

M/s. QualiMed GmbH, BoschstraBe 16, D-21423, Winsen, Germany.

SUNA TM

Stent Delivery System (Cobalt Chromium Coronary Stent)

Stnt Length (mm): 8, 10, 12, 14, 16, 18, 19, 24, 28, 34, 38.(As per FSC)Balloon Dia (mm): 2.00, 2.25, 2.50, 2.75, 3.00, 3.25, 3.50, 4.00.


1’s

2years in 5-

A3

years Shelf life

report.

Applied on 14-6-2011.Letter issued 23-10-2012.Reminder issued on 20-1-2017.




c. Clinical Data, if any.d. Valid copy of Drug

Sale Licence.e. Approval of shelf life


f. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.

B) CathetersS.No


Exporter.

Name of Medical

Device (s)

Price &

Pack size

Shelf life

Remarks/ shortcomi

ngs

Decision

1. M/s. SES Associates Institutional Distributors & Government Suppliers, Lahore

Manufactured by:M/s. Kimal Plc. Arundel Road, Uxbridge, Middlesex, UB8, United Kingdom.

Angio FLOWCardiac Catheter

(Product codes and sizes as per Free Sale Certificate)


02 years

Applied on 23-8-2011.Letter Issued on24-10-2012.Reminder issued on 16-11-2016.Final reminder on 3-2-2017


PKR.35,000/-,b. Original and valid Free




from regulatory





2. M/s Intek Corporation, # 30,1st Floor, Al-Amin Plaza, The Mall, Rawalpindi.Legal Manufacturer:M/s Terumo Corporation, 44-1-2 Chome, Hatagaya, Shibuya-ku, Tokyo, Japan.

Actual manufacturer:Ashitaka factory of terumo corporation 150,maimaigi-cho,fujinomiya city, schizouka prefecture 418-0015,Japan.

Radifocus Optitorque Angiographic Catheters.

Size: 4fr, 5fr, 6frLength: 80cm, 100cm, 110cm.(As per FSC)


36 months

Applied on 20-10-2011Letter issued on 14-10-2013.Reminder issued on 20.01.2017Further deficiencies communicated on 01.02.2017


3. M/s Intek Corporation, # 30,1st Floor, Al-Amin Plaza, The Mall, Rawalpindi.Legal Manufacturer:M/S Terumo Corporation, 44-1-2 Chome, Hatagaya, Shibuya-Ku, Tokyo, Japan.Actual manufacturer:Ashitaka Factory Of Terumo Corporation

Ryujin Plus, PTCA Dilatation Catheter.

(As per FSC)


36 Months

Applied on 20-10-2011Letter issued on 14.10.2013Reminder issued on 20.01.2017Further deficiencies communicated on 01.02.2017



150,Maimaigi-Cho,Fujinomiyacity, Schizouka Prefecture 418-0015, Japan.

4. M/s Surgi World,303 Mohammadia Plaza, College Road, Rawalpindi.

Manufactured by:M/s Medcomp, 1499 Delp Drive Harleys Villa, USA.

Pro-Picc ® Central Vein Infusion Catheter. (All sizes)


5 years











Vascu-Picc ® Central Vein Infusion Catheter (All sizes)


5 years












Pro-Fuse ® CT Ports (Central Vein Infusion Catheter with port) (All sizes)


5 years









7. M/s Surgi World,303 Mohammadia Plaza, College Road,Rawalpindi


Multi-Cath Central Vein Infusion Catheter(All sizes, Single, Double and Triple Lumen)


5 years









8. M/s Johnson & Johnson (Pvt) Ltd, Plot.No.10

Envoy Guiding Catheters

Decontrolled till

3 years

Applied on 4-5-2012



& 25, Sector 20, Korangi Industrial Area, Karachi.Legal ManufacturerM/s Codman & Shurtleff, Inc. 325 Paramount Drive Raynham, MA, USA.Manufacturing Site:M/s Codman & Shurtleff. Calle Cirrcuito Interior Norte No.1820, Parque Industrial Salvarcar, Ciudid Juarez, Chihuaha, CP 32575, Mexico.

Exporting & Releasing Site:European Distribution Cente, Johnson & Johnson,Belgium.

-

Envoy 5f

-

Envoy 6f

-

Envoy-XB

policy decision by Policy Board/ Federal Government

Differential fee not paid.Letter issued on 18-3-2013.Reminder on 24-1-17








9. M/s ACP Systems, Karachi.


Shipped From:Medtronic Trading NL BV, Earl Bakkenstraat 10, Neatherland.

Sprinter NC/SC RX Balloon Dilatation, Intravascular Catheters.


24 months

a. Deferred for rectification of following shortcomings:a. Differential fee






f. OrigInal Credentials of manufacture as decided






Sprinter Legend RX Balloon Dilatation, Intravascular Catheters.


24 months









Manufactured by:M/s Medtronic Mexico s.de R.L.de CV,Mexico


Sprinter Legend RX Balloon Dilatation, Intravascular Catheters.


24 months









Manufactured b:yM/s Medtronic

Catheters. Decontrolled till policy decision by Policy

24 months



applied for not specified.


Mexico s.de R.L.de CV, Mexico

Board/ Federal Govt.








Manufactured byM/s Medtronic, Inc, USA

Catheters. Decontrolled till policy decision by Policy Board/ Federal Government

36 months



applied for not specified.







14. M/s Claris Medical, 54-A, Street 5, Sector F-8/3, Islamabad./

Pantera Coronary Balloon

Balloon Length (mm)

Decontrolled till policy decision by

Not mentioned.



Sale Certificate as


Manufactured by:M/s Biotronic AG Ackerstrasse 6, 8180 Bulach, Switzerland.

Contract Medical International GmbHLauensteiner Strasse 37, 01277 Dresden, Germany.

6,10,15,20,25, 30.

Balloon Dia (mm): 1.25, 1.5, 2.0, 2.5,3.0, 3.5, 4.0.

Policy Board/ Federal Govt.

decided above by Registration Board.






15. M/s Claris Medical, 54-A, Street 5, Sector F-8/3, Islamabad./Manufactured by:M/s Biotronic AG Ackerstrasse 6, 8180 Bulach, Switzerland. Contract Medical International GmbHLauensteiner Strasse 37, 01277 Dresden, Germany.

Pantera Leo- Non-Compliant High Pressure Balloon.

Balloon Length (mm) 8,12,15,20,30.

Balloon Dia (mm):2.0, 2.25,2.5, 2.75, 3.0, 3.25, 3.5, 3.75, 4.0, 4.50, 5.00.


Not mentioned.









16. M/s. SES Associates Distributors & Government Suppliers, LahoreManufactured byM/s. QualiMed Innovative Medizinproduk

Juturna-V TM

PTA Balloon Catheter

Balloon Length (mm):20,30,40,50,60,80,100, 120.

Decontrolled till policy decision by Policy Board/ Federal Gover

3 years



b. Approval of shelf life from regulatory authority or Stability


et GmbH, Winsen, Germany.

Balloon Dia (mm):3,4,5,6,7,8,9,10,12, 14.

Usable Catheter Length :50cm, 75cm, 135cm.

nment data to support claimed shelf life.

c. OrigInal Credentials of manufacture as decided above by Registration Board.

d. Copy Valid Drug Sale License,

17. M/s. SES Associates Distributors & Government Suppliers, Lahore

Manufactured byM/s. Kimal Plc. Arundel Road, Uxbridge, Middlesex, UB8, 2SA,U.K

Manufacturing Site:Sher Wood Road, Aston Fields Industrial Estate, Bromsgrove, Worcesterhire, UK.

Central Venous Catheter Altius.Sizes, types and products codes as per FSC.


3 years



b. Clarification as manufacturing site not specified.






18. M/s Cardiac Care, 848-C, Shadman-I, Lahore.

Manufactured byM/s Vygon-5 rue Adeline -95440-Ecouen, France.

Leader- Cath

Codes:115.090, 115.092, 115.094115.096, 115.11, 115.118

Decontrolled till policy decision by the Federal Government

60 months

Applied on 1-1-2013.Letter Issued on 16-6-2014. Reminder issued on 19-1-2017.



b. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board .



e. OrigInal Credentials of manufacture as decided



19. M/s Cardiac Care, 848-C, Shadman-I, Lahore.


Multicath 2, Multicath 3.

Codes of Multicath 2:6202.20, 6202.24, 6202.27, 6204.17.

Codes of Multicath 3:6208.25, 6209.25.


60 months

Applied on 1-1-2013Letter issued on16-6-2014. Reminder issued on 19-1-2017







20. M/s. Ontech Corporation, M-02 Mezzanine Floor, Lakhani corner Block.13-A, Gulshan-e- Iqbal,Karachi.

Manufactured by:M/s. Ameco Medical Industries, Industrial Zone B4 Plot 119, East 10th

Ramadan City, Egypt.

Central Venous Catheters

(As per FSC)


05 years

Applied on 5-4-2011Letter issued on 6-12-2013.Reminder issued on 7-10-2016.


PKR.35,000/-b. Original and valid Free





f. Valid Drug Sale Licence.

21. M/s. Saru International,Flat A/4 Mehboob Heights’ Sector 11-C-1-North Karachi.

Manufactured byM/s. Nanchang

Healthicon, Central Venous Catheter/ Kit-Single/ Double /Triple Lumen (Infusion Series).


05 years

Applied on 12-4-2011.Letter issued 26-9-2012.Reminder issued on 27-2-2015 and



different types applied on same application.



Biotek Medical Device Co. Ltd., No.18,2nd

gaoxin road, high-tech development zone, Nanchang City. China.

nment 7-10-2016.






Manufactured byM/s. ClearStream Technologies Ltd., Moyne Upper, Enniscorthy Co. Wexford, Ireland.

Nimbus Pico U PTCA Catheter(Catheter).


03 years






e. Valid Drug Sale Licence.

23. M/s. TM Marketing, 9/SB-2 Miran Muhammad Shah Road, K.D.A Scheme#1 Karachi.Manufactured by:M/s. Clear Stream Technologies Ltd., Moyne Upper, Enniscorthy Co. Wexford, Ireland.

Nimbus Salvo PTCA Catheter(Catheter).

(As per FSC)


03 years

Applied on 18-4-2011Letter Issued on 26-9-2012Reminder issued on 4-3-2015Final reminder issued on 6-10-2016.






e. OrigInal Credentials of





Manufactured byM/s. Merit Medical Systems, Inc. 1600 Weat merit, Parkway, South Jordan, Utah, 84095-2416 U.S.A.Manufacturing location:Merit Medical System, Inc, 1111 South Velasco Angleton, TX 77515 USA.

Concierge Guiding Catheter

(As per FSC)


03 years

Applied on 18-4-2011Letter Issued26-9-2012Reminder issued on 4-3-15Final reminder issued on 6-10-2016









Manufactured byM/s. Merit Medical Systems, Inc. 1600 Weat merit, Parkway, South Jordan, Utah, 84095-2416 U.S.A.

Manufacturing location:Merit Medical

Performa ®, Softouch ® Diagnostic Catheter

(As per FSC)


03 years

Applied on 18-4-2011Letter Issued 26-9-2012Reminder issued on 4-3-15Final reminder issued on 6-10-2016


PKR.35,000/-,b. Clarification as 2 major

groups of catheter applied on one application.




f. OrigInal Credentials of


System, Inc, 1111 South Velasco Angleton, TX 77515 USA.


g. Valid Drug Sale Licence.

26. M/s. Maxims Medical, 534 H Block, St. No.13, Phase-5,DHA, Lahore.

Responsible Manufacturer:M/s. Abbott Vascular, 3200, Lakeside Drive, Santa Clara, California CA 95054, USA.

Manufacturing Site:M/s. Abbott Vascular, Instruments Deutsuhland,GmbH, Rudolf-diesel-dtrabe 29, 72414, Rangendingen, Germany.

Mercury PTCA Balloon Catheter

(As per FSC)


02 years

Applied on 23-4-2011Stents and Catheters from Ireland Source already registered in the name of M/s Digital Imaging System, Lahore.Authorization letter/sole agency agreement issued by Indian region.Letter for deficiencies issued on 23-10-2012Reminder issued on 7-10-2016.








g. Clarification for product sizes and codes and different sites of manufacture.

27. M/s. Maxims Medical,534-H-Block, Phase-5,St.No-13, Defence, DHA, Lahore.

Responsible Manufacturer:M/s. TemMed Medical Co. Ltd.,no 48, Keji road. Miyun Industrial district, Beijing, 101500, P.R. China.

Path Maker PTCA Balloon Catheter

(As per FSC)


02 years

Applied on 23-4-2011Letter for deficiencies issued on 23-10-2012Reminder issued on7-10-2016.









g. Clarification for product sizes and codes and different sites of manufacture.

h. Last inspection report28. M/s Interex

Company,195 Block 7/8 KMCHS Justice Inamullah Road, Karachi/Manufactured byM/s.Datascope Corporation, `15 Law Drive, Fairfield, New Jersey 7400, USA.Shipped FromM/s Maquet Middle East FZ-LLC, G005 Nucleotide Complex,Dubai Biotechnology & Research Park, P.O.Box 214742.

Sensation Plus Intra Aortic Balloon Catheter.

(As per FSC)


Not mentioned in form 5-A.




c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.



29. M/s Interex Company,195 Block 7/8 KMCHS Justice Inamullah Road, Karachi/Manufactured byM/s.Datascope Corporation, `15 Law Drive, Fairfield, New Jersey 7400, USA.Shipped FromM/s Maquet Middle East FZ-LLC, G005 Nucleotide

Linear Intra Aortic Balloon Catheter.

7.5 FR.







d. OrigInal Credentials of manufacture as decided above by Registration


Complex,Dubai Biotechnology & Research Park, P.O.Box 214742.

Board.e. Valid Drug Sale

Licence.

30. M/s Interex Company,195 Block 7/8 KMCHS Justice Inamullah Road, Karachi/Manufactured byM/s.Datascope Corporation, `15 Law Drive, Fairfield, New Jersey 7400, USA.Shipped FromM/s Maquet Middle East FZ-LLC, G005 Nucleotide Complex, Deferred.Board decided that final reminder shall be issued that the firm will provide following deficiencies with in 7 days in case of non compliance the application shall be dispose off.

Dubai Biotechnology & Research Park, P.O.Box 214742.

Mega Intra Aortic Balloon Catheter.









31. M/s Interex Company,195 Block 7/8 KMCHS Justice Inamullah Road, Karachi/Manufactured by

Z-Med II Catheter.

Balloon Dia (mm): 23, 25, 26, 28, 30.

Balloon

Decontrolled till policy decision by the Federal




b. Original and valid authorization letter/sole agency agreement from


1. M/s.NuMed, Inc 2880 Main Street, Hopkinton, NY, 12965, USA.


Length (cm): 2, 3, 4, 5,6.

Government

manufacturer as decided above by Registration Board .




32. M/s Interex Company,195 Block 7/8 KMCHS Justice Inamullah Road, Karachi/

Manufactured by1. M/s.NuMed, Inc 2880 Main Street, Hopkinton, NY, 12965, USA.


Tyshak II Catheter (GMDN Code 17453).

Balloon Dia (mm): 12, 13, 14, 15, 16, 17, 18, 20, 22, 23, 25, 30.

Balloon Length (cm): 2, 3, 4, 5,6.










Manufactured by1. M/s.NuMed, Inc 2880 Main

Z-5 Catheter.(GMDN Code 10747).Balloon Dia (mm): 9.5, 13.5.Balloon Lengh (cm): 0.95, 1.35.






c. Approval of shelf life


Street, Hopkinton, NY, 12965, USA.


1’s from regulatory authority or Stability data to support claimed shelf life.




Manufactured by1. M/s.NuMed, Inc 2880 Main Street, Hopkinton, NY, 12965, USA.


BIB Stent Placement Catheter

Balloon Length (mm): 12, 14, 15, 16, 18, 20, 22, 24.

Balloon Dia (cm): 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5.


1’s








35. M/s Hakimsons (Pvt) Ltd, Hakimsons House, A/56/S.I.T.E. Manghopir Pir Road, Karachi.Manufactured by:M/s Life Vascular Devices Biotech, S.L., C.I.F. B-65405169,

Xperience Coronary Balloon Dilatation Catheter

Balloon Length (mm): 10, 15, 20, 25,30, 40.

Balloon Dia (cm): 1.50, 2.00, 2.50, 3.00, 3.50,


3 years.

Applied on 9-1-2014Letter Issued on 18-3-2014.Final reminders issued on2-3-2015Letter Issued18-1-2017.Letter Issued3-2-2017.

Deferred for rectification of following shortcomings:a. OrigInal Credentials of



Cami de Ca n’Ubach, 11 (pol. IND. Les Fallulles), 08620 SANT VICENC, DELS HORTS, Barcelona, Spain.

4.00, 4.50.

36. M/s Hakimsons (Pvt) Ltd, Hakimsons House, A/56/S.I.T.E. Manghopir Pir Road, Karachi.Manufactured by:M/s Life Vascular Devices Biotech, S.L., C.I.F. B-65405169, Cami de Ca n’Ubach, 11 (pol. IND. Les Fallulles), 08620 SANT VICENC, DELS HORTS, Barcelona, Spain.

Oceanus 35 PTA Balloon Dilatation Catheter

Balloon Length (mm): 20, 40, 60, 80,120, 150, 200.

Balloon Dia (cm): 5, 6, 7,8, 9, 10, 12.

Catheter Length (cm): 80, 140.


3 years.

Letter Issued on 18-3-2014.Final reminders issued on2-3-2015Letter Issued

18-1-2017.Letter Issued3-2-2017.




c. Labeling information.

37. M/s Hakimsons (Pvt) Ltd, Hakimsons House, A/56/S.I.T.E. Manghopir Pir Road, Karachi.Manufactured by:M/s Life Vascular Devices Biotech, S.L., C.I.F. B-65405169, Cami de Ca n’Ubach, 11 (pol. IND. Les Fallulles), 08620 SANT

Oceanus 14 Peripheral Balloon Dilatation Catheter

Balloon Length (mm): 40, 60, 80,120, 150, 200.

Balloon Dia (cm): 1.5, 2.0, 2.5, 3.0, 3.5, 4.0.

Catheter Length (cm): 100, 150.


3 years.

Letter Issued on 18-3-2014.Final reminders issued on2-3-2015Letter Issued18-1-2017.Letter Issued3-2-2017.




c. Labeling information.


VICENC, DELS HORTS, Barcelona, Spain.

38. M/s Johnson & Johnson Pakistan (Pvt) Limited, Fl.19, Sub Plot F-1, Kehkashan Scheme No.5,Main Boat Basin, Clifton, Karachi.Legal ManufacturerM/s Cordis Corporation, 14201 North West 60th

Avenue,Miami Lakes, FL 33014, USAASSEMBLERM/s Cordis de Mexico, S.A. de C.V. Circuito Interior Norte# 1820 Parque Industrial Salvarcar Ciudad Juarez, Chihuahua Mexico 32574.

ADROIT TM

Guiding Catheter.

Useable Catheter Length (cm): 55, 90, 100, 125.

Size: 6 F

(As per FSC)

Decontrolled till policy decision by the Policy Board/Federal Govt.

3 years

Applied on 4-3-2014Letter issued on20-2-2015.2nd letter issued on 02-02-2017.

Deferred for rectification of following shortcomings:a. Application on Form-

5A as per format prescribed.




39. M/s Johnson & Johnson Pakistan (Pvt) Limited, Karachi.Legal Manufacturer:M/s Siemens Medical Solutions USA, Inc. 685 East Middlefield Road, Mountain View, CA 94043 USAPhysical Site:M/s Siemens Ltd Seoul, 2nd

AcuNav TM

Diagnostic Ultrasound Catheter

Sizes and codes as per Free SaleCertificate.


3 years


5A as per prescribed format.





& 3rd Venturee Building, Pohang Technopark, 394,Jigok-ro-Nam-gu Pohang-si, Gyeongsangbugdo, 790-834, Republic of Korea.


40. M/s Interex Company,195 Block 7/8 KMCHS Justice Inamullah Road, Karachi/Manufactured by1. M/s.NuMed, Inc 2880 Main Street, Hopkinton, NY, 12965, USA.


Bonhoeffer Multi-Track Mitral Dilatation Kit.

Balloon Length (mm): 12, 14, 15, 16, 18, 20, 22, 24.

Balloon Dia (cm): 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5.


1’s





c. Valid Drug Sale Licence.

41. M/s Johnson & Johnson Pakistan (Pvt) Limited, Fl.19, Sub Plot F-1, Kehkashan Scheme No.5,Main Boat Basin, Clifton, Karachi.Legal Manufacturer:M/s Cordis Cashel, Cahir Road, Cashel, Co. Tipperary, Ireland.Physical Manufacturer:

Aviator Plus PTA Balloon Dilatation Catheter

Decontrolled till policy decision by the Federal Govt.

3 years

Applied on 8-9-2014Letter issued on23-2-2015.Letter Issued on3-2-2017





d. Valid Drug Sale Licence.


M/s Cordis de Mexico, S.A. de C.V. Circuito Interior Norte # 1820 Parque Industrial Salvarcar Ciudad Juarez, Chihuahua CP 32574 Mexico.

42. M/s Johnson & Johnson Pakistan (Pvt) Limited, Fl.19, Sub Plot F-1, Kehkashan Scheme No.5,Main Boat Basin, Clifton, Karachi.Legal Manufacturer:M/s Cordis CashelCahir Road, Cashel Co. Tipperary, Ireland.Physical Manufacturers:M/s Cordis de Mexico, S.A. de C.V. Circuito Interior Norte # 1820 Parque Industrial Salvarcar Ciudad Juarez, Chihuahua CP 32574 Mexico.

Slalom PTA Balloon Dilatation Catheter

Codes and sizes as perFree sale certificate.


3 years

Applied on 23-9-2014.Letter issued on26-2-2015.Letter Issued on3-2-2017


5A not as per prescribed format.



43. M/s Johnson & Johnson Pakistan (Pvt) Limited, Fl.19, Sub Plot F-1, Kehkashan Scheme No.5,Main Boat Basin, Clifton, Karachi.

Manufacturer:

Sleek PTA Balloon Dilatation Catheter

(Sizes as per Free Sale Certificate).


3 years

Applied on 11-12-2014Letter Issued on 14-9-2015.Letter Issued on3-2-2017

Deferred for rectification of following shortcomings:a. Application on Form



c. Approval of shelf life from regulatory


M/s Clear Stream Technologies Ltd, Moyne Upper Enniscorthy County Wexford, Ireland.




44. M/s Johnson & Johnson Pakistan (Pvt) Limited, Fl.19, Sub Plot F-1, Kehkashan Scheme No.5,Main Boat Basin, Clifton, Karachi.

Manufacturer:M/s Clear Stream Technologies Ltd, Moyne Upper Enniscorthy County Wexford, Ireland.

Sleek OTW PTA Balloon Dilatation CatheterBalloon Length (mm): 20, 40,80, 100,120, 150, 220, 280.

Balloon Dia (cm): 1.75, 2.00, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0.


3 years








45. M/s B.Braun Pakistan (Pvt) Limited, The Forum Suite # 216, Khayaban-e-Jami, Clifton Block-9, Karachi/

Manufacturer:M/s Pendra Care International B.V. Van der Waalspark 22, 9351 VC Leek, The Netherlands.

Serpia Hydrophilic Guiding Catheter.

5Fr, 6Fr, 7Fr, 8Fr.

(Diff. product codes available)


3 years


Convey TM

Guiding Catheter applied by M/s Ferozsons Labs.

Primum Hydrophillic guiding Catheter applied by M/s Health Tec from same source.Various

Rejected.Cases in which more than one authorization letter/sole agency agreement has been granted by the manufacturer/ licence holder for the same product with different brand names, the sole agency agreement of manufacturer will be considered for the grant of registration.


configurations (one hole, two hole, without hole) given in catheter.

46. M/s. Health Tec,10-B, Street No.24, Valley Road, Westridge-I Rawalpindi.

Manufacturer:M/s PendraCare International B.V. Van der Waals Park 22, 9351 VC Leek, The Netherlands.

Pointer Angiographic Catheter.

Sizes as per Free Sale Certificate.


3 years

Applied on 30-9-2015Letter Issued on 19-01-2016

Same product “Angiodyn Angiography Catheter” already registered with same source.

Deferred for clarification as for the Same product “Angiodyn Angiography Catheter” already registered from same source to the applicant via M/S B.Braun Germany to B.Braun Pakistan, the Board Decided to issue showcause to M/S B.Braun Pakistan regiarding the clarification of their sole agency agreement from the manufacturer.

47. M/s Genus,220, D.M.C.H.S, Block-3 Sirajuddaula Road, Karachi.Manufactured By:M/s Umbra Medical Products, Inc, 8930 East Roan Lane, Inverness, Florida 34450 USA.

Hawk PTCA Ballon Catheter Non Compliant



2 years

Applied on 4-11-2015Letter Issued on 11-8-2016. Reminder issued on 18-1-2017.



b. Valid Drug Sale Licence.

48. M/s Genus,220, D.M.C.H.S, Block-3 Sirajuddaula Road, Karachi.Manufactured By:M/s Umbra Medical Products, Inc, 8930 East Roan Lane, Inverness, Florida 34450

Falcon Guiding Catheter



3 years

Applied on 5-11-2015Letter Issued on 11-8-2016.Reminder issued on 18-1-2017.





USA.49. M/s Genus,

220, D.M.C.H.S, Block-3 Sirajuddaula Road, Karachi.Manufactured By:M/s Umbra Medical Products, Inc, 8930 East Roan Lane, Inverness, Florida 34450 USA.

Hawk PTCA Balloon Catheter Semi Compliant



2 years

Applied on 5-11-2015Letter Issued on 11-8-2016. Reminder issued on 18-1-2017.




50. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons, Amangarh, Nowshera.Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way. Marlborough, MA, 01752. USAManufacturing Site:M/s. Boston Scientific Limited, Ballybrit Business Park, Galway, Ireland.

Flextome TM Cutting Balloon TM

Monorail TM

Microsurgical Dilatation Device

Balloon Length (mm): 06, 10, 15, 20, 24, 28, 32.Balloon Dia (mm)2.00, 2.25, 2.50, 2.75, 3.00, 3.25, 3.50, 3.76, 4.00.


3 years



51. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons, Amangarh,Nowshera.Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way. Marlborough, MA, 01752.

NC Emerge TM Monorail TM PTCA Dilatation Catheter

(As per FSC)


3 years

Applied on 1-12-2015Letter Issued on 11-8-2016.Further deficiencies communicated on02-02-2017


a. OrigInal Credentials of manufacture as decided above by Registration Board.


USAManufacturing Site:M/s. Boston Scientific Ltd, Ballybrit Business Park, Galway, Ireland.

52. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons, Amangarh, Nowshera.Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way. Marlborough, MA, 01752. USAManufacturing Site:M/s. Availmed S.A de C.V. Av. Paseo Reforma No.8950, C.P.22116 La Mesa, Tijuana Baja California, Mexico.

Runway TM

Guide Catheter

Product code and sizes as per Free Sale Certificate.


3 years


53. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons, Amangarh, Nowshera.Legal Manufacturer:M/s Pendra Care International B.V. Van der Waals park 22, 9351 VC Leek, Netherland.Manufacturing Site:M/s Pendra Care International

Convey TM

Guiding Catheter

Product code and sizes as per Free Sale Certificate.


3 years


Primum Hydrophillic guiding Catheter applied by M/s Health Tec from same source.Serpia Hydorphilic Guiding Catheter applied by

Rejected.Cases in which more than one authorization letter/sole agency agreement has been granted by the manufacturer/ licence holder for the same product with different brand name, the sole agency agreement of manufacturer will be considered for the grant of registration.


B.V. Van der Waals park 22, 9351 VC Leek, Netherland.

M/s B. Braun from same source.

54. M/s. Health Tec,10-B, Street No.24, Valley Road, Westrige-I Rawalpindi.

Manufacturer:M/s PendraCAre International B.V. Vander Waals Park 22, 9351 VC Leek, The Netherlands.

Primum Hydrophilic Guiding Catheter.

Sizes as per Free Sale Certificate.

Free Sale Certificate has configuration of catheter holes and without holes.


1’s

3 years

Applied on 2-2-2016Serpia Hydrophilic Guiding Catheter applied by M/s B. Braun from same source.Convey TM

Guiding Catheter applied by M/s Ferozsons Labs from same source.Letter of shortcomings sent on19-1-2017Shortcoming received.


Cases in which more than one authorization letter/sole agency agreement has been granted by the manufacturer/ licence holder for the same product with different brand name, the sole agency agreement of manufacturer will be considered for the grant of registration.

55. M/s. ACP System,13-23, Naval Fleet Club, Iqbal (S.J) Shaheed Road,Karachi.Owner Operator:M/s Medtronic, Inc. 710 Medtronic Parkway NE Minneapolis, MN 55432, USA.Legal Manufacturer:M/s Medtronic Vascular37A Cherry Hill Dr DANVERS MA USA

Pro-Flo Diagnostic Angiography Catheter

Types, Sizes & Models as per Free Sale Certificate.


3 years

Applied on16-3-2016.Letter issued on 18-1-2017.Letter Issued on3-2-2017

Deferred for rectification of following shortcomings:a. Form 5A as per not

information provided.b. Original and valid





01923Contract Manufacturing Site:M/s Availmed S.A. De C.V. Av. Paseo Reform No. 8950 Interior (B1, C1, E1, E2, F2, G1) (Local A.B.C.G.H) La Mesa, Tijuana, Baja California 22116, Mexico.

56. M/s. ACP System,13-23, Naval Fleet Club, Iqbal (S.J) Shaheed Road,Karachi.Owner Operator:M/s Medtronic, Inc. 710 Medtronic Parkway NE Minneapolis, MN 55432, USA.Legal Manufacturer:M/s Medtronic Vascular37A Cherry Hill Dr DANVERS MA USA 01923Contract Manufacturing Site:M/s Availmed S.A. De C.V. Av. Paseo Reform No. 8950 Interior (B1, C1, E1, E2, F2, G1) (Local A.B.C.G.H) La Mesa, Tijuana, Baja California 22116,

Site Seer Cardiovascular Diagnostic Angiography Catheters



3 years

Applied on 16-3-2016Letter issued on 18-1-2017.Letter issued on 3-2-2017


a. Form 5A as per not information provided.





Mexico.57. M/s. ACP

System,13-23, Naval Fleet Club, Iqbal (S.J) Shaheed Road,Karachi.Name of Owner Operartor:M/s Medtronic, Inc. 710 Medtronic Parkway NE Minneapolis, MN 55432, USA.Manufacturing Site:M/s Medtronic Vascular37A Cherry Hill Dr DANVERS, MA USA 01923

Launcher Guiding Catheters



2 years

Applied on 16-3-2016Letter issued on 18-1-2017.Letter issued on 3-2-2017


a. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.

b. Copy Valid Drug Sale License,

58. M/s. ACP System,13-23, Naval Fleet Club, Iqbal (S.J) Shaheed Road,Karachi.Owner/ Operator:M/s Medtronic, Inc. 710 Medtronic Parkway NE Minneapolis, MN 55432, USA.Manufacturing Facility:M/s Medtronic Vascular, 37-A, Cherry Hill Drive, Danvers, MA 01923, USA.

Sherpa NX Guiding Catheter



2 years

Applied on 16-3-2016Letter issued on 18-1-2017.Letter Issued on3-2-2017

.



b. Copy Valid Drug Sale License,

59. M/s Alliance Medical, 12-B, 1st Floor, Agro Flats, Shadman, Lahore.

Biosensors Central Venous Catheter Kit


36 months

Applied on 8-3-2016.Letter issued on 18.1.2017.




Manufactured by:M/s Biosensors International Pte. Ltd, 36 Jalan Tukang, Singapore 619266.

the Policy Board/Federal Government



60. M/s Alliance Medical, 12-B, 1st Floor, Agro Flats, Shadman, Lahore/


Safety wedge thermodilution catheters with biotray


36 months

Applied on 8-3-2016.Letter issued on18-1-2017.

Deferred for rectification of following shortcomings:a. Application on

Prescirbed Form-5Ab. Original and valid Free






g. Clinical Data, if any.h. Complete

specifications with details of analytical procedures

61. M/s Alliance Medical, 12-B, 1st Floor, Agro Flats, Shadman, Lahore/


Biosensors Embolectomy Catheters


36 months

Applied on 8-3-2016.Letter issued on 18-1-2017.





d. Copy Valid Drug Sale


License,62. M/s. Promed

International, CB-6349 Amarpak Plaza, Jhelum Road, Rawalpindi.Legal Manufacturer:M/s Biosensors Europe SA, Rue De Lausanne 29, 1110 Morges, Switzerland.Manufacturing Site:M/s Biosensors Interventional Technologies Pte Ltd, 36 Jalan Tukang, Singapore 619266, Singapore.

Powerline TM

PTCA CatheterProduct sizes and codes as per FSC


1’s

36 months

Applied on 20-4-2016Letter of shortcomings issued on 18-1-2017.





d. Orignal Credentials of manufacture as decided above by Registration Board.

e. Copy Valid Drug Sale License,

f. Clinical data, if any.

63. M/s Hashir Surgical Services (Pvt) Ltd,1st Floor, House No.16, Street 1, Sector F-2, Phase-6, Hayatabad, Peshawar.Sub-office: Office no.05,2nd floor syed’s tower, university road,Manufactured By:M/s Intra Special Catheter GmbH, Oststrasse 2, 66780 Rehlingen-Siersburg, Germany

Venoseld Central Venus Catheter-I Lumen.

Sizes:14G, 16G, 18G, 20G,24G.

Length (cm): 9, 13, 16, 20, 30.(As per free sale certificate)


5 years


a. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.

b. Orignal Credentials of manufacture as decided above by Registration Board.

64. M/s Hashir Surgical Services (Pvt) Ltd,

Trilucath Central Venous Catheter-3


5 years

Applied on 2-5-2016Letter


a. Approval of shelf life


1st Floor, House No.16, Street 1, Sector F-2, Phase-6, Hayatabad, Peshawar.Sub-office: Office no.05,2nd floor syed’s tower, university road,Manufactured By:M/s Intra Special Catheter GmbH, Oststrasse 2, 66780 Rehlingen-Siersburg, Germany

Lumen.(As per FSC)

Ref:323085, 323015, 323025, 323035, 323017, 323027, 323037, 323028Sizes:5.5F, 7F, 8.5F.Length (cm): 8, 13, 16, 20, 30.

decision by the Policy Board/ Federal Government

Issued on 2-11-2016.



65. M/s Hashir Surgical Services (Pvt) Ltd,1st Floor, House No.16, Street 1, Sector F-2, Phase-6, Hayatabad, Peshawar.Sub-office:Office no.05,2nd floor syed’s tower, university road,Manufactured By:M/s Intra Special Catheter GmbH, Oststrasse 2, 66780 Rehlingen-Siersburg, Germany

Duocath Central Venus Catheter 2-Lumen.

Sizes: 4F, 5F, 7F, 8F.

Length (cm): 5, 6, 8, 10, 13, 15, 20, 30.


5 years


a. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.


66. M/s Hashir Surgical Services (Pvt) Ltd,1st Floor, House No.16, Street 1, Sector

Quadrocath Central Venus Catheter4-Lumen.

(As per

Decontrolled till policy decision by the

5 years

Applied on 2-5-2016Shortcoming letter sent on26-10-


a. Approval of shelf life from regulatory authority or Stability data to support claimed


F-2, Phase-6, Hayatabad, Peshawar.Sub-office:Office no.05,2nd floor syed’s tower, university road,Peshawer.Manufactured By:M/s Intra Special Catheter GmbH, Oststrasse 2, 66780 Rehlingen-Siersburg, Germany.Sterilization Site:PFM Medical msg GmBH, Am soterberg 4; D-66620 Nonnweller-Otzenhausen;Germany.

FSC) Policy Board/ Federal Government

2016 2nd letter sent on19-10-163rd

shortcoming communicated on02-02-2016.

shelf life.b. Orignal Credentials of


67. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons, Amangarh, Nowshera.Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way. Marlborough, MA, 01752, USA.Manufacturing Site:M/s. Boston Scientific Corporation, Two Scimed Place, Maple Grove, MN55311, USA

Coyote TM ES Monorail TM

PTA Balloon Dilatation Catheter.



37 months

Applied on 15-7-2016Letter issued on18-1-2017.






e. Clinical Data, if any.

68. M/s. Ferozsons Coyote TM Decont 37 Applied Deferred for rectification of


Laboratories Limited, P.O. Ferozsons, Amangarh, Nowshera.Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way. Marlborough, MA, 01752, USA.Manufacturing Site:M/s. Boston Scientific Corporation, Two Scimed Place, Maple Grove, MN55311, USA

Monorail TM

PTA Balloon Dilatation Catheter.


rolled till policy decision by Policy Board/ Federal Government

months

on 15-7-2016Letter issued on 18-1-2017.

following shortcomings:



c. Orignal Credentials of manufacture as decided above by Registration Board.

d. Clinical Data, if any.

69. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons, Amangarh, Nowshera.Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way. Marlborough, MA, 01752, USA.Manufacturing Site:M/s. Boston Scientific Corporation, Two Scimed Place, Maple Grove, MN 55311, USA

Coyote TM ES Over The Wire TM PTA Balloon Dilatation Catheter.



25 months

Applied on 15-7-2016Letter issued on18-1-2017.






70. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons, Amangarh,

Mustang TM

Over The Wire PTA Balloon Dilatation

Decontrolled till policy decisio

37months

Applied on 15-7-2016Letter issued on


a. Original and valid authorization letter/sole


Nowshera.Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way. Marlborough, MA, 01752, USA.Manufacturing Site:M/s. Boston Scientific Corporation, Ballybrit Business Park, Galway , Ireland.

Catheter.


n by Policy Board/ Federal Government

18-1-2017.a.

agency agreement from manufacturer as decided above by Registration Board.




71. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons, Amangarh, Nowshera.Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way. Marlborough, MA, 01752, USA.Contract Manufacturing Site:M/s. Teleflex Medical, Unit 7,8 & 9, Annacotty Business Park, Annacotty Country Limerick, Ireland.

Imager TM II Angiographic Catheter.

Product codes and sizes as per Free Sale Certificate.


25months

Applied on 15-7-2016Letter issued on 18-1-2017.






72. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons, Amangarh, Nowshera.Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston

Coyote TM

Over The Wire PTA Balloon Dilatation Catheter.

Product codes and sizes as per Free Sale


37 months

Applied on 15-7-2016Letter issued on 18-1-2017.a.



b. Approval of shelf life from regulatory authority or Stability


Scientific Way. Marlborough, MA, 01752, USA.Manufacturing Site:M/s. Boston Scientific Corporation, Two Scimed Place, Maple Grove, MN55311, USA

Certificate. nment data to support claimed shelf life.



73. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons, Amangarh, Nowshera.Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way. Marlborough, MA, 01752, USA.Manufacturing Site:M/s. Boston Scientific Corporation, Two Scimed Place, Maple Grove, MN 55311, USA.

Sterling TM

Monorail TM

PTA Balloon Dilatation Catheter



37months







74. M/s Bio Medics Medical System, F-597, F-Block, Satellite Town, Rawalpindi.

Manufactured By:M/s Alco Advanced Lightweight Constructions GmbH, Am Borsigturm 50, 13507, Berlin, Germany.

OSIRA PTCA ® Catheter(Rapamycin Eluting Coronary Dilatation Catheter)

(As per FSC)


18 months

Applied on 6-4-2016Letter issued on19-1-2017.Further shortcoming communicated on01-02-2017.

(The firm given undertaken that they need one-month




c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.d. Clinical data, if

any.


time period to fulfill deficiencies/documents required for registration)

75. M/s Johnson & Johnson Pakistan (Pvt) Limited, Fl.19, Sub Plot F-1, Kehkashan Scheme No.5 Main Boat Basin, Clifton, Karachi.

Legal Manufacturer:M/s BioSense Webster, Inc. 15715 Arrowy Hwy, Irwidale, CA USA 91706.

Pentaray Catheter

(product codes and sizes as per Free Sale Certificate)


3 years

Applied on 25-8-2016.Letter issued on 19-1-2017.Reminder issued on 02-02-2017.


5A duly signed and stamped.




e. Clinical Data, if any.76. M/s Johnson &

Johnson Pakistan (Pvt) Limited, Fl.19, Sub Plot F-1, Kehkashan Scheme No.5,Main Boat Basin, Clifton, Karachi.Legal ManufacturerM/s BioSense Webster, Inc, 15715 Arrowy Hwy, Irwidale, CA, USA 91706.

EZ Steer Catheter



3 years

Applied on 25-8-2016.Letter issued on 19.1.2017.Reminder issued on 02-02-2017.


a. Application on Form-5A duly signed and stamped.




77. M/s A.H Distributors,Kh-1183, Lane No.5, Peshawar Road, Rawalpindi./Legal

Ursa Angiographic Catheter

(product codes and sizes as per Free Sale


36 months


a. Original and valid Free Sale Certificate with clear status as decided above by Registration Board.


Manufacturer:M/s Curatia Medical Ltd, 198 Xiangjiang Road, New District Suzhou 215011, China.Manufacturing Facility:M/s Curatia Medical Ltd, 198 Xiangjiang road, New District Suzhou 215011, China.

M/s Curatia Medical Ltd, 9 Peiyuan Road, New District Suzhou 215163, China.

Certificate) Board/ Federal Government



d. Clinical Data,e. Approval of shelf life


f. Method of manufacturing and Analytical Specification.

78. M/s Johnson & Johnson Pakistan (Pvt) Limited, ///Fl.19,/ Sub Plot F-1, /Kehkashan Scheme TNo.5,Main Boat Basin, Clifton, Karachi.

Legal ManufacturerM/s BioSense Webster, Inc, 15715 Arrowy Hwy, Irwidale, CA, USA 91706.

Webster Catheters



3 years

Applied on 25-8-2016.Letter issued on02-11-2016.Reminder issued on 02-02-2017.






e. Clinical trial data, if any,

79. M/s Johnson & Johnson Pakistan (Pvt) Limited, Fl.19, Sub Plot F-1, Kehkashan Scheme No.5,Main Boat Basin, Clifton,

Thermocool Catheters


Decontrolled till policy decision by the Policy Board/ Federa

3 years

Applied on 20-9-2016Letter issued on 12.1.2017.Letter Issued on3-2-2017 (Firm Has


5A duly signed and stamped.

b. Clarification as many types/products applies in application.

c. Original and valid Free Sale Certificate as


Karachi.

Legal ManufacturerM/s BioSense Webster, Inc, 15715 Arrowy Hwy, Irwidale, CA USA 91706.

l Government

Requested to grant 10-12 weeks for furnishing above mentioned data)




f. Orignal Credentials of manufacture as decided above by Registration Board.

g. Clinical trial data, if any

80. M/s Mediland Pakistan (Pvt) Limited, Office No. B-09, 2nd

Floor, Masood Arcade, IJP Road, Near Saidpur Road, Rawalpindi.

Manufactured by:M/s Datascope Corporation, 1300Macarthur Blvld MAHWAH, NJ USA 07430

Intra Aortic Balloon Catheter


Not mentioned

Applied on 27-10-2016.Letter issued on 19-1-2017.

i.






e. Orignal Credentials of manufacture as decided above by Registration Board.

f. Clincal Data, if any.

Case No.02: Fresh applications for registration of Medical Devices.Following firms have applied for registration of medical devices for import.

A) CanullaS. Name of

Importer and Manufacture/

Exporter.

Name of Medical

Device (s)

Demanded price &

Pack size

Shelf life

Remarks Decision

1. M/s Cardiac Care, 848-C, Shadman-I,

Aortic Root Cannula-with Vent

Decontrolled(12Ga,

3 years

Applied on 20-7- 2012

Deferred for rectification of following


Lahore.Manufactured byM/s Sorin Group USA, Inc, 14401 W. 65th

Way,Arvada, CO, 80004, USA.

Line.(Aortic Perfusion Cannula)

Product codes as per Free Sale Certificate and Form 5-A.

14Ga, 16Ga)

Letter of deficiencies issued on 31-10-2012Reminders issued on 01-02-2017 and3-2-2017.

shortcomings after personal hearing of authorized representative:a. Differential fee

PKR.35,000/-,b. Original and valid

Free Sale Certificate clarifying the status of legal manufacturer along with manufacturing site as decided by Registration Board.




f. Clarification as manufacturer status is not clear on copy of free sale certificate.

g. Clarification as product name is different on Form 5A and free sale certificate copy.

2. M/s Cardiac Care, 848-C,Shadman-I, Lahore.

Manufactured byM/s Sorin Group USA,

Cannulation Tourniquet Set (Perfusion Set)

Product

Decontrolled(TS-10130, TS-10262,TS-10066, TS-10015, TS-10020,TS-10061,TS-10050,

3 years

Applied on 20-7- 2012Letter of deficiencies issued on 31-10-2012Reminders

Deferred for rectification of following shortcomings after personal hearing of authorized representative:a. Differential fee

PKR.35,000/-,


Inc, 14401 W. 65th


codes as per Free Sale Certificate and Form 5-A.

TS-10040, TS-10010)

issued on 01-02-2017 & 3-2-2017.

b. Original and valid Free Sale Certificate clarifying the status of legal manufacturer along with manufacturing site as decided by Registration Board.






Manufactured byM/s Sorin Group USA, Inc, 14401 W. 65th


Retrograde Cardioplegia Cannula Self Inflating (Perfusion Cannula)


Decontrolled(Different size)

3 years

Applied on 20-7- 2012Letter of deficiencies issued on 31-10-2012Reminders issued on 01-02-2017 and 3-2-2017.








f. Clarification as manufacturer status is not clear on copy of Free sale certificate.




One Piece Venous Return Cannula-Non Reinforced (Venous Perfusion Cannula)


Decontrolled(Different sizes)

3 years

Applied on 20-7- 2012Letter of deficiencies issued on 31-10-2012Reminders issued on 01-02-2017 and 3-2-2017.





d. Approval of shelf life from regulatory








Coronary Artery Perfusion Cannula


Decontrolled

3 years

Applied on 20-7- 2012Letter of deficiencies issued on 31-10-2012Reminders issued on 01-02-2017.







f. Clarification as


manufacturer status is not clear on copy of free sale certificate.

6. M/s Cardiac Care, 848-C, Shadman-I, Lahore.Manufactured byM/s Sorin Group USA, Inc, 14401 W. 65th


Aortic Arch Cannula- Non Reinforced(Aortic Perfusion Cannula)



3 years

Applied on 20-7- 2012Letter of deficiencies issued on 31-10-2012Reminders issued on 01-02-2017 & 3-2-2017.









Manufactured by

Vessel Cannula With/Without Wing and Valve.

Product

Decontrolled

3 years

Applied on 20-7- 2012Letter of deficiencies issued on 31-10-

Deferred for rectification of following shortcomings after personal hearing of authorized representative:


M/s Sorin Group USA, Inc, 14401 W. 65th


codes as per Free Sale Certificate and Form 5-A.

2012Reminders issued on 01-02-2017.

a. Differential fee PKR.35,000/-,

b. Original and valid Free Sale Certificate clarifying the status of legal manufacturer along with manufacturing site as decided by Registration Board.





8. M/s Cardiac Care, 848-C, Shadman-I, Lahore.Manufactured byM/s Sorin Group USA, Inc, 14401 W. 65th


Pericardial Sump(Aortic Perfusion Cannula)



3 years

Applied on 20-7- 2012Letter of deficiencies issued on 31-10-2012Reminders issued on 01-02-2017 & 3-2-2017.

Deferred for rectification of following shortcomings after personal hearing of authorized representative:


b. Original and valid Free Sale Certificate clarifying the status of legal manufacturer along with manufacturing site


as decided by Registration Board.





9. M/s Medica,C-9-C, 24th

Commercial Street-II, Ext-DHA, Karachi.

Manufactured byM/s Sorin Group Italia, Italy.

Stockert Cannula.

Decontrolled

3 years

Applied on 08-05-2012Letter issued on 24.4.2013Reminder issued on 11.07.2013Letter issued on 3rd March, 2015Final reminder given on 2nd

February, 2017





d. Approval of shelf life from regulatory




CathetersS.#

Name of Importer &

Manufacture/ Exporter.

Name of Medical

Device (s)

Demanded price &

Pack size

Shelf life

Remarks Decision

1. M/s Iqbal & Company,Islamabad.

Manufacturing Site:M/s Renax Medical Co. Ltd, Thailand.

Arrow Catheters (Blood Tubing/Lines Set for Hemodialysis) Single & Double Chamber).

DecontrolledDifferent sizes, gauges, types)

Not clear.

Applied on 22-5-2012Letter of shortcoming issued on 24-4-2013.Reminders issues on 2-3-2015 and 1-2-2017.



Free Sale Certificate as decided above by Registration Board.




f. Clinical Data, if any.


h. Specification and analytical methods.

i. Method of manufacturing.




Umbilical Catheter

Sizes 3FR, 4FR, 5FR, 6FR, 7FR, 8FR

Length: 38cm

Decontrolled

5 years

Applied on 1-1-2013Letter of shortcoming issued on 16-6-2014.Reminder issues on3-2-2017.









Easydrain

(Catheter for Pleural/Thoracis Drainage)

Codes:681.06,681.08, 681.082, 681.10.

Decontrolled

60 months

Applied on 1-1-2013Letter of shortcoming issued on 16-6-2014.Reminder issues on3-2-2017.




c. Approval of shelf life from regulatory authority or Stability data to support claimed


shelf life.d. Orignal

Credentials of manufacture as decided above by Registration Board.


4. M/s Sakuf Trading, 34-G, Phase-1, Commercial Area, Defence Housing Authority, Lahore Cantt.

Manufactured By:M/s Balt Extrusion, 10, rue de la Croix Vigneron 95160, Montmorency, France.

Fargo Line (Braided Guiding Catheters)

Codes & sizes as per FSC.

- 5 years

Applied on 21-11-2016Shortcoming letter issued on 20-1-2017








g. Copy Valid Drug Sale License.

5. M/s Sakuf Trading, 34-G, Phase-1, Commercial Area, Defence Housing Authority, Lahore Cantt.Manufactured By:

Magic & Baltacci (Flow guided Micro Catheters)


- 5 years

Applied on 21-11-2016Shortcoming letter issued on 20.1.2017


PKR.35,000/-,b. Clarification as 2

products appliedc. Original and valid

Free Sale


M/s Balt Extrusion, 10, rue de la Croix Vigneron 95160, Montmorency, France.





g. Clinical Data, if any.


6. M/s Al-Hamd Enterprises, FL-11/1/1, Block-6, Gulshan-e-Iqbal, Karachi.

Manufactured By:M/s Ribbel Interntional Ltd, 20th Mile, Jatheri Road, P.O.Rai, Haryana, India.

Silky Gold Foley Balloon Catheter

Not mentioned

5 years

Applied on 21-12-2016Letter of shortcoming issued on2-2-2017

Deferred for rectification of following shortcomings:a. Clarification as

address on sole agency agreement is different on Form 5A.







g. Specification and analytical methods.

h. Method of manufacturing.

i. Importability of product from India as per present Import Policy Order.

7. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons, Amangarh, Nowshera.Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way,MarlboroughMA, 01752, USA.Manufacturing Site:M/s. TechDevice Corporation, 650 Pleasamt Street, Watertown, MA 02472, USASterilization Site:M/s Boston Scientific Coventry (formally Steris Isomedix) 8 Industrial Drive Coventry, RI-02816, USA.

Rigiflex TM II Single Use Achalasia Balloon Dilator



Oneyear




b. Original and valid authorization letter/sole agency agreement from legal manufacturer as decided above by Registration Board.




8. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons, Amangarh, Nowshera.Legal

Hurricane RX Biliary Balloon Dilatation Catheter

Codes &

Decontrolled till policy decision by Policy Board/ Federal Governmen

02months



Free Sale Certificate as


Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way, Marlborough, MA, 01752, USA.Manufacturing Site:M/s. Boston Scientific Limited, Business & Technology Park, Model Farm Road, Cork, IrelandSterilization Site:M/s Synergy Health Ireland Ltd, IDA Business & Technology park Sragh Tullamore Co. Offaly, Ireland.

sizes as per FSC.

t decided above by Registration Board.

b. Original and valid authorization letter/sole agency agreement from legal manufacturer as decided above by Registration Board.




f. Clarification as Address on letterof authorization is different than on Form 5-A.

9. M/s. Maxims Medical, 534-H Block, St. No.13, Phase 5, DHA, Lahore.

Manufactured by:M/s MINVASYS, 7 REU DU FOSSE Blanc 92230, France.

Yangtze PTCA Balloon Dilatation Catheter



3 years

Applied on 23-1-2017Shortcoming letter issued on2-2-2017.



b. Valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.

c. Approval of shelf life from regulatory authority or Stability data to


support claimed shelf life.




10. M/s Hashir Surgical Services (Pvt) Ltd,1st Floor, H#No.16, St.#1, F-2, Phase-6, Hayatabad, Peshawar.

Sub-office: Office no.05,2nd

floor syed’s tower, university road,Manufactured By:M/s Intra Special Catheter GmbH, Oststrasse 2, 66780 Rehlingen-Siersburg, Germany

Trilucath Hemodialysis Catheter-3 Lumen.

Sizes: 12F

Length (cm): 13, 16, 20, 24.


5 years

Applied on 2-5-2016Shortcoming Letter issued on 14-12-2016 & 2-2-2017.




11. M/s. Universal Enterprises, 29 Block-3 OVCHS Stadium Road,Karachi.

ManufacturerM/s. Haidylena For Advanced Medical Industries, Egypt.

Dual Lumen Catheter Kit

Decontrolled

3 years

Applied on 11-5-2011

Shortcoming letter issued on 12-10-2012.Reminders issued on2-3-2015 &6-10-2016



Address and name of manufacturer not mentioned on Form 5A.


d. Original and valid authorization letter/sole agency


agreement from manufacturer as decided above by Registration Board.



g. Clinical Data, if any.


i. Specification and analytical methods

j. Method of manufacturing.

12. M/s. Ali Gohar & Co. (Pvt) Ltd., Karachi.

Legal Manufacturer:M/s. Mediquip Son, BHD., Kangar Perlis, Malaysia,

Manufacturer:M/s Mediquip SDN, BHD., Kangar Perlis, Malaysia.

Dover Silicone/Hydrogel Coated Latex Foley Catheter (all types, sizes & accessories)

Decontrolled

5 years


Shortcoming letter issued on8-11-2012Reminders issued on 18-4-2014 & 31.10.2016.







f. Analytical procedure


g. Clarification as product applied is silicone or hydrogel coated.

13. M/s. Sakuf Trading,34-G Phase I, Commercial Area, Defence Housing Authority, Lahore Cantt Pakistan.

Manufactured by:M/s BALT EXTRUSION, 10, ru de la Croix Vigneron 95160 MONTMORENCY FRANCE.

Eclipse & Copernic 2L (Double Lumen Occlusion Balloons)


05 Years

Applied on 21-11-2016Letter for short comings issued on 02-02-2017








g. Copy Valid Drug Sale License

h. Clarification regarding application of 2 products together


Manufactured byUnit I:M/s Romsons International,62

Peritoneal Dialysis Catheter Set

Decontrolled

05 years

Applied on 19-4-2011Letter of shortcomings issued on 12-10-2012.Reminder issued on 2-3-2015Final




industrial estate Nunhai, Agra-282006 India.

Unit II:Romsons International Unit II 59jC, Noida Dadri Road, Phase II, Noida-201 301, Uttar Pardesh, India.

Reminder issued on 07-10-2016Reply received on 24-10-2016,






g. Specification and analytical methods.

h. Method of manufacturing.


Manufacturer:M/s Ameco Medical Industries, Industrial Zone,B4, Plot 119 East, 10th of Ramadan City, Arab Republic of Egypt.

Amecath Catheter Kit

Decontrolled

3 years

Applied on 19-4-2011Letter of shortcomings issued on 12-10-2012.Reminder issued on 2-3-2015Reply received on 01-04-2015 Final Reminder issued on 26-10-2016





d. Orignal Credentials of




f. Analytical procedure and outline of method of manufacturing.

16. M/s. Universal Enterprises, 29 Block-3 OVCHS Stadium Road,Karachi

Manufactured byM/s. Ameco Medical Industries, Industrial Zone,B4, Plot 119 East, 10th of Ramadan City, Arab Republic of Egypt..

Amecath Double Lumen Catheter.

Decontrolled

03 years

Applied on 19-4-2011Letter of shortcomings issued on 12-10-2012.Reminder issued on2-3-2015Final Reminder issued on 07-10-2016Reply received on 24-10-2016, the firm requested for an extension of one month till07-11-2016 for the submission of short comings.







f. Analytical procedure and outline of method of manufacturing.

17. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons, Amangarh, NowsheraKPKLegal Manufacturer:M/s. Boston

Flexima Nasobiliary Catheter with Guidewire



03Years

Applied on 24-1-2017Letter of shortcomings issued on 01-01-2017




Scientific Corporation, 300 Boston Scientific Way, Marlborough, MA, 01752, USA.Manufacturing Site:M/s. Boston Scientific Corporation, 780 Brookside Drive, Spencer IN-47460, USA.Sterilization Site:M/s Boston Scientific Coventry, 8 Industrial Drive Coventry, RI 02816, USA.M/s Synergy Health AST Venlo (Formally Known as Isotron Nederland B.V) Faunalaan 38, 5928 RZ Venlo Netherlands.M/s Synergy Health Ireland Ltd (Formally Known as Isotron Ireland Ltd), IDA Business & Technology park Sragh Tullamore Co. Offaly, Ireland.




18. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons, Amangarh, Nowshera.Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston

MaxForce TTS High Performance Balloon Dilatation Catheter



24 months




b. Original and valid authorization


Scientific Way. Marlborough, MA, 01752, USA.Manufacturing Site:M/s. Boston Scientific Limited, Business and Technology Park , Model Form Road, Cork, IrelandSterilization Site:M/s Synergy Health Ireland Ltd, IDA Business and Technology Park, Sragh Tullamore County, Offaly, Ireland.

letter/sole agency agreement from manufacturer as decided above by Registration Board.



19. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons, Amangarh, Nowshera.KPKLegal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way, Marlborough, MA, 01752, USA.Manufacturing Site:M/s. Boston Scientific Corporation, 780 Brookside Drive, Spencer IN-47460, USA.Sterilization Site:M/s Boston Scientific Coventry, 8 Industrial Drive

Flexima Nasobiliary Catheter with Jagware Guidewire



03Years








Coventry, RI 02816, USA.

M/s Synergy Health AST Venlo (Formally Known as Isotron Nederland B.V) Faunalaan 38, 5928 RZ Venlo Netherlands.

M/s Synergy Health Ireland Ltd (Formally Known as Isotron Ireland Ltd), IDA Business & Technology park Sragh Tullamore Co. Offaly, Ireland.

20. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons, Amangarh, Nowshera.Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way, Marlborough, MA, 01752, USA.Manufacturing Site:M/s Boston Scientific Corporation, 780 Brookside Drive, Spencer IN-47460, USA.Sterilization Site:M/s Boston Scientific Coventry, 8 Industrial Drive Coventry, RI 02816, USA.

Flexima Nasobiliary Catheter



03Years










21. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons, Amangarh, Nowshera.KPKLegal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way. Marlborough, MA, 01752, USA.Manufacturing Sites:M/s. Boston Scientific Limited, Business and Technology Park , Model Form Road, Cork, IrelandSterilization Sites:M/s Boston Scientific Corporation. 8 Industrial Drive Coventry, RI 02816, USA.

Extractor TM

Pro Retrieval Balloon Catheter



2 Years








M/s Synergy Health Ireland Ltd, IDA Business and Technology Park, Sragh Tullamore County, Offaly, Irelamabd.

M/s Synergy Health AST, Venlo Faunalaan 38, 5928 RZ Venlo, Netherlands.

STERIS Isomedix Services, 3459 South Clinton Avenue, South Plainfield, New Jersey 07080, USA.

M/s Synergy Health AST, SRL, B13.1, Street 4, Avenue 1, EI Coyol Free Zone, EL Coyol Alajeula 20102, Costa Rica.

22. M/s Hakimsons Pvt. Ltd, (2011) Hakimsons House, A/56, S.I.T.E. Manghopir Road, Karachi.

Manufactured byM/s Pennine Health Care Ltd. City Gate, London Road, Derby De, 24 8WY United Kingdom.

Catheters Nelaton/Suction.

Decontrolled

3 years

Applied on 05-03-2011.Letter Issued on 24-10-2012.Reminder issued on 02-03-2015Reminder issued on 06-10-2016Final Reminder issued on4-2-2017.



many types are applied.







23. M/s. Fresenius Medical Care Pakistan (Pvt) Ltd., 137-A, Faisal Town, Lahore.Legal Manufacturer:-M/s. Health Line International Corporation, Centerville, USA.Manufacturing Plant and Asia Office:M/s Health Line International Corporation Nanzhuang, (Foshan), China.(Free Sale China Provided)

HLIC Hemodialysis Catheters

Decontrolled

3 years

12-3-2011Letter issued on26-7-2013Reminder Letter issued 14-11-2016


24. M/s. Ali Gohar& Co. (Pvt) Ltd., Karachi. /

Legal Manufacturer:M/s. CovidienIIc Hampshire Sstreet, Mansfield, MA, USA.

Manufacturer:M/s. Mallinckrodt

Endobronchial Suction Catheters/ Tubes and accessoriesProduct Size and codes as per FSC

Decontrolled

05 years

Applied on 24-03-2011Letter issued on 29-03-2011Letter issued on 04-12-2013Letter issued on 18-04-2014Final Reminder




c. Original and valid authorization letter/sole agency agreement from manufacturer as


Medical Cornmaddy, Athlone, Co. Westmeath, Ireland.

issued on 26-10-2016





25. M/s Mana& Co,204 New Medicine Market, Near Densohall, Karachi.

Manufactured byM/s SuzhouYudu Medical Co.Ltd, Eastern XinzhuangTown, ChangshuJiangsu, China.

Exported byNingbo Greetmed Medical Instrument Co.Ltd. 18F, Building 1, Wante Center, Ningbo, China.

Medicare Suction Catheter

De-controlled

05years

Applied on 16-8-2011Letter issued on 25-10-2012Reminder issued on 2-3-2015Final Reminder 31-10-2016








26. M/s Mana& Co,204 New Medicine Market, Near

Medicare Nelton Catheter.

De-controlled

05 years




Densohall, Karachi.

Manufactured byM/s SuzhouYudu Medical Co.Ltd, Eastern Xinzhuang Town, Changshu Jiangsu, China.

Exported byNingbo Greetmed Medical Instrument Co.Ltd. 18F, Building 1, Wante Center, Ningbo, China

issued on 25.10.2012Reminder issued on 2-3-2015Final Reminder 31.10.2016







27. M/s Sadqain HealthCare (Pvt) Ltd, Rawalpindi.

Manufactured byM/s Intersurgical Limited Crane House, Molly Millars Lane Wokingham, Berkshire,United Kingdom.

Intersurgical – Paediatric/ Neonatal/Adult Catheter Mount-Patient Connection-3535000-3514000-3508000

De-controlled

Applied on 20-8-2011Letter issued on 24-10-2012Final Reminder 31-10-2016Final reminder 3-2-2017





d. Approval of shelf life from regulatory authority or Stability data to support claimed


shelf life.e. Orignal



28. M/s Sakuf Trading, 34-G, Phase-1, Commercial Area, DHA, Lahore Cantt.Manufactured By:M/s Balt Extrusion, 10, rue de la Croix Vigneron 95160, Montmorency, France.

Sonic (Detachtable Tip Braided Microcatheters)



5 years

Applied on 21-11-2016Letter issued 28-12-2016Letter Issued on 01-02-2017








29. M/s Sakuf Trading, 34-G, Phase-1, Commercial Area, DHA, Lahore Cantt.

Manufactured By:M/s Balt Extrusion, 10, rue de la Croix Vigneron

Goldballoon (Detachable Balloon)



5 years

Applied on 21-11-2016Letter issued 28-12-2016Letter Issued on 01-02-2017




c. Original and valid


95160, Montmorency, France.






Rubicon TM

18 Support Catheter



37months

Applied on 25-7-2016Letter issued 18-01-2017






31. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons,

Mustang TM

Over The Wire PTA Balloon

Decontrolled till policy decision by Policy

37months




Amangarh, Nowshera.Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way. Marlborough, MA, 01752, USA.Manufacturing Site:M/s. Boston Scientific Corporation, Two Scimed Place, Maple Grove, MN 55311, USA.

Dilatation Catheter.

Balloon Dia (mm):3, 4, 5, 6, 7, 8, 9, 10, 12.

Balloon Length (mm):20, 30, 40, 60, 80, 100, 120, 150, 180, 200.

Board/ Federal Government

issued 18-01-2017






Rubicon TM

35 Support Catheter



37months






d. Orignal Credentials of manufacture as decided above by Registration


Board.33. M/s. Ferozsons

Laboratories Limited, P.O. Ferozsons, Amangarh, Nowshera.Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way. Marlborough, MA, 01752, USA.Manufacturing Site:M/s. Boston Scientific Corporation, Business & Technology Park, Model Farm Road, Cork , Ireland.

Renegade Fiber Braided Microcatheter.



37months







34. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons, Amangarh, Nowshera.Legal Manufacturer:M/s Boston Scientific Corporation, 300 Boston Scientific Way. Marlborough, MA, 01752, USA.Manufacturing Site:M/s. Boston Scientific Corporation, Two Scimed Place, Maple Grove, MN 55311, USA.

Rubicon TM

14 Support Catheter



37months









Sterling TM 14 Monorail TM

PTA Balloon Dilatation Catheter

Balloon Dia (mm):1.5, 2.0, 2.5,3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6,0, 6.5, 7.0, 8.0.

Balloon Length (mm):10, 15, 20, 30, 40, 60, 100, 150, 200, 220.


37months







36. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons, Amangarh, Nowshera.Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way, Marlborough, MA, 01752, USA.Manufacturing Site:M/s. Boston Scientific

Interject Clear/Contrast Injection Therapy Needle Catheter



37months


Deferred for rectification of following shortcomings:a. Clarification as

Brand is not as per free sale certificate.


c. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by


Corporation, 780 Brookside Drive, Spencer IN-47460, USA.Sterilization Site:M/s Boston Scientific Coventry, 8 Industrial Drive Coventry, RI 02816, USA.M/s Synergy Health AST Venlo (Formally Known as Isotron Nederland B.V) Faunalaan 38, 5928 RZ Venlo Netherlands.


Registration Board



37. M/s B.Braun Pakistan (Pvt) Limited, The Forum Suite # 216, Khayaban-e-Jami, Clifton Block-9, Karachi/Legal Manufacturer:M/s B.Braun Melsungen AG, Caril-Braun-StraBe 1, 34212 Melsungen, Germany.Manufacturing Site:B. Braun Medical Industries Sdn. Bhd, Bayan Lepas Free

Espocan(Set for Combined Spinal and Epidural Anaesthesia)

(Sizes and codes as per Free Sale Certificate)


5 years

Applied on 23-6-2016Letter issued on 01-02-2017




c. Orignal Credentials of manufacture as decided above by


Industrial Zone 11900 Penang, Malaysia.

Registration Board.

38. M/s B.Braun Pakistan (Pvt) Limited, The Forum Suite # 216, Khayaban-e-Jami, Clifton Block-9, Karachi.

Legal Manufacturer:M/s B.Braun Melsungen AG, Caril-Braun-StraBe 1, 34212 Melsungen, Germany.

Manufacturing Site:B. Braun Medical Industries Sdn. Bhd, Bayan Lepas Free Industrial Zone 11900 Penang, Malaysia.

Pencan Pencan Paed, Spinocan , GuideNeedle & Spinal Introducer.

(Sizes and codes as per Free Sale Certificate)


5 years






d. Clarification for Brand name of product applied.

39. M/s. Digital Imaging System,121 habitat, Shadman II , Ghaus-ul-Azam Road,Lahore.

Name of Owner Operator and manufacturing Facility:Volcano Corporation2870 Kilgore rd, Rancho cordova, CA USA 95670

Eagle Eye Paltinum & ST-IVUS Catheter


2 years

Applied on 03-02-2017Letter Issued on 04-02-2017





40. M/s. Digital Imaging System,

Traveller RX Coronary Dilatation


3 years




121 habitat, Shadman II , Ghaus-ul-Azam Road,Lahore

Responsible Manufacturer:M/s Abbott Vascular,3200 Lakeside Drive, Santa Clara, California 95054, USA.Manufacturing Site:M/s Abbott Vascular,26351 Ynez road, temecula, CA 92591, USA.

M/s Abbott Vascular Costa Rica, 52 Calle 3, B31, Coyol Free Zone, El Coyol, Alajuela, Costa Rica(Free Sale Costa Rica)

Catheter Policy Board/ Federal Govt.

Letter Issued on 04-02-2017

shortcomings:a. Original and valid



c. Analytical procedure and specification.

41. M/s. Life Cares, M-20 Falaknaz Plaza, Shahra-e-Faisal, Karachi.

Manufactured byM/s. Marflow AG, Soodstrase 57, CH-8134 Adliswil, Zurich, Switzerland.

Urology Catheters


5 years

Applied on 26-3-2014Letter issued on 4.8.2014Letter Issued on 02-02-2017


prescribed Form 5A.



d. Approval of shelf life from regulatory authority or


Stability data to support claimed shelf life.



42. M/s Life CaresM-20, Falaknaz plaza, Shahra-e-Faisal,Karachi.

Manufactured by:M/s Yilson Medical Technology Co., Ltd, 5/F, Fuxuan, Bldg, 28 East Hepping Road, Longhua, New District, Shenzhen Guangdong, China.

PTCA Ballon Catheter (ADVAN) SC/NC/CTO all sizes

3 years

Applied onLetter Issued on 02-02-2017


prescribed Form 5A.






43. M/s Dora Enterprises, 54-B, Model Town, Lahore.

Manufactured by:M/s Giant Medical Equipment

Dora Hemodialysis Catheter Kits



Not mentioned



Free Sale Certificate with clear status as decided above by Registration


(Guangzhou) Co. Ltd, No.10, Juncheng Road, Eastern Area, Economic & Technical Development, District 510760 Guangzhoy, China.

Board.b. Approval of shelf

life from regulatory authority or Stability data to support claimed shelf life.



e. Method of manufacturing and QC Testing.


44. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons, Amangarh, Nowshera.Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way, Marlborough, MA, 01752, USA.Manufacturing Site:M/s. Boston Scientific Limited, Business & Technology Park, Model Farm Road, Cork, IrelandSterilization Site:M/s Synergy Health Ireland Ltd (Formally Known as Isotron Ireland Ltd), IDA Business & Technology

CRE Pulmonary Balloon Dilatation Catheter



03 years








park Sragh Tullamore Co. Offaly, Ireland.

45. M/s F.W Distributors, F.W Building, Opp Poonch House, Adamjee Road, Rawalpindi.

Legal Manufacturer:M/s Coloplast A/S, Holtedam 1, 3050Humlebaek, Denmark.

Supraflow Suprapubic Catheter



Not mentioned

Applied on 27-10-2016Letter issued on 01.2.2017

Deferred for rectification of following shortcomings:a. Copy Valid Drug

Sale License,b. Clinical Data, if

any.

46. M/s Sakuf Trading, 34-G, Phase-1, Commercial Area,Defence Housing Authority, Lahore Cantt.Manufactured By:M/s Balt Extrusion, 10, rue de la Croix Vigneron 95160, Montmorency, France.

Vasco + (Braided Micro Catheters)


- 5 years









B) Stents:

S. Name of Name of Demanded Shelf Date of Decision


# Importer and Manufacture/

Exporter.

Medical Device (s)

price & Pack size

life application / Letter issuance

date1. M/s. Sakuf

Trading,34-G Phase I, Commercial Area, Defence Housing Authority, Lahore Cantt Pakistan.Manufactured by:M/s BALT EXTRUSION, 10, ru de la Croix Vigneron 95160 MONTMORENCY FRANCE.

LEO+ / LEO + Baby Intracranial Stents

Decontrolled till policy decision by the Federal Govt.

05 Years

Applied on 21.11.2016Letter for short comings issued on 02.02.2017








g. Clarification regarding application of 2 products together

2. M/s. Sakuf Trading,34-G Phase I, Commercial Area, Defence Housing Authority, Lahore Cantt.

Manufactured by:M/s BALT EXTRUSION,

Silk + (Intracranial Self Expandable Stents)


05 Years

Applied on 21-11-2016Letter of short comings issued on 02-02-2017




c. Original and valid


10, ru de la Croix Vigneron 95160 MONTMORENCY FRANCE.





3. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons, Amangarh, Nowshera.Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way, Marlborough, MA, 01752, USA.Manufacturing Site:M/s. Boston Scientific Corporation, 780 Brookside Drive, Spencer IN-47460, USA.Sterilization Site:M/s Boston Scientific Coventry, 8 Industrial Drive Coventry, RI 02816, USA.

M/s Synergy

Flexima Biliary Stent with Delivery System



3Years








Health AST Venlo (Formally Known as Isotron Nederland B.V) Faunalaan 38, 5928 RZ Venlo Netherlands.


4. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons, Amangarh, Nowshera.KPKLegal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way, Marlborough, MA, 01752, USA.Manufacturing Site:M/s. Boston Scientific Corporation, 780 Brookside Drive, Spencer IN-47460, USA.Sterilization Site:M/s Boston Scientific Coventry, 8 Industrial Drive Coventry, RI 02816, USA.

M/s Synergy

C-Flex Double Pigtail Biliary Stent



03 Years








Health AST Venlo (Formally Known as Isotron Nederland B.V) Faunalaan 38, 5928 RZ Venlo Netherlands.


5. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons, Amangarh, Nowshera.Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way, Marlborough, MA, 01752, USA.Manufacturing Site:M/s. Boston Scientific Limited, Ballybrit Business Park, Galway, Ireland.Sterilization Site:M/s Synergy Health Wesport Ltd., Lodge Road, Westport Co Mayo, Ireland.

Wallstent Biliary Endoscopic Biliary Endoprosthesis (Uncovered)



24months







6. M/s. Ferozsons Laboratories Limited, P.O.

Wallstent Enteral Endoprosthes


02Years




Ferozsons, Amangarh, Nowshera.Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way, Marlborough, MA, 01752, USA.Manufacturing Site:M/s. Boston Scientific Limited, Ballybrit Business Park, Galway, Ireland.Sterilization Site:M/s Synergy Health Ireland Ltd., (Isotron), IDA Business & Technology Park Co. Offaly, Ireland.

is with Unistep Plus Delivery System (Colonic and Duodenal)


Policy Board/ Federal Government

Letter of shortcomings issued on01.01.2017

shortcomings:a. Original and valid





7. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons, Amangarh, Nowshera.Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way, Marlborough, MA, 01752, USA.Manufacturing Site:M/s. Boston Scientific Corporation, 780 Brookside Drive, Spencer IN-47460, USA.Sterilization

Biliary Stent Introducer



03Years






d. Orignal


Site:M/s Boston Scientific Coventry, 8 Industrial Drive Coventry, RI 02816, USA.




8. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons, Amangarh, Nowshera.Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way, Marlborough, MA, 01752, USA.Manufacturing Site:M/s. Boston Scientific Corporation, 780 Brookside Drive, Spencer IN-47460, USA.Sterilization Site:

RX Biliary Stent with RX Delivery System



03Years






d. Orignal Credentials of


M/s Boston Scientific Coventry, 8 Industrial Drive Coventry, RI 02816, USA.M/s Synergy Health AST Venlo (Formally Known as Isotron Nederland B.V) Faunalaan 38, 5928 RZ Venlo Netherlands.



9. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons, Amangarh, Nowshera.Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way, Marlborough, MA, 01752, USA.Manufacturing Site:M/s. Boston Scientific Corporation, 780 Brookside Drive, Spencer IN-47460, USA.

Advanix Biliary Stent with NaviFlex RX Delivery SystemPre-loaded center bend.



1’s

2 Years






d. Orignal Credentials of manufacture as decided above by


Registration Board.

10. M/s. Ferozsons Laboratories, P.O. Ferozsons, Amangarh, Nowshera.Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way. Marlborough, MA, USA 01752.Manufacturing Site:M/s. Boston Scientific Corporation, two scimed place MAPLE GROVE, MN USA 55311

Epic TM Over The Wire Self- Expanding Nitinol Stent with Delivery System



37 months




b. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board .



11. M/s. Life Cares, M-20 Falaknaz Plaza, Shahra-e-Faisal, Karachi.

Manufactured by:M/s. Marflow AG, Soodstrase 57, CH-8134 Adliswil, Zurich, Switzerland.

Urology Stents


5 years

Applied on 26-3-2014Letter Issued on 04-08-2014 and 02-02-2017.Previously registered in the name of \M/s Burraq International, Lahore in 231st

meeting. Now deregistered.



b. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board

c. Approval of shelf life from regulatory authority or Stability data to support claimed


shelf life.d. Orignal



12. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons, Amangarh, Nowshera.Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way. Marlborough, MA, 01752, USA.Manufacturing Site:M/s. Boston Scientific Corporation, Two Scimed Place, Maple Grove, MN 55311, USA.Sterilization Site:M/s Synergy Health (Tullamore), IDA Business & Technology Park, Tullamore County Offaly, Ireland.

Wallstent-Uni TM

Endoprosthesis Self Expanding Stent



25months






13. M/s B.Braun Pakistan (Pvt) Limited, The Forum Suite # 216, Khayaban-e-Jami, Clifton Block-9, Karachi/Legal Manufacturer:M/s B.Braun Melsungen AG, Caril-Braun-

Coroflex Blue Neo Coronary Stent System(Sizes and codes as per Free Sale Certificate)


2 years



StraBe 1, 34212 Melsungen, Germany.Manufacturing Site:M/s B.Braun Melsungen AG Vascular System Sieversufer 8, 12359 Berlin, Germany.

14. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons, Amangarh, Nowshera.Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way, Marlborough, MA, 01752, USA.Manufacturing Site:M/s. Boston Scientific Corporation, Ballybrit Business Park, Galway, Ireland.

Wallgraft TM

Over The Wire Endoprosthesis with Unistep TM

Plus Delivery System


30months





15. M/s. Ferozsons Laboratories, P.O. Ferozsons, Amangarh, Nowshera.Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way. Marlborough, MA, USA 01752.Manufacturing Site:M/s. Boston Scientific

Express TM Vascular SD Monorail TM Premounted Stent System



37 months






Corporation, Two Scimed Place, Maple Grove, MN 55311, USA.Sterilization Site:M/s BSC Coventry, 8 Industrial Drive Coventry, RI 02816, USA.


16. M/s. Ferozsons Laboratories, P.O. Ferozsons, Amangarh, Nowshera.Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way. Marlborough, MA, USA 01752.Manufacturing Site:M/s. Boston Scientific Corporation, BAllybrit Business Park, Galway, Ireland.Sterilization Site:M/s Synergy Health Ireland Limited (Tullamore) IDA Business & Technology Park, Tullamore,Co, Offaly, Ireland., RI 02816, USA.

Express TM LD Vascular Over The Wire Premounted Stent System



37 months



authorization letter/sole agency agreement from manufacturer as decided above by Registration Board .



17. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons, Amangarh, Nowshera.Legal Manufacturer:M/s Boston

Ultraflex TM Esophageal NG Stent System



02Months



authorization letter/sole agency agreement from manufacturer as


Scientific Corporation, 300 Boston Scientific Way, Marlborough, MA, 01752, USA.Manufacturing Site:M/s. Boston Scientific Limited, Ballybrit Business Park, Galway, Ireland.




18. M/s F.W Distributors, F.W Building, Opp Poonch House, Adamjee Road, Rawalpindi.Legal ManufacturerM/s Coloplast A/S, Holtedam 1, 3050Humlebaek, Denmark.

Biosoft Duo Multi Length Hydro-Coated Urethral Stent Kit Kits (Long Term)



Not mentioned

Applied on 27.10.2016Letter issued on 01-2-2017

Deferred for rectification of following shortcomings:a. Approval of shelf

life from regulatory authority or Stability data to support claimed shelf life.

b. Copy of valid drug sale licence.

19. M/s. Maxims Medical, 534-H Block, St. No.13, Phase 5, DHA, Lahore.Manufactured by:M/s Eurocor GmbH In den Dauen 6a 53117 Bonn Germany.

E Magic PlusDrug Eluting Stent



3 years

Applied on 27-1-2017Letter issued on 01.2.2017Following deficiencies are required:


Form 5A duly signed and stamped.



d. Approval of shelf life from regulatory authority or Stability data to




f. Valid drug sale licence.

20. M/s F.W Distributors, F.W Building, Opp Poonch House, Adamjee Road, Rawalpindi.Legal ManufacturerM/s Coloplast A/S, Holtedam 1, 3050Humlebaek, Denmark.

Double Loop Urethral Stent in PA OR PU (Short Term)



Not mentioned

Applied on 27.10.2016Letter issued on 01.2.2017


Form 5A duly signed and stamped.





f. Valid drug sale licence.

g. Clinical data, if any.


Item No.III: Pharmacy Services Division.

Case No 01: Prevailing capacities of approved Bio-Equivalence study centers in Pakistan

Registration Board in its 265th Meeting held on 24th and 25th January 2017 vide Case

No 04 advised Pharmacy Services Division to present prevailing capacities of approved Bio-

Equivalence Study Centers in Pakistan. Requisite data has been acquired and is asunder:

Sr. No.

Name of centers

Capacity to

conduct studies/

year

Anticipated time to complete one study Operational

Labs

Bed / volunteer capacity

CertificationsSingle Drug

Compound Drug

1

Dr. Panjwani Center for Molecular Medicine and Drug Research, Karachi

5003

Months

04 Months

Microbiological Lab

Analytical LabComputer lab

100

i. ISO 17025: 2005

ii. ISO 9001: 2008

iii. GCP vendor Assessment Certificate by Abbott

2

Pharma Professional Services. Karachi

1203-04 Month

s

03-04 Months

Microbiological Lab


30

Pre-assessment for the ISO–17025 accreditation; by Pakistan National Accreditation Council (PNAC)

3 BeSt Centre, UVAS, Lahore 04

03-04 Month

s

04-05 Months

Microbiological Lab


30 ISO 17025

4

Institute of Biological Biochemical & Pharmaceutical Sciences, Dow University, Karachi

1603-04 Month

s

03-04 Months

Microbiological Lab


28 ISO 17025:2005

5

Pakistan Drug Testing and Research Center, Lahore

1503

Months

03 Months

Microbiological Lab


24

i. ISO 1702-2005 by PNAC

ii. MoU with USP, USA

It has been prayed earlier that the condition of Bioavailability / Bioequivalence studies be

made mandatory to establish interchangeability for multisource generics as per

recommendations of the Drug Registration board according to Biopharmaceutical

classification system (BCS).


Decision: Registration Board deliberated the case in detail that in order to make mandatory conditions of Bio-equivalence/Bioavailability studies of registered drug in accordance with the Biopharmaceuticals Classification System (BCS) as per WHO guideline to establish the interchangeability and to ensure the safety, efficacy and quality of marketed drugs. Registration Board advised Pharmacy Services Division to hold a consultative meeting (after consultation from DRAP) of all stakeholders including approved Bio-equivalence centers to further deliberate future course of action.

Case No. 02 Drug Safety Package Inserts/ Prescribing Information updates of Hepatitis-C Antivirals.

The MHLW and the PMDA (Japan) in May 2016 have announced that the package

insert for various Hepatitis C antivirals (telaprevir, simeprevir sodium, daclatasvir,

asunaprevir, vaniprevir, sofosbuvir, ledipasvir acetonate/ sofosbuvir and ombitasvir) will be

updated to include precautions for use in patients currently infected or with a history of

Hepatitis B Virus infection. Cases of reactivation of Hepatitis B reported with simeprevir,

daclatasvir, asunaprevir, sofosbuvir, and ledipasvir acetonate/sofosbuvir have occurred in

Japan as well as other cases outside Japan.

The Food and Drug Administration (FDA) in October 2016 has advised that a boxed

warning about the risk of Hepatitis B Virus (HBV) reactivation is added to the drug labels of

Direct-Acting Antivirals (DAAs) which are being used to treat chronic Hepatitis C virus

(HCV) infection. HBV reactivation was not reported as an adverse event in the clinical trials

submitted for the DAA approvals because patients with HBV co-infection were excluded

from the trials.

In this regard all those licensee, manufacturing direct-acting antivirals for Hepatitis C

may be advised to:

1. Update the package inserts/ prescribing information to include risk of Hepatitis B Virus (HBV) reactivation and create box warnings as under:

2. PE & R Division (DRAP) may ensure implementation of package inserts/ prescribing information’s update under intimation to Pharmacy Services Division.

Decision: Registration Board deliberated the case and decided as follows;a. Following shall be added to the warnings and precaution section of the

package inserts of all direct acting anti-viral for hepatitis C, including Ledipasvir, Daclatasvir, Ledipasvir-Sofosbuvir, Simeprevir, and Sofosbuvir etc by the concern Registration holder and intimate the package inserts update to the PE & R divisions of the Drug Regulatory Authority of Pakisatan.


PRECAUTIONS FOR USE IN PATIENTS CURRENTLY INFECTED OR HAVE A HISTORY OF HEPATITIS-B VIRUS (HBV), BECAUSE

OF REACTIVATION OF HEPATITIS-B VIRUS

Section of Package Inserts to be Updated

Update Information

Warnings & PrecautionsRisk Of Hepatitis B Virus Reactivations.Risk of hepatitis B virus (HBV) reactivation might occur in patients who have a current or previous infection with HBV and are treated with certain direct-acting antiviral (DAA) medicines for hepatitis C virus like Ledipasvir, Daclatasvir, Simeprevir, and Sofosbuvir etc. Health care professionals should screen all patients for evidence of current or prior HBV infection before starting treatment with DAAs, and monitor patients using blood tests for HBV flare-ups or reactivation during treatment and post-treatment follow-up

b. All the Registration holder of direct acting anti-viral for hepatitis C shall create a boxed warnings in the package inserts to warn the health care professional, about the risk of hepatitis B virus (HBV) reactivation as under:-

WARNINGS: RISK OF HEPATITIS B VIRUS (HBV) REACTIVATION Direct acting anti-viral like Ledipasvir, Daclatasvir, Simeprevir, and

Sofosbuvir etc have been associated with hepatitis B virus (HBV) reactivation in patients who have a current or previous infection with HBV and are treated with certain Direct-Acting Antiviral (DAA) medicines for hepatitis C virus.Health Care Professionals should screen all patients for evidence of current or prior HBV infection before starting treatment with DAAs, and monitor patients through blood tests for HBV flare-ups or reactivation during treatment and post-treatment follow-up.

Case No.03: Drug safety package inserts/ prescribing information updates of the drug oral Ketoconazole

USFDA in 2013 took several actions related to Ketoconazole (Nizoral®) oral tablets,

including limiting the drug’s use by warning that it can cause severe liver injuries, which

may potentially result in liver transplantation or death and adrenal insufficiency by

decreasing the body’s production of corticosteroids. The FDA approved label changes and

added a new Medication Guide to address these safety issues including a strong

recommendation against its use (contraindication) in patients with liver disease, and new

recommendations for assessing and monitoring patients for liver toxicity. As a result,

Ketoconazole oral tablets should not be a first-line treatment for any fungal infection.

Ketoconazole should be used for the treatment of certain fungal infections, known as

endemic mycoses, only when alternative antifungal therapies are not available or tolerated.


According to the FDA, the topical formulations of Ketoconazole have not been associated

with liver damage, adrenal problems, or drug interactions.

On 25 July 2013, the European Medicines Agency’s Committee (EMA) on Medicinal

Products for Human Use (CHMP) recommended that the marketing authorizations of oral

Ketoconazole-containing medicines should be suspended throughout the European Union

(EU). The CHMP concluded that the risk of liver injury is greater than the benefits in treating

fungal infections. The CHMP concluded that, although liver injury such as Hepatitis is a

known side effect of antifungal medicines, the incidence and the seriousness of liver injury

with oral Ketoconazole were higher than with other antifungals. The CHMP was concerned

that reports of liver injury occurred early after starting treatment with recommended doses,

and it was not possible to identify measures to adequately reduce this risk. The Committee

also concluded that the clinical benefit of oral Ketoconazole is uncertain as data on its

effectiveness are limited and do not meet current standards, and alternative treatments are

available. Taking into account the increased rate of liver injury and the availability of

alternative antifungal treatments, the CHMP concluded that the benefits did not outweigh the

risks. Topical formulations of Ketoconazole (such as creams, ointments and shampoos) can

continue to be used as the amount of Ketoconazole absorbed throughout the body is very low

with these formulations. Ketoconazole is an antifungal medicine used to treat infections

caused by dermatophytes and yeasts. The committee approved Ketoconazole HRAa medicine

used to treat adults and children above the age of 12 years with a rare disease of Cushing’s

syndrome because of its greater benefit then risks.

Health Canada in June 2013 has revised to the Product Monograph (PM) regarding

the risk of potentially fatal liver toxicity. Ketoconazole has been associated with rare cases of

serious hepatotoxicity including liver failure and death. The Warnings’ sections of the PM

was updated to include the following additional instructions:

Ketoconazole tablets are indicated for the treatment of serious or life threatening systemic fungal infections and should not be considered for mild to moderate infections.

Oral Ketoconazole has been associated with hepatic toxicity, including cases with fatal outcomes.

Liver function tests should be performed in all patients before starting treatment, at week 2 and 4, and monthly thereafter.

Treatment should be stopped if liver parameters are elevated (> 3 times the normal limit) or if patients develop clinical signs or symptoms consistent with liver disease such as anorexia, nausea, vomiting, jaundice, fatigue, abdominal pain, dark urine, or pale stools.


In this regard all those licensee, manufacturing oral Ketoconazole may be advised to:

1. Update the package inserts/ prescribing information to include the risk of liver injury hepatotoxicity including liver failure and death and create warnings.

2. Create warnings to restrict the use of oral Ketoconazole for the treatment of certain fungal infections, known as endemic mycoses, only when alternative antifungal therapies are not available or tolerated.

3. To add a strong recommendation against its use (contraindication) in patients with liver disease, and new recommendations for assessing and monitoring patients for liver toxicity.

4. With the approval of Drug Registration Board restricting the use of oral Ketoconazole to be used only in the rare disease of Cushing’s syndrome, removing of all its other indications.

5. PE & R Division (DRAP) may ensure implementation of package inserts/prescribing information update under intimation to Pharmacy Services Division.

Decision: Registration Board deliberated the case and decided that a show-cause notice will be served by the concerned registration section to those firms having registration of oral Ketoconazole in Pakistan.


Item No. IV: Pharmaceutical Evaluation & Registration Division.

Items Cases No. of Cases

Item No. 1 Deferred cases 8

Item No. 2 Applications with differential fee submitted up to September, 2015 84

Item No. 3 Anomaly applications which were not included in list I 3

Item No. 4 Applications of new licenses / new sections 34

Item No. 5 Stability Cases 4

Item No. 6 Verification of authenticity of stability study 1

Item No. 7 Import cases 14

Item No. 8 Miscellaneous Cases 2

Total 150


Case No. 01: Deferred casesSr.#

Name and address of

manufacturer / Applicant

Brand Name(Proprietary

name + Dosage Form + Strength)

CompositionPharmacologic

al GroupFinished product

Specification

Type of Form

Initial date, diaryFee

including differential

feeDemanded Price / Pack

size

Remarks on the

formulation (if any)

including International

status in stringent

drug regulatory agencies /

authoritiesMe-too status

GMP status as depicted

in latest inspection

report (with date) by the Evaluator

Previous

Remarks of the Evaluat

or.

Decision

1. M/s AmaanPharma 30km,SheikhupuraRoad Lahore.DML No.000808 dated:25-02-15LiquidInjectionAmpoule(Hormones) No.F.1-6/2013-Lic dated 2nd

March, 2015

Kamelone-25InjectionEach ml contains:NandroloneDecanoate(USP)….25mgAnabolic Steroid(USP)

Form 5Dy.No: 1446Date:06.3.2015Rs.20000/- Rs.60/-Pack of 1×1ml ampoule

Not providedDeca-durabolinInjection (OBSPharma)

249th Meeting Registration Board held on 18-19th May, 2015.Deferred for following:1. Confirmation of formulation in reference drug agencies.2. Clarification from Licensing regarding requirement for manufacturing facility of anabolic steroidal hormones.N.B: (Requirments of LiquidParticle Counter shall be observed as per decision of Registration Board) Division

Evaluation By PEC Firm has provided copy of letter issued by Secretary CLB, dated 02-03-2015, stating

the approval for grant of DML by way of formulation for following sections:i. Liquid Injectable Ampoule (General)

ii. Liquid Injectable Ampoule (Hormone)iii. Liquid Injectable Ampoule (Steroid)

Firm has provided Copy of GMP inspection report conducted on 18-10-2016, confirming the availability of Liquid particle counter

Firm has not provided any evidence of approval by reference regulatory authorities for applied formulation


Decision: Registration Board deferred the case for evidence of approval by reference regulatory authorities.

2. M/s AmaanPharma 30km,SheikhupuraRoad Lahore.DML No.000808 dated:25-02-15LiquidInjectionAmpoule(Hormones) No.F.1-6/2013-Lic dated 2nd

March, 2015

Kamelone-50InjectionEach ml contains:NandroloneDecanoate(USP)….50mgAnabolic Steroid(USP)

Form 5Dy.No: 1467Dated:06-03-2015Rs. 20,000/-Rs.60/-Pack of 1×1ml ampoule

BNF: Deca-Durabolin(MSD)Deca-durabolinInjection (OBSPharma)

249th Meeting Registration Board held on 18-19th May, 2015.Deferred for Clarification from Licensing regarding requirement formanufacturing facility of anabolic steroidal hormones.N.B: (Requirments of Liquid Particle Counter shall beobserved as per decision ofRegistration Board) Division





Decision: Approved3. M/s Amaan

Pharma 30km,SheikhupuraRoad Lahore.DML No.000808 dated:25-02-15LiquidInjectionAmpoule(Hormones) No.F.1-6/2013-Lic dated 2nd

March, 2015

Apelone InjectionEach ml contains:NandrolonePhenpropionate (USP) ….25mgAnabolic Steroid(USP)

Form 5Dy.No: 1463Dated:06-03-2015Rs. 20000/-Rs. 130/-Packof 1ml ×3 ampoule

Not providedDurabolinInjection(OBS)

249th Meeting Registration Board held on 18-19th May, 2015.Deferred for following:1. Confirmation offormulation in reference drug agencies.2. Clarification from Licensing regarding requirement formanufacturing facility of anabolic steroidal hormones.N.B: (Requirments of Liquid Particle Counter shall be observed as per decision ofRegistration


Board) DivisionEvaluation By PEC

Firm has provided copy of letter issued by Secretary CLB, dated 02-03-2015, stating the approval for grant of DML by way of formulation for following sections:

i. Liquid Injectable Ampoule (General)ii. Liquid Injectable Ampoule (Hormone)

iii. Liquid Injectable Ampoule (Steroid) Firm has provided Copy of GMP inspection report conducted on 18-10-2016,

confirming the availability of Liquid particle counter Firm has not provided any evidence of approval by reference regulatory authorities for

applied formulationDecision: Registration Board deferred the case for evidence of approval by reference regulatory authorities.

4. M/s AmaanPharma 30km,SheikhupuraRoad Lahore.DML No.000808 dated:25-02-15LiquidInjectionAmpoule(Hormones) No.F.1-6/2013- Lic dated 2nd

March, 2015

Jaberone InjectionEach ml contains:TestosteroneEnanthate(USP)…250mgAndrogen / SexHormone(USP)

Form 5Dy.No: 1464Dated: 06-03-2015Rs. 20000/-Rs.275/-Packof1ml ×3ampoule

BNF:TestosteroneEnantate (Nonproprietary)TestovironeInjection(Bayer)

249th Meeting Registration Board held on 18-19th May, 2015.Deferred for clarification from Licensing regarding requirement formanufacturing facility of anabolic steroidal hormones.N.B: (Requirements of Liquid Particle Counter shall be observed as per decision of Registration Board) Division





Decision: Approved5. M/s Amaan

Pharma 30km,SheikhupuraRoad Lahore.DML No.000808 dated:25-02-15LiquidInjectionAmpoule(Hormones)

Testerone-100InjectionEach ml contains:Testosteronepropionate(B.P)…30mgTestosteronephenylpropionate(B.P)…60mgTestosteroneIsocaproate(B.P)…60mg

Form 5Dy.No: 1470Dated:06-03-2015Rs. 20000/-Rs. 210/-PackOf 1ml ×3ampoule

BNF: Sustanon250 (MSD)Sustanon (OBS)

249th Meeting Registration Board held on 18-19th May, 2015.Deferred for clarification from Licensing regarding requirement formanufacturing facility of anabolic steroidal hormones.N.B:


No.F.1-6/2013-Lic dated 2nd

March, 2015

TestosteroneDecanoate(B.P)…100mg(Androgen / SexHormone)

(Requirements of LiquidParticle Counter shall be observed as per decision ofRegistration Board) Division





Decision: Approved with Innovator’s specs6. M/s Epharm

Labs, Karachi

Iropharm SyrupEach 5ml contains:-Iron Polymaltose Complex eq. to elemental Iron ……..50mg(Anti anaemic)

Form-529-11-2010Dy No. 767Rs.8000/-Rs.12,000/-04-8-201460mlRs.90.00

Not provided.Rubifer syrup by AGPInspection date 12-04-2011

263rd Meeting Registration Board held on 29-30th November, 2016Deferred for evidence of approval in reference regulatory authorities

Evaluation By PECFollowing reference stated by firm has been verified:“Maltofer syrup by M/s Aspen Pharma, approved by TGA-AustraliaDecision: Approved with Innovator’s specs

7. M/s Epharm Labs, Karachi

Ceftin Injection 250mgEach ml contains:-Cefuroxime as Sodium …..250mg(Antibiotics)Cephalosporin

Form-529-11-2010Dy. No. 2043Rs.8,000/-Rs.12,000/-04-8-201414‘sAs per SRO

Zinacef-MHRADaycef by Shrooq PharmaLast inspection report15-09-2016GMP status is good.

263rd Meeting Registration Board held on 29-30th November, 2016Deferred for clarification of composition as “Each ml contains”

Evaluation By PECFirm has stated that we have applied with following composition:

Ceftin Injection 250mgEach vial contains:-Cefuroxime as Sodium…..250mg

USP monograph for applied formulation is availableDecision: Approved with USP specs


Ceftin Injection 750mgEach ml contains:-Cefuroxime as Sodium …….750mg

Form-529-11-2010Dy No.2042Rs.8000/-Rs.12,000/-04-8-2014N/A

Zinacef by GSK-MHRAZinacef by GSKZecef by BoschLast

263rd Meeting Registration Board held on 29-30th November, 2016

Deferred for clarification of


(Antibiotics)CephalosporinU.S.P. Specs

N/A inspection report15-09-2016GMP status is good.

composition as “Each ml contains”

Evaluation By PECFirm has stated that we have applied with following composition:

Ceftin Injection 750mgEach vial contains:-Cefuroxime as Sodium…..750mg

USP monograph for applied formulation is availableDecision: Approved with USP specs


Case No.02: Applications with differential fee submitted up to September, 2015Sr. #

Name and address of manufactu

rer / Applicant



CompositionPharmacologi

cal GroupFinished product

Specification

Type of Form

Initial date,diaryFee


fee

Demanded Price /

Pack size

Remarks on the



status in stringent drug

regulatory agencies /

authorities

Me-too status

GMP status as depicted in

latest inspection


Remarks of the

Evaluator.

Decision

1. M/s Pakheim International Pharma LahoreContract manufactured byM/s. Friends Pharma Lahore

Ceftiheim 1000mg Injection

Each vial contains:-Ceftriaxone as sodium USP ….1000mg

Cephalosporin

USP Specs

Form 59-8-2010Dy. No. 74628000/-+42000/-19-8-2014As per SRO

Ceftriaxone (IM/IV) by Lupin(USFDA Approved)

Rocephin by Roche

Last inspection report (Friends Pharma)6-10-2016Firm was operating at good level of compliance.

Firm has initial agreement with Synchro Pharma. Now he wants to make agreement with Friends pharma. Agreement Letter is attached.

Firm has Injection (Dry powder Cephalosporin) Section.

Approved

2. M/s Healthtek (Pvt) Ltd.Plot No. 14, Sector 19, Korangi Industrial AreaKarachi

Cefpi 2g InjectionEach vial contains:-Sterile Powder Cefpirome Sulphate MS eq. to Cefpirome …..…2g

(Cephalosporin Antibiotic)

Form-5Duplicate27-12-2010

Rs.8,000/-27-12-2010+Rs.12,000/-18-11-2014

1’s ampouleAs per SRO

Cefrom 2g/20ml by Sanofi Aventis(ANSM France)

Vcef by Bosch

Last inspection report24-5-2016 confirms that overallGMP is good.

Me-too status could not be confirmed

Firm has claimed Mfg. Specs and the product is not present in available versions of BP and USP (B.P 2013 & USP 39)

Deferred for evidence of me-too status

3. M/s Healthtek (Pvt) Ltd.

Slate MR 375mg TabletsEach modified


Alfatil LP 375mg film coated SR

Approved


Plot No. 14, Sector 19, Korangi Industrial AreaKarachi

release film coated tablet contains:-Cefaclor Monohydrate eq. to Cefaclor ………375mg

(Cephalosporin Antibiotics)

USP Specs

Rs.8000/-12-10-2010+Rs.12,000/-18-11-20148’sAs per PAC

tablets by Pharmaceuticals Dexo SA(ANSM Approved)

Ceclor MR 375 mg tab by AGP



Slate MR 500mg TabletEach modified release film coated tablet contains:-Cefaclor Monohydrate USP eq. to Cefaclor ……..500mg

(Cephalosporin Antibiotic)USP Specs


Rs.8000/-30-10-2010+Rs.12,000/-18-11-2014

10’sRs. 475.00

Alfatil LP 500mg film coated SR tablets by Pharmaceuticals Dexo SA(ANSM Approved)

Ceclor MR 500mg tab by AGP


Approved


Slate MR 750mg Tablets

Each modified release film coated tablet contains:-Cefaclor Monohydrate eq. to Cefaclor …………750mg

(Cephalosporin Antibiotics)

USP Specs


Rs.8000/-29-10-2010+Rs.12,000/-18-11-2014

8’sAs per PAC

Alfatil LP 750mg film coated SR tablets by Pharmaceuticals Dexo SA(ANSM Approved)

Ceclor MR 750mg tab by AGP

Last inspection report 24-5-2016 confirms that overallGMP is good.

Approved

6. M/s. Aries Pharmaceuticals (Pvt) Ltd.1-W, Industrial

Rosuvas-10 Tablets

Each film coated tablet contains:-

Form 516-08-2012Dy. No. 771

Rs.8000/-15-8-2012

Crestor 10mg tablets by AstraZaneca(MHRA Approved)

Firm has claimed Mfg. Specs and the product is not present in available

Approved with innovator’s specs


Estate, HayatabadPeshawar, Pakistan

Rosuvastatin ……10mg

(Hypolipidaemics)

+Rs.12,000/-17-07-2014

1x10’sAs Per SRO

Rovista by Getz Pharma

Last inspection report 03-08-2016Stated grant of additional section and renewal of DML.

versions of BP and USP (B.P 2013 and USP 39)

7. M/s. Aries Pharmaceuticals (Pvt) Ltd.1-W, Industrial Estate, HayatabadPeshawar, Pakistan

Macrotac 250mg Tablets

Each film coated tablet contains:-Azithromycin dihydrate equivalent to Azithromycin …250mg

(Macrolide)

USP Specs

Form 5.Dy No. 78715-8-2012Rs.8000/-15-8-2012

+Rs.12,000/-17-07-2014

1x10’sAs Per SRO

Azithromycin 250mg Tablet by Sandoz(MHRA Approved)Azomax tab by Novartis

Last inspection report03-08-2016Stated grant of additional section and renewal of DML

Approved


Macrotac 500mg Tablets

Each film coated tablet contains:-Azithromycin dihydrate equivalent to Azithromycin ….…500mg(Macrolide Antibiotic)USP Specs

Form 516-08-2012Dy No. 774

Rs.8000/- 15-8-2012+12,000/-17-07-2014

1x10’sAs Per SRO

Azithromycin 500mg Tablets by Sandoz(MHRA Approved)

Azomax tab by Novartis

Last inspection report03-08-2016Grant of renewal of DML.

Approved


Droxil 250mg Dry Suspension

Each 5ml contains:-Cefadroxil ……….250mg

(Cephalosporin)

USP Specs

Form 520-01-2011Dy No. 172

Rs.8000/-20-1-2011+Rs.12,000/-17-07-2014

60mlAs Per SRO

Cefadroxil 250mg suspension(MHRA Approved)

Evacef by Highnoon

Last inspection report 03-08-2016Stated grant of additional section & renewal of DML

Approved



Droxil 500mg Capsules

Each capsule contains:-Cefadroxil………….500mg

(Cephalosporin)

USP Specs

Form 520-01-2011Dy No. 171

Rs.8000/-20-1-2011+Rs.12,000/-17-07-2014

2x6’sAs Per SRO

Cefadroxil 500mg Capsule by Sandoz(MHRA Approved)

Cedrox by Platinum

Last inspection report 03-08-2016Stated grant of additional section and renewal of DML

Approved


Flurbisad Tablets 100mg

Each tablet contains:-Flurbiprofen ……….100mg

(Analgesic NSAID)

USP Specs

Form 516-08-2012Dy No. 783

Rs.8000/-15-8-2012+Rs.12,000/-17-07-2014

1x10’s2x10’s3x10’sAs Per SRO

Froben by Mylan(MHRA Approved)

ANSAID Tablet by PfizerLast inspection report03-08-2016Stated grant of additional section and renewal of DML

Approved


Fungitab Tablets 200mg

Each tablet contains:-Ketoconazole…………200mg

(Antifungal agent)

USP Specs

Form 516-08-2012Dy No. 785

Rs.8000/-15-8-2012+Rs.12,000/-17-07-2014

1x10’sAs Per SRO

Ketoconazole 200mg Tablets by Mylan Pharma(USFDA Approved)

Spike by Highnoon

Last inspection report03-08-2016 Stated grant of additional section and renewal of DML.

Deferred for safety reason as discussed in Pharmacy Services agenda

13. M/s. Aries Pharmaceuticals (Pvt) Ltd.1-W, Industrial Estate,

Melox 7.5mg Tablets

Each tablet contains:-Meloxicam …...7.5mg

Form 516-08-2012Dy No. 792

Rs.8000/-15-8-2012Rs.12,000/-

Meloxicam 7.5mg Tablet(MHRA Approved)

Last inspection report 03-08-

Approved


HayatabadPeshawar, Pakistan

(Oxicam NSAID)

BP Specs

17-07-20141x10’sAs Per SRO

2016Stated grant of additional section and renewal of DML.


Melox 15mg Tablets

Each tablet contains:-Meloxicam………..15mg

(Oxicam NSAID)

BP Specs

Form 516-08-2012Dy No. 788

Rs.8000/-15-8-2012+Rs.12,000/-17-07-2014

1x10’sAs Per SRO

Meloxicam 15mg Tablet(MHRA Approved)

Meflex by AGP

Last inspection report03-08-2016Stated grant of additional section and renewal of DML.

Approved


Mebaver Tablets 135mg

Each coated tablet contains:-Mebeverine ………135mg

(Antispasmodic: Gastroprokinetic)

BP Specs

Form 5116-6-2012Dy No. 241Rs.8000/-15-8-2012+Rs.12,000/-17-07-2014

3x10’sAs Per SRO

Colofac Tablets by Mylan(MHRA Approved)Mebrin by paramount Pharma

Last inspection report 03-08-2016Stated grant of additional section and renewal of DML.

Approved


Aceclo Tablets 100mg

Each film coated tablet contains:-Aceclofenac………..100mg

(Phenyl Acetic Acid, Analgesic)

Form 516-08-2012Dy No. 775

Rs.8000/-15-8-2012+Rs.12,000/-17-07-20141x10’s2x10’s3x10’sAs Per SRO

Preservex 100mg tablets by Almirall Ltd.(MHRA Approved)

Acemed by Novartis

Last inspection report03-08-2016Stated grant of additional section

Firm has claimed Mfg. Specs and the product is not present in available versions of BP and USP (B.P 2013 and USP 39)

Approved with Innovator’s specs

17. M/s. Aries Pharmaceuticals (Pvt) Ltd.

Cimedin Tablets 400mg

Each film

Form 516-08-2012Dy No. 777

Tagamet 400mg Tablets by Chemidex Pharma

Approved


1-W, Industrial Estate, HayatabadPeshawar, Pakistan

coated tablet contains:-Cimetidine…………..400mg

(H2 Blocker)

USP Specs

Rs.8000/-15-8-2012+Rs.12,000/-17-07-20141x10’sAs Per SRO

(MHRA Approved)Tagamet by GSK



Destil Tablets 5mgEach film coated tablet contains:-Desloratadine………..5mg

(Antihistamine)

Form 516-08-2012Dy No. 778

Rs.8000/-15-8-2012+Rs.12,000/-17-07-2014

1x10’sAs Per SRO

Neoclarityn 5mg Tablets by MSD(MHRA Approved)Destina by Hilton Pharma

Last inspection report03-08-2016Stated grant of additional section and renewal of DML.




Sulcare Tablets 25mg

Each tablet contains:-Levosulpiride………….25mg

(Antidepressant)

Form 516-08-2012Dy No. 768

Rs.8000/-15-8-2012

+Rs.12,000/-17-07-2014

2x10’sAs Per SRO

Not provided.

Levopraid tab by Pacific Pharma


Formulation is rejected as per 250th DRB meeting

Firm has claimed Mfg. Specs and the product is not present in available versions of BP & USP (B.P 2013 & USP 39)

Deferred for review.


Naproesic 500mg Tablets

Each film coated tablet contains:-Naproxen ………..500mg

(Analgesic NSAID)

USP Specs

Form 516-08-2012Dy No. 741

Rs.8000/-15-8-2012+Rs.12,000/-17-07-2014

2x10’sAs Per SRO

Naprosyn 500mg by Atnahs Pharma(USFDA Approved)

Synflex by ICI

Last inspection report03-08-2016Stated grant of renewal of DML.

Approved

21. M/s Rotexmedica Pakistan

Voxin 500mg CapsulesEach capsule

Form 5Dy. No.

2275

Not provided.

Transamin

Firm has claimed Mfg Specs while

Deferred for evidence of approval by


(Pvt) Ltd, Islamabad

contains:-Tranexamic Acid …… 500mg

(Anti hemorrhagic)

07-2-2011Rs.8000/=07-2-2011

Rs.12,000/=08-12-2014

30’s20’s

As Per PRC

500mg capsule by Hilton

Last inspection report 29-03-2016Panel recommends the issusance of GMP certificate

the product is present in Japanese Pharmacopeia.

Reference Authority status could not be confirmed

reference regulatory authorities

22. M/s Swiss Pharmaceuticals

Utramax 250mg CapsuleEach capsule contains:Tranexamic Acid….250 mg

(Anti hemorrhagic)

Form-5Duplicate28-7-2010Dy.No.1448

Rs.8000/- (Photocopy)+Rs.12,000/-12-11-201420’sRs.130/-

Hexatron capsule 250 mg byNippon Shinyaku Co., Ltd(PMDA Japan)

Transamin 250mg capsule by Hilton Pharma

Last inspection report 19-04-2016Shows acceptable level of GMP compliance.

Firm has claimed Mfg Specs while the product is present in Japanese Pharmacopeia.

Approved

23. M/s Swiss PharmaceuticalKarachi

Utramax 500mg CapsuleEach capsule contains:Tranexamic Acid…..500 mg

(Anti hemorrhagic)


Dy.No.1449Rs.8000/-

(Photocopy)+

Rs.12,000/-12-11-2014

20’sRs.250/-

Cyklokapron in USA

Transamin by Hilton Pharma

Last inspection report 19-04-2016Shows acceptable level of GMP compliance.


Firm has claimed Mfg. Specs while the product is present in Japanese Pharmacopeia.

Deferred for evidence of approval by reference regulatory authorities


Ezidin 2mg Tablet

Each tablet contains:Tizanidine Hydrochloride…2mg(Muscle relaxants)

USP Specs


Dy.No.1440Rs.8000/-

(Photocopy)+

Rs.12,000/-12-11-2014

10’sRs.160/-

Zanaflex 2mg tablet (USFDA Approved)

Agile 2mg tablet by Wilshire

Last inspection report19-04-2016Acceptable level of GMP.

Approved Reference will be sent to Budget & accounts Division for verification of challan & Chairman registration Board will authorise issuance of registration


letter25. M/s Swiss

PharmaceuticalKarachi

Ezidin 4mg Tablet

Each tablet contains:Tizanidine Hydrochloride….4mg

(Muscle relaxants)

USP Specs


Dy.No.1443Rs.8000/-

(Photocopy)+

Rs.12,000/-12-11-2014

10’sRs.290/-

Zanaflex 4mg tablet (USFDA Approved)

Agile Forte 4mg tablet

Last inspection report19-04-2016Shows acceptable level of GMP compliance.

Approved Reference will be sent to Budget & accounts Division for verification of challan & Chairman registration Board will authorize issuance of registration letter


Pulmoflox 250mg InfusionEach 100ml contains:Levofloxacin …250 mg

(Antibiotic)


Dy.No.1439Rs.8000/-

(Photocopy)+

Rs.12,000/-12-11-2014

1x100mlRs.200/-

Levaquin USA

Levocil by CCL

Last inspection report19-04-2016Acceptable level of GMP compliance.

Levofloxacin Injection is present in Japanese Pharmacopeia



27. M/s Swiss Pharmaceutical Karachi

Rozet TabletEach film coated tablet contains:Rosuvastatin calcium eq. to Rosuvastatin…5mgEzetimibe…10mg

(anti hyper lipidimic)

Form-5Duplicate

29-10-2010Dy.No.1881

Rs.8000/-(Photocopy)

+Rs.12,000/-12-11-2014

10’sRs.306

Rosuzet by MSD(TGA Approved)

Rovista EZ by Getz



Approved with innovator’s specs.Reference will be sent to Budget & accounts Division for verification of challan & Chairman registration Board will authorise issuance of registration letter


Rozet TabletEach film coated tablet contains:Rosuvastatin calcium eq. to rosuvastatin ..…10mgEzetimibe ...…10mg

(anti hyper

Form-5Duplicate

29-10-2010Dy.No.1883


+Rs.12,000/-12-11-2014

10’sRs.385


Rovista EZ by Getz

Last inspection report19-04-2016Acceptable


Approved with innovator’s specs.Reference will be sent to Budget & accounts Division for verification of challan & Chairman


lipidimic) level of GMP compliance.

registration Board will authorise issuance of registration letter


Rozet TabletEach film coated tablet contains:Rosuvastatin calcium eq. to rosuvastatin…20mgEzetimibe…10mg

(anti hyper lipidimic)

Form-5Duplicate

29-10-2010Dy.No.1880


+Rs.12,000/-12-11-2014

10’sRs.513


Rovista EZ by Getz



Approved with innovator’s specs.Reference will be sent to Budget & accounts Division for verification of challan & Chairman registration Board will authorize issuance of registration letter


Emycin 250mg CapsuleEach capsule contains:Azithromycin……….250 mg(Antibiotic)

USP Specs

Form-521-05-2012Dy.No.769Rs.8000/-

Rs.12,000/-04-8-2014

6’sRs.200/-

Zithromax 250mg Capsule by Pfizer(MHRA Approved)

Azomax Capsule by Novartis

Inspection date 15-09-2016Firm is operating at Good level of Compliance.

Approved


Emycin DS 500mg CapsuleEach capsule contains:Azithromycin……….500 mg(Antibiotic)USP Specs

Form-521-05-2012Dy.No.770Rs.8000/-

Rs.12,000/-04-8-2014

3’sRs.150/-

Not provided.

Zygrel by Searle

Inspection date 15-09-2016Firm is operating at Good level of Compliance.



32. M/s. Mcolson Research Laboreatories (Pvt) Ltd,

Alfason 0.5mcg TabletsEach tablet contains:-Alfacalcidol…

Form 525-11-2014Dy No. 332800015-01-2011+

N/ABon-One tab by Martin Dow Pharma

Last inspection

Reference Authority status could not be confirmedFirm has

Deferred for formulation review.


Sheihupur ………..0.5mcg

(Vitamin-D Analogue)

1200024-11-201410’sAs Per SRO

report23-06-2-15 confirms that the firm displays a positive attitude towards GMP compliance

claimed Mfg. Specs and the product is not present in available versions of BP and USP (B.P 2013 & USP 39)

33. M/s.Mcolson Research Laboreatories (Pvt) Ltd, Sheihupur

Dexifen Tablets 300mgEach film coated tablet contains:-Dexibuprofen ……..300mg

(NSAID)

Form 515-1-2011Dy No. 1421800015-01-2011+1200024-11-201430’sAs Per SRO

Seractil by Gebro Pharma(MHRA Approved)

Tercica tablet by Sami Pharma

Last inspection report 23-06-2-15 confirms that the firm displays a positive attitude towards GMP compliance



34. M/s. Friends Pharma (Pvt.) Ltd.

Penfred InjectionEach ml containsPentazocine (as lactate)…30mg

Narcotic antagonist/analgesic

BP Specs

Form 531.03.2015Dy. No. 4588000Rs.12000/= 31.03.20151x5’sAs per SRO

Talwin Injection by Hospira Inc(USFDA Approved)

Iscigon by Isis Pharma

Last inspection report 6-10-2016The panel granted the cGMP for export purpose.

Pentazocine is not found in INCB yellow list (for narcotic substances)

Deferred for confirmation of Psychotropic section approval

35. M/s. Wnsfeild Pharmaceuticals, Hattar

Deprelax-50Tablets

Each tablet contains:-Sertraline HCl eq. to Sertraline ……….50mg

(SSRI)

USP Specs

Form 516-4-2012Dy No. 99Rs.8000/-Rs.12000/-26-12-143x10’sAs fixed by Govt.

Zoloft 50mg Tablet by Pfizer(USFDA Approved)

Zoloft by Pfizer

Last inspection report23-11-2016The firm is following cGMP compliance.

Approved


36. M/s Innvotek PharmaceuticalsIslamabad.

Zesty-500 Tablets

Each film coated tablet contains:-Azithromycin Dihydrate USP……500mg

(Antibiotics)USP Specs

Form 5Dy.No.7605-01-2011Rs.8000/=05-01-2011+Rs.12,000/=04-02-20151x10’sAs Per SRO

Zithromax 500mg Tablet by(USFDA Approved)Azomax by Novartis

Last inspection report 14-07-2016The company is complying with GMP requirement

Approved


UDCA-250 Capsules

Each capsule contains:-Ursodeoxycholic Acid BP ……..250mg

(Bile Acids)

BP Specs

Form 5Dy.No.7205-01-2011Rs.8000/=05-01-2011+Rs.12,000/=04-02-20151x10’sAlu Alu packingAs Per SRO

Ursodeoxycholic acid by Concordia(MHRA Approved)

Urso by AGP Pharma

Last inspection report14-07-2016The company is complying with the GMP requirements.

Approved


UDCA-500 Capsules

Each capsule contains:-Ursodeoxycholic Acid USP ..……..500mg

(Bile Acids)

BP Specs

Form 5Dy.No.7705-01-2011Rs.8000/=05-01-2011+Rs.12,000/=04-02-20151x10’sAlu Alu packingAs Per SRO

Not provided.

Urso by AGP Pharma

Last inspection report14-07-2016The company is complying with the GMP requirements.

Reference Authority status is not provided



Clin-V Vaginal CreamEach gram contains:-Clindamycin as Phosphate ……...20mg

(Antibacterial, gynecological)

USP Specs

Form 5Dy.No.7805-01-2011Rs.8000/=05-01-2011+Rs.12,000/=04-02-201540gmAs Per SRO

USFDA-Approved

Clycin-V vaginal cream by Shaigan

Last inspection report14-07-2016The company is complying with the GMP requirements

Cream/Ointment section cannot be confirmed.

Reference Authority status cannot be confirmed

Deferred for confirmation of section approval



Clin-T 1% TopicalLotion

Each ml contains:-

Clindamycin Phosphate eq. to Clindamycin USP…..10mg

(Antibiotic)

Form 5Dy.No.7905-01-2011Rs.8000/=05-01-2011+Rs.12,000/=04-02-201530mlAs Per SRO

Dalacin T Lotion by Pfizer(MHRA Approved)

Dalacin-T by Pfizer

Last inspection report14-07-2016The company is complying with GMP requirements

Lotion section cannot be confirmed.

Topical solution and suspension is available in USP while the innovator product is topical emulsion

Deferred for confirmation of section approval

41. M/s Panacea Pharmaceuticals Islamabad

Fluvox 50mg Tablets

Each tablet contains:-Fluvoxamine Maleate (USP)……50mg(5HT Reuptake Inhibitor)SSRI’sUSP Specs

Form 524-02-2015Dy.No.1078Rs.8000/=+Rs.12,000/=24-02-201510’s60’sAs Per SRO

Luvox Tablets by Ani(USFDA Approved)

Voxamine 50 mg tablet by PharmevoLast inspection report8-12-2016GMP compliant.

Approved

42. M/s. Hamaz Pharma

Zeetop 20mg TabletsEach Tablet Contains:-Zinc Sulphate Monohyrate USP eq. to ….20mg elemental Zinc.(Indirectly-acting sympathomimetic)

BP Specs

Form 503.03.2015Dy. No. 351Rs.8000/=+Rs.12000/-2-3-20151*10’sAs per brandleader

Not ProvidedZindigi by Zafa Pharmaceuticals

Last inspection report26-12-2016The firm is following all the legal aspects of GMP requirements.

Reference Authority status is not provided

Applied formulation is approved by WHO as dispersible tablet

Deferred for confirmation of dosage form whether dispersible tablet or otherwise

43. M/s Shaigan Pharmaceuticals (Pvt) Ltd, Rawalpindi

Brim – 10 TabletsEach tablet contains:-Cyclobenzaprine HCl (USP) ….10mg

(Autonomic Nervous System Drug)USP Specs

Form 527-03-2015Dy.No.1953Rs.8000/=+Rs.12,000/=25-03-20151x10’sAs Per SRO

USFDA Approved

Flexagil by CCL Pharma

Last inspection report17-08-2016The Panel recommended for the grant of 7 new sections.

Approved

44. M/s Tensin – 8 Form 5 USFDA Firm has Approved


Shaigan Pharmaceuticals (Pvt) Ltd, Rawalpindi

TabletsEach tablet contains:-Candesartan Cilexetil….. 8mg(Angiotensin II Receptor Antagonist)

27-03-2015Dy.No.1975Rs.8000/=+Rs.12,000/=25-03-20152x7’sRs. 167

Approved

Advant by Getz Pharma,

Last inspection report 17-08-2016The Panel recommended for the grant of 7 new sections.

claimed Mfg. Specs and the product is not present in available versions of BP and USP (B.P 2013 and USP 39)

with innovator’s specs


Ruwin 200mg Capsules

Each capsule contains:-Cefixime as Trihydrate (USP) ……….. 200mg

(Cephalosporin)USP Specs

Form 527-03-2015Dy.No.1973Rs.8000/=+Rs.12,000/=25-03-20151x5’sRs. 185

Suprax by Lupin PharmaceuticalsIcef Capsule by ICILast inspection report17-08-2016The Panel recommended for the grant of 7 new sections.

Reference Authority status cannot be confirmed.

Deferred for evidence of approval by reference regulatory authorities as stated reference is incorrect


Trulac Ophthalmic SolutionEach ml contains:-Ketorolac Tromethamine (USP)…………..0.50%(Anti-Inflammatory(NSAIDs)

Form 527-03-2015Dy.No.1960Rs.12,000/=+Rs.8000/=25-03-20155ml(LDPE)Rs 120

USFDA Approved

Ketrosan by Sante PharmaDylac by Dyson PharmaLast inspection report17-08-2016The Panel recommended for the grant of 7 new sections.




Eyesoft Gel

Each gm contains:-Polyacrylic Acid BP …2mg

(Acrylic Acid Polymer)

Form 527-03-2015Dy.No.1958Rs.12,000/=+Rs.8000/=25-03-20151*10gm (HDPE)Rs. 180

Viscotears by NovartisUSA/UKViscotears by Novartis

Last inspection report17-08-2016The Panel recommended for the grant of 7 new sections.



Deferred for evidence of approval by reference regulatory authorities as stated reference is incorrect

48. M/s Ltroze 2.5mg Form 5 Femara by Deferred for


Shaigan Pharmaceuticals (Pvt) Ltd, Rawalpindi

TabletsEach tablet contains:-Letrozole (USP) …….2.5mg

(Cytostatics)

USP Specs

27-03-2015Dy.No.1962Rs.8000/=+Rs.12,000/=25-03-20151x10’s3x10’sPrice not mentioned.

Novartis(MHRA Approved)

Femara by NovartisLast inspection report 17-08-2016The Panel recommended for the grant of 7 new sections.

decision regarding requirement of manufacturing facility for Letrozole

49. M/s Shaigan Pharmaceuticals Pvt. Ltd, Rawalpindi

GI Stable CapsulesEach capsule contains:-Saccharomyces Boulardii (Lyophilized)……… 250mg(Probiotics)

Form 528-05-2012Dy.No.1970Rs.8000/+Rs.12,000/= dated25-03-20151x10’sRs. 525 /pack

Proflora B by BioHealth(TGA Approved)

Enflor by Hilton PharmaLast inspection report17-08-2016The Panel recommended for the grant of 7 new sections.


Deferred for comments of Health &OTC Division as per DRAP Act, 2012

50. M/s Global Pharmacetucials Islamabad

Aloram XR 3mg Tablets

Each extended release tablet contains:-Alprazolam ……….. 3mg(Hypnotic)USP Specs

Form 506-10-2010Dy.No.2110Rs.12000/=+Rs.8000/=26-03-201510’s20’s30’sAs Per SRO

USFDA ApprovedXanax by Pfizer

Last inspection report23,24-08-2016GMP Compliance is good

Me too status is not confirmed

Deferred for submission of application on Form 5-D with all required formalities & correction of pharmacological group

51. M/s Global Pharmaceuticals Islamabad

Dikin-T 32mg Tablets

Each film coated tablet contains:-Dihydroartemisinin ….. 32mgPiperaquine Phosphate. 320mgTrimethoprim ………. 90mg

( Antimalarial )

Form 501-12-2010Dy.No.2138Rs.15000/=+Rs.5000/=26-03-20158’s.As Per SRO

USA

Armiqin by Pharmevo

Last inspection report23,24-08-2016GMP Compliance is good

Firm has initially applied it on Form 5D but now firm changed it on form 5.SRA and me too status are not confirmed

Firm has claimed Mfg. Specs and the product is not present in available versions of BP and USP (B.P

Deferred for evidence of approval by reference regulatory authorities/WHO & me-to status as stated reference is not correct


2013 & USP 39)

52. M/s Global Pharmaceuticals Islamabad

Sorias 25mg CapsulesEach capsule contains:-Acitretin ……….. 25mg( Antiposriasis )

USP Specs

Form 513-12-2010Dy.No.2140Rs.12000/=+Rs.8000/=26-03-201510’s30’sAs Per SRO

Soriatane by stiefel labs(USFDA Approved)Acetin 25mg capsule by GenomeLast inspection report 23,24-08-2016GMP Compliance is good

Approved

53. M/s. Friends Pharma Lahore

Antibact CreamEach gram contains:-Fusidic acid….2%

Antibiotic

BP Specs

Form 531-3-2015Dy No. 4598000/+12000/31-3-20151x1’s(15gm)As per SRO

FUCIDIN 2% Cream by Leo Pharma(MHRA Approved)FUCIDIN 2% Cream by LeoLast inspection report6-10-2016The panel grant the cGMP for export purpose.

Firm has topical Cream/Ointment Section

Approved


Somafin Injection 250mg /ml

Each ml contains:-Citicolin (as sodium) …..250mg

Neutrotonic

Form 531-3-2015Dy No. 463Rs 8,000/-23-05-2011+Rs 12,000/-31-3-20151x10’sAs per SRO

Not provided.

Cificolin-H by Pharmark

Last inspection report6-10-2016The panel grant the cGMP for export purpose.

Rs 8000, fee challan is not in original.

Reference Authority status cannot be confirmed.

Firm has claimed Mfg. Specs & product is not present in available versions of BP &USP (B.P 2013 & USP 39)

Deferred for clarification of composition as applied formulation is approved in France with strength of 250mg/2 ml


Tramafac Injection

Each 2ml ampoule containsTramadol Hydrochloride: …….100 mg.

Form 531-3-2015Dy.No.4628000/12000/31-3-20151X5’sAs per SRO

Tramadol hydrochloride 50 mg/ml solution for injection.-MHRA

Tramal by Searle

Last inspection

Firm has injectable section.

Firm has claimed Mfg. Specs and the product is not present in available versions of BP



Opioid analgesic

report 6-10-2016The panel granted cGMP for export purpose.

and USP (B.P 2013 & USP 39)

56. M/s. Friends Pharma (Pvt.) Ltd.

Artemose Dry Suspension

Each 5ml contains:-Artemether……….15mgLumefantrine……..90mg

Antimalarial

Form 531.03.2015Dy. No. 457/R&I8000Rs.12000/=31.03.20151x1’sAs per SRO

Melamet suspension by Advacare Pharma U.S.AArtem Plus by Hilton Pharma

Last inspection report 6-10-2016The panel granted cGMP for export purpose.

Firm has claimed Mfg. Specs and the product is Present in International Pharmacopeia-16

Approved with International Pharmacopeia specs

57. M/s Caraway Pharmaceuticals Rawat.

Cara-Glip 25mg TabletsEach tablet contains:-Sitagliptin ……25mg(Antidiabetic, Hypoglycemic)

Form 510-09-2012Dy.No.3038Rs.8000/=+Rs.12,000/=24-04-201530’sAs Per SRO

Januvia by MSD-MHRASita by CClLast inspection report:9-12-2016Overall GMP compliance was good.

Firm has claimed Mfg. Specs and the product is present in USP 39

Approved with USP specs


Cara-Glip 50mg TabletsEach tablet contains:-Sitagliptin ……..50mg(Antidiabetic, Hypoglycemic)


Januvia by MSD-MHRASita-CCl

Last inspection report:9-12-2016Overall GMP compliance was good.




Caravil 50mg TabletsEach tablet contains:-Vildagliptin……50mg(Antidiabetic, Hypoglycemic)


Galvus by Novartis (MHRA Approved)Galza by CCL

Last inspection report: 9-12-2016Overall GMP compliance was good.



60. M/s Caraway Pharmaceuticals Rawat

Dicrays 50mg TabletsEach tablet contains:-Diclofenac Sodium ……

Form 516-11-2011Dy.No.3034Rs.8000/=+Rs.12,000/=

MHRA

Artifen by Abbott.Last inspection report:

Firm has claimed Mfg. Specs and the product is present in available

Deferred for clarification of dosage form as reference product is


50mg(Phenylacetic Acid)

NSAID

24-04-201520’sAs Per SRO

9-12-2016Overall GMP compliance was good.


available as delayed release tablets whereas firm has applied plain tablet


Cetazine 10mg TabletsEach tablet contains:-Cetirizine …….. 10mg(Anti Allergic)


Zyrtec(MHRA Approved)Allergo by Pharmix

Last inspection report: 9-12-2016Overall GMP compliance was good.




Tizenax 2mg TabletsEach tablet contains:-Tizanidine …….. 2mg(Skeletal Muscle Relaxant)


Zanaflex 2mg tablet (USFDA Approved)Agile 2mg tablet by Wilshire

Last inspection report:9-12-2016Overall GMP compliance was good.



63. M/s. Alliance Pharmaceuticals, Peshawar

A-Vid 400mg TabletsEach film coated tablet contains:-Ofloxacin ………400mg

(Quinolone)

USP Specs

Form 520-6-2012Dy No. 567Rs.8000+Rs.1200011-6-201510’s(blister pack)As Per SRO

USFDA ApprovedAdiflox by Davis pharma

Last inspection report:24-11-2016Overal GMP is found Satisfactory.



Allispar 100mg TabeltsEach film coated tablet contains:-Sparfloxacin….100mg

(Quinolone Antibiotic)

Form 520-6-2012Dy No 577Rs.8000+Rs.1200011-6-201510’sAs Per SRO

USA

Sparaxin by Abbott

Last inspection report: 24-11-2016Overal GMP is found Satisfactory.


Firm has claimed Mfg. Specs and the product is not present in available versions of BP and USP (B.P 2013 & USP

Deferred for formulation review


39)65. M/s.

Alliance Pharmaceuticals, Peshawar

Allispar 200mg TabeltsEach film coated tablet contains:-Sparfloxacin………..200mg

(Quinolone Antibiotic)

Form 520-6-2012Dy No 577Rs.8000+Rs.1200011-6-201510’sAs Per SRO

Zagam by Mylan(USFDA Approved but Discontinued)

Spactrum by TAGMALast inspection report:24-11-2016Overal GMP is found satisfactory


Deferred for formulation review


Tprim 50mg Tablets

Each film coated tablet contains:-Topiramate …50mg

(Antipsychotic)

Form 520-6-2012Dy No 575Rs.8000Rs.1200011-6-20151x10’s2x10’s3x10’s6x10’sAs Per SRO

Topamax-MHRALegent by Amarant

Last inspection report:24-11-2016Overal GMP is found satisfactory




Astofin Syrup

Each 5ml contains:-Ketotifen as Hydrogen Fumarate ………..1mg

(Histamine H1 receptor antagonist)

Form 520-6-2012Dy No. 570Rs.8000/-Rs.1200011-6-201560ml120ml90ml250ml450mlPrice not mentioned

Zaditen Syrup of M/s Teva-Health Canada approved

Aria by Highnoon





Allzopic 2mg Tablets

Each film coated tablet contains:-Eszopiclone ………..2mg

(Hypnotics, Sedative)USP Specs

Form 520-6-2012Dy No. 576Rs.8000/-Rs.1200011-6-20151x10’s2x10’sAs Per SRO

Eszopiclone Tablet-USFDA

Clonexa 2mg Tablets by ATCO


Eszopiclone is not present in INCB Green list

Approved



Alpride 25mg TabletsEach film coated tablet contains:-Levosulpiride….25mg(Antidepressant)

Form 520-6-2012Dy No. 566Rs.8000/-Rs.1200011-6-20151x10’s2x10’sAs Per SRO

Not provided.

Levoma by GenomeLevopride by Pacific

Last inspection report:24-11-2016Overal GMP is found satisfactory

Formulation is rejected as per 250th DRB meeting


Deferred according to decision of 250th RB meeting as the formulation is not available in reference drug regulatory agencies.

70. M/s. Don Valley Pharma.

Atostat Tablet 40mgEach tablet contains:-Atorvastatin ………..40mg(HMG-CoA reductase inhibitor, Anti lipemic)

Form 512.08.2015Dy. No. 348Rs.8000/-+Rs.12000/12.08.201510’sAs per brand leader

USFDA

Cholestor by PDHLast inspection report24-8-2015Granted CGMP certificate (Valid for 1 year)



71. M/s. Don Valley Pharma.

Cardiopil TabletEach tablet contains:-Carvedilol……….12.5mg

Alpha adrenergic blocker(Anti-hypertensive)

Form 512.08.2015Dy. No. 347Rs.8000/Rs.12000/= 12.08.201510’sAs per SRO

Carvedilol tablet-MHRADilatrend by Martin Dow

Last inspection report 24-8-2015Granted CGMP certificate (Valid for 1 year)



72. M/s Valor Pharmaceuticals Islamabad.

Adoderm Cream 0.1%Each tube contains:-Methyl Prednisolone Aceponate …….0.1%

(Corticosteroids)

Form 506-04-2015Dy.No.2346Rs.8000/=Rs.12,000/=06-04-20151*1’sN/A

Advantan 0.1% CreamBayer (TGA)Advantan by Bayer Health Care

Last inspection report:01-08-2016 shows that overall GMP compliance is good.



73. M/s Shaigan Pharmaceuticals (Pvt)

Bliss 200mg TabletsEach film coated tablet

Form 527-03-2015Dy.No.1956Rs.8000/=

Plaquenil by Concordia PharmaUSFDA

Approved


Ltd, Rawalpindi

contains:-Hydroxychloroquine Sulfate (USP) ……. 200mg

(Anti-Malarial, Anti-Rheumatic)USP Specs

+Rs.12,000/=25-03-20153x10’sRs 270

HCQ 200 by Getz Pharma

Last inspection report 17-08-2016Grant of additional section


Boost-D SuspensionEach 5ml contains:-Ossein Mineral Complex…250mgVitamin-D …400 IU

( Minerals + Vitamin-D Supplement)

Form 527-03-2015Dy.No.1980Rs.12,000/=+Rs.8000/=25-03-201560 mlRs.120

Not provided.

Bonmin by S.J. & G Fazul Ellahie

Last inspection report17-08-2016Grant of additional section


Atomic absorption is given in equipment list.


Deferred for submission of complete formulation of Ossein Mineral complex


Dvit 1g InjectionEach ml contains:-Cholecalciferol (BP)……1g

( Vitamin D Analogue)


Clacijex in USA,EU

Calcijex by Abbott PharmaBonky by RG Pharma

Last inspection report 17-08-2016Grant of additional section.

The SRA and Me too provided are that of calcitriol which is 1, 25-dihydroxycholecalciferol (vitamin D).

SRA and Me too in this strength not found. (1mcg/ml)


Deferred for evidence of approval by reference regulatory authorities & me-too status as stated reference is not correct

76. M/s Shaigan Pharmaceuticals (Pvt)

Pegalin – 100 CapsulesEach capsule contains:-

Form 527-03-2015Dy.No.1969Rs.8000/=

Lyrica by PfizerUSFDA

Firm has claimed Mfg. Specs and the product is not



Ltd, Rawalpindi

Pregabalin …….. 100mg

(Anticonvulsant)

+Rs.12,000/=25-03-2015Rs. 325/2x7’s

Gabica by Getz Pharma


present in available versions of BP and USP (B.P 2013 & USP 39)


Tensin – 16 Tablets

Each tablet contains:-Candesartan Cilexetil 16mg

(Angiotensin II Receptor Antagonist)

Form 515-11-2010Dy No. 1951Rs.8000/=+Rs.12,000/=25-03-20152x7’s/ Rs. 300

Atacand by AstrazenecaUSFDA

Advant by Getz Pharma,





Temprin TabletsEach tablet contains:-Artemether ………. 20mgLumefantrine …….120mg

(Anti-Malarial)

Form 527-03-2015Dy.No.1964Rs.8000/=+Rs.12,000/=25-03-20152x28’sRs 272

Coartem by NovartisUSFDAArtheget by Getz



Approved with USP pharmacopoeia specs

79. M/s.CCL Pharma Lahore

Orinase-Met 1/850 TabletEach tablet contains:-Glimepiride …..1mgMetformin HCl USP extended release ……850mg

(anti-diabetic)

Form528-10-2014Dy No. 1498000+1200028-10-20143x10’sAs per brand leader

Not provided

Getfomin by Getz Pharma

Last inspection report 21-03-2016For renewal of DML.


Me too not available in this strength. (available in 1/500 mg, 2/500 mg)



80. M/s.CCL Pharma

Orinase-Met 2/850 Tablet

Form528-10-2014

Exermet mfgd by Cipla

Reference Authority

Deferred for evidence of


Lahore Each tablet contains:-Glimepiride …..2mgMetformin HCl USP extended release ……850mg

(anti-diabetic)

Dy No. 1508000+1200028-10-20143x10’sAs per brand leader

India



status could not be confirmed



approval by reference regulatory authorities & me-too status as stated reference is not correct


Orinase- Met ER 2/1000 TabletEach tablet contains:-Glimepiride …..2mgMetformin HCl USP extended release ……1000mg

(anti-diabetic)

Form528-10-2014Dy No. 14880001200028-10-20143x10’sAs per brand leader

N/A








Orinase-Met ER 1/1000 TabletEach tablet contains:-Glimepiride …..1mgMetformin HCl USP extended release ……1000mg(anti-diabetic)

Form528-10-2014Dy No. 14780001200028-10-20143x10’sAs per brand leader

N/A





Firm has claimed Mfg. Specs and the product is not present in available



versions of BP and USP (B.P 2013 & USP 39)


Donzil 5mg TabletsEach tablet contains:-Donepezil HCl ………… 5mg

Acetyl Cholinesterase Inhibitor

USP Specs

Form 524-02-2015Dy.No.1076Rs.8000/=Rs.12,000/=24-02-201510’s20’s30’sAs Per SRO

Aricept by EisaiUSFDA

DoneceptBy Atco Pharma

Last inspection report8-12-2016GMP status:Good.

Approved


Clofin 50mg TabletsEach tablet contains:-Clomiphene Citrate ….. 50mg

(Estrogen receptor inhibitor)

USP Specs

Form 516-02-2015Dy.No.970Rs.8000/=Rs.12,000/=16-02-201510’s20’s30’sAs Per SRO

Clomid by Sanofi AventisUSFDA

Cerophene by Hilton

Last inspection report 8-12-2016GMP status: Good.

Deferred for decision regarding requirement of manufacturing facility for Clomiphene Citrate

Case No. 3: Anomaly applications which were not included in List-ISr. #

Name and address of






Specification

Type of Form



fee

Demanded Price /

Pack size

Remarks on the

formulation (if any) including International



authorities

Me-too status


latest inspection


Remarks of the

Evaluator.

Decision

1. M/s. Medisearch Pharmaceuticals Private Limited, Lahore

Calxone 250mg Injection IV/IMEach vial contains:-

Form-525-04-2013Dy No. 2840Rs.8,000/- to be

Rocephin by Roche(MHRA Approved)

Rocephin

Deferred for last GMP inspection report of M/s McOlson Research


Contract manufactured by M/s McOlson Research Laboratories (Pvt) Ltd. Sheikhupura

Ceftriaxone Sodium eq. to Ceftriaxone USP…250mg

CephalosporinUSP Specs

confirm+Rs.42,000/-25-04-20131’sAs Per SRO

500mg by Roche

Last inspection report (McOlson)23-06-2-15 confirms that the firm displays a positive attitude towards GMP compliance

Laboratories conducted within one year

2. M/s. Medisearch Pharmaceuticals Private Limited, LahoreContract manufactured by M/s. McOlson Research Laboratories (Pvt) Ltd. Sheikhupura

Calxone 500mg Injection IV/IMEach vial contains:-Ceftriaxone Sodium eq. to Ceftriaxone USP…500mg

Cephalosporin

USP Specs

Form-525-04-2013Dy No. 2839Rs.8000/- to be confirm+Rs.42000/-25-04-20131’sAs Per SRO


Xone-Star 250mg Injection by M.s Mediate Pharmaceuticals

Last inspection report (McOlson)23-06-2-15 confirms that the firm displays a positive attitude towards GMP compliance.

Deferred for last GMP inspection report of M/s. McOlson Research Laboratories conducted within one year

3. M/s. Medisearch Pharmaceuticals Private Limited, LahoreContract manufactured by M/s. McOlson Research Laboratories (Pvt) Ltd. Sheikhupura

Calxone 1gm Injection IV/IMEach vial contains:-Ceftriaxone Sodium eq. to Ceftriaxone USP…1gm

Cephalosporin

USP Specs

Form-525-04-2013Dy No. 2838Rs.8000/- to be confirm+Rs.42000/-25-04-20131’sAs Per SRO


Rocephin 1gm by Roche

Last inspection report (McOlson)23-06-2-15 confirms that the firm displays a positive attitude

Deferred for last GMP inspection report of M/s. McOlson Research Laboratories conducted within one year


towards GMP compliance


Case No. 4: Applications of New licenses / New sectionsSr.#

Name and address of manufact

urer / Applicant


name + Dosage Form +

Strength)Composition

Pharmacological GroupFinished product

Specification

Type of FormInitial date,

diaryFee including differential

feeDemanded

Price /Pack size

Remarks on the




authorities

Me-too status


latest inspection


Remarks of the Evaluator.

Decision

New LicenseCase-1 M/s Biorific Pharmaceuticals (Pvt) LtdThe CLB in its 250th meeting held on 27th October 2016 has considered and approved the grant of Drug Manufacturing License (by way of formulation) letter No. F.1-48/2003-lic with following section:Dry powder Section (Veterinary)Liquid Syrup Section (Veterinary)Now the firm has applied for following products/molecules in each sectionDry powder Section (Veterinary) 9 Products / 9 moleculesLiquid Syrup Section (Veterinary) 7 Products/6molecule

Dry powder Section (Veterinary) 9 Products/ 9 molecule1. M/s.

Biorific Pharma,Plot No.143, Industrial Triangle Kahuta Road, Islamabad.

Doxic Dry PowderEach 100gm powder contains:-Doxycycline HCI……50g(Antibiotic)

Form-514.12.2016.Dy. No.392Rs.20,000/-Decontrolled100g500g1Kg

Not ProvidedSeldox Powder by Selmore Pharma (Reg No 058717)

Inspection Report dated 21-10-2016 that overall evaluation and inspection as Good.

Provided me too status has Doxycycline Hyclate while Doxic dry powder has Doxycycline HCl.

Firm has claimed USP Specs and the product is not present in available versions of BP and USP (B.P 2013 and USP 39)

Approved

2. M/s. Biorific Pharma,Plot No.143, Industrial Triangle Kahuta Road,

ENCOF Dry PowderEach 100g powder contains:- Enramycin…….4% (w/w)(Antibiotic)

Form-514-12-2016.Dy. No.393Rs.20,000/-Decontrolled \ pack

Not Provided

Endradin by ICI

Inspection Report dated 21-10-2016 stated that

Me too status cannot be confirmed.

Firm has claimed Mfg. Specs and the product is not present in available versions of BP

Deferred for evidence of me-too status as stated reference is not correct


Islamabad. size100g500g1Kg

overall evaluation and inspection as Good.

and USP (B.P 2013 and USP 39)

3. M/s. Biorific Pharma,Plot No.143, Industrial Triangle Kahuta Road, Islamabad.

Renflush (Vet) PowderEach 100g powder contains:-Ammonium Chloride ………45gMagnesium Sulphate ………25gSodium Sulphate ……………25gSorbitol …………5g(Detoxification, Nephritid & hepatitis/ Laxatives, antacid)

Form-514.12.2016.Dy. No.394Rs.20,000/- Decontrolled\ pack size100g500g1Kg

Not Provided

Renal Powder by Biolab (Reg no 143173)Inspection Report dated 21-10-2016 that overall evaluation and inspection as Good.


Deferred for review of formulation by Dr. Qurban Ali (Member Registration Board)


Sondex (Vet) Dry PowderEach g powder contains:-Neomycin Sulphate …….…60mgOxytetracycline HCI ……….…200mgStreptomycin Sulphate ……20mg(Antibiotic)

Form-514.12.2016.Dy. No.395Rs.20,000/-Decontrolled\ pack size100g500g1Kg

Not Provided

Neostrep Powder by Attabak Pharma (Reg no 075720)


Firm has claimed USP. Specs and the product is not present in available versions of BP and USP (B.P 2013 and USP 39)

Deferred for review of formulation by Dr. Qurban Ali, (Member Registration Board)


SP-COX Dry PowderEach 100g powder contains:-Sulfachlorpyrazine SAodium HCI eq. to..... 30g(Antibacterial)

Form-514.12.2016.Dy. No.396Rs.20,000/-Decontrolled\ pack size100g500g1Kg

Not Provided

Chloricox by Intervac pharma (Reg no 046596)



Approved



Tycotop (Vet) Dry PowderEach g powder contains:-Doxycycline HCI ………400mgTylosin Tartrate ………...200mg(Antibiotics)

Form-514-12-2016.Dy. No.397Rs.20,000/-Decontrolled\ pack size100g500g1Kg

Not ProvidedDoxityl by ICI

Inspection Report dated 21-10-2016 stated that overall evaluation and inspection as Good.

Me too status cannot be confirmed


Approved


Vitafic (Vet) Dry PowderEach 100g powder contains:-PotassiumCitrate …….18gSodium Citrate ……..12gVit.B1 ……….0.03gVit.B2…..…0.015gNicotinamide.…0.32gMenadioneBisulphate .0.115gVitamin C……1.1g(Multivitamins)

Form-5Decontrolled\ pack size100g500g1Kg 14-12-2016.Dy. No.398Rs.20,000/-

Not Provided

Methex powder by univet pharma






Ronlex (Vet) Dry PowderEach 1000g powder contains:-Tylosine Tartrate ……………38gSulfamethoxy Pyridazine Sodium …………...75gTrimethoprim …….…15gPhenylbutazone Sodium….…25gGuaifenesin……10g(Antibiotics)

Form-514-12-2016.Dy. No.399Rs.20,000/-Decontrolled\ pack size100g500g1Kg

Samyang AnIpharma co., Ltd

Cotrizyn Plus Oral Powder by Biolab Pharma


Me-too is not confirmed.



9. M/s. Biorific Pharma,Plot No.143, Industrial Triangle Kahuta

DOT-C PowderEach 1000g powder contains:-Doxycycline Hcl …….400gmTylosine Tartarate …200gmColistin

Form-514-12-2016.Dy. No.404Rs.20,000/-New

Not Provided

Mexin plus by Meidcure Labs (Reg no 058956)

Firm has claimed USP. Specs and the product is not present in available versions of BP and USP (B.P 2013 and USP

Deferred for review of formulation by Dr. Qurban Ali, (Member


Road, Islamabad.

Sulphate .........1000 MIUBromhexine Hcl …10gmAntibiotic/Expectorant

License Decontrolled\ pack size100ml500ml1000ml

Inspection Report dated 21-10-2016 stated that overall evaluation and inspection as Good.

39) Registration Board)

Liquid Syrup Section (Veterinary) 7 Products/6molecule


Trimzin SuspensionEach 100ml contains:-Trimethoprim B.P. (Vet)……8%Sulphadiazine B.P. (Vet)…..40%(Antibiotic/Folic Acid Antagonists)

Form-5New License14.12.2016.

Dy. No.400Rs.20,000/-100ml500ml1000ml

Not provided

Trytont by ICI pakistan






Rofloc LiquidEach 100ml contains:-Enrofloxacin…………10% (w/v)Colistin Sulphate.......400 MIU(Antibiotic/Floroquinolone)

Form-514.12.2016.Dy. No.402.Rs.20,000/Decontrolled\ pack size100ml500ml1000ml

Not Provided

Enrotin Solution by Attabak pharma (Reg no 049793)Inspection Report dated 21-10-2016 that overall evaluation and inspection as Good.

Enrotin (Me too) contains Colistin Sulphate 50MIU while Rofloc contain 400MIU.




Rofin LiquidEach 100ml liquid contains:-Florofenicol…………..11% w/v(Antibiotics)

Form-514.12.2016.

Dy. No.403Rs.20,000/-Decontrolled\ pack size100ml500ml1000ml

Not ProvidedNaflofas Oral liquid by Intervac Pharma




Approved

13. M/s. Florific Liquid Form-5 Nuflor 2.3% Firm has claimed Approved


Biorific Pharma,Plot No.143, Industrial Triangle Kahuta Road, Islamabad.

Each 100ml liquid contains:-Florofenicol…23gm(Antibiotics)

14.12.2016.Dy. No.405Rs.20,000/-Decontrolled\ pack size100ml500ml1000ml

by Intervec Inc. FDA

Floroforte by D-maarson Pharma (Reg no 074073)


Mfg. Specs and the product is not present in available versions of BP and USP (B.P 2013 and USP 39)


Ensufic LiquidEach ml contains:-Enrofloxacin..... 75mgSulfamethoxy pyridazine…75mgSulfamethazine ………50mgTrimethoprim..25mg(Antibiotics)

Form-514-12-2016.Dy. No.406Rs.20,000/-New License2. Decontrolled\ pack size100ml500ml1000ml

Not Provided

Cinafas by Intervac



Firm has claimed BP. Specs and the product is not present in available versions of BP and USP (B.P 2013 and USP 39)



Bromix (Vet) LiquidEach ml liquid contains:-Bromhexine HCI …………20mgMenthol…….40mg(Expectorant)02 years

Form-514-12-2016.Dy. No.407Rs.20,000/-New License2. Decontrolled\ pack size100ml500ml1000ml

Spectra Brom-M by SpectraVet

Bro man by D-Maarson Pharma (Reg no 073994)



Approved

16. M/s. Biorific Pharma,Plot No.143,

ACEDEX LiquidEach 1000ml contains:-Propylene glycol……..12000

Form-514-12-2016.Dy. No.408

Tx-nil-t by Ekspol Pharma polandPresti-E by

SRA and me too status cannot be confirmed.Firm has claimed BP. Specs and

Deferred for review of formulation by Dr.


Industrial Triangle Kahuta Road, Islamabad.

mgAmmonium propionate....10000mgSorbitol……1000mg Vitamin E....20000mgPotassium.....10000mg(Treatment of bovine ketosis Acetonemia)

Rs.20,000/-Decontrolled\ pack size100ml500ml1000ml

Eksfol pharma


the product is not present in available versions of BP and USP (B.P 2013 and USP 39)

Qurban Ali, (Member Registration Board)

Case-2 M/s Genetics Pharmaceuticals (Pvt) LtdM/s Genetics Pharmaceuticals (Pvt) Ltd was issued new DML for Tablet (General) and Capsule (General Section) dated 25-08-2016 in248th CLB meeting held on 13th July 2016.

The following products were presented in 264th DRB meeting1. Tablet (General) Section- 18 Products (5 Molecules)2. Capsule (General) Section- 9 products (2 Molecules)

Now, following few more products are evaluated and added in 266th DRB meeting1. Tablet (General) Section- 10 Products (3 Molecules)2. Capsule (General) Section- 8 products (2 Molecules)

1. Tablet (General) Section- 10 Products (3 Molecules)

17. M/s. Genetics Pharmaceuticals (Pvt) Ltd. 539-A Sundar Industrial Estate, Lahore

DIBIAN 10mg Tablets

Empagliflozin

Each Film Coated Tablet contains: Empagliflozin ……..10 mg

Sodium Glucose Co-transporter 2 (SGLT2) Inhibitors

Form 5-DDy No. 43717-11-2016PKR 50,000/-9-11-201610’s14’s20’s28’sPrice AS Per SRO

Jardiance by Boehringer Ingelheim USFDA

N/A

Firm has been granted new DML dated 25-08-2016

Stability data along with relevant documents are not provided.


Deferred for submission of stability data as per guidelines of 251st

DRB meeting


DIBIAN 25mg Tab

Each Film Coated Tablet contains: Empagliflozin .…..25 mg

Sodium Glucose Co-transporter 2 (SGLT2) Inhibitors

Form 5-DDy No. 44317-11-2016PKR 50,000/-9-11-201610’s14’s20’s28’s

Price AS Per SRO

Jardiance by Boehringer Ingelheim USFDA

N/A





DRB meeting



LURAX 80mg Tab

Each Film Coated Tablet contains:Lurasidone Hydrochloride ……80 mg

Atypical Antipsychotic

Form 5-DDy No. 46417-11-2016PKR 50,000/-9-11-201610’s14’s20’s28’sAs per SRO

USFDA approved

N/A


The product is not present in INCB Green List




DRB meeting


LURAX 120mg tab

Each Film Coated Tablet contains: Lurasidone Hydrochloride …..120 mg


Form 5-DDy No. 45017-11-2016PKR 50,000/-9-11-2016

10’s14’s20’s28’s

As per SRO

Latuda by Sunovion Pharms InC,USFDA approved

N/A






DRB meeting


LURAX 60mg tab

Each Film Coated Tablet contains:Lurasidone Hydrochloride …….60 mg

Form 5-DDy No. 46717-11-2016PKR 50,000/-9-11-2016

10’s14’s20’s28’s

As per SRO


N/A






DRB meeting

22. M/s. Genetics Pharmaceuticals (Pvt) Ltd. 539-A

LURAX 40mg Tab

Each Film Coated Tablet contains: Lurasidone Hydrochloride

Form 5-DDy No. 46817-11-2016PKR



Stability data along with relevant

Deferred for submission of stability data as per


Sundar Industrial Estate, Lahore

…….40 mg


50,000/-9-11-2016

10’s14’s20’s28’sAs per SRO

N/A


documents are not provided.


guidelines of 251st

DRB meeting


LURAX 20mg TabEach Film Coated Tablet contains: Lurasidone Hydrochloride ……20 mg


Form 5-DDy No. 46217-11-2016PKR 50,000/-9-11-2016

10’s14’s20’s28’s

As per SRO


N/A






DRB meeting


SAPHRIN 10mg Tab

Each Sublingual Tablet contains: ASENAPINE (as maleate) ….10mg

Atypical antipsychotic

Form 5-DDy No. 43617-11-2016PKR 50,000/-9-11-2016

10’s14’s20’s28’s

Price As per SRO

Saphris by Forest Labs LLC, USFDA

N/A






DRB meeting


SAPHRIN 2.5mg Tab

Each Sublingual Tablet contains:Asenapine (as maleate)….2.5mg


Form 5-DDy No. 46517-11-2016PKR 50,000/-9-11-2016

10’s14’s


N/A




Firm has claimed Mfg. Specs and the product is not present in


DRB meeting


20’s28’s

Price As per SRO

available versions of BP and USP (B.P 2013 and USP 39)


SAPHRIN 5mg TabEach Sublingual Tablet contains:Asenapine (as maleate) …….5 mg


Form 5-DDy No. 46317-11-2016PKR 50,000/-9-11-2016

10’s14’s20’s28’s

Price As per SRO


N/A






DRB meeting

Capsule (General) Section- 8products ( 2 Molecules)27. M/s.

Genetics Pharmaceuticals (Pvt) Ltd. 539-A Sundar Industrial Estate, Lahore

ALZAR 21/10mg Cap

Each Extended release Capsule contains: Memantine Hydrochloride ……21mg, (Extended Release Pellets 10%w/w), Donepezil Hydrochloride………....10mg

NMDA receptor Antagonist

Form 5-DDy No. 444 17/11/2016Fee 50,000/-9-11-2016Rs 50,00022-12-201610’s14’s20’s28’s

Price as per SRO

Namzaric Capsule by Forest Lab USFDA

N/A




GMP of Alphamed, Formulations, India is attached. Valid upto 27-12-2016. (GMP is expired).

COA of pellets is attached.


DRB meeting

28. M/s. Genetics Pharmaceuticals (Pvt) Ltd. 539-A Sundar Industrial Estate,

ALZAR 14/10mg CapEach Extended release Capsule contains: Memantine Hydrochloride…….14 mg,(Extended Release Pellets),

Form 5-DDy No. 442 17/11/2016Fee RS 50,000/-9-11-2016


N/A

Firm has been granted


Firm has claimed Mfg. Specs and the product is not present in


DRB Minutes for 266th Meeting of Registration Board. 156

Lahore Donepezil Hydrochloride…….10mg


Fee Rs 50,00022-12-201610’s14’s20’s28’s

Price as per SRO

new DML dated 25-08-2016

available versions of BP and USP (B.P 2013 and USP 39)

GMP of Alphamed, Formulations, India is attached. Valip upto 27-12-2016. (GMP is expired).


meeting


ALZAR 28/10mg CapEach Extended release Capsule contains: Memantine Hydrochloride ……..28 mg,(Extended Release Pellets), Donepezil Hydrochloride …….10mg


Form 5-DDy No. 446 17/11/2016Fee RS 50,000/-9-11-2016Fee Rs.50,00022-12-201610’s14’s20’s28’s

Price as per SRO


N/A



Firm has claimed Mfg. Specs and the product is not present in available versions of BP and USP (B.P 2013 and USP 39)GMP of Alphamed, Formulations, India is attached. Valip upto 27-12-2016. (GMP is expired).

COA of pellets is attached imported from India.


DRB meeting


ALZAR 7/10mg CapEach Extended release Capsule contains: Memantine Hydrochloride……7mg,(Extended Release Pellets), Donepezil Hydrochloride…….10mg


Form 5-DDy no. 439 17/11/2016Fee RS 50,000/-9-11-2016Fee Rs 50,00022-12-201610’s14’s


N/A





DRB meeting


20’s28’s

Price as per SRO

GMP of Alphamed, Formulations, India is attached. Valip upto 27-12-2016. (GMP is expired).



CARYLAR 1.5mg CapEach Capsule contains:Cariprazine (As Hydrochloride) …………1.5 mg


Form 5-DDy No. 45317-11-2016PKR 50,00010’s14’s20’s28’s

Price As per SRO

Vraylar by Forest RES INST INC, USFDA approved

N/A






DRB meeting


Carylar 4.5mg Cap

Each Capsule contains: Cariprazine (As Hydrochloride)…....4.5 mg


Form 5-DDy No. 45717-11-2016PKR 50,00010’s14’s20’s28’sPrice As per SRO


N/A






DRB meeting


CARYLAR 3mg Cap

Each Capsule contains:Cariprazine (As Hydrochloride) ……3 mg



Vraylar by Forest RES INST INC,USFDA approved

N/A




Firm has claimed BP. Specs and the product is not present in available


DRB meeting


Price As per SRO



CARYLAR 6mg Cap

Each Capsule contains:Cariprazine (As Hydrochloride) ……6 mg



Price As per SRO


N/S






DRB meeting

Case No. 5 Stability CasesStability Case 1

Sr. No.

Name & Address of

Manufacturer / Applicant

Brand Name(Proprietary Name +

Dosage Form + Strength),

Composition,Pharmacological

Group,Finished Product

Specification

Type of Form,Initial

Diary & Date, Fee (including differential

fee),Demanded Price / Pack

size

International Availability / Local

Availability

GMP Inspection Report Date &

Remarks

Previous DRB Decision / Remarks (if any)

1. M/s Barrett Hodgson Pakistan (Pvt.) Ltd.,

Karachi.

Ocudine Plus Eye Drops

Each ml contains:Olopatadine as HCl…1mgKetorolac Tromethamine…4mg

Anti-inflammatory

Form-5D

Diary No.115/15. AD(II)16-03-2015

Rs. 50,000/-

Rs. 385.50/-5ml(or as per SRO)

Duplicate

Acupat Eye Drops by Allergan, India.

Not applicable

Inspection conducted on 02-02-2016 shows good GMP compliance.

Pharmaceutical Development Studies, Validation of Analytical Methods and Process Validation are not submitted.

Approval of applied formulation in reference authorities has not been not confirmed.


STABILITY STUDY DATA

Drug Ocudine Plus Eye DropsName of Manufacturer M/s Barrett Hodgson Pakistan (Pvt.) Ltd.,


Manufacturer of API Olopatadine HCl: Indoco Remedies Ltd., India.Ketorolac Tromethamine: Hetero Drugs Ltd., India.

API Lot No. Olopatadine HCl: RK15OTH001, RK14OTH001Ketorolac Tromethamine: 2KL0761214, 2KL0680715

Description of Pack(Container closure system) LDPE bottle

Stability Storage Condition Accelerated: 40°C ± 2°C / NMT 25%RHReal Time: 30°C ± 2°C / NMT 35% ± 5%RH

Time Period Accelerated: 6 MonthsReal Time: 6 Months

Frequency Accelerated: 0,4,12,26 (Weeks)Real Time: 0,12,26 (Weeks)

Batch No. EXP-OP-157 PLT-OP-001 PLT-OP-002Batch Size 500ml 1,000ml 1,000mlManufacturing Date February 2015 May 2016 May 2016Date of Initiation February 2015 May 2016 May 2016No. of Batches 03

DOCUMENTS / DATA PROVIDED BY THE APPLICANT

Sr. No. Documents To Be Provided Status

1. COA of API Yes

2.Approval of API by regulatory authority of country of origin or GMP certificate of API manufacturer issued by regulatory authority of country of origin.

Indoco: Name of API (Olopatadine HCl) not mentioned in scope of inspection. Hetero Drugs: Not provided

3. Protocols followed for conduction of stability study and details of tests. Yes

4. Data of 03 batches will be supported by attested respective documents like chromatograms, laboratory reports, data sheets etc. Yes

5. Documents confirming import of API etc. Yes

6. All provided documents will be attested (name, sign and stamp) for ensuring authenticity of data / documents. Yes

7. Commitment to continue real time stability study till assigned shelf life of the product. Yes

8. Commitment to follow Drug Specification Rules, 1978. Yes


REMARKS OF EVALUATOR(AD PEC-I)

GMP Certificate of API Manufacturer:o Indoco: Name of API (Olopatadine HCl) not mentioned in scope of inspection.o Hetero Drugs: Not provided.

Justify the conditions mentioned for Relative Humidity as follows:o Accelerated: NMT 25%RH.o Real Time: NMT 35% ± 5%RH.

Pharmaceutical Development Studies, Validation of Analytical Methods and Process Validation are not submitted.

International availability referred to Acupat by Allergan India.

Decision: Registration Board deferred the case for following points: Evidence of approval for applied formulation by reference regulatory authorities Justification for conditions mentioned for Relative Humidity Analytical method validation data

Stability Case No 2

Sr. No.

Name & Address of






Specification

Type of Form,Initial Diary &

Date, Fee (including

differential fee),Demanded

Price / Pack size

International Availability /

Local Availability

GMP Inspection

Report Date & Remarks

Previous DRB Decision /

Remarks (if any)

1. M/s Helix Pharma (Pvt) Ltd Karachi.

Sofoled 90mg/400mgTabletEach film coated tablet contains:-Ledipasvir……90mgSofosbuvir……400mg(Direct Acting Antiviral)

Form 5-DDairy No. 512dated 11-04-2016Rs.50,000/-As per SROAs per SRO

Harvoni, FDA.Harvoni, Ferozsons, Pakistan.

260th Meeting Registration Board held on 28-29th June, 2016.Deferred for rectification of mentioned deficiencies and submission of stability data


Drug Sofoled tablets 400/90 mgName of Manufacturer M/s Helix Pharma Karachi.Manufacturer of API

Sofosbuvir Ruyuan HEC Pharm Co.,Ltd.Ledipasvir Ruyuan HEC Pharm Co.,Ltd.

API Lot No. Sofosbuvir YAK-EM201602201W1Ledipasvir YAX-201604002R1

Description of Pack(Container closure system) Alu/Alu blister packed in Unit carton with product insert

Stability Storage Condition Real Time: 30°C ± 2°C / 65% ± 5%RHAccelerated: 40°C ± 2°C / 75% ± 5%RH

Time Period Real Time: 6 MonthsAccelerated: 6 Months


Frequency Real Time: 0,1,2,3 & 6 (Months)Accelerated: 0,3 & 6 (Months)

Batch No. TF-001 TF-002 TF-003Batch Size 500 tablets 500 tablets 500 tabletsManufacturing Date June 2016 June 2016 June 2016Date of Initiation June 2016 June 2016 June 2016No. of Batches 03



1. COAs of API Yes


Yes(Copy of GMP

Certificates have been submitted)



5. Documents confirming import of API etc.

Yes(Copy of Invoices Attested by ADC Karachi has been

submitted)



8. Commitment to follow Drug Specification Rules, 1978. Yes

REMARKS OF EVALUATOR(AD PEC-II)

Firm has submitted Stability data as per guidelines of 251st RB meeting. Firm has used Ledipasvir in pure form whereas Innovator has used Ledipasvir Spray dried dispersion

as Ledipasvir is susceptible to the influence of gastrointestinal pH and fed state. Method of dissolution applied in stability study is different from that recommended by USFDA

Decision: Registration Board deferred the case for clarification of following points: Firm has used Ledipasvir in pure form whereas Innovator has used Ledipasvir Spray dried

dispersion as Ledipasvir is susceptible to the influence of gastrointestinal pH and fed state. Method of dissolution applied in stability study is different from that recommended by USFDA


Stability Case 3Sr. No.

Name &Address of






Specification

Type of Form,Initial Diary&

Date, Fee (including

differential fee),Demanded

Price/ Pack size


Local Availability

GMP Inspection


Previous DRB

Decision / Remarks (if

any)

1. M/s The Schazoo Pharmaceutical Laboaratories PVT. LTD. 20kmLahore Jaranwala Road District Sheikhupura.

LIVANZA 30mg Film Coated Tablet, Oral

Each Film Coated Tablet contains;Daclatasvir(as Hydrochloride)…. 30mg

HCV Nucleotide Analogue

Form 5DDy. No. 102323/02/2016

Rs 20,00023/02/2016

Pack size (3 × 10)

Price 7,030/- per pack

Daclinza, MHRA approved

N/A

Last inspection report on 16/01/2010 confirms good level of GMP compliance.

The firm has claimed In House specifications.


Drug Livanza 30mg film coated tablet (Daclatasvir)Name of Manufacturer M/s. The Schazoo Pharmaceutical Laboratories PVT. LTD.Manufacturer of API M/s Laurus Labs Private Limited, IndiaAPI Lot No. ADCTRVSP10050316Description of Pack(Container closure system)

Laminated Aluminum Foil (cold form) Packed in Bleach Board Carton.

Stability Storage Condition Real Time: 30’C +_ 2’C / 65%+_ 5%RHAccelerated: 40’C +_ 2’C / 75%+_ 5%RH

Time Period Real Time:4 MonthsAccelerated:6Months

Frequency Real Time:0,1,2,3,4 (Month)Accelerated:0,1,2,3,4,6,8,12,16,20,24,26 (weeks)

Manufacturing date June 2016 June 2016 June 2016Date of Initiation 28/06/2016 28/06/2016 28/06/2016Batch Nos. LN-T1-16 LN-T2_16 LN-T3-16Batch Size 2500 Tablets 2500 Tablets 2500 TabletsNo. of Batches 03



1. COA of API Yes

2. Approval of API by regulatory authority of country of origin or GMP certificate of API manufacturer issued by regulatory authority of country of origin. Yes







8. Commitment to follow Drug Specification Rules, 1978. No


Fee submitted is only 20,000/- while required fee is 50,000/- as per requirement of form 5D. Provide Analytical Validation & Pharmaceutical Development. Commitment to follow drug specification rules 1978 is not provided. Provided data for long term tem stability is of 4 months while as per requirement data for 6

months shall be provided.Decision: Registration Board deferred the case for reasons as under:

Submission of differential fee of Rs. 30,000/- as per requirement of Form 5-D Submission of Analytical Method validation data Submission of long term stability data of remaining two months

Stability Case 4Sr. No.

Name &Address of






Specification

Type of Form,Initial Diary&

Date, Fee (including differential

fee),Demanded Price/ Pack

size


Local Availability

GMP Inspection


Previous DRB Decision /

Remarks (if any)

1. M/s The Schazoo Pharmaceutical Laboaratories PVT. LTD. 20kmLahore Jaranwala Road District Sheikhupura.

LIVANZA 60 mg Film Coated Tablet, Oral

Each Film Coated Tablet contains;Daclatasvir(as Hydrochloride)…. 60mg

HCV Nucleotide Analogue

Form 5DDy. No. 102223/02/2016

Rs 20,00023/02/2016

Pack size (3 × 10)

Price 13,770/- per pack

Daclinza, MHRA approved

N/A

Last inspection report on 16/01/2010 confirms good level of GMP compliance.

The firm has claimed In House specifications.


Drug Livanza 60 mg film coated tablet (Daclatasvir)Name of Manufacturer M/s. The Schazoo Pharmaceutical Laboratories PVT. LTD.Manufacturer of API M/s Laurus Labs Private Limited, IndiaAPI Lot No. ADCTRVSP10050316Description of Pack(Container closure system) Laminated Aluminum Foil (cold form), Pre printed aluminum foil.

Stability Storage Condition Real Time: 30’C +_ 2’C / 65%+_ 5%RHAccelerated: 40’C +_ 2’C / 75%+_ 5%RH

Time Period Real Time:4 MonthsAccelerated:6Months

Frequency Real Time:0,1,2,3,4 (Month)


Accelerated:0,1,2,3,4,6,8,12,16,20,24,26 (weeks)Manufacturing date June 2016 June 2016 June 2016Date of Initiation 28/06/2016 28/06/2016 28/06/2016Batch Nos. LN-T1-16 LN-T2_16 LN-T3-16Batch Size 2500 Tablets 2500 Tablets 2500 TabletsNo. of Batches 03



1. COA of API Yes


Yes






8. Commitment to follow Drug Specification Rules, 1978. No


Fee submitted is only 20,000/- while required fee is 50,000/- as per requirement of form 5D. Provide Analytical Validation & Pharmaceutical Development. Commitment to follow drug specification rules 1978 is not provided. Provided data for long term tem stability is of 4 months while as per requirement data for 6

months shall be provided.Decision: Registration Board deferred the case for reasons as under:

Submission of differential fee of Rs. 30,000/- as per requirement of Form 5-D Submission of Analytical Method validation data Submission of long term stability data of remaining two months


Case No. 6: Verification of authenticity of stability studyA follow up inspection of M/s Macter International Limited, F-216, S.I.T.E., Karachi

was carried out by a team of experts comprising of Prof. Dr. Rafeeq Alam Khan (Member Registration Board), Dr. Saif ur Rahman Khattak (Director, Central Drugs Laboratory, DRAP, Karachi) and Mrs. Muneeza Khan (Area FID, DRAP, Karachi) on 21st January, 2017 as per instructions of DRAP, Islamabad letter No. F.2-17/2016-PEC (M-263), dated 17th January 2017.

The inspection focused mainly on the areas as identified by the previous panel of experts during their inspection for the verification of stability data submitted by the firm in respect of their products namely Daclavir (Daclatasvir) 30mg and 60mg on 21st November 2016. The panel also evaluated other areas related to the production of tablets dosage form for compliance to cGMP. The observations and recommendations are communicated as under.

1. DACLAVIR 30mg TABLETS (Daclatasvir 30mg)

Sr. No.

Name &Address of Manufacturer /

Applicant

Brand Name(Proprietary Name + Dosage

Form + Strength), Composition,Pharmacological Group,

Finished Product Specification

Type of Form,Initial Diary& Date,

Fee (including differential fee),

Demanded Price/ Pack size


Availability


Remarks

1. M/s Macter International LimitedKarachi.

Daclavir Tablets 30mgTabletEach film-coated tablet contains:Daclatasvir ….……...30mgChronic Hepatitis C (HCV) infection in adults.

Form 5 D with fee Rs. 50,000/- vide Dy. # 986, 3.4.2015.Each per tablet, per capsule, per 5ml, per inhalation etc:Rs.2000/ tabRs.28,000/14‘sRs.56,000/28‘s

Internationally available in USA as Daklinza 30 mg Tablet

2. DACLAVIR 60mg TABLETS (Daclatasvir 60mg)

Sr. No.

Name &Address of Manufacturer /

Applicant

Brand Name(Proprietary Name + Dosage

Form + Strength), Composition,Pharmacological Group,

Finished Product Specification

Type of Form,Initial Diary& Date,

Fee (including differential fee),

Demanded Price/ Pack size


Availability


Remarks

1. M/s Macter International Limited. Karachi.

Daclavir Tablets 60mgTabletEach film-coated tablet contains:Daclatasvir ….……...60mgChronic Hepatitis C (HCV) infection in adults.

Form 5 D with fee Rs. 50,000/- vide Dy.# 984, dated 03.04.2015.Each per tablet, per capsule, per 5ml, per inhalation etc:Rs.3000/ tabRs.42,000/14‘sRs.84,000/28‘s

Internationally available in USA asDaklinza 60 mg Tablet


S. No.

Observations of previous inspection Current status

1. HVAC system is in-effective hence efficient cleaning of the area is impossible.

Efficiency of the related HVAC system has been increased by changing the filters and introduction of booster blowers and slight modification in designing. The system is also re-qualified.

2. False ceiling (where available) is broken and becoming source of contamination and inadequate control on the environment hence new ceiling with smooth surfaces is required.

New false ceiling with smooth surfaces has been introduced.

3. Wooden doors need to be replaced by any suitable and non-reactive material doors.

Wooden doors have been replaced with powder coated miled steel doors which is generally a non-reactive material.

4. No gauges are available to monitor the pressure differential.

New calibrated gauges have been installed and monitoring of pressure differential is properly made.

5. Compression machines and the mixers are very old and becoming the source of contamination and cross contamination.

Polishing/ painting and buffing of all machines in the production area have been done and strict monitoring and measures are also in-place to control the contamination and cross contamination.

6. Floors are highly stained and unsmooth which need to be improved by using non-reactive material.

Epoxy flooring has been introduced with overall smooth surfaces.

7. Overall monitoring and controls be improved to comply GMP regulations.

1. The HVAC system has been properly qualified along with the validation of the area.

2. Specific measures have also been made to control the bioburden.

3. The water system and the water (De-ionized) itself are properly qualified.

4. The compressed air to the area is also qualified.

5. The already executed cleaning validation has been based upon the worst case scenario where N Nitazoxanide and Alpha calcidol are the reference drugs. Since Daclatasvir is water soluble and permeable compound lying in BCS class 2 therefore does not warrant for further cleaning validation studies.

6. The light system in the production area is also as per established ASTM guidelines.

7. Measures have been made to have authorized entry to the production area.

8. The number of technical supervising staff has also increased.

Conclusion: Keeping in view the improvements and up gradations made by the firm in the tablet section to bring it compliant to cGMP, the panel is satisfied technically and scientifically to recommend the facility for the manufacturing of Daclavir (Daclatasvir) 30mg and 60mg tablets and also recommend registration thereof in the name of the firm.


Decision: Registration Board decided to approve registration of DACLAVIR (Daclatasvir) 30mg Tablets and DACLAVIR (Daclatasvir) 60mg Tablets by M/s Macter International Limited, F-216, S.I.T.E., Karachi. Manufacturer will place first three production batches on long term stability studies through proposed shelf life and on accelerated studies for six months

Case No.07: Import CasesA. Human Import Priority Cases

Sr.#

Name and address of

manufacturer /

Applicant

Brand Name

(Proprietary name + Dosage Form +

Strength)Compositio

nPharmacol

ogical Group

Finished product

Specification

Type of FormInitial date,diaryFee

including differenti

al fee

Demanded Price /

Pack size

Remarks on the



status in stringent

drug regulatory agencies /

authorities

Me-too status


in latest inspection


Remarks of the

Evaluator.

Decision

New Formulation/Combination

1. 2. M/s. Servier Research andPharmaceuticals Pakaistan Private Limited, 65 MainBoulevard Gulberg, Lahore.ManufacturerM/s. Servier Ireland Industries Ltd,. Gorey Road, Arklow_Co. Wicklow Ireland.

TRIPLIXAM 5/1.25/5Film coated Tablet

Each film coated tablet contains;Perindopril Arginine…. 5mgIndapamide…. 1.25mgAmlodipine… 5mg

ACE inhibitorThiazide DiureticCalcium

Form 5ADy. No. 317420/12/16Fee 50,000/-Price not proposedPack size30’s, 60’s

Triplixam By ServeirANSM, FranceN/AOriginal legalized Medicinal Product Certificate of France issued on 25th July, 2014. The product is not in the market for free sale in country of origin. The GMP status of manufacturer is good.

The product has market authorization but it is not available in the market.


The Registration Board was apprised that firm has provided fresh COPP on the first day of meeting which have not been scrutinized yet.The Board deferred application for consideration in next meeting with proper evaluation regarding fee


Agonist sale & other details of application.

3. 4. M/s. Servier Research andPharmaceuticals Pakaistan Private Limited, 65 MainBoulevard Gulberg, Lahore.ManufacturerM/s. Servier Ireland Industries Ltd,. Gorey Road, Arklow_Co. Wicklow Ireland


Each film coated tablet contains;Perindopril Arginine…. 10mgIndapamide…. 2.5mgAmlodipine…. 10mg

ACE inhibitorThiazide DiureticCalcium Agonist

Form 5ADy No. 317320/12/2016Fee 50,000/-PricePack Size

Triplixam By ServeirANSM, FranceN/AOriginal legalized Medicinal Product Certificate of France issued on 25th July, 2014.The GMP status of manufacturer is good.


Firm has claimed Mfg. Specs and the product is not present in available versions of BP and USP (B.P 2013 and USP 39).

The Registration Board was apprised that firm has provided fresh COPP on the first day of meeting which have not been scrutinized yet.The Board deferred application for consideration in next meeting with proper evaluation regarding fee sale & other details of application.

5. 6. M/s. Servier Research andPharmaceuticals Pakaistan Private Limited, 65 MainBoulevard Gulberg, Lahore.ManufacturerM/s. Servier Ireland Industries Ltd,. Gorey Road, Arklow_Co. Wicklow Ireland




Form 5ADy No. 317620/12/2016Fee 50,000/-PricePack Size30’s & 60’s

Triplixam By ServeirANSM, FrnaceN/AOriginal legalized Medicinal Product Certificate of France issued on 25th July, 2014.The GMP status of manufacturer is good.



The Registration Board was apprised that firm has provided fresh COPP on the first day of meeting which have not been scrutinized yet.The Board deferred application for consideration in next meeting with proper evaluation regarding fee sale & other details of application.

7. 8. M/s. Servier Research andPharmaceuti


Form 5ADy No. 317520.12.201

Triplixam By ServeirANSM, Frnace

The product has market authorization but it is not

The Registration Board was apprised that


cals Pakaistan Private Limited, 65 MainBoulevard Gulberg, Lahore.ManufacturerM/s. Servier Ireland Industries Ltd,. Gorey Road, Arklow_Co. Wicklow Ireland



6Fee Rs.50,000/-PricePack Size30’s & 60’s

N/AOriginal legalized Medicinal Product Certificate of France issued on 25th July, 2014.The GMP status of manufacturer is good.

available in the market.


firm has provided fresh COPP on the first day of meeting which have not been scrutinized yet.The Board deferred application for consideration in next meeting with proper evaluation regarding fee sale & other details of application.

9. 10. M/s Servier Research and Pharmaceuticals Private limited, 65- main Boulevard Gulberg,, Lahore.

ManufacturerLes Laboratories Servier Industrie, 905, route de Saran 45520 Gidy France

Cosyrel 10/10 Film Coated Tablet

Each Film coated tablet contains:Bisoprolol …10mgPerindopril Arginine …10mgBeta BlockerACE Inhibitor

Form 5-A

Dy. # 536, dated09-06-2016.Fee Rs.50,000/-

Price not proposed

Pack size10’s & 30’s

AcerycalHPRA, IrelandCosimprel By Serveir LithuaniaAsembix by serveir,Latvia

N.A

Original legalized COPP of France is attached which confirms the good level of GMP compliance.


Firm has claimed Ph. Eur. Specs and the product is not present in available versions of BP and USP (B.P 2013 and USP 39).

Deferred for confirmation of free sale status in country of origin i.e. France


ManufacturerLes


Each film coated tablet contains:Bisoprolol……5mgPerindopril Arginine…5mg

Form 5-A with fee Rs.50,000/- vide Dy. # 538, dated 09-06-2016.

Price not proposed


Cosimprel by ServierHPRA, IrelandCosimprel By Serveir LithuaniaAsembix by serveir,Latvia

N.A

Original


Firm has claimed Ph. Eur. Specs and the product is not present in available versions of



Laboratories Servier Industrie, 905, route de Saran 45520 Gidy France

Beta BlockerACE Inhibitor

legalized COPP of France is attached which confirms the good level of GMP compliance.

BP and USP (B.P 2013 and USP 39).




Each film coated tablet contains:Bisoprolol ……10mgPerindopril Arginine …5mg



Price not proposed


Cosimprel by ServierHPRA, IrelandCosimprel By Serveir LithuaniaAsembix by serveir,LatviaN.AOriginal legalized COPP of France is attached which confirms the good level of GMP compliance.


Firm has claimed Ph. Eur. Specs and the product is not present in available versions of BP and USP (B.P 2013 and USP 39)





Each film coated tablet contains:Bisoprolol ………5mgPerindopril Arginine .....10mg



Price not proposed


Cosimprel by ServierHPRA, IrelandCosimprel By Serveir LithuaniaAsembix by serveir,Latvia

N.AOriginal legalized COPP of France is attached which confirms the good level of GMP compliance


Firm has claimed Ph. Eur. Specs and the product is not present in available versions of BP and USP (B.P 2013 and USP 39).


Blood Bags

17. 18. M/s Briogene Pvt Ltd, 303,

MACOPHARMA Blood Bags

Form 5ADy. No.3022

The product is registered by TGA

Deferred for submission of following


Progressive Centre, Block 6, PECHS, Sharah e Faisal, Karachi.ManufacturerMaco Pharma Rue lorthiois-59420 Mouvaux France

Triple Blood Bags with anti coagulant and preservative solution.The firm has applied for two models,1. MRE6506LO triple blood bags with CPDA1, for collection of 450ml ± 10% of blood.2. MRE7506LO triple blood bags with CPDA1 for collection of 500ml ± 10% of blood.Ph. Eur. Specs for constituents for anti- coagulants

19/12/2016Fee 50,000/- 08/12/2016 & Fee 50,000/- 19/12/2016Price not proposedPack size24 per box

Australia (Certificate attached)N/ACertificates attached:1. EC certificate2. ISO 13485 certificate3. Certificate of registration4. Certificate of conformity5. Copy of Free sale certificate

original & legalized documents :

Free sale certificate from France

ISO 13485 certificate

19. 20. M/s Briogene Pvt Ltd, 303, Progressive Centre, Block 6, PECHS, Sharah e Faisal, Karachi.ManufacturerMaco Pharma Rue lorthiois-59420 Mouvaux France

MACOPHARMA Blood BagsQuadruple Blood Bags with anti-coagulant and preservative solution, the firm has applied for two models,1. MQE6506LO Quadruple blood bags with CPDA1, for Collection

Form 5ADy. No.302119/12/2016Fee 50,000/- 08/12/2016 & Fee 50,000/- 19/12/2016Differential Fee 50,000/-08/12/2016

Price not proposed

The product is registered by TGA Australia (Certificate attached)N/ACertificates attached:1. EC certificate2. ISO 13485 certificate3. Certificate of registration4. Certificate of conformity5. Copy of Free sale certificate

Deferred for submission of following original & legalized documents :




of 450ml ± 10% of blood.2. MQE7506LO Quadruple blood bags with CPDA1 for collection of 500ml ± 10% of blood.Ph. Eur. Specs for constituents for anti- coagulants

Pack size24 per box

21. 22. M/s Briogene Pvt Ltd, 303, Progressive Centre, Block 6, PECHS, Sharah e Faisal, Karachi.ManufacturerMaco Pharma Rue lorthiois-59420 Mouvaux France

Macopharma Blood BagsDouble Blood Bags with anti cosgulsnt and preservative solution, the firm has applied for two models.1.MDE6502LO Double blood bags with CPDA1 for collection of 450ml ± 10% of blood.2.MDE7501LO double blood bads with CPDA1, for collection of 500ml ± 10% of blood.Ph. Eur. Specs for constituents for anti- coagulants

Form 5ADy. No.302319/12/2016Fee 50,000/- 08/12/2016 & Fee 50,000/- 19/12/2016Price not proposedPack size24 per box

The product is registered by TGA Australia (Certificate attached)N/ACertificates attached:1. EC certificate2. ISO 13485 certificate3. Certificate of registration4. Certificate of conformity5.Copy of Free sale certificate

Deferred for submission of following original & legalized documents :



23. 24. M/S. Briogene

MACOPHARMA

Form 5ADy No.

The product is registered

Deferred for submission of


PvtLtd 303, Progressive centre, Block 6, PECHS, Sharah e faisal, Karachi 75400-PakistanManufactured byMaco Pharma Rue lorthiois-59420 Mouvaux France

Blood BagsSingle Blood Bag with anti-coagulant and preservative solution, the firm has applied for;MSE6501LO Single blood bag with CPDA1, for collection of 450 ± 10% of blood.Ph. Eur. Specs for constituents for anti-coagulants

163022-08-16Fee 20,000/- 22/08/2016 & 50,000/-19/12/2016 & 30,000/-08/12/2016Total fee 100,000/-Price not proposedPack size24 per pack

by TGA Australia (Certificate attached)N/ACertificates attached:1. EC certificate2. ISO 13485 certificate3. Certificate of registration4. Certificate of conformity5. Copy of Free sale certificate

following original & legalized documents :



25. 26. M/s Pharmatec Pakistan PVT LTDManghopir Road, SITE, Karachi.ManufacturerMinarini Manufaturing Logistics and Services S.r.I Via Campo Di Pile, Italy

BILAXTEN 20mg Tablet

Each tablet contains:Bilastine…… 20mg

Anti Histamine

Form 5A

Dy. No. 142129/11/2016Fee 50,000/-PriceRs 300/- for 10’sRs 600 for 20’sPack size10’s & 20’s

Ilaxten 20mg tablet, by Amerinin farmaceutica international, MHRA approvedN/AOriginal Legalized COPP issued by AIFA ITALI confirms the good level of GMP compliance. The product is in the market of the country of origin.GMP certificate issued by AIFA is also attached



B. Veterinary Import (Priority) Cases

27.M/s Ghazi Brothers, Ghazi House, D-

Antitermyl Water Soluble Powder

Form 5-ADy No. 7655PKR

International availability not provided

Firm has claimed Mfg. Specs and the product is not

Deferred for review of formulation by Dr. Qurban


35. K.D.A. Scheme No.1, Miran Muhammad Shah Road, Karachi-75350 /

Manufactured by:

M/s. CEVASA S.A.23rd Street Nº 293 - Pilar Industrial Park, Pilar, State of Buenos Aries, Argentina.

Dosage form: Water Soluble oral Powder

Each 100 gram contains:-Acetyl Salicylic Acid…17gmCaffeine ………..2gmVitamin C (Ascorbic acid) ……….3gm(Non-steroidal Anti-inflammatory, Xanthine derivative, Vitamin).

50,000/-Dated: 16-05-2013

Pack size: 100g, 1 kg, 5Kg

Price: De controlled

N/A

Original legalized free sale certificate of argentina is attached which confirms the free sale of product in country of origin.GMP Status: Certificate issues on 11October 2012 by Argentina

present in available versions of BP and USP (B.P 2013 and USP 39)

Ali. (Member Registration Board)

Case No. 8: Miscellaneous Cases

A. Deferred Cases of Itopride 50mg Tablets

Itopride 50mg tablets were deferred for review since 242nd meeting of registration board for confirmation of reference of registration in PMDA Japan. The reference for Itopride 50mg tablets was confirmed from PMDA Japan and 12 previously deferred cases were presented before the Board in 265th DRB Meeting. The following cases were missed and are hereby presented before the Board.

Sr.# Name and address of






Specification

Type of Form



feeDemanded

Price /Pack size

Remarks on the




authoritiesMe-too statusGMP status as

depicted in latest

inspection report (with date) by the Evaluator

Decision of previous meeting

Decision of 266th

DRB meeting

1. M/s AGP Limited, B-23, S.I.T.E,

Tablet ProkinEach tablet contains:

30-11-2010Dy.No.335 Form 5

Ganaton –JapanGanaton –

Deferred for confirmation of approval status



KarachiPriority # 641

Itopride HCl 50mg(Gastro prokinetic )

Rs.8000/-Rs.12,000/-05-09-2013 PhotocopyPack size of10s Rs. 165/-

Abbott

Inspection report dated 10-06-2015Recommends renewal of DML

of formulation in PMDA Japan(259)

Reference will be sent to Budget & accounts Division for verification of challan & Chairman registration Board will authorize issuance of registration letter

2. M/s. Alson Pharmaceuticals, Peshawar

Alsoton TabletsEach film coated tablet contains:-Itopride Hydrochloride….50 mg(Dopamine D2 receptor antagonist)

2x8’sAs Per SRO

Ganaton –JapanGanaton – Abbott

Deferred till the payment of CRF, latest inspection report and correction of Master formulation and M.O.P. (238)

Deferred for review of formulation (250)

Deferred for confirmation of following details of file: Date & Diary number of submission Details of fee submission

3. M/s IcebergPharmaceuticals(Pvt) Ltd, Plot #144, NowsheraIndustrial Estate,Risalpur, KPK

Icepride TabletEach Tabletcontains ItoprideHCl 50mg.Gastroprokinetics

Form-517-06-2015 diaryNo 227.Rs20,000As per SRO/1x10 tabletblister pack.

International availability isnot provided.2. Strength of active ingredientsare given in salt form,however calculations foractive are not given in saltform, which requiresjustifications.3. Role of inactive ingredientsand justification of quantitiesused is not provided.4. The firm has mentionedProduction Manager/inchar

Deferred forrectification ofshortcomingsandconfirmationof formulationby referencedrugregulatoryauthorities(M-252)

Registration board deferred for want of information as under: Strength of active ingredients are given in salt form, however calculations for active are not given in salt form, which requires justifications. Role of inactive ingredient and justification of quantities used is not provided. The firm has mentioned Production Manager/incharge Javed Iqbal in


ge Javed Iqbal in Form-5 whilein DML approved staff forproduction is Mr. NajeebUllah, which requiresclarification.5. Approval of section is notattached.6. Specifications of raw materialare incomplete and thespecifications of excipientsare not given.7. Master formulation is notprovided by the firm.8. Finished productspecifications are incomplete.

Form-5 while in DML approved staff for production is Mr. Najeeb Ullah, which requires clarification. Approval of section is not attached

Master formulation is not provided by the firm. Finished product specifications are incomplete

4. M/sUnipharma(Pvt) Ltd.4.5kmManga-RaiwindRoad Lahore.

Unipride TabletEach Tabletcontains:Itopride HCl……..50mg(Antispasmodicandgastroprokinetic)

Form-5Dy. No: 1532Rs.8000/-Dated: 08-06-2011Rs.12,000/-Dated: 31-07-2013Rs.150/1x10’s

Productliterature ofGanaton 50 mg(Abbott, Japan)shows that thedrug isavailable inJapan since1983.However, samecannot be verified fromPDMA asofficial websiteprovidesinformationfrom 2004-2014JapanMe-too:GanatonItopride HCl50mgof AbbottLaboratories(Pakistan)Limited.

Deferred forprovision ofcommitmentrequired by the firm(as approved in 251stmeeting)Proposed shelf life ofthe drug is 3 years inthe dossier (max.2 years). As approved in251st meeting of RB). Detail of coatingmaterial is notprovided.Documents in the dossier are not signed by QC & production manager.

Approved with innovator’s specs.


Last GMPinspection wasconducted on23-01-2015

(Deferred forconfirmation ofavailability offormulation inPDMA Japan in 250thmeeting of RB) (M-255)

Deferred asformulationis under review.(M-257)

5. M/s OBSPakistan (Pvt)Ltd, C14 SITEKarachi.

Obspride 50mgTabletEach film coated tablet contains:Itopride hydrochloride…50mg(Gastroprokinetic agent)

Form-5Dy. No: 1507Dated.05.08.2013Rs.20,000/-Rs.176.47/10’s,

Ganaton (Abbott)

Deferred as per250th meeting ofRB forconfirmation ofavailability ofthis formulationin PMDA Japan(M-257)


6. M/s MedicraftPharmaceuticalsPvt Ltd,Hayatabad,Peshawar.

Gastopride 50mgTabletsEach tablet contains:-Itopride HCl……50mg(Gastroprokinetic)

Form-525-03-2013vide diaryNo. 176 R&IRs.20,000.As per SRO.

Ganaton byM/s Abbott.Firm is GMPcompliant asper inspectiondated 29-07-2015

Deferred asper decisionof the Boardin 250th meeting‘DeferredFor confirmationofavailabilityofformulationin PMDAJapan’(M-258)


7. M/s Medisearch Pharmacal (Pvt.) Ltd, 5km, Raiwind Manga Road, LahorePriority # 669

Gerd Cure TabletEach tablet containsItopride HCl …50mg(prokinetic / antiemetic)

31-08-2012 Dy # 85568000/- Form 512000/05 -11-2013Pack size3 x 10 Rs. 425/-

Ganaton –AbbottGMP compliant section vide inspection report dated

Deferred as product is under review and latest inspection report of the firm conducted within one year and decision of CLB on recommendation of PQCB, Punjab(M-260)

Deferred for confirmation of GMP status from QA/L&T Division


B. Registration of Drugs not included in List-1Following application was received through Letter No. F 6-2/2016(R-III) dated 19 th January, 2017 for the subject cited above. According to the letter, the firm has applied on 03-03-2014 with complete fee 20,000/- submitted on 28-02-2014, but this application was missed in all lists sent to Pharmaceutical Evaluation Cell. The application has now been evaluated and hereby presented before the board. Sr.#

Name and address of manufacturer / Applicant

Brand Name(Proprietary name + Dosage Form + Strength)CompositionPharmacological GroupFinished product Specification

Type of FormInitial date, diaryFee including differential feeDemanded Price / Pack size

Remarks on the formulation (if any) including International status in stringent drug regulatory agencies / authoritiesMe-too statusGMP status as depicted in latest inspection report (with date) by the Evaluator

Remarks by Evaluator

Decision

1. M/s Werrick Pharmaceuticals

Islamabad

Progesic Extra TabletsEach Film Coated Tablet contains:Paracetamol…. 325mgTramadol HCL …. 37.5 mg

Analgesic

USP Specs

Form 528-02-2014

Dy. No. 661

20,00028-02-2014

10’s20’s30’s

As per SRO

Tramacet tabletBy Grunenthal

Ltd(MHRA

Approved)

Tonoflex P tablet by Sami

PharmaLast inspection

report dated2-2-2017

recommends the renewal of

DML

Approved


B. Miscellaneous cases.Case No.01: Drug Product Specifications.

Registration Board in 264th meeting made following observation / decision regarding

the drug product specification assigned to the registered drugs.

“Registration Board noticed that some manufacturers are misleading / mis-interrupting the term Manufacturer’s/In-house/company’s specifications in non-compliance to Drug (Specification) Rules, 1978. It was further noticed that for products that are not yet included in the pharmacopeia of reference regulatory authorities, then Manufacturer’s/In-house/company’s specifications approved by the Board is actually based on innovator’s company specifications approved by the regulatory authority of any reference country including USFDA, Health Canada, EMA, TGA Australia, PMDA Japan, United Kingdom, Germany, France, Switzerland, Netherlands, Austria, Denmark, Sweden and Norway or drugs registered in atleast three European Union counties. Moreover, drug products registered with any official pharmacopoeial specifications shall follow specifications present in the latest edition of that publication.

WHO Specifications shall be followed for biological products, vaccines or other

drugs where pharmacopeial reference of reference regulatory authorities is not available,

but WHO recommended it for developing countries.”

In view of the above decision of the Board, while mentioning specifications for non pharmacopeial products “as per innovator’s specification”, the existing condition in Form-6 regarding drug product specification has been re-drafted/elaborated as under:-

The registered drugs shall conform to the specifications of official pharmacopoeia as provided in the Rules. However, if the drug is not yet included in any of the pharmacopoeia, it shall conform to the innovator’s company specifications as approved by the regulatory authority of any reference countries specified by the Registration Board subject to compliance of Drug (Specifications) Rules, 1978. The innovator’s specifications, however, are valid only till inclusion of the product in the official pharmacopoeia of reference countries as specified by the Registration Board.

Decision: Registration Board reviewed the matter in the light of its earlier decision and decided that for non-pharmacopeial products “as per innovator specifications” may be mentioned as specifications and further revised the conditions regarding specifications of the product as under:

i. The registered drugs shall conform to the specifications of pharmacopoeial reference as provided in the Rules. In case, if the drug is not yet included in any of the pharmacopoeia, it shall conform to the innovator’s company specifications as approved by the regulatory authority of any reference countries specified by the Registration Board subject to compliance of Drug (Specifications) Rules, 1978. The innovator’s specifications, however, are valid only till inclusion of the product in the official pharmacopoeia of reference countries as specified by the Registration Board.

ii. WHO Specifications shall be followed for biological products, vaccines or other drugs where such products are not included in the official pharmacopoeia of reference countries as specified by the Registration Board.Registration Board further advised that all the registrations letters of approved

products pending due to clarification regarding specifications of the product, should be issued immediately without waiting for the minutes.


Registration-I

Case No.02: Grant of additional packs of already registered drugs.

M/s. Selmore Pharmaceuticals (Pvt) Ltd., Lahore has applied for approval of

additional packs of their following registered veterinary drug for use in close shed poultry

farming where flock size is very high.

S. No. Regn. No. Name of Drug/ Composition

Existing Pack Demanded Additional Pack

1. 035150 Tilcosin SolutionEach ml contains:-Tilmicosin…….250mg

60ml120ml250ml

500ml1000ml

M/s. Selmore Pharmaceuticals (Pvt) Ltd., Lahore has deposited the required fee Rs.10,000/-

and submitted following supporting documents:-

i) Copy of registration letter.ii) Copy of Drug Manufacturing License.iii) Copy of renewal status.iv) Copy of CRF.

The packs of 500ml & 1000ml are already given to different firms.

Decision: Registration Board approved the grant of additional packs of 500ml and 1000ml for Tilcosin Solution (Reg.No. 035150) on same terms and conditions.


Registration-IICase No.03: Registration of drug after grant of NOC. a) M/s Scilife Pharma (Pvt) Limited Plot # FD-57/58-A2, Korangi Creek Industrial Park

(KCIP), Karachi has applied for change of registration from the name of M/s Opal

Laboratories to their name:-

S.# Regn. No.

Brand Name with Generic Initial Registration Letter Date

Last Renewal

submission date

Applied for Change of

registration

Status in reference

drug agencies

1. 076365 Glusimet 50mg/1000mg tabletEach film coated tablet contains:Sitagliptin phosphate monohydrate eq. to Sitagliptin……..50mgMetformin HCl…..1000mg

22.04.2014 Renewal not yet due

09.01.2017 MHRA, UKJanumet 50/1000Merck, Sharp & Dohme Limited

2. 076370 Glusit 100mg tabletEach film coated tablet contains:Sitagliptin phosphate monohydrate eq. to Sitagliptin……100mg


09.01.2017 MHRA, UKJanuvia100 mgMerck, Sharp & Dohme Limited

3. 076369 Glusit 50mg tabletEach film coated tablet contains:Sitagliptin phosphate monohydrate eq. to Sitagliptin……50mg


09.01.2017 MHRA , UKJanuvia50 mgMerck, Sharp & Dohme Limited

4. 076366 Glusimet 50mg/500mg tabletEach film coated tablet contains:Sitagliptin phosphate monohydrate eq. to Sitagliptin…….50mgMetformin HCl……500mg


09.01.2017 US FDAJanumet50/500MERCK SHARP DOHME

In support the firm has submitted following documents:i. Application on form 5 with Rs. 20,000/- as prescribed fee for each product.

ii. NOC from M/s Getz Pharma and M/s Opal Laboratories, Karachi respectively.iii. Copy of registration letter and renewal status.iv. Undertaking of not have same product registration.v. A copy of DML of M/s Scilife Pharma, Karachi dated 01.06.2016.

vi. Copy of last panel inspection dated 29.03.2016Decision: Registration Board decided as follows:

Cancellation of registration of products Glusimet 50mg/1000mg tablet, Glusit 100mg tablet, Glusit 50mg tablet, Glusimet 50mg/500mg tablet from M/s Opal Laboratories, Karachi.

Approved grant of registration of products mentioned at serial number 1-4 in the name of M/s Scilife Pharma (Pvt) Ltd., Karachi. Reference will be sent to Cost & Pricing Division for confirmation of MRP of the product.


b) M/s Scilife Pharma (Pvt) Limited Plot # FD-57/58-A2, Korangi Creek

Industrial Park (KCIP), Karachi has applied for change of registration from the name of M/s

Getz Pharma, Karachi and M/s Opal Laboratories (S.No 11-13) respectively to their name:-

S.# Regn. No.

Brand Name with Generic

Initial Registration Letter Date

Last Renewal

submission date

Applied for Change of

registration

Status in reference

drug agencies

NOC from

1. 061705 Trupril 20mg TabletEach tablet contains:Lisinopril as Dihydrate…..20mg(USP Specification)

15.07.2010 03.07.2015 14.11.2016Renewal is OK

USFDA M/s Getz

2. 067315 Norplat 150mg TabletsEach film coated tablet contains:Clopidogrel……150mg

29.12.2010 16.10.2015 14.11.2016Renewal is OK

International availability

not confirmed

M/s Getz has issued NOC for Norplat 300mg

3. 066914 Scitin 8mg TabletsEach tablet contains:Betahistine dihydrochloride…..8mg

18.10.2010Change of brand name08.03.2011

12.01.2016 14.11.2016Renewal is OK

MHRA, UKBetahistineAurobindo Pharma-

Milpharm Ltd

-do-

4. 066915 Scitin 16mg TabletsEach tablet contains:Betahistine dihydrochloride…..16mg

18.10.2010Change of brand name08.03.2011

12.01.2016 14.11.2016Renewal is OK

MHRA, UKBetahistineAurobindo Pharma-

Milpharm Ltd

-do-

In support the firm has submitted following documents:i. Application on form 5 with Rs. 20,000/- as prescribed fee for each

product.ii. NOC from M/s Getz Pharma , Karachi

iii. Copy of registration letter and renewal status.iv. Undertaking of not have same product registration.v. A copy of DML of M/s Scilife Pharma, Karachi dated 01.06.2016.

vi. Copy of last panel inspection dated 29.03.2016Decision: Registration Board decided as follows:

Cancellation of registration of products at S.No. 1, 3 and 4 from M/s Getz Pharma, Karachi.

Deferred product at S.No.02 for NOC of M/s Getz Pharma, Karachi. Approved grant of registration of products mentioned at S.No. 1, 3 and 4 in

the name of M/s Scilife Pharma (Pvt) Ltd., Karachi. Reference will be sent to Cost & Pricing Division for confirmation of MRP of the product.


Case No.04: Request by firm for De-registration of pharmaceutical Drug ProductM/s Abbott, Karachi has requested the Registration Board to de-register their

following registered product.

S.No

Reg. No Name of Drug(s) & Composition

Pack Size Initial Date of Registration

Reason for De-registerion

1 005407 Isoptin InjectionEach ml contains:Verapamil HCL….. 2.50 mg

5 x 2 ml 27th June, 1997

“We do not have significant demand of the said product from market justifying our minimum order quantity”

Decision: Registration Board did not accede to the request of M/s Abbot, Karachi and directed the firm to ensure availability of Isoptin Injection in the country.

Case No.05: Re-grant of Drugs Manufacturing License to M/s. Kohs Pharmaceuticals (Pvt) Ltd., Plot No. P/8, S.I.T.E Hyderabad

Drugs Manufacturing License (DML) of M/s. Kohs Pharmaceuticals (Pvt) Ltd., Plot

No. P/8, S.I.T.E Hyderabad (DML No. 000132) was declared invalid by the Drug Licensing

Division, DRAP. The DML was again granted on 17-10-2015 with same license number .i.e.

(DML No. 000386).

The case was also discussed in the 265th meeting of Registration Board where

representative of the firm admitted for re-grant of drugs manufacturing license. The case is

submitted for consideration of Registration Board with regards to deliberation on status of

registration of drugs registered with the firm after its DML was declared invalid.

Decision: Registration Board observed that as a result of declaration of Drug Manufacturing License invalid, the registration of drugs of Kohs Pharmaceuticals (Pvt) Ltd., Plot No. P/8, S.I.T.E Hyderabad shall also become invalid. The firm, therefore, has to apply a fresh for getting registration of the products after grant of (re-grant) of Drug Manufacturing License. These applications, however, will be given priority consideration in view of the position explained above.


Registration-IV

Case No.06: Re-grant of Drugs Manufacturing License to M/S Rakaposhi Pharmaceuticals, Peshawar.

The drugs manufacturing license of M/s. Rakaposhi Pharmaceuticals, Hayatabad

Industrial Estate, Peshawar (DML NO.000386) was declared invalid by the Drug Licensing

Division, DRAP, vide letter dated 26th May, 2015 as the application for renewal of DML

from 21-6-2014 to 20-6-2019 was received seven months after due date of renewal i.e. 21-6-

2014.

Subsequently the Licensing Division vide letter dated 5 th August, 2015 Board

informed that the Central Licensing Board in its 242nd meeting held on 8th July, 2015 has

approved the grant (re-grant) the Drug Manufacturing License with same license number .i.e.

(000386).

The case is submitted for consideration of Registration Board with regards to status of

registration of drugs registered with the firm after its DML was declared invalid.

Decision: Registration Board observed that as a result of declaration of Drug Manufacturing License invalid, the registration of drugs of M/s Rakaposhi Pharmaceuticals, Hayatabad Industrial Estate, Peshawar shall also become invalid. The firm, therefore, has to apply a fresh for getting registration of the products after grant of (re-grant) of Drug Manufacturing License. These applications, however, will be given priority consideration in view of the position explained above.


Registration-V

Case No.07: Change in formulation / change of description of dosage form

a. M/S. Schazoo Zaka (Pvt) Ltd, Sheikhupura

M/s. Schazoo zaka (Pvt), Ltd, Sheikhupura has requested for change of description of

dosage form from Syrup to Suspension of below mentioned product as per detail below:-

S. No

Reg No. Name of Drug (s) & Composition Proposed New Dosage form

1 013084 Rifapin H Dry SyrupIsoniazid……………………….50mgRfiampicin……………………..100mg

Rifapin Suspension

According to firm Assistant Director (I&E), DRAP, Lahore has pointed out that

“Rifapin-H Dry Syrup is registered product but it is mentioned as Rifapin H Dry Suspension

on COA, and invoices etc”.

Firm informed that they are already manufacturing dry powder suspension instead of

syrup. Moreover no fee has been deposited in this regard by considering it correction in

registration letter. There is no evidence of approval of liquid formulation (syrup/suspension)

containing Rifampicin and Isoniazid in reference regulatory authority or WHO.

Decision: Registration Board deferred the case for confirmation of approval status of applied formulation in reference regulatory authorities / WHO.

b. M/S. Don Valley Pharmaceuticals (Pvt), Ltd, Lahore.

M/s. Don Valley Pharmaceuticals (Pvt), Ltd, Lahore has requested for change of

dosage form of their registered products as per detailed below:-

S.No. Reg.No. Existing Formulation Proposed Formulation1 017758 Clamentin Syrup

Each 5ml contains:-Amoxycillin trihydrate eq to:Amoxycillin (as trihydrate)……..250mgClavulenic acid (as potassium salt)……..62.5mg

Clamentin SuspensionEach 5ml contains:-Amoxycillin trihydrate eq to:Amoxycillin (as trihydrate)……..250mgClavulenic acid (as potassium salt)……..62.5mg

2. 017394 Clamentin SyrupEach 5ml contains:-Amoxycillin trihydrate eq to:Amoxycillin (as trihydrate)……..125mgClavulenic acid (as potassium salt)……..32.8mg

Clamentin SyrupEach 5ml contains:-Amoxycillin trihydrate eq to:Amoxycillin (as trihydrate)……..125mgClavulenic acid (as potassium salt)……..32.8mg


Firm has submitted following documents

i. Initial registration letter and transfer of product registration to new manufacturing site.

ii. Product renewal status.ii. Justification/reason for change of formulation.

Firm has not submitted fee the reason provided that they want to revise formulation as

per innovator (GSK), the applied formulation also provided in BNF-72 .

Decision: Keeping in view status of product in BNF-72, Registration Board acceded to request of M/s Don Valley Pharma, Lahore for correction in description of dosage form in registration letter. Moreover, the Board advised registration sections to proceed for correction in brand names of already registered products.

Case No.08: Issuance of registration letter of approved products of M/s. Hamaz Pharmacetuical (Pvt) Ltd, Multan

M/s Hamaz Pharmaceuticals, Multan has requested for issuance of registration letters

for their products approved in 255th meeting of registration board as per detailed below:-

S/No

Name and address of



name + Dosage Form +

Strength)Composition

Pharmacological GroupFinished product

Specification

Type of FormInitial date,

diaryFee including differential fee

Demanded Price / Pack

size

International

status in stringent regulatory agencies

Me-too status


in inspection report (dated)

Decision (255th

meeting)

Remarks

1. M/s Hamaz Pharmaceuticals (Pvt.) Ltd, 13-km, Lutafabad, Bosan Road, MultanADDITIONAL SECTION - Liquid Injectable (Ampoule/Vial) (General and General Antibiotics) approved in 242nd meeting

Nixin IV InfusionEach 100 ml bottle contains Ciprofloxacin (as Lactate) 200 mgQuinolone Antibiotics(USP Specification)

Form 5Rs. 20,000/- vide Dy. No. 4844 dated 04-08-2015

Pack of1 x 100 ml/ price 971.

FDA approved Ciproxin (Bayer)Caralox (Caraway)

As per letter issued by Licensing Section the firm has ampoule / Vial section. Registration Board approved only 10 products in the section (ampoule/ vial).


of CLB2. -do- Lupin IV

Infusion 500 mgEach 100 ml contains Levofloxacin 500mgQuinolone Antibiotic(USP Specification)

Form 5Rs. 20,000/- vide Dy. No. 4830 dated 04-08-2015Pack of1 x 100 ml vial / price 300.

FDA approved Livaquin (Johnson)Leflox (Getz)

Approved

3. -do- ESTADOL IV Infusion 1gEach 100 ml contains Paracetamol USP… 1 gmAntipyretic / analgesic(USP Specification)

Form 5Rs. 20,000/- vide Dy. No. 4816 dated 04-08-2015Pack of1 x 100 ml vial / price 80.

TGA approved paracetamol (Bristol)Provas (Sami)

Approved

4. -do- Ocian (WFI)

Each ampoule contains Water for Injection… 10ml

WFI(USP Specification)

Form 5Rs. 20,000/- vide Dy. No. 4812 dated 04-08-2015MRP. Rs 5.00 for 1’s per 10mlMRP. Rs 250.00 for 25’s per 10mlMRP. Rs. 500 for 50’s per 10 mlMRP. Rs. 4.00 for 1’s per 5mlMRP. Rs. 100.00 for 25’s per 05 mlMRP Rs. 200 for 50’s per 05 mlMRP Rs. 400 for 100’s per 05 mlMRP Rs. 150 for 50’s per 03 mlMRP Rs 300 for 100’s per 03ml.

MHRA approved WFI (TARO)

WFI (Epoch)

Approved


5. -do- 3-D InjectionEach ampoule (1 ml) contains Cholecalciferol (Vit D3)…. 250,000 IU equal to 5 mgVitamin(USP Specification)


MRP. Rs 165 for 01 Ampoule

International availability

Indrop-D (Neutro)

Approved

6. -do- Phonac Injection 75 mgEach ampoule (2 ml) containsDiclofenac Sodium USP 75 mgLignocaine HCl 20 mgPhenylacetic acid/ anesthetic(Manufacture Specification)


MRP Rs 140 per 05 Ampoule

Afenac – plus (ACMA Laboratories Pakistan Ltd)

Deferred for confirmation of approval status of same dosage form in reference regulatory authorities.

Same dosageform isapproved in 3 countries ofEMA Latvia, Lithuania andpoland

7. -do- Cloprel Injection 10 mgEach ampoule (2ml) containsMetoclopramide HCl … 10mgAntidopaminergic(USP Specification)

Form 5Rs. 20,000/- vide Dy. No. 4841 dated 04-08-2015MRP Rs 230 per 10 AmpouleMRP Rs. 410 per 20 ampoules

MHRA approved metoclopramide (Ennogen)Maxolon (GSK)

Approved

8. -do- Dinate Injection....... 50 mgEach ampoule (1ml) containsDimenhydrinate … 50mgAntihistamine(USP Specification)

Form 5Rs. 20,000/- vide Dy. No. 4845 dated 04-08-2015MRP Rs 250 per 25 AmpouleMRP Rs. 410 per 20 ampoules

FDA approved Dimenhydrinate (APP Pharma)Gravinate (Searle)

Approved

9. -do- Lignox Injection 20 mgEach ampoule (2ml) containsLignocaine HCl anhydrous… 20 mgLocal anesthetic(BPSpecification)


MRP Rs 187 per 100 Ampoules

MHRA approved Lidocaine Injection BP (B-Braun germany)Xylocaine (Barrett)

Approved

10. -do- Ferin Injection 100 mgEach ampoule (5

Form 5Rs. 20,000/- vide Dy. No.

MHRA approved Ferrologic

Approved


ml) containsIron Sucrose Complex … 100 mgHaematinic(USPSpecification)

4834 dated 04-08-2015

MRP Rs 1831 per 05 Ampoules x 5ml

20 mg/ml (Fresenius germany) Bisleri (Sami)

While processing registration letters it was found that firm had been issued show cause notice

(24.06.2016) from Q,A for stoppage of production/prosecution in the Drug court /any other

action taken by concerned board . The observations of FID included following areas:

General/General Antibiotic Area Cephalosporin area Penicillin Area Quality Assurance Validation and Caliberation

Firm had submitted reply on 09.07.2016 in which firm assured to rectify all shortcomings

within 6 months and requested to withdrawn show cause. The case was submitted in 249 th

meeting of CLB (held on 29.08.2016) and the Board decided to conduct panel GMP

inspection of the firm on approved format under schedule B-II of Drugs (LR&A) rules , 1976

and directed panel to submit brief report in tabulated form identifying previous observations

and current status with clear recommendations

Firm has submitted GMP inspection report conducted by DDC Bosan Town Multan

(26.12.2016), where GMP compliance has been reported. Firm has requested to grant

registration of above mentioned approved products of new section (Liquid injectable

ampoule/vial)

Decision: Keeping in view above position, Registration Board advised to issue registration letters of products approved in 255th meeting of Registration Board and also approved product at S.No.06 as it is approved by regulatory authorities of three European countries.

Case No.09: Deferred products of M/s. 3S Pharmaceuticals (Pvt) Ltd. Lahore.

Registration Board in its 237th meeting deferred following products of M/s. 3S Pharma

Lahore due to following short comings.

S.No Name of the drugs with composition

Pack Size

Proposed Price

Date of Submission

Remarks

1. Gonasin 150 CapsuleEach capsule contains:-Fluconazole………150mg(Anti fungal)

1x1 Rs.150.00 11-05-10 RM and Finished product specifications. Inspection report is not enclosed. Dissolution is not present.

2 Netel 100 Tablets 2x10 Rs.130.00 11-05-10 -do-Minutes for 266th Meeting of Registration Board. 190

Each tablet contains:-Atenolol………….100mg(Anti-hpertensive)

3 Threefen 200mg TabletEach tablet contains:-Ibuprofen…………200mg(Anti pyretic (NSAIDs)

50x10 As per SRO

11-05-10 -do-

4 Omcid TabletEach tablet contains:-Omeprazole ………20mgSodium bircarbonate ………600mgMagnesium hydroxide ……..700mg(Proton pump inhibitor + Antacid + Laxative)

1x7 Rs.130.00 11-05-10 -do-/ Composition is mentioned for 40mg omeprazole, average wt. is 1300mg which is less then composition of active ingredients. Dissolution is not present.Formulation??

5 Omjet Plus CapsuleEach capsule contains:-Omeprazole…….20mgSodium bicarbonate ………1100mg(Proton pump inhibitor + Antacid)

1x10 Rs.130.00 11-05-10 RM and Finished product specifications. Inspection report is not enclosed. Currently deferred for review committee. Dissolution is not present.

6 Ardis 5mg TabletsEach chewable tablet contains:-Montelukast sodium ………..5mg(Anti ashtamatic (Bronchodilater)

2x7 Rs.225.00 11-05-10 RM and Finished product specifications. Composition is for compressed tablets.

7 Medifen 50mg TabletsEach tablet contains:-Diclofenac Sodium …………50mg(NSAID)

2x10 Rs.100.00 11-05-10 RM and Finished product specifications. Inspection report is not enclosed. Dissolution is not present.

8 Ardis TabletsEach tablet contains:-Glucosamine……….500mgChondroitin Sulfate Sodium …………….400mgGlycosaminoglycan (Amino acid)

20’s Rs.595.00 14-06-10 F.Insp.Report?Dissolution test method not given.

9 Mexet Tablets 400mgEach film coated tablet contains:-Moxifloxacin………400mg(Fluoronquinolone)

5’s Rs.690.00 14-06-10 Final Inspection Report.Dissolution test method not given.

10 Oslo Tablets 200mgEach film coated tablet contains:-Ofloxacin………….200mg(Anti-biotic, Quinolones, Anti-infectives)

10’s Rs.297.00 14-06-10 -do-

11 Felro tablets 100mgEach tablet contains:-Flurbiprofen………100mg(NSAID)

30’s Rs.190.00 14-06-10 -do-


12 Gema Tablets 320mgEach tablet contains:-Gemifloxacin…….320mg(Fluoro Quinolone)

7’s Rs.1050.00

14-06-10 -do-

13 Threemol TabletsEach tablet contains:-Paracetamol………..500mg(Anti-pyretic)

20x101000 Jar

pack

Rs.140.00Rs.300.00

Deferred for GMP & Product specific inspection

14 Threefen TabletsEach tablet contains:-Ibuprofen………….400mg(Anti pyretic)

25x10 Rs.400.00 -do-

15 Zeesin 250mg CapsuleEach capsule contains:-Azithromycin…….250mg(anti bioitic)

1x62x6

Rs.275.00Rs.398.00

-do-

The case was reconsidered in 263rd meeting of Registration Board

The firm had submitted Rs.8000/- for each product. Now the fee for the registration

procedure has been increase, the firm has submitted the differential fee amounting to Rs.

12000/- for each registration as follows. The firm has provided required documents except

Product specific inspection for S.No 7,13,14 and 15 is not provided. Dissolution profile of

products at S.No 9 and 12 is not provided.

Decision: Registration Board deferred the case for evaluation of registration application as per requirement of Form 5.

Now the firm has provided following documents

1) Form 5 and documents as per Form 5 for each product2) DML (23.06.2009) and copy of fee deposit slip for DML renewal (05.06.2014)3) Evidence of section approval from CLB (Tablet General and Capsule General)4) GMP inspection report (12.02.2015)

Decision: Registration Board deferred for latest GMP status of firm. Moreover product at S.No.04 is also deferred for confirmation of approval status by reference regulatory authorities and product at S.No.05 is deferred for expert opinion.


Item No.V: Biological Drugs Division.

Registration Board deliberated that since last few meetings, products of non-

reference countries have been deferred for submission of biosimilarity data and clinical data

(where applicable). Such products shall be considered by the Registration Board after getting

aforementioned data, provided that product is licensed for sale and available for sale in

market in country of origin.

Moreover, products from non-reference countries have already been registered by

Registration Board at time of erstwhile Drug Control Organization, Ministry of Health and

DRAP. The safety and efficacy of these molecules/ formulations is already proven in

reference countries. The products if approved by Registration Board are also subject to the

inspection of the facility abroad by the panel of inspectors as nominated by the DRAP. The

Registration Board also advised Biological Division to club all such cases as deferred in

previous meetings for consideration in next Board meeting subject to fulfillment of all

requirements as per Form-5A.

Case No.01 Left over agenda of 265th meeting of Registration Board.i. Imported veterinary biologicals from non-reference countries.

S. No.

Name of Importer & Manufacturer

Brand Name & Composition

Type of FormDy No & Date of applicationFee submittedPack size/ Demanded Price

Document details (CoPP)Me too status/New molecule

Remarks Decision

1. Huzaifa International, Commercial Area, Aziz Bhatti Town, SargodhaKomipharm International Co., Ltd. 17, Gyeongje-Ro, Siheung-Si, Gyeonggi-Do, The republic of Korea

PRO-VACTM CPVEach ml containsAttenuated Canine Parvovirus (FK strain)……100 %Streptomycin...20µg/ml Penicillin…200unit/mlGentamicin….50 µg/ml

For 5-A 119-ADC(BD) 06-12-20161494 30-11-2016Rs. 100000/-24-10-20161’s (1 dose)

Legalized GMP and Legalized Free Sale certificate is submitted.

Deferred for evaluation of strain by Dr.Qurban Ali, Member Registration Board.

2. Huzaifa International, Commercial Area, Aziz Bhatti Town, SargodhaKomipharm International Co., Ltd.

PRO-VACTM FP(lyophilized part)

Each dose (0.5ml) contains: TCH Fowl Pox Virus Culture……50% SPGG……….50%

Form 5-A 118-ADC(BD) 06-12-20161495 30-11-2016Rs. 100000/-24-10-2016Pack: 1’s (1000doses)

Legalized GMP and Legalized Free Sale certificate is submitted.

The diluent is also a part of pack composition; the firm has submitted Rs. 100000/- fee for the registration of diluent.

Deferred for evaluation of strain by Dr. Qurban Ali, Member Registration Board.


17, Gyeongje-Ro, Siheung-Si, Gyeonggi-Do, The republic of Korea

(Diluent )Each 1000 ml contains:Nacl....8gKCl....0.2gNa2HPO4. 2H2O....2.6gKH2PO4....0.2gPhenol red...q.s.Distilled water....up to 1000ml

Diluent 10ml vial

3. Snam Pharma, 61-G, Defence Housing Authority, Phase I, LahoreBioveta, a.s., Komenskeho 212/12, 683 23 Ivanovice na Hane, Czech Republic

Ornivac ND(Emulsion for injection for domestic fowl)

Each dose contains: Inactivated paramyxovirus Pseudopestis avium, strain NDV SL-93… >4log2HIT*(The geometric mean of specific antibodies determined by hem- agglutination inhibition testing the serum of vaccinated chicken)

Form 5-A797-ADC(BD) 02-08-20163412(R&I)02-08-2016Rs. 100000/-02-08-2016Pack: 10 x 2500 doses10 x 5000 dosesPrice:Decontrolled

Valid Legalized CoPP No. 079/2016 dated04-04-2016

Deferred for evaluation of strain by Dr. Qurban Ali, Member Registration Board.

4. M/s Agriprom Pakistan (Pvt) Ltd.66 west wood colony, thokar niaz baig, Lahore.

M/s Laboratorios VencoFarma Do Brasil Ltda.237 Travessa Dalva de Oliveira, Parque das Industrias Leve, Londrina-PR

Vencomax 12Each dose (1 ml) contains:Lyophilized part:Distemper Virus (Rockborn strain)….. at least 102,5 TCID50/doseCanine adenovirus CAV 2……. at least 102,5 TCID50/doseParvovirus Cornell 916…… at least 102,5

TCID50/doseParainfluenza virus AMV…….. at least 102,5 TCID50/doseGentammicin….. maximum 30 µg/ml Amphotericin B…….. Maximum 2.5 µg/ml.

Liquid Part:Leptospira canicola bacterin……. 1,5 x 106

germs/doseLeptospira icterohaemorrhageni Bacterin…….Leptospira copenhageni bacterin ……. 1,5 x 106

germs/doseLeptospira Pomona bacterin …..1,5 x 106

Form 5-A08-ADC(BD) 04-01-2017312(R&I)04-01-2017Rs. 100000/-03-01-2017

1 dose vial (lyophilized) 20’s1 dose vial (liquid) 20’s

Valid legalize GMP Certificate N0

159/2016Legalize FSC N0

940/2016

Separate fee for the registration of liquid part is required. The firm submitted diluent is part of formulation and can not be used separately.

Stability data is not submitted. The firm was asked to submit data however it was not provided.One of the indications in the vaccine is treatment of hepatitis. The firm was asked to provide clarification regarding which antigen/ viral strain is involved in the prophylaxis against Hepatitis. The firm submitted

Deferred for evaluation of product by Dr. Qurban Ali and submission/ clarification of following by the firm:

1. Separate fee for the registration of liquid part.

2. Stability data.

3. One of the indications in the vaccine is treatment of hepatitis while firm has submitted that CAV2 virus is involved in prophylaxis against hepatitis. However the available


germs/doseLeptospira grippotyphosora bacterin ….1,5 x 106

germs/doseLeptospira pyrogenes bacterin ….1,5 x 106

germs/doseLeptospira hardjo bacterin …..1,5 x 106

germs/dose

(Vaccine against Canine Distemper, Parvovirus, Coronavirus, Parainfluenza, Hepatitis, Adenoviruses and Leptospirosis)

Shelf Life: 24months

that CAV2 virus is involved in prophylaxis against hepatitis. However the available literature indicates that CAV-1 vaccines provide immunity against Hepatitis. This requires clarification.

literature indicates that CAV-1 vaccines provide immunity against Hepatitis. This requires supporting evidence from published literature/ reference regulatory agencies

5. M/s Agriprom Pakistan (Pvt) Ltd.66 west wood colony, thokar niaz baig, Lahore.

M/s Laboratorios VencoFarma Do Brasil Ltda.237 Travessa Dalva de Oliveira, Parque das Industrias Leve, Londrina-PR

Paraven R2C.Each dose (5ml) contains:Bovine Coronavirus ………..104.5TCID50

Rotavirus G6 …………104.5TCID50

Rotavirus G10 ………….104.5TCID50

Escherichia coli O26 bacterin….105 germsEscherichia coli K99/F41 bacterin sample S30....….105 germsEscherichia coli 0111 bacterin…..105 germsClostridium perfringens C toxoid, β toxin …….atleast 10UI/doseClostridium perfringens D toxoid, ἑ toxin …….atleast 10UI/dose(vaccine against Bovine Rotavirus, coronavirus, Colibacillosis and Enteroxaemia)Shelf Life: 24months

Form 5-A08-ADC(BD) 04-01-2017312(R&I)04-01-2017Rs. 100000/-03-01-2017Pack size 50ml



940/2016

New formulation

Stability data is not submitted. The firm was asked to submit data however it was not provided..

Deferred for evaluation of product by Dr. Qurban Ali and submission/ clarification of following by the firm:a.Stability

data.

6. M/s Agriprom Pakistan (Pvt) Ltd.66 west wood colony, thokar niaz baig, Lahore.M/s Laboratorios

RonvacEach dose contains:Inactivated virus Feline Rhinotracheitis……. minimum 10-4TCID50

Inactivated virus Calicivirosis..minimum 10-4TCID50

Inactivated virus Feline

Form 5-A08-ADC(BD) 04-01-2017312(R&I)04-01-2017Rs. 100000/-03-01-20171 dose vial 40’s



940/2016

Stability data is not submitted. The firm was asked to submit data however it was not provided.

Deferred for review of product by Dr. Qurban Ali and submission/ clarification of following by the firm:


VencoFarma Do Brasil Ltda.237 Travessa Dalva de Oliveira, Parque das Industrias Leve, Londrina-PR

Panleukopenia................... minimum 10-4TCID50

(Vaccine against Feline Panleukopenia, Calicivirus and RhinotracheitisShelf Life: 24months

a. Stability data.

7. M/s Agriprom Pakistan (Pvt.) Ltd.66 west wood colony, Thokar Niaz Baig, Lahore.

M/s Laboratorios VencoFarma Do Brazil Ltd.237 Travessa Dalva de Oliveira, Parque das Industrias Leve, Londrina-PR

Raiva CannisEach dose (1ml) contains:Suspension of inactivated rabies virus….minimum106.0DL50

(Inactivated vaccine against the rabies)


Form 5-A08-ADC(BD) 04-01-2017312(R&I)04-01-2017Rs. 100000/-03-01-20171 dose vial 50’s

Stability data is not submitted. The firm was asked to submit data however it was not provided.

Valid legalized Free Sale Certificate is required as product is not included in the submitted FSC.

Deferred for evaluation of product by Dr. Qurban Ali and submission/ clarification of following by the firm:a.Stability

data.b.Valid

legalized Free Sale Certificate/ CoPP.

8. M/s Ghazi BrothersGhazi House,D-35, K.D.A Scheme No.1,Miran Muhammad Shah Road Karachi

M/s TANGSHAN YIAN BIOLOGICAL ENGINEERING CO.,LTDNo.120,Huoju Rd.,High Tech Developing Zone Dist., Tangshan, Hebei Province ,P.R China

RABEND

Each dose (1ml) contains:Inactivated Rabies Antigen (Strain CTN-1) …….2 I.U


Form 5A1210(R&I)19-02-2013Rs. 50,000/-22-01-2013

Multiple pack sizes are demanded(1 dose vial,10 doses vial,1 dose syringe)

Legalized Free Sale certificate No. 121100B0/50648Issuing date: 25/11/2011(Expired)Legalized GMP No. 121100B0/50651Expiry date.14/06/2016(Expired)

Legalized Free Sale Certificate and GMP were Valid at the time submission of the application but now expired.

Multiple dosage forms and Pack sizes are applied.

Approved as per import policy for finished drugs. Firm will select one pack size and provide valid legalized Free Sale Certificate and GMP/ CoPP.Chairman Registration Board shall permit the issuance of registration letter.

9. M/s Orient Traders InternationalCM-10, Block-A, kazimabad, Model colony, Karachi

Bronchipharm(lyophilisate for suspension for chicken)Each dose(0.1ml) contains:Avian Infectious Bronchitis virus, live,

Form 5-A207-ADC(BD) 26-12-20163724(R&I)26-12-2016Rs. 100000/-20-12-2016

Valid Legalized CoPP No.R-92/2016/1/2520 dated 07/09/2016

Multiple Pack sizes are demanded.

In CoPP it is mentioned at # 2A.3 that the

Deferred for clarification of following by the firm:

a. In CoPP it is mentioned at #


M/s Pharmagal Bio, spol. s r.o.Murgasova 5, 949 01 Nitra, Slovak Republic

strain H120….103.0EID50-104.5EID50**50% embryonic infective dose-the virus titre required to produce infection in 50% of the embryos inoculated

Pack: 1 x 2000 doses1 x 5000 doses1 x 100 doses1x 500 doses1x 1000 dosesPrice: Decontrolled

status of the License holder is “c” (i.e. Firm is not involved in manufacturing and packaging/or Labeling)While at # 2A.3.1 where the name and address of manufacturer is required, the same name and address of Firm is mentioned.

2A.3 that the status of the License holder is “c” (i.e. Firm is not involved in manufacturing and packaging/ or Labelling, While at # 2A.3.1 where the name and address of manufacturer is required, the same name and address of Firm is mentioned.

b. Desired pack size.

10. M/s Orient Traders International CM-10, Block-A, kazimabad, Model colony, KarachiM/s Pharmagal Bio, spol. s r.o. Murgasova 5, 949 01 Nitra, Slovak Republic

Avipharm NDEach dose(0.1ml) contains:Newcastle disease virus, live, strain La Sota, minimum 106.0+EID50- maximum 107.0+EID50**50% embryonic infective dose.

Form 5-A206-ADC(BD) 26-12-20163725(R&I)26-12-2016Rs. 100000/-20-12-2016Pack:10 x 5000 doses10 x 2000 doses10x 1000 dosesPrice: Decontrolled

Valid Legalized CoPP No.R-91/2016/1/2519 dated 06/09/2016

Multiple Pack sizes are demanded.

In CoPP it is mentioned at # 2A.3 that the status of the Licence holder is “c” (i.e. Firm is not involved in manufacturing and packaging/or Labeling)While at # 2A.3.1 where the name and address of manufacturer is required, the same name and address of Firm is mentioned.

Deferred for clarification of following by the firm:

a. In CoPP it is mentioned at # 2A.3 that the status of the License holder is “c” (i.e. Firm is not involved in manufacturing and packaging/or Labelling While at # 2A.3.1 where the name and address of manufacturer is required, the same name and address of Firm is mentioned.

b.Desired pack size.


ii. Miscellaneous/Deferred Cases

a. Product applied by M/s Hospital Services and Sales, Karachi deferred in 260th

meeting of Registration Board.


Brand name & Composition

Fee Status & Pack size

Document Details

Decision of RB

Remarks Decision

Hospital Services & Sales 13-C Annex, Block 6, P.E.C.H.S, Shahrah-e-Faisal, Karachi 75400.

Parent Company/Lic. Holder:QYH Biotech Company Ltd.,Building. No. 20, Part 11, ABP, No. 188, Southwest 4th

Ring Road, Fengtai District, Beijing, China.

Manufacturing Site:Zhengzhou Bio-Pharmaceutical Factory of QYH Biotech Co. Ltd., Shibalihe, South Surburb, Zhengzhou City, Henan Province, P. R. China.

QYH-ND IB EDS(Newcastle Disease, Infectious Bronchitis & Egg Drop Syndrome Vaccine, Inactivated)

Each one dose contains:-Inactivated Newcastle Disease virus La Sota strain (the virus titer is ≥ 3x108.0EID50/ 0.1ml before inactivation), inactivated Infectious Bronchitis virus M41 strain (the virus titer is ≥ 3x106.0EID50/ 0.1ml before inactivation) and inactivated Egg Drop Syndrome virus AV127 strain (the HA titer of the virus is ≥ 1:30720 before inactivation),

(For Veterinary Use)

22-Dec-10

Deposited fee100000/-

Balance FeeNil

Pack Sizes:(250mL / Bottle)

Legalized Free Sale Certificate No. (2011) 160132129 Dated01-06-2013

Legalized CoPP No. 3 Dated10-12-2015

Product License No.(2010) 01008Dated 09-03-2010

Legalized GMP Certificate No.(2014) 220Dated16-10-2014

Deferred for confirmation of local availability/ approval of similar vaccine.

The firm submitted product is locally available with following brand name & Reg. No.MEDIVAC NE-EDS-IB EMULSION(Reg. No. 059195)

Registration Board deferred the above product for evaluation of Egg Drop Syndrome virus AV127 strain by Dr. Qurban Ali, Member Registration Board.


b. Deferred case of 260th meeting of Registration Board of M/s Opulent International, Karachi.

M/s Opulent International, Karachi applied for the registration of following product.

The product was considered in 260th meeting of Registration Board. The firm has submitted the

valid legalized CoPP vide no. COPP/CERT/MD/26507/2015/11/10485/48273 dated 14-09-2016

indicating availability of product in the country of origin. The detail of the product is as follows:

S. No.





Decision in 260th RB

Decision

1 M/s Opulent International Karachi.

M/s Reliance Life Sciences, Pvt Limited, Plant-1 Sandhra Textile Mills Compound, Ground and First Floor C.S. No. 1621 Plot No. 3 Plan 1 Pandurang Budhkar, Marg Worli Mumbai.

IMMUNOREL(Human Normal Immunoglobulin for Intravenous Administration)Each 50ml contains:Protein…..50g/ LIgG…..2.5gStabilizer Maltose....100g/LIgA content≤ 80mg/LIgG subclasses ………Normal distribution

Immunoglobulin

Shelf life: 36 months

Form-5A

Dy. No 11198 dated 28-05-2014

100000 dated28-06-2013

98 USD / vial

Legalized CoPP /CERT/MD/26507/2015/11/10485/48262 dated 28-4-2015 valid up to 09-3-2017

Deferred for clarification for non-availability of product in the country of origin and valid reason thereof by the regulatory body and confirmation of availability of similar products in country.

Registration Board approved the product as per import policy for Finished Drugs and as per valid legalized CoPP.

c. Transition of Formulation from Lyophilized to Liquid Form of WinRho SDF Injection (025216) M/s Eastern Trade and Distribution Co. Pvt Limited Karachi.

M/s Eastern Trade and Distribution Co. Pvt Limited Karachi have informed that their

principal M/s Cangene Corporation, Canada is transitioning the formulation of their

registered product WinRho SDF Injection from lyophilized to Liquid formulation. The

existing formulation was supplied as freeze dried powder I vial along with single ampoule of

sterile water for injection, while the new formulation is liquid injection will contain a

convenient formulation ready to use 3ml single dose vial of 1500IU (300mcg) of Anti Rho

(D) in glass vial


The liquid formulation is approved by Health Canada, detailed below:

Existing WinRho SDF Lyophilized formulation composition

New approved SDF Liquid formulation

Each vial contains:Human Anti-D Immunoglobulin (in house)………300 mcg

Glycine Ph. Eur/ USP……22.5 mgSaodium chloride Ph. Eur/ USP…..7 mgPloysorbate 80 Ph. Eur/ USP…..0.3mgWater for Injection Ph. Eur/ USP……QS ** Removed by lyophilization.

Each vial contains:Human Anti-D Immunoglobulin (in house)………300 mcg

Maltose USP………………..0.135gPloysorbate 80 Ph. Eur/ USP…..0.39mgWater for Injection Ph. Eur/ USP……QS *

The case was considered in 260th meeting of Registration Board and Board decided as follows:“Registration board did not accede to the request of the firm for change of formulation from lyophilized to liquid form of Winrho SDF injection (025216) as present formulation is also approved by regulatory authority of Canada. However firm was advised to apply fresh application with prescribed fee for new formulation/ dosage design.”

It is pertinent to mention that above liquid formulation has already been approved by

Registration Board in its 253rd meeting. The details are as under:

Sr. No.

Name of Importer &

Manufacturer

Brand Name &

Composition

Date ofapplication /

Fee status

Document Details

Remarks Decision in 253rd

meeting

Decision

1 EasternTrade &Distribution Co. (Pvt) Ltd.,Karachi.

CANGENECORPORATION,155 Innovation Drive, Innipeg,Manitoba,Canada,R3T 5Y3

WinRho ® SDFLiquid InjectionEach l vialcontains:-Rho D Immune Globulin Human 1500 units (300mcg).(Biologics).

Date ofapplication17.08.2011Deposited fee100000Balance FeeNil

CoPP No.59723 dated24/02/2015validity 1yearProduct LiscNo.02302578. dated16/06/2008.Indications.Anti-Rho (D)

ProductManufacturedbyCANGENEcorporationManitoba,Canada,R3T 5Y3confirmedCOPPprovidedNo. 59723fromCanada.

Approved Registration Board upheld its decision on product in 253rd meeting of Registration Board in which the product is already approved in liquid formulation. The decision of the board in the 260th

meeting regarding request of firm for transition of formulation from lyophilized to liquid form of WinRho SDF Injection is deleted.


d. Products applied by M/s Huzaifa International, Sargodha deferred in 262nd


Following products of M/s Huzaifa International, Sargodha were considered in 262nd

meeting of Registration Board for the expert opinion of Dr. Qurban Ali. The details are as

follows:

With reference to the product at sr. no. 1 , the firm has submitted a certificate from

Ministry of Security & Public Administration that the address KomiPharm International Co.

Ltd., 1236-6, Chongwang-Dong, Shihung-Si, Kyonggi-Do, The republic of Korea which is

old address based on land lot numbers is same as KomiPharm International Co. Ltd., 17,

Gyeongje –ro, Siheung-si, Gyeonnggi-do, Korea which is based on road names and building

numbers. The both addresses are identical and legally valid.

S. No.

Name of Importer/

Manufacturer

Brand Name / Composition

Date of application/ fee status/

Price/ packs

Documents submitted

Me too

Decision of RB in 262nd

meeting

Expert opinion of

Dr. Qurban Ali

Decision

1 M/s Huzaifa International, Commercial Area, Aziz Bhatti Town Sargodha

KomiPharm International Co, 17, Gyeongje –ro, Siheung-si, Gyeonnggi-do, Korea.

PRO-VACTM

CRDF

Each dose contains:

Mycoplasma gallisepticum culture, (Fstrain)…..more than 105

CCUStabilizer for lyophilized ……20%

Prevention against mycoplasma gallisepticum

Shelf Life: 18 months

Form 5A

18-ADC (BD)10/08/20168526/2016(R&I)08-08-2016

Rs.100,000/-20-08-2016

Decontrolled/1000 doses

Legalized FSC dated 20.1.2015

Legalized GMP dated 20.4.016

Deferred for clarification that Address of manufacturer provided on the FSC and GMP are different and expert opinion of Dr. Qurban Ali.

Firm shall also submit separate fee along with application for registration of diluent.

Recommended for registration.

The firm has submitted seertae fee 100000/- for diluent

Approved as per import policy for Finished Drugs and as per valid legalized CoPP/ FSC &GMP.

2 M/s Huzaifa International, Commercial Area, Aziz Bhatti Town Sargodha

KomiPharm International Co, 17, Gyeongje –

PRO-VACTM

AE-FP(lyophilized part)

Each dose contains:

Avian Encephalomyelitis virus (Calnek 1143 strain).≥10 2.8EID50

17-ADC (BD)10-08-20163525/2016(R&I)08-08-2016

Rs.100,000/-25-07-2016Rs. 100000/-

Decontrolled/1000 dose

Legalized FSC dated 21.11.14

Legalized GMP certificate dated20-4-2016

Deferred for expert opinion of Dr. Qurban Ali, Member Registration Board.

Firm shall also submit separate fee

Recommended subject to warning:i.vaccine virus of Avian Encephalomyelitis (Calnek 1143 strain) is fully

Approved as per import policy for Finished Drugs and as per valid legalized CoPP/ FSC &GMP. The following warning shall be included


ro, Siheung-si, Gyeonnggi-do, Korea.

Attenuated Fowl Pox Virus, TCH…….≥102.8

EID50LPGG -----50%

(Diluent )Each 1000 ml contains:Nacl....8gKCl....0.2gNa2HPO4 . 12H2O....2.6gKH2PO4....0.2gPhenol red...q.s.Distilled water....upto 1000ml

Prevention against Avian Encephalomyelitis and Fowl pox


Diluent: 10 ml vial

along with application for registration of diluent.

virlent and should therefore not be given to bids younger than 2 months of age or birds in lay.

ii.birds should be separated fron non-vaccinated birds in particular to chicken, pheasants, quail and turkeys.

iii.s must wash and disinfect hand after vaccination.

in the registration letter:i.vaccine virus of Avian Encephalomyelitis (Calnek 1143 strain) is fully virulent and should therefore not be given to birds younger than 2 months of age or birds in lay.

ii.d birds should be separated from non-vaccinated birds in particular to chicken, pheasants, quail and turkeys.

iii.rs must wash and disinfect hand after vaccination.

e. Products applied by M/s Orient Animal Health, Karachi deferred in 262nd

meeting of Registration Board.Following products of M/s Orient Animal Health, Karachi were considered in 262nd

meeting of Registration Board for the expert opinion of Dr. Qurban Ali. The other experts i.e.

Prof. Dr. Masood Rabbani, Prof. Dr. Khushi Muhammad and Dr. Muhammad Arshad has

also recommended the above products for registration in Pakistan. The details are as follows:

S. No.

Name of Manufacturer

Name of Drug and Composition

Date of application / Fee status

Documentary details


Meeting

Expert opinion of Dr.Qurban

Ali

Decision

1 GENERA d.d.Svetonedjelijska2, Kalinovica,10436 RakovPotok, Croatia.

Pestikal La Sota® SPF, Lyophilisate for suspensionEach single dosevaccine contains:Live lento genicNewcastle disease

Dy.No.2407(R&I) dated07-4-2015

Fee Rs.100,000/- dated

LegalizedProductMarketing authorizationregistration No.525-10 /1278-15-2

Registration Board deferred for evaluation by Dr. Qurban Ali, Member

M/s Genera Rakov Potok, Croatia was established in 1901. The manufacturer, M/s Genera

Registration Board approved the product as per import


virus,La Sota strain ≥ 106.0 EID 50Pharmacological group:Immunological fordomestic fowl live viralvaccine againstNewcastle diseaseOculonasaly, Oral,SprayingRoute of Adm: Oculonasaly, Oral,spraying

07-4-2015

Box of 10 vialof 1000, 2500,& 5000 vaccineDoses

Unit price:Decontrolled /25, doses.

dated28-1-2015Enclosed.

Legalized GMPCertificate No.409-8/ 2013-2Dated17.4.2013enclosed

Registration Board.

are well known for animal health and agriculture, products development, production and sale in Croatia. The company was formally known as Veterina which changed to Genera in 2009.

The products at sr. No. 1-4 are fit for use and recommended for registration

policy for Finished Drugs and as per valid legalized CoPP.

2 Orient AnimalHealth (Pvt) Ltd,Karachi

Manufacturer

GENERA d.d.Svetonedjelijska2, Kalinovica,10436 RakovPotok, Croatia.

Pestikal® B 1 SPFlyophilisate forsuspension

Each single dosevaccine contains;Live lento genicNewcastle disease virus,strain Hitchner B 1 ≥106.0 EID 50 (embryoinfective dose 50) =virus dose which infects50% of inoculatedchiken embryos

Pharmacological group:Immunological fordomestic fowl live viralvaccine againstNewcastle diseaseOculonasaly, Oral.

Dy.No. 2409(R&I) dated07-4-2015

Fee Rs.100000/- dated07-4-2015

Unit price:DecontrolledBox of 10 vialof 1000, 2500,& 5000 vaccinedoses

LegalizedCertificate ofGMP No. 409-8/2013-2 dated17-4-2013enclosed

Legalized MarketauthorizationCertificateregistration No.525-10 / 1278-15-2 dated28.1.2015 enclosed

Registration Board deferred for evaluation by Dr. Qurban Ali, Member Registration Board.

-do- Registration Board approved the product as per import policy for Finished Drugs and as per valid legalized CoPP.

3 Orient AnimalHealth (Pvt)

Gumbokal® IM FORTE

Dy. No. 2408

Legalized Market

Registration Board

-do- Registration Board


Ltd,Karachi

Manufacturer


SPF, lyophilisate forSuspension

1 dose of vaccinecontains:Attenuated live virus ofGumboro disease(infectious bursaldisease), strain VMG 91≥ 10 4.0 TCID 50

Pharmacological group:Immunologicalformulation for birds,farm poultry Live virusvaccine, virus ofinfectious bursal disease(Gubmoro disease)For active immunizationof chickens withinherited maternalantibodies againstGumboro disease.

Oral admintration

(R&I) dated07-4-2015

Fee Rs.100000/- dated07-4-2015

10x1000 doses10x 2000 doses10x2500 doses10x5000 doses

Unit price:Decontrolled

authorizationcertificateregistration No525-10/1278-15-2 dated 28-1-2015. enclosed

Legalized GMPCertificate No.409-8/2013-2dated 17-4-2013enclosed

deferred for evaluation by Dr. Qurban Ali, Member Registration Board.

approved the product as per import policy for Finished Drugs and as per valid legalized CoPP.

4 Orient AnimalHealth (Pvt) Ltd,Karachi

Manufacturer


Bronhikal® I SPF,lyophilisate forsuspension

One dose of vaccinecontains:Attenuated live virus ofAvian infectiousbronchitis, strain H-120≥ 103.5 EID50

Pharmacological group:Immunological for aves,domestic fowl.For active immunizationof chickens from dayold onwards to prevent

Dy. No. 2410(R&I) dated07-4-2015

Fee Rs.100000/- dated07-4-2015

10x1000 doses10x 2500 doses


Legalized Marketauthorizationcertificateregistration No.525-10/ 1278-15-2 dated28-1-2015. enclosed

Legalized GMPCertificate No.409-8/ 2013-2Dated17-4-2013enclosed

Registration Board deferred for evaluation by Dr. Qurban Ali, Member Registration Board.

-do- Registration Board approved the product as per import policy for Finished Drugs and as per valid legalized CoPP.


mortality, clinical signsand lesions of the avianInfectious bronchitis.

f. Hiprabovis-4 applied by M/s Marush Pharma, Lahore.S.#.


Name of Drug and Composition


Documentary details

Remarks Decision

1. LaboratoriosHipr a S.A. Avda. La Selva Amer (Girona), Spain

Hiprabovis-4(Solvent for Injectable suspension)Composition per dose(3ml):Inactivated Infectious Bovine Rhinotracheitis Virus, strain LA.....ELISA≥50Inactivated Parainfluenza-3 virus, strain SF4.....IHA≥1/16Inactivated Bovine Viral Diarrhoea virus, strain NADL........ELISA≥50

Dy.No. 248(R&I) dated03-01-2017

Fee Rs.50000/- dated03-01-2017

30 dose vial


Legalized CoPP dated 01-12-2014

The Registration Board in its 258th

meeting approved the product and accordingly the registration letter was issued to the firm vide registration no. 081815 for the lyophilisate part containing live Bovine respiratory Syncitial Virus, Strain Lym-56 The firm has now requested for the issuance of letter for the solvent part.


g. Products applied by M/s Bromed Animal Health, Lahore deferred in 262nd


Following products of M/s Bromed Animal Health, Lahore were considered in 262nd

meeting of Registration Board for the expert opinion of Dr. Qurban Ali. The details are as follows:

Sr. No.



Type of Form

Dy No & Date of application

Fee submitted

Pack size/ Demanded Price

Document details (CoPP)

Me too status/New molecule

Decision of RB in 262nd meeting

1.BroMed animal Health, LahoreMiddle East for Vaccines (ME VAC)Egypt.

ME VAC IB+ND+EDSInactivated tetravalent Virus Vaccine of Inactivated Virus Vaccine

Each dose (0.5ml) contains:Inactivated Virus Vaccine of Infectious Bronchitis Disease of IB Classical

Form-5

Dy No. 276 (R&I) DRAP dated 25-1-2016

Fee deposited; Rs. 100000/- dated 21-1-2016 vide challan no.

Copy of GMP submitted.

Deferred for expert opinion for confirmation of prevalence of strain by Dr. Qurban Ali, Member Registration Board


(Eg/11539F)& IB Variant type 2 (Eg/1212B)……≥107EID50/dose at release.

Inactivated Newcastle Disease NDV/Chicken/Egypt/11478AF/2011 (ND)……≥108EID50/dose at release (>128PD50).

Inactivated Egg Drop Syndrome Virus (EDS’76) ≥106EID50/dose at release.

Mantonied ISA 70VG..…0.35 mlInactivant BEI…..0.0005ml

Bulk saline …… Q.S.to 0.5mlTotal …. 0.5ml

Immunization agaiunst above viruses

Shelf life : 24 monthsRoute of adm: IM/ SC

0131612.

300 and 500 ml vial

2. BroMed animal Health, Lahore

Middle East for Vaccines (ME VAC)Industrial area 2 Piece 22-24, New Salhia, el Sharkia Head Office: 20 Jospeh teto el nozha el gededa, Cairo, Egypt.

ME FLUVAC H9+ND 0.5Inactivated tetravalent Virus Vaccine of Inactivated Virus Vaccine.

Each dose (0.5ml) contains:

Inactivated Avian Influenza A/Chicken / Egypt/ 114940v/NLQP /2011 (H9N2)…. ≥108EID50/dose before inactivation.

Inactivated Virus Vaccine of Infectious Bronchitis Disease of IB Classical (Eg/11539F)& IB Variant type 2 (Eg/1212B)……≥107EID50/dose at release.

Inactivated Newcastle Disease

Dy. No. 277 (R&I) DRAP dated 25-1-2016

Fee deposited: Rs. 100000/- dated 05-1-2016 vide challan no. 0131611

300 and 500 ml vial

Copy of GMP submitted

Deferred for expert opinion for confirmation of prevalence of strain by Dr. Qurban Ali, Member Registration Board


NDV/Chicken/Egypt/11478AF/2011 (ND)……≥108EID50/dose at release (>128PD50).

Mantonied Isa 70..…0.35 mlFormaldehyde solution..0.0045ml

Bulk saline…… Q.S.to 0.5mlTotal ….. 0.5ml

Protection against avaian influenza, IB classic and Variant ,ND infections in breedes and layers

Route of adm: SCShelf life: 24 months

Expert opinion of Dr. Qurban Ali:The subject vaccine (1) is a multi-component poultry vaccine against Infectious

Bronchitis, Newcastle disease and Egg DropSyndrom. The formulation is tetravalent

inactivated. Strain types of the virus are as follows:-

i. IB Classical (Eg/11539F)ii. IB Variant type 2 (Eg/1212B)

iii. NDV/Chicken/Egypt/11478F/2011iv. EDS 76

The subject vaccine (2) is ME FLUVAC H9+ND 0.5. It is an inactivated tetravalent Viral Vaccine containing:-

i. Avian Influenza A/Chicken?Egypt/114940v/NLQP/2011(H9N2)ii. IB Classical (EG/11539F)

iii. IB Variant Type 2 (Eg/1212B)iv. NDV/Chicken/Egypt/11478 AF/2011

Before any dicision details on immunological justification for use in poultry of

Pakistan is required for the above two formulations in addition to technical profile of the

manufacturer. Moreover, status of registration in other than country of origin is not known.

Decision: Deferred for submission/ clarification of following by the firm:a. Details on immunological justification for use in poultry of Pakistan

for the above two formulationsb. Technical profile of the manufacturer.c. status of registration in other than country of origin.


h. Products applied by M/s Hivet Animal Health Business, Lahore deferred in 262nd


Following products of M/s Hivet Animal Health Business, Lahore were considered in

262nd meeting of Registration Board for the expert opinion of Dr. Qurban Ali. The details are

as follows:

Sr. No.



Type of Form

Dy No & Date of application

Fee submitted





meeting

1.Investigacion Aplicada S.A.de C.V. 7 Norte 416, Col. Centro, C.P. 75700, Tehuacan,Puebla, Mexico.

Emulmax IBH +ND

Inactivated virus emulsified vaccine against Inclusion Body Hepatitis disease and Newcastle disease.

Each 0.5ml contains:

SHP-IAP/92….106.7

dict/ml

SHP-IAP/94…106.7

DICT/ml

SHP-IAP/95…104.7

DICT/mlNewcastle LaSota strain…108.7DIEP50% / ml

Inactivated virus emulsified vaccine

For prevent Hydropericardium Syndrome and Newcastle Disease in broilers.

Proposed shelf life : 18 months

Form 5A

Dy NO. 2871 R&I DRAP dated 23.6.2016

Fee deposited Rs.100000/- dated23-6-2016

Price:De-controlled

Legalized free sale dated03-06-2016


2. Investigacion Aplicada S.A.de C.V. 7 Norte 416, Col. Centro, C.P. 75700, Tehuacan, Puebla, Mexico.

Emulmax IBHInactivated virus emulsified vaccine against inclusion body Hepatitis disease

Each 0.5ml e contains:SHP-IAP/92…107.0

DICT/ml

Form 5A

Dy No. 2812 R&I DRAP dated23-6-2016

Fee deposited Rs. 100000/- dated

Legalized free sale dated 03-06-2016



SHP-IAP/94…107.0

DICT/ml

SHP-IAP/95….107.0

DICT/ml

Inactivated emulsified vaccine

SubcutaneousTo prevent Hydropericardium Syndrome disease caused by adenovirus group 1,4 serotype in broilers

Proposed shelf life: 24 months

22-6-2016

De-controlled1000 dose bottle

Expert Opinion of Dr. Qurban Ali:Information on immunological relevance, justification of strains of IBH viz-a-viz

poultry in Pakistan for inclusion Body Hepatitis (IBH) component of vaccine may please be requested to applicant firm.

Moreover, rationale of formulation with ND Lasota; both vaccines route of administration and results of challenge studies as a potential vaccine against Hydro Pericardium Syndrome (HPS) are required.

Decision: Deferred for submission/ clarification of following by the firm:a. Information on immunological relevance, justification of strains of IBH

viz-a-viz poultry in Pakistan for inclusion Body Hepatitis (IBH) component of vaccine.

b. Rationale of formulation with ND LaSota.c. Both vaccines route of administration and results of challenge studies as a

potential vaccine against Hydro Pericardium Syndrome (HPS).

i: Clinical data of Enoxa (Enoxaparin 80, 60,40 & 20 mg) PFS appliedbyM/s Scilife Pharma Karachi.

Sr.No.

Name of Importer / Manufacturer


Date of application / Fee status / Packing / MRP

Documentary details

Decision in 263rd meeting

Decision

1. SciLife Pharma (Pvt) Ltd. Karachi, Pakistan

Manufacturer:

Hebi Changshan Biochemical Pharmaceutical Co., Ltd. No.9 Fuqiang Road, Zhengding,

EnoxaSolution for injection(Enoxaparin sodium )

Each pre-filled syringe contains:80mg/0.8mlEnoxaparin sodium USP…80mg(equivalent to 8,000 IU anti-Xa activity in 0.8ml)

Pharmacological group:

Dy No. 359 Dir (Bio) dated 08-6-2013

Fee Rs. 50000/- dated 27-6-2013 + 50000/- dated 09-11-2015

Unit pack size: 2 Pre-Filled Syringes

Price Rs. 487/- per

Legalized COPP No. 20150348Date 03.6.2015. enclosed

Product License No. GUOYAOZHUNZIH20063910 dated

Legalized GMP Certificate No. CN20130314 dated

Registration Board deferred above products for submission of clinical trial data.

Registration Board approved the product as per import policy for Finished Drugs and as per valid legalized


Shijiazhuang, China.

Anti-thrombotic Agent Pre-filled Syringe. 15.10.2013 Valid until 14.10.2018 enclosed

CoPP.


Manufacturer:

Hebi Changshan Biochemical Pharmaceutical Co., Ltd. No.9 Fuqiang Road, Zhengding, Shijiazhuang, China.

Enoxa [Specs: USP](Enoxaparin sodium) Injection 40mg/0.4 ml in PFSSolution for injection.

Each pre-filled syringe contains:Enoxaparin Sodium USP….40mg(equivalent to 4,000 IU anti-Xa activity in 0.4ml).

Pharmacolgical group:Anti-thrombotic Agent


Fee Rs. 50000/- dated 27-6-2013 +50000/- dated09-11-2015

Unit pack size: 2 Pre-Filled syringesPrice Rs. 625/-Rs.312.50/- per Pre-Filled Syringe

Legalized GMP Certificate No. CN20130314 date 15.10.2013 enclosedValid until14-10-2018.

Legalized COPP No. 20150346 date 03-06-2015 enclosed

Product License No. GUOYAOZHUNZI H20063913Copy of Power of Attorney enclosed




Manufacturer:

Hebi Changshan Biochemical Pharmaceutical Co., Ltd. No.9 Fuqiang Road, Zhengding, Shijiazhuang, China.

Enoxa [Product Specs: USP](Enoxaparin Sodium) Injection 60mg/0.6 in PFS

Each pre-filled syringe contains:Enoxaparin sodium USP…..60mg (equivalent to 6,000 IU anti-Xa activity in 0.6ml)

Pharmacological group:Anti-thrombotic Agent


Fee Rs. 50000/- 27-6-2013 +50000/- dated 09-11-2015

Unit pack size: 2 Pre-Filled Syringes

Price: Rs. 802/-Rs.401/- per Pre-Filled Syringe

Legalized COPP No. 20150347 dated 03-6-2015 valid until 30-4-2017 enclosed

Product License No. GUOYAOZHUNZI H20063919

Copy of GMP Certificate NO. CN20130314 dated15-10-2013 valid until27.10.18.enclosed




Manufacturer:

Hebi Changshan Biochemical Pharmaceutical Co., Ltd. No.9 Fuqiang Road, Zhengding,

Enoxa[Product Specs: USP]Enoxaparin SodiumSolution for Injection20mg/0.2ml in PFS

Each pre-filled syringe contains:Enoxaparin sodium USP….20mg(equivalent to 2,000 IU anti-Xa acitivity in 0.2ml)

Pharmacolgical group:


Fee Rs. 50000/- dated 27-6-2013 + 50000/- dated09-11-2015

Unit pack size: 2-Prefilled syringes

Price: 356/-Rs. 178/- per Pre-

Legalized COPP NO. 20150345 dated 03-6-2015 enclosed

Product License No. GUOYAOZHUNZI H20063911

Copy of GMP Certificate No. CN20130314 dated 15-10-


Registration Board approved the product as per import policy for Finished Drugs and as per valid legalized


Shijiazhuang, China.

Anti-thrombotic Agent Filled Syringe. 2013 valid until 14-10-2018 enclosed

CoPP.

j. Expert opinion on product applied by M/s Vet Crown Animal Health Lahore.

BIAROMVAC-Pan and AVIPOX-GAL of M/sVet Crown (Animal Health

International Lahore, were considered in 258th meeting of Registration Board and were

deferred for the expert opinion of following experts.

a. Dr Muhammad Afzal, NVL Islamabadb. Dr Masood Rabbani, UVAS Lahorec. Dr. Muhammad Arif Awan, CASQAB, Quetta

The experts have furnished expert opinions and detailed as under:S.#. Company Name and

ManufacturerName of Drug and Composition


Documentary details

1 Vet Crown(Animal Health) International. Lahore Pakistan

Manufacturer

S.C Romvac Company S.A, Soseaua Centurii nr.7,077190 Voluntari, Jud. llfov-Romania.

BIAROMVAC-PAInfectious Bursal Disease (IBD)

Each dose contains Active substance:Live IBD virus attenuated strain (PA 43-94) contain minimum 103.5 Eid 50 to maximum 105.5 Eid 50.

Pharmacological group:Vaccine (Lypholized).

Route of Adm: Ocular conjuctival, IM, OralShlef life : 18 months

Dy No. 1183 (R&I) dated 24-2-2016


Unit price: De- Controlled

Legalized COPP NO. 930/3 dated 28.9.2015

Market authorization no. 120170 dated 17-5-2012

GMP Certificate No. 29/2013/RO dated 17-12-2013

2 Vet Crown(Animal Health) International. Lahore Pakistan

Manufacturer

S.C Romvac Company S.A, Soseaua Centurii nr.7,077190 Voluntari, Jud. llfov-Romania.

AVIPOX-GAL(Avian pox disease.

Each vaccinal dose (0.01ml) contains:The Avian pox virus-Galinar attenuated strainGal-MP1with minimum titre 102 and maximum titre 105

DIE50 / Vaccinal dose.

Pharmacological group:Vaccine (Lyophilized).

Shelf life: 18 monthsRoute of adm: transdermal

Dy.No. 1184 (R&I) DRAP dated 24.2.2016


Price: De-controlled.

Legalized COPP No. 930/7/28 dated 28-9-2015

Market authorization No. 120010 dated 17-1-2012.

GMP Certificate No. 29/2013/RO dated 17-12-2013

Drugs available in the country of origin.


Dr .Muhammad Afzal,TI (Ex-Chief Scientist-II) NVL Islamabad.

i. BIAROMVAC-PA Infectious Bursal Disease.1. BiaRomvac PA is a vaccine against infectious Bursal Disease (IBD) containing attenuated IBD virus strain PA 93-94 of Romanian origin. Antigenic relationship of this strain with those of Pakistan origin IBD strains have not been established in the literature and no data has been presented in this regard. Thus utility of this vaccine in providing protection against local strains cannot be established or predicted.2. The dossier states (page 22-23 and many other places) “The optimum vaccine efficacy depends of the flock epidemiological situation and of the area where the birds are raised and evaluated under the direct coordination of the veterinary doctor which assures the sanitary – veterinary supervision on the base of the immunological status determination;. It further goes on to state “efficacy is influenced by the maternally derived antibodies”. These statements clearly indicate that recommendation on the time of vaccination will depend on local practices and epidemiological situation of the area. No documentation in this regard is available in the supplied dossier.

3. The dossier does not explain various methods used in vaccine preparation but mentions that these were carried out in accordance with company SOP. The details of these SOPs are missing in the dossier.4. The dossier presents different statements in various section regarding the use of embryos from SPF / conventional eggs in the preparation of vaccine. In Part II of the dossier (section II A.3 introductory para, 3.2 composition of vaccine and II.B.1.1 technical flow2 diagram), it is stated that vaccine is manufactured from embryos derived from SPF eggs. However contrary to this, paras 3.1.8 and II.C.1.2.1.2 stats that embryos from SPF / commercial grade or conventional eggs are used.

Opinion: The discrepancy mentioned in comment 4 has to besorted out before any recommendation on registration of the product could be made.

ii. Avipox GalAvi pox Gal contains an Italian strain of Avian Pox virus strain, Gal-MP1. This

vaccine is recommended for vaccination in hens for 90days age, In necessary situation tye minimum age for application in hens is 60days. The manufacturer recommends that in hens 1st vaccination should be done by Avipox-Col-81 vaccine and afterrevaccination with Avipox Gal. the manufacturer further recommends that no other vaccine should be administered before or after14 days from vaccination with Avipox-Gal.SPF/conventional hen embryonated eggs are used in vaccine manufacturing.

Absence of mycoplasma in the vaccine bactes is shown by cuturing on PPLO. It is now universally known that many mycoplasma will not grow on PPLO media or too fgastidious to grow. The standaed method used now universally by all leading vaccine manufacturer mycoplasma detection using PCR with universal mycoplasma primer.Opinion:Attenuated virus vaccine using conventional eggs may be source of introduction of unknown viruses in the country. Thus this vaccine AVIPOX GAL is not recommended for registration for use in Pakistan

Prof. Dr Mohammad Arif Awan CASVAB, Quetta


Biaromvac-PA & Avipox GalAll the information and technical data represented in the dossier for the two products

are satisfactory. As safety and efficacy of the presented products are concerned, the data meet the international standard and is comparable to the recommendations reflected in OIE manual for veterinary vaccine production. National Veterinary Laboratories (NVL), Islamabad may be requested, if necessary.

Furthermore, the vaccine based on the local strains of IBD and Avain Pox disease needs rigorous experimentation on isolation, characterization, attenuation, vaccine production and quality control. However comparative research studies will also be required to further see the suitability of the vaccine (attenuated or inactivated) based on locally isolated virus strain or the foreign strain vaccine. For this aspect the linkage of industry (commercial vaccine production units) and universities may be motivated, encouraged and financially support to address such research pursuits.

Dr. Masood Rabbani, UVAS Lahorei. Biaromvac-PA

It is freeze dried vaccine containing live attenuated (PA 43-94) strain of Infectious B ursal Disease Virus/Gumboro virus) embryo adapted virus. It is used to control outbreaks of IBD in commercial, rural, wild birds. It contains minimum amount of immunogen as 103.5-5.5 units of EID50/dose.

Gumboro/IBD is prevailing in Pakistan and causing serious economic losses in form of mortility, morbidity, immunodepression, and poor growth response of survivers.

ii. Avipox Gal:It is live attenuated strain of fowl pox virus (Galinar MP1 strain). Each

vaccinal dose (0.01ml) contains 102-5 units of EID50. It is used to control pox in avain species that is serious health hazard for rural, commercial, wild and zoo birds.

Status of the Vaccines in Pakistan: The above mention poltry vaccines are not being propduced in Pakistan and are not used in rural poltry. These vaccines are already registered with many companies in Pakistan.

Comments: Based on the “quality control data, results of the experimental trials and composition of the vaccines”. Each of the above mention vaccines against the poultry disease in Pakistan seem to be safe and effective.

Recommendation: It is therefore recommended that the said vaccines may be registered in Pakistan in the best interest of poultry farmers.

The case is submitted before the board for consideration please.

Decision in 262nd meeting: Registration Board deferred for evaluation by Dr. Qurban Ali, Member Registration Board.

The opinion of Dr. Qurban Ali is as under:a. Biaromvac-PA

Deferredi. Unless manufacturer clarifies with written statement that the production of

vaccine is exclusively and entirely on SPF Eggs.ii. Moveover, manufacturer produces SPF Eggs Quantity, Number and Source of

SPF Eggs Consignments for the last three yrears for vaccine production.


b. Avipox-GALDeffered

i. Unless manufacturer clarifies with written statement athat the production of vaccine is exclusively and entirely on SPF Eggs.

ii. Moveover, manufacturer produces SPF Eggs Quantity, Number and Source of SPF Eggs Consignments for the last three years for vaccine production.

Decision: Deferred for following clarification by the firm for above products:i. Unless manufacturer clarifies with written statement that the production

of vaccine is exclusively and entirely on SPF Eggs.ii. Moreover, manufacturer produces SPF Eggs Quantity, Number and

Source of SPF Eggs Consignments for the last three years for vaccine production.

iii. Clarification that which strain of Live IBD virus attenuated strain (PA 43-94) is in BIAROMVAC-PA

k. Request for import on bulk basis and individual repack locally by M/s Medi Pak Limited Lahore.M/s Medi Pak Limited Lahore has submitted an application for permission bulk

import and local repacking of teir following registered drugs.

Sr. No.

Product name Reg. No Manufacturer

1. Epogen IV 2000IU vials 043049 Laboratorio Pablo Cassara- Argentina2. Epogen IV 4000IU vials 043050

3. Epogen IV 10000IU vials 059006

The firm informed that bulk vilas will be imported as labelled / pre printed from

manufacturer abroad and only operation done at Medi Pak will be individual outer cartooning

along with insertion of PIL at their controlled packing facility under strict environmental

condition.

The firm has submitted following documents:a. Application on Form-5Ab. Fee of 100000/- for each i.e 300000/- in total.c. Copies of eveidence of renewal.d. Copy of additional pack approval.

Decision: Registration Board deliberated that packaging is the part of manufacturing process and after the aforesaid process the quality control testing and release is responsibility of manufacture, therefore the Board deferred above products for confirmation of following by the firm:

a. Quality control facility for testing of above products.b. Cold storage facility for outer cartooning along with insertion of PIL.


iii. Local Manufacturing of Biological Drugs1. M/s BF Biosciences, Lahore.a. Eritrogen (Erythropoietin) 2000IU PFS.

Sr.No.


Brand Name, Composition, Pharmacological group,Shelf life

Type of Form, Dy. No & date of application, Fee status, Packing & demanded MRP

Documentary details (CoPP etc.)Reference agencies status,Me too

Remarks

1 M/s BF Biosciences Ltd.,5km- Sunder Raiwind Road, Raiwind, Lahore

Eritrogen 2000IUEach prefilled syringe (1ml) contains:Recombinant Human Erythropoietin alpha........2000IU

Mitosis stimulating factor & differentiating hormoneShelf Life: 24 months

Form-5134/2014(R&I)09-05-2014Rs. 2000007-05-2014Pack of 6’s (PFS)Price:As per SRO

DML No. 000655 dated 30-01-2014GMP certificate No. 20132021-000 033-15 dated 08-6-2015 of M/s ZELLTEK S.A, Ruta Nacional No 168 S/N, Pasaje “EI Pozo’, Parque Tecologico Litoral , of the Province of Santa Fe, of the Argentine Republic valid for 01 year.

Eprex of Janssen-Cilag Ltd., UK

Sepo 2000IU/ml PFS by Al-Karim Distributors, Karachi

Evaluation as per decision of 246th meeting of Registration Board.S.No.

Documents and data required as per 246th

meeting

Documents and data submitted Remarks

1. Legalized GMP certificate of biological drug as an evidence that the manufacturer is an authorized manufacturer of that particular biological drug in its country of origin.

Firm has submitted the Legialized GMP certificate No. 20132021-000 033-15 dated 08-6-2015 of M/s ZELLTEK S.A, Ruta Nacional No 168 S/N, Pasaje “EI Pozo’, Parque Tecologico Litoral , of the Province of Santa Fe, of the Argentine Republic valid for 01 year.

GMP certificate is expired.

2. Structural similarity of subject biological drug product (concentrate/ ready to fill bulk for further processing) with reference biological product (innovator)

Under Eludication of structure of API, comparative analysis with EPO Standard BPR is provided by M/s ZELLTEK S.A, Argentine Republic.

i. Glycoform analysisii. Primary Structure

iii. Secondary Structureiv. Tertiary structurev. Disulfide bridges

vi. N-terminal sequencevii. Sialic Acid Content

viii. Native N-glycans profileix. Neutra N-glycans profile

Clarification is required whether API or bulk concentrate or redy to fill bulk, will be imported as manufacturing process mentioned in Form-5 shows only filling and packing, while GMP certificate shows API export.Structural similarity data of the API is provided with standard BPRStructural similarity performed is of API with


x. O-glyscosilatin site occupationxi. Content of dimmers and related

substances of high molecular weight

xii. Invivo biological activity.

BPR standard instead of reference product.

As per decision in 246th

meeting, structural similarity of subject biological drug product (concentrate/ ready to fill bulk for further processing) with reference biological product (innovator) is required.

Results of structural analysis of EPO standard BPR at sr. No. iv, vi, vii, viii, ix, x, xi and xii are not provided.

3. Authorization to manufacture the finished biological product for trial studies

Not provided Not provided

4. Bio-comparability studies including identity testing to parent molecule, purity testing, in vitro biological activity, potency and toxicity with support of iso-electro focusing data, gel electrophoresis, Western-Blot and other analytical techniques) and stability studies of finished biological product

Under Bio-comparibility studies, comparison between Eritrogen and Eprex is provided by BF Biosciences Ltd.

i. Immunocharacterization using Western Blot technique

ii. Biological activity using ELISA.

Long term and Accelerated stability data of trial batch is provided by the firm.

Real Time study temp. 50C ±30C.

Accelerated study temp. 250C±20C.

Source of API: Zelltek S.A, Argentine Republic

Trial batch size:120 PFS

Stabilty data provided is of one trial batch.

5. Others

Decision: Registration Board deferred the above product due to paucity of time.

b. Eritrogen (Erythropoetin) 4000IU PFSSr.No.





Remarks

1 M/s BF Biosciences Ltd.,5km- Sunder

Eritrogen 4000IUEach prefilled syringe (1ml) contains:

Form-5135/2014(R&I)09-05-2014Rs. 20000

DML No. 000655 dated 30-01-2014GMP certificate No. 20132021-000 033-15


Raiwind Road, Raiwind, Lahore

Recombinant Human Erythropoietin alpha........4000IU

Mitosis stimulating factor & differentiating hormone


07-05-2014Pack of 6’s (PFS)Price:As per SRO

dated 08-6-2015 of M/s ZELLTEK S.A, Ruta Nacional No 168 S/N, Pasaje “EI Pozo’, Parque Tecologico Litoral , of the Province of Santa Fe, of the Argentine Republic valid for 01 year.


Sepo 4000IU/ml PFS by Al-Karim Distributors, Karachi

Evaluation as per decision of 246th meeting of Registration Board.

S.No. Documents and data required as per 246th

meeting






Under Eludication of structure of API, comparative analysis with EPO Standard BPR is provided by M/s ZELLTEK S.A, Argentine Republic.i. Glycoform analysis

ii. Primary Structureiii. Secondary Structureiv. Tertiary structurev. Disulfide bridges


viii. Native N-glycans profileix. Neutra N-glycans profilex. O-glyscosilatin site occupation

xi. Content of dimmers and related substances of high molecular weight


Clarification is required whether API or bulk concentrate or redy to fill bulk, will be imported as manufacturing process mentioned in Form-5 shows only filling and packing, while GMP certificate shows API export.Structural similarity data of the API is provided with standard BPRStructural similarity performed is of API with BPR standard instead of reference product.



Results of structural analysis


of EPO standard BPR at sr. No. iv, vi, vii, viii, ix, x, xi and xii are not provided.

3. Manufacturer to manufacture the finished biological product for trial studies






Stability data of trial batch is not provided.

5. OthersDecision: Registration Board deferred the above product due to paucity of time.

c. Eritrogen (Erythropoetin) 10000IU PFS

Sr.No.


Brand Name, Composition, Pharmacological group, Shelf life



Remarks


Eritrogen 10000IUEach prefilled syringe (1ml) contains:Recombinant Human Erythropoietin alpha.......10000IU



Form-5136/2014(R&I)09-05-2014Rs. 2000007-05-2014Pack of 6’s (PFS)Price:As per SRO

`DML No. 000655 dated 30-01-2014

GMP certificate No. 20132021-000 033-15 dated 08-6-2015 of M/s ZELLTEK S.A, Ruta Nacional No 168 S/N, Pasaje “EI Pozo’, Parque Tecologico Litoral , of the Province of Santa Fe, of the Argentine Republic valid for 01 year.


Me Too status needs confirmation.

Evaluation as per decision of 246th meeting of Registration Board.S.No. Documents and data

required as per 246th

meeting


1. Legalized GMP certificate of biological drug as an evidence that the manufacturer is an authorized manufacturer of that particular biological

Firm has submitted the Legialized GMP certificate No. 20132021-000 033-15 dated 08-6-2015 of M/s ZELLTEK S.A, Ruta Nacional No 168 S/N, Pasaje “EI Pozo’, Parque Tecologico Litoral , of the Province of



drug in its country of origin. Santa Fe, of the Argentine Republic valid for 01 year.






viii. Native N-glycans profileix. Neutra N-glycans profilex. O-glyscosilatin site occupation

xi. Content of dimmers and related substances of high molecular weight


Clarification is required bulk concentrate or redy to fill bulk, will be imported as manufacturing process mentioned in Form-5 shows only filling and packing, while GMP certificate shows API export.

Structural similarity data of the API is provided with standard BPRStructural similarity performed is of API with BPR standard instead of reference product.





Not provided





Long term and Accelerated stability data of trial batch is provided by the firm.

Real Time study temp. 50C ±30C.

Accelerated study temp. 250C±20C.

Source of API: Zelltek S.A, Argentine Republic

Trial batch size:119 PFS

Stabilty data provided is of one trial batch.

5. Others



d. Eritrogen (Erythropoetin) 10000IU VialSr.No.




Documentary details (CoPP etc.)Reference agencies status, Me-too

Remarks


Eritrogen 10000IUEach vial (1ml) contains:Recombinant Human Erythropoietin alpha.......10000IU



Form-5682/2014(R&I)13-06-2014Rs. 20000 11-06-2014Pack of 6’s (Vials)Price:As per SRO

DML No. 000655 dated 30-01-2014

GMP certificate No. 20132021-000 033-15 dated 08-6-2015 of M/s ZELLTEK S.A, Ruta Nacional No 168 S/N, Pasaje “EI Pozo’, Parque Tecologico Litoral , of the Province of Santa Fe, of the Argentine Republic valid for 01 year.Epogen by Amgen, USAPDpoetin by Nextar Pharma, Karachi.

Evaluation as per decision of 246th meeting of Registration Board.S.No.

Documents and data required as per 246th meeting










viii. Native N-glycans profileix. Neutra N-glycans profilex. O-glyscosilatin site

occupationxi. Content of dimmers and

related substances of high molecular weight


Firm mentioned the erythropotein concentrate will be formulated locally under the manufacturing method, however structural similarity data of the API is provided with standard BPR

Structural similarity performed is of API with BPR standard instead of reference product.









5. Others

Decision of RB in 260th meeting:“Regiatration Board deliberated and deferred these applications that manufacturing and quality control of biological products require specialized facilities and approval from the Licensing Division, DRAP. The Baord dicussed that theses manufacturing units have already been granted registrations of various biological products for local manufacturing (mostly therapeutic proteins). As theses firms have applied for registration for local manufacturing of various biological products including rDNA products, Theraputic protein, Monocronial antibodies, Vaccines (Live, Attentuated, rDNA vaccines, so the Board decided to have opinion of licensing division DRAP regarding approved manufacturing facilities (categories of biological products) of these firms and status of already registerd biological drugs from these firms.”Decision: Registration Board deferred the above product due to paucity of time.

e. Peg-INF 180mcg/0.5ml PFSSr.No.





Remarks


Peg-INF 180mcg/0.5ml(Pre-filled syringe)Each PFS contains:Peginterferon alfa 2a…….180mcg

Immunostimulating agent/ Cytokine


Form-5137/2014(R&I)09-05-2014Rs. 20000 07-05-2014Pack of 1’s (PFS)Price:As per SRO

DML No. 000655 dated 30-01-2014

GMP certificate No. 20132021-000 033-15 dated 27-04-2015 of M/s Gemabiotech S.A., Fray Justo Sarmiento 2350-5th

floor Building E2, The city Buenos Aires of Argentina Rwepublic valid for 01 year.

Pegasys of Roche Products, UKPegasys of Roche Pakistan


S.No.

Documents and data required as per 246thmeeting



Firm has submitted the Legalized GMP certificate No. 20132021-000 033-15 dated 27-04-2015 of M/s Gemabiotech S.A., Fray Justo Sarmiento 2350-5th floor Building E2, The city Buenos Aires of Argentina Republic valid for 01 year.



Under Eludication of structure of API Peg Interferon alfa-2a , comparative analysis with Pegasys is provided by M/s Gemabiotech S.A., Argentina Republic

i. Determination of molecular weight by Mass spectrometry

ii. Identification by HPLCiii. Immunoidentification by Western

Blotiv. Determination of the sequence by

Mass spectrometry (MALDI-TOF)v. Determination of Tertiary structure by

Fluoresence spectrophotometryvi. Biological activity

vii. Determination of impuritiesviii. Determination of related proteins

ix. Microbial assay.3. Manufacturer to manufacture

the finished biological product for trial studies

Not provided


Biocomparability studies performed by M/s BF Biosciences Limited of Peg-INF with RMP Pegasys includes:i. Physical description

ii. pHiii. Assay Protein concentrationiv. Immunoidentification testv. Presence of free interferon alfa 2a in

Peg-INFvi. Lower molecular weight impurities

vii. Free PEG(Polyethylene glycol)viii. Related protein

ix. Biological activity.5. Others Stability data is required

Decision in 262nd meeting:“Deferred for rectification of shortcomings as mentioned above along with the confirmation of manufacturing facility (PFS). Moreover the board also advised to provide the details of already registered products in the same facility



2. M/s Macter International Limited, Karachi

a. Redimab (Rituximab) 100mg/10ml VialSr. No.





Remarks

1 M/s Macter International Limited, Karachi

Redimab 100mg(Concentrate for solution for infusion)Each vial (10ml) contains:Rituximab ………10mg.Monoclonal antibodyShelf Life: 2 years

CTD1861/2014 (R&I)22-04-2014Rs. 20000/-20-04-2014Pack of 1’s (Vial)Price: As per PRC

GMP certificate No. CN20110019 dated 09-10-2011

Mabthera by Roche Products Limted, UK

Ristova of Roche Pakistan Limited.

Evaluation as per decision of 246th meeting of Registration Board.Sr. No Documents and data required as per

246th meetingDocuments and data submitted by M/s Macter International Karachi

Remarks

1 Legalized GMP certificate of biological drug as an evidence that the manufacturer is an authorized manufacturer of that particular biological drug in its country of origin.

Legalized GMP Certificate No. CN20110019 DATED 09-10-2011 valid until 08-10-2016 M/s Shanghai CP Guojian Pharmaceutical co., Ltd. China.

2 Structural similarity of subject biological drug product (concentrate/ ready to fill bulk for further processing) with reference biological product (innovator)

Characterization of Primary and secrondary structure of redimab and its comparability analysis with innovator retuximab sold under brand name of Rituxan by M/s Shanghai CP Guojian Pharmaceutical co., Ltd. China following methods: N-terminal amino acid sequenced

analysis, C-terminal Lys truncation by mass

peptide maping by sequence coverage.

Molecule weight by reducing SDS PAGE.

MALDI-TOF Mass spectrum performed the test results demonstrate that the main components of basically identical, and the molecular weight of relative to each other

Peptide Mapping by RP-HPLCwhich demosntrates that our products are homogeneioujs and stable.

Comparison of Methionine Oxidation for Anti-CD20 innovator.

Biological Charatarization was done by biocactivity determination and affinity comparison by immumofluorescence method.

Impurities by SEC-HPLC, SDS-PAGE

3 Manufacturer to manufacture the finished Not provided.Minutes for 266th Meeting of Registration Board. 223

biological product for trial studies4 Bio-comparability studies including

identity testing to parent molecule, purity testing, in vitro biological activity, potency and toxicity with support of iso-electro focusing data, gel electrophoresis, Western-Blot and other analytical techniques) and stability studies of finished biological product

Comparitive analysis of finished drug (Redimab) with Ristova of Roche:Identity by SDS PagePurity by:SDS Page (Silver staining)Gel Filteration HPLCProtein content by UV (280nm)Biological activityGeneral safety tests :BET and sterlity

Stability data of locally manufactured finished product (accelerated and real time) is provided.

5 Others Certificateof analyisis of Rituximab bulk is submitted.Clinical Data has also been submitted.


b. Redimab (Rituximab) 500mg/50ml VialSr.No.





Remarks


Redimab 500mg/50ml(Concentrate for solution for infusion)Each vial (50ml) contains:Rituximab ………500mg.

Monoclonal antibodyShelf Life: 2 years

Form-51860/2014(R&I)22-04-2014Rs. 20000/01-04-2014Pack of 1’s (Vial)Price:As per PRC

GMP certificate No. CN20110019 dated 09-10-2011

Mabthera by Roche Products Limted, UK

Ristova of Roche Pakistan Limited.

Evaluation as per decision of 246th meeting of Registration Board.Sr. No


Documents and data submitted by M/s Macter International Karachi

Remarks


Legalized GMP Certificate No. CN20110019 DATED 09-10-2011 valid until 08-10-2016 M/s Shanghai CP Guojian Pharmaceutical co., Ltd. China.


Characterization of Primary and secrondary structure of redimab and its comparability analysis with innovator retuximab sold under brand name of Rituxan by M/s Shanghai CP Guojian Pharmaceutical co., Ltd. China following methods: N-terminal amino acid sequenced

analysis,Minutes for 266th Meeting of Registration Board. 224

C-terminal Lys truncation by mass peptide maping by sequence coverage.

Molecule weight by reducing SDS PAGE.

MALDI-TOF Mass spectrum performed the test results demonstrate that the main components of basically identical, and the molecular weight of relative to each other

Peptide Mapping by RP-HPLCwhich demosntrates that our products are homogeneioujs and stable.

Comparison of Methionine Oxidation for Anti-CD20 innovator.

Biological Charatarization was done by biocactivity determination and affinity comparison by immumofluorescence method.

Impurities by SEC-HPLC, SDS-PAGE3 Manufacturer to manufacture the

finished biological product for trial studies

Not provided.

4 Bio-comparability studies including identity testing to parent molecule, purity testing, in vitro biological activity, potency and toxicity with support of iso-electro focusing data, gel electrophoresis, Western-Blot and other analytical techniques) and stability studies of finished biological product

Comparitive analysis of finished drug (Redimab) with Ristova of Roche:Identity by SDS PagePurity by:SDS Page (Silver staining)Gel Filteration HPLCProtein content by UV (280nm)Biological activityGeneral safety tests :BET and sterlityStability data of locally manufactured finished product (accelerated and real time) is provided.

5 Others Certificateof analyisis of Rituximab bulk is submitted.Clinical Data has also been submitted.

Decision: Registration Board deferred the above product due to paucity of time.c. Epocan (Epoietin Alfa) 2000IU/ml Vial.

Sr. No.





Remarks


Epocan 2000IU/ml(Solution for injection)Each vial (ml) contains:

Form-51626/2014(R&I)15-04-2014Rs. 20000 31-03-2014

Legalized CoPP no. WHO-CPP-CERT-JN-130801 dated 01-08-2013Legalized Free Sale Certificate no. 2013-107


Epoietin alfa………2000IU(0.0135mg)

Hematopoiettic agent.

Shelf Life: 3 years

Pack of 1’s (Vial)Price:As per PRC

dated 26-08-2013Legalized GMP certificate No. K5087 dated 25-11-2009

Epogen by Amgen, USA

EPO by Nexpharm

Evaluation as per decision of 246th meeting of Registration Board.Sr. No



Remarks


Legalized GMP Certificate No. CN20140140 date of issuance 17-3-2014 valid upto 16-03-2019 M/s Shandong Kexing Bio – Products co., Ltd. Tangwangshan Road, Mingshui Development Zone, Zhangqiu, Shandong, China submitted.

Legalized Free Sale Certificate No. 2015-157 date of issuance 16-11-2015 valid for two year for date of issuance for Erythropoietin injection submitted.Legalized COPP No. WHO. CPP-CERT-ZQ-151116 date of issuance16-11-2015


Not provided Only comparative studies conducted locally are submitted.

Under structural similarity, the firm provided the structural characterization of ready to fill bulk with reference to European Pharmacopoeia.Bioequivalence study is provided by the firm with Eprex.

4 Manufacturer to manufacture the finished biological product for trial studies

5 Bio-comparability studies including identity testing to parent molecule, purity testing, in vitro biological activity, potency and toxicity with support of iso-electro focusing

Comparative analysis of Recombinant Human Erythropoietin (Drug substance) Vs RMP Recormon Roche is submitted and following test are carried out by M/s Macter International, Karachi SDS-PAGE (Silver staining)

Comparative analysis of drug substance vs RMP Recormon Roche is provided instead of Finished drud product Epocan 2000IU.


data, gel electrophoresis, Western-Blot and other analytical techniques) and stability studies of finished biological product

SDS-PAGE (Coomassie staining) Isoelectric focusing Purity (By Gel filtration chromatography) Sialic Acid (by Resorcinol Method) Protein content (By ELISA)Comparitive analysis of Finished product VS BRP Erythropoetin Alfa EDQM is also submitted and following test are carried out:

Identity by ELISA, Potency by Elisa, Total Protein content (By Lowry Assay), General Safety Test (By Bacterial endotixin test by gel Clot Method (LAL Test), Sterility Test by membrane filtration method.

Comparitive analysis of Finished product VS BRP Erythropoetin Alfa EDQM is provided instead of RMP Recormon Roche.

6 Others Specification of ready to filled bulk of M/s Shandong Kexing bioproducts Co., Ltd, ChinaIdentification test, Physical tests (Appearance Visible particles), Chemical tests (pH, Content of sodium ion content of citrate ion content of protein Osmolality, Activity tests (Activity in vitro , Activity in vivo), Sterility and BET , Abnormal toxicity test.

Finished products specification of M/s Macter International Karachi as under:

Physical Appearance, ParticulateMater, Extractable volume, pH, Osmaolality, Immuno-identification, Potency, Content of Protein, BET, Sterility, Abnormal Toxicity.

The firm has also submitted accelerated and real time stability studies

Decision: Registration Board deferred the above product due to paucity of time.d. Epocan (Epoietin Alfa) 4000IU/ml Vial.

Sr. No.





Remarks


Epocan 4000IU/ml(Solution for injection)Each vial (ml) contains:Epoietin alfa………4000IU(0.027mg)

Hematopoiettic agent.Shelf Life: 3 years

Form-51626/2014(R&I)15-04-2014Rs. 20000/-31-03-2014Pack of 1’s (Vial)Price:As per PRC

Legalized CoPP no. WHO-CPP-CERT-JN-130801 dated 01-08-2013Legalized Free Sale Certificate no. 2013-107 dated 26-08-2013Legalized GMP certificate No. K5087 dated 25-11-2009Epogen by Amgen, USA


Erithromax by Pharmatec Pakistan (Pvt.) Ltd.

Evaluation as per decision of 246th meeting of Registration BoardSr. No


meeting


Remarks



Legalized Free Sale Certificate No. 2015-157 date of issuance 16-11-2015 valid for two year for date of issuance for Erythropoietin injection submitted.Legalized COPP No. WHO. CPP-CERT-ZQ-151116 date of issuance 16-11-2015

GMP submitted reflects that manufacturer is authorize to manufacturer Recombinant Human Erythropoietin injection.


Not provided Only comparative studies conducted locally is submitted.

Under structural similarity, the firm provided the structural characterization of ready to fill bulk with reference to European Pharmacopoeia.

Bioequivalence study is provided by the firm with Eprex.

4 Authorization to manufacture the finished biological product for trial studies


5 Bio-comparability studies including identity testing to parent molecule, purity testing, in vitro biological activity, potency and toxicity with support of iso-electro focusing data, gel electrophoresis, Western-

Comparative analysis of Recombinant Human Erythropoietin Vs RMP Recormon Roche is submitted and following test are carried out by M/s Macter International, Karachi SDS-PAGE (Silver staining)

Comparative analysis of drug substance vs RMP Recormon Roche is provided instead of Finished biological product Epocan 4000IU.


Blot and other analytical techniques) and stability studies of finished biological product

SDS-PAGE (Coomassie staining)

Isoelectric focusing Purity(By Gel filtration

chromatography) Sialic Acid (by Resorcinol

Method) Protein content (By ELISA)Comparitive analysis of Finished product VS BRP Erythropoetin Alfa EDQM is also submitted and following test are carried out:Identity by ELISA, Potency by Elisa, Total Protein content (By Lowry Assay), General Safety Test (By Bacterial endotixin test by gel Clot Method (LAL Test), Sterility Test by membrane filtration method.

Comparitive analysis of Finished product VS BRP Erythropoetin Alfa EDQM is provided instead of RMP.


Finished products specification of M/s Macter International Karachi as under:Physical Appearance, ParticulateMater, Extractable volume, pH, Osmaolality, Immuno-identification, Potency, Content of Protein, BET, Sterility, Abnormal Toxicity.

The firm has also submitted accelerated and real time stability studies


e. Epocan (Epoietin Alfa) 10000IU/ml Vial.

Sr.No Name of Brand Name, Type of Form, Documentary details Remarks


. Manufacturer Composition, Pharmacological group,Shelf life

Dy. No & date of application, Fee status, Packing & demanded MRP

(CoPP etc.)Reference agencies status,Me too


Epocan 10000IU/ml(Solution for injection)Each vial (ml) contains:Epoietin alfa………10000IU(0.0675mg)

Hematopoietic agent.

Shelf Life: 3 years

Form-51627/2014(R&I)15-04-2014Rs. 20000 31-03-2014Pack of 1’s (Vial)Price:As per PRC

Legalized CoPP no. WHO-CPP-CERT-JN-130801 dated 01-08-2013Legalized Free Sale Certificate no. 2013-107 dated 26-08-2013Legalized GMP certificate No. K5087 dated 25-11-2009

Epogen by Amgen, USA

PDpoetin by Nextar Pharma, Karachi.

Evaluation as per decision of 246th meeting of Registration Board

Sr. No


meeting


Remarks



Legalized Free Sale Certificate No. 2015-157 date of issuance 16-11-2015 valid for two year for date of issuance for Erythropoietin injection submitted.Legalized COPP No. WHO. CPP-CERT-ZQ-151116 date of issuance 16-11-2015

GMP submitted reflects that manufacturer is authorized to manufacturer Recombinant Human Erythropoietin injection.


Not provided Only comparative studies conducted locally is submitted

Under structural similarity, the firm provided the structural characterization of ready to fill bulk with


reference to European Pharmacopoeia.

Bioequivalence study is provided by the firm with Eprex.

4 Authorization to manufacture the finished biological product for trial studies



Comparative analysis of Recombinant Human Erythropoietin Vs RMP Recormon Roche is submitted and following test are carried out by M/s Macter International, Karachi SDS-PAGE (Silver staining) SDS-PAGE (Coomassie staining) Isoelectric focusing Purity (By Gel filtration

chromatography) Sialic Acid (by Resorcinol Method) Protein content (By ELISA)

Comparitive analysis of Finished product VS BRP Erythropoetin Alfa EDQM is also submitted and following test are carried out:Identity by ELISA, Potency by Elisa, Total Protein content (By Lowry Assay), General Safety Test (By Bacterial endotixin test by gel Clot Method (LAL Test), Sterility Test by membrane filtration method.

Comparative analysis of drug substance vs RMP Recormon Roche is provided instead of Finished biological product Epocan 10000IU.

Comparitive analysis of Finished product VS BRP Erythropoetin Alfa EDQM is provided instead of RMP.


Finished products specification of M/s Macter International Karachi as under:Physical Appearance, ParticulateMater, Extractable volume, pH, Osmaolality, Immuno-identification, Potency, Content of Protein, BET, Sterility, Abnormal Toxicity.

The firm has also submitted accelerated


and real time stability studies.


g. T-Mab (Trastuzumab) 150mg Vial.Sr.No.





Remarks


T-Mab(Powder for concentrate for solution for infusion)Each vial contains:Trastuzumab………..150mg

Antineoplastic monoclonal antibody

Shelf life: 2 years

Form-5930/2014(R&I)17-04-2014Rs. 2000013-01-2014Pack of 1’s (Vial)Price:As per PRC

Legalized GMP Certificate No. CN20110019 dated 09-10-2011 valid until 08-10-2016

Herceptin 150mg by Roche Products Limited, UK

Evidence of Local availability is required.




Remarks


Legalized GMP Certificate No. CN20110019 dated 09-10-2011 valid until 08-10-2016 M/s Shanghai CP Guojian Pharmaceutical co., Ltd. China.


Charactrization of Primary and secondary structure of anti-HER2 rh.MAb and its comparability analysis with innovator Herceptin by M/s Shanghai CP Guojian Pharmaceutical co., Ltd. China following methods: The pimary structure of anti-HER2 rhMAb.

Similarity in secondary sturucture by circular dichroism (CD) and Spectra.

Similarity in IEF profile. Similarity in molecular weight by reducing

SDS-PAGE. MALDI-TOF Mass spectrum performed

the test results demonstrate that the main components of basically identical, and the molecular weight of relative to each other.

Peptide Mapping by RP-HPLC which demosntrates that our products are homogeneioujs and stable.

N-Glycosylation Analtysis. SDS-PAGE Purity


SEC-HPLC Purity Similarity in Biological Activities and

Immunological Properties Biological Charatarization was done by

biocactivity determination and affinity comparison by immumofluorescence method.

Impurities by SEC-HPLC, SDS-PAGE3 Authorization to manufacture the

finished biological product for trial studies

Not provided.


Biocomparability of finished drug the firm has submitted following data are as under:

Comparative Analysis of Locally Manufactured Drug Product of T-Mab 150 mg with Reference Medicinal Product Harceptin, Materials, Indentificatin (BySDS-PAGE& By Isoelectric focusing), Purity (By SDS-PAGE& By Gel Filtration Chromatography), Biological activity, General Safety Tests By Bacterial Endotoxin Test (By Gel Clot Method), Sterility Test.Stability Studies of Locally Manufactured Drug Product of T-Mab 150mg.Real Time stability studies, Accelerated stability studies

5 Others Non-clinical study The firm submitted data are as under:1. Pharmacology(Primary pharmacology, Secondary Pharmacology, Safety Pharmacology, Pharmacodynamic drug interactions).2. Pharmacokinatics(Absorption, distribution, Metabolism, Excretion, Pharmacokinetics Drug Interaction)3. Single-Dose Toxicity(Acute Single-Dose toxicity for intravenous injection anti-HER2 rh MAB of CPGJ into mice)4. Repeat-Dose toxicity(Repeat-Dose toxicity for intravenous injection anti-HER2 rh MAB of CPGJ into rhesus)5. Genotoxicity(Genotoxicity of –HER2 rh MAB of CPGJ)6. Hepolytic Study(Hemolytic Study of –HER2 rh MAB of CPGJ)

Decision: Registration Board deferred the above product due to paucity of time.g. T-Mab (Trastuzumab) 440mg Vial.

Sr.No.


Brand Name, Composition, Pharmacological

Type of Form, Dy. No & date of application, Fee

Documentary details (CoPP etc.)Reference

Remarks


group,Shelf life

status, Packing & demanded MRP

agencies status,Me too


T-Mab(Powder for concentrate for solution for infusion)Each vial contains:Trastuzumab………..440mg

Antineoplastic monoclonal antibodyShelf life: 2 years

Form-5927/2014(R&I)17-04-2014Rs. 20000/-13-01-2014Pack of 1’s (Vial)Price:As per PRC

Legalized GMP Certificate No. CN20110019 dated 09-10-2011 valid until 08-10-2016

Herceptin by Roche Pakistan

Evidence of availability in reference drug agencies is required.



meeting


Remarks


Legalized GMP Certificate No. CN20110019 dated 09-10-2011 valid until 08-10-2016 M/s Shanghai CP Guojian Pharmaceutical co., Ltd. China

The application of the firm is considered in 257th meeting of RB wherein it was deferred for evaluation by the division.


Charactrization of Primary and secondary structure of anti-HER2 rh.MAb and its comparability analysis with innovator Herceptin by M/s Shanghai CP Guojian Pharmaceutical co., Ltd. China following methods: The pimary structure of anti-HER2

rhMAb. Similarity in secondary sturucture by circular dichroism (CD) and Spectra.

Similarity in IEF profile. Similarity in molecular weight by

reducing SDS-PAGE. MALDI-TOF Mass spectrum

performed the test results demonstrate that the main components of basically identical, and the molecular weight of relative to each other.

Peptide Mapping by RP-HPLC which demosntrates that our products are homogeneioujs and stable.

N-Glycosylation Analtysis. SDS-PAGE purity. SEC-HPLC Purity Biological Charatarization was done by

biocactivity determination and affinity comparison by immumofluorescence method.

Impurities by SEC-HPLC, SDS-PAGE3 Manufacturer to manufacture

the finished biological product for trial studies.

Not provided.



Biocomparability of finished drug the firm has submitted following data are as under:

Comparative Analysis of Locally Manufactured Drug Product of T-Mab 440mg WITH Reference Medicinal Product Harceptin, Materials, Indentificatin (BySDS-PAGE& Isoelectric focusing), Purity (By SDS-PAGE& By Gel Filteration Chromatography), Protein Content (By UV), Biological Activity, General Safety Tests By Bacterial Endotoxin Test (By Gel Clot Method), Sterility Test.Stability Studies of Locally Manufactured Drug Product of T-Mab 440.Real Time stability studies, Accelerated stability studies

5 Others Animal Toxicology study The firm submitted data are as under:

1. Pharmacology(Primary pharmacology, Secondary Pharmacology, Safety Pharmacology, Pharmacodynamic drug interactions).2. Pharmacokinatics(Absorption, distribution, Metabolism, Excretion, Pharmacokinetics Drug Interaction)3. Single-Dose Toxicity(Acute Single-Dose toxicity for intravenous injection anti-HER2 rh MAB of CPGJ into mice)4. Repeat-Dose toxicity(Repeat-Dose toxicity for intravenous injection anti-HER2 rh MAB of CPGJ into rhesus)5. Genotoxicity(Genotoxicity of –HER2 rh MAB of CPGJ)6. Hepolytic Study(Hemolytic Study of –HER2 rh MAB of CPGJ)



h. Macgrastim (Filgrastim (rhGCSF) 300mcg/ 1.2 ml) vial.Sr.No.





Remarks


Macgrastim (Filgrastim)Each vial contains:Filgrastim…..300mcg/1.2ml

Colony Stimulating Factor

Shelf Life: 2 years

Form-51118/2014(R&I)10-10-2014Rs. 20000 16-09-2014Pack of 1’s (Vial)Price:As per PRC

Legalized CoPP no. 2013-039 dated 16-08-2013Legalized GMP certificate no. CN20130269 dated 30-09-2013Grastim by CCL Pharma, Lahore.

Evidence of availability in reference drug agencies is required.



meeting


Remarks


Legalized CoPP No: CN20130269 dated 30.09.2013 valid upto 29.09.2018 of M/s Hangzhou Jiuyuan Gene Engeineering Co., Ltd, China indication that the manufacturer has approval to manufacture the rhGCSF injection


Physicichemical and biosililarity analysis of rhGSCF with Filgrastim produced by Kirin Brewery Co., Japan:rhGSCF Formula/ chemical structure. Molecular weight:

SDS reducing PageHPLC

Purity:Gel electrophoresisIsoelecric focusingRP HPLCSEC HPLCCapillary electrophoresis

Assay for chemical structure:Sequencung of rDNAUV spectrumComposition of amino acidsPepetide mappingN- terminal sequencing

Immunology:Identification by wetstern blotELISA

Bilogical activity:In vitroIn vivo


Not provided.



Comparative Analysis of Locally Manufactured Product Macgrastim Liquid Solution for Injection (300 mcg/ 1.2 ml ) VS Neupogen (Innovator):

Immunoidentification by western blot

Purity by SDS Page Purity by gel filteration Potency protein by Bradford assay Bilogical activity by cell

proliferation assay General safety tests: BET and

sterility

Clarification required as comparative analysis performed by the firm is with Neupogen having composition 300mcg/1 ml while applied product Macgrastim’s composition is 300mcg/1.2ml.

5 Others Certificate of analysis of bulk material to be supplied is submitted.Stability data of finished product (accelerated and real time is provided)Clincal data submitted.


i. Biovac HB (Hepatitis B Vaccine) 10mcg/0.5mlS.#.

Name of Importer/

Manufactruer

Brand Name /Composition

Date of application/Fee

status/price

Documentary details

Remarks

1. Macter International Ltd. 216, SITE, Karachi, Pakistan (Local Manufacturer)

Bulk material source:LG Life Sciences Korea.

Biovac HB 10mcg/0.5ml(Recombinant Hepatitis B Vaccine)Each 100ml of vaccine contains: Purified hepatitis B surface antigen (rDNA) (Host: Saccharomyces cerevisiae AB 110, Vector: pYLBC-A/G-UB-HBs)……2mg

Prevention of Hepatitis BShelf Life: 2 years

Form-5182/2014(R&I)10-03-2014Dy No.40 DDC (BD) Dated17-3-2014

Fee Rs. 20,000/-Dated 21-8-2013Pack Size: 1’s & 10’s (vial)Price: As per PRC

Legalized CoPP No. 2015-A1-0917 Dated16-7-2015Legalized GMP No.2015-F1-0102 dated09-4-2015Engerix B by GSK, UKEngerix B by GSK, Pakistan

a. Firm has submitted the CoPP FSC and GMP of bulk material issued from regulatory body of Korea.

b. Under finished product specifications firm has provided, tests of Physical appearance, aluminum content, Potency by Elisa, identification and purity by SDS-Page, endotoxin bioburden and sterility tests.

2. Macter International Ltd. 216, SITE, Karachi, Pakistan (Local Manufacturer)

Bulk material

Biovac HB 20mcg/ml(Recombinant Hepatitis B Vaccine)Each 100ml of vaccine contains: Purified hepatitis

Out Dy No. 184 dated 10.3.2014

Rs.20,000/- dated21-8-2013Pack Size: 1’s & 10’s (vial)Price. As per PRC

Legalized CoPP No. 2-13-A1-1023 Republic of Korea dated 08-05-2013Legalized Free sale certificate No. 2013-A1-

a. Firm has submitted the CoPP FSC and GMP of bulk material issued from regulatory body of Korea.

b. Under finished


source:LG Life Sciences Korea.

B surface antigen (rDNA) (Host: Saccharomyces cerevisiae AB 110, Vector: pYLBC-A/G-UB-HBs)……2mgPrevention of Hepatitis BShelf Life: 2 years

1022 dated 08-5-2013Legalized GMP certificatDated 15-3-2013 enclosed.Engerix B by GSK, UKEngerix B by GSK, Pakistan

product specifications firm has provided, tests of Physical appearance, aluminum content, Potency by Elisa, identification and purity by SDS-Page, endotoxin bioburden and sterility tests.

Evaluation as per decision of 246th meeting of Registration BoardSr. no.

Documents/ data as per requirement of DRB 246

Documents / data submitted by Macter

Remarks

1. Legalized GMP certificate of biological drug as evidence that manufacturer is an authorized manufacturer of that particular biological drug in its country of origin

Legalized GMP certificate by KFDA issued on March 15, 2013.

WHO prequalification certificate and Web link of WHO website linkhttps://extranet.who.int/gavi/PQ_Web/  for WHO prequalified vaccine manufacturers included in GAVI program is provided.

Legalized COPP certificate no. 2013-A1-1023 issued on May 08, 2013 is provided.

Notarized and legalized (by Pakistan embassy Soule, South Korea) GMP certificate Issued by Korea Food & Drug Administrationon March 15, 2013 is submitted.

WHO pre-qualification letterIssued by Coordinator quality, safety and standard is submitted.This product & manufacturer are included in the list of prequalified vaccines & manufacturer at WHO web link https://extranet.who.int/gavi/PQ_Web/.

Notarized and legalized (by Pakistan embassy Soule, South Korea) COPP certificate no. 2013-A1-1023 issued on May 08, 2013 is provided.

2. Structural similarity of subject biological drug product (ready to fill bulk) with reference biological product (innovator).

Product characterization is performed for comparability with WHO reference standard of NIBSC Hep B antigen & innovators product Engerix B of GSK by SDS PAGE (mol. Wt.), UV spectrophotometry (identification), Circular Dichorism (secondary structure), electron microscopy (particle morphology), gradient centrifugation (density), gradient Centrifugation (homogeneity), Tryptic digestion & SDS Page, N Terminal sequence (identity), C terminal sequencing (identity), Amino acid composition,

Studies are performed by LG life Sciences South Korea are available in provided CTD dossier.


https://extranet.who.int/gavi/PQ_Web/

https://extranet.who.int/gavi/PQ_Web/

thin layer chromatography (phospholipid composition), Antigenicity by ELISA (efficacy), Size Exclusion Charmatography and SDS page for purity,

3. Bio comparability studies including identity testing to parent molecule, purity testing, in vitro biological activity / potency testing and toxicity with support of IEF data, gel electrophoresis, western blot and other analytical methods and stability studies of finished drug.

Comparative analysis of locally produced drug product with Reference medicinal product (Engerix B).Identity: SDS PAGEPurity: SDS PAGEPotency: ELISAGeneral safety testsBacterial Endotoxin test, Sterility test and abnormal toxicity test.Stability data is provided by the firm. (Long term and accelerated stability data)

Comparative studies of local batches with innovators product Engerix B of GSK are provided.

4. Others Animal toxicity studies and clinical trial studies are submitted

Pharmacokinetics and toxicological studies are provided.

Decision of RB in 260th meeting:“Regiatration Board deliberated and deferred these applications that manufacturing and quality control of biological products require specialized facilities and approval from the Licensing Division, DRAP. The Baord dicussed that theses manufacturing units have already been granted registrations of various biological products for local manufacturing (mostly therapeutic proteins). As theses firms have applied for registration for local manufacturing of various biological products including rDNA products, Theraputic protein, Monoclonal antibodies, Vaccines (Live, Attentuated, rDNA vaccines, so the Board decided to have opinion of licensing division DRAP regarding approved manufacturing facilities (categories of biological products) of these firms and status of already registerd biological drugs from these firms.”


j. Neupeg (Peg-Filgrastim) 6mg/ml vial.Sr. No.


Brand Name, Composition,

Pharmacological group,

Shelf life

Type of Form, Dy. No & date of

application, Fee status, Packing & demanded MRP

Documentary details (CoPP etc.)Reference agencies

status,Me too

Remarks


Neupeg 6mg/ml (Pegfilgrastim)Each vial contains:Pegfilgrastim……..6mg/ml

ImmunomodulatorShelf Life: 2 years

Form-5 OutDy.#163, 10-3-2014Rs. 8000/- 31-10-2011Rs. 12000/-09-10-2012 Pack of 1’s (Vial)Price: Rs. 53730/-

Legalized CoPP No. MFG/WHO-COPP/INTAS/2016/128492, Legalized GMP certificate No. 16091293 dated19-09-2016

Evidence of local and international availability in reference drug agencies is required.




meeting


Remarks


GMP certificate No. 16091293 dated 19.09.2016 valid upto 18-09-2018 issued by Food & Drug Control Administration, Gujrat state, India to Intas Biopharmaceuticals Ltd., Plot No. 423/P/A, Sarkhei Bavla Highway, Village Moraiya, Talika Sanand, Gujrat.


Physicichemical and biosimilarity analysis of Intas’ Pegfilgrastim with RMP Neulasta of Roche Products:Primary sequence/structure analysis(includes sequence correctness, and position of disulphide linkage) N terminal sequence GCSF DNA sequence Amino acid composition Peptide map analysis Western BlotpI determination Isoelectric focusingIdentity (pegylation) SDS-PAGE(non-reducing;iodine

stain)Tertiary structure analysis UV Spectroscopy Fluoresence SpectroscopyMolecular weight determination Mass Spectrophotometry (MALDI)Product related variants, differing in molecular weight SDS-PAGE (Non-reducing; silver

stain) SE HPLCCharge/Hydrophobicity related variants RP HPLCCharge related variants Cation Exchange Chromatography

HPLC (CEx-HPLC)Biological activity In-vitro biological activity


Not provided.

4 Bio-comparability studies including identity testing to parent molecule, purity testing, in vitro biological activity, potency and toxicity with support of iso-electro focusing data, gel electrophoresis, Western-Blot and other analytical

Biocomparability studies provided by the firm for Neupeg with Neulastim of Roche, Switzerland.Physicochemical comparison of Neupeg with RMP Neulastim: Expression host Molecular size of free filgrastim

molecule Pegylation chemistry

Biocomparability studies are performed with Neulastim of Roche, Switzerland which is available as Pre-filled syringe and its composition is 6mg/0.6ml, While Neupeg of Macter, Pakistan is a vial and its


techniques) and stability studies of finished biological product

Molecular size of Pegylated Conjugate Concentration of Pegfilgrastim Route of administration Peptide map Non-reducing SDS-PAGE Immunoblot Size exclusion chromatography RP HPLC ChromatogramStability data is provided by the firm.(Long term & accelerated stability data.)

composition is 6mg/ml.

.

5 Others Animal StudiesComparative safety, efficacy clinical trials


Case No.02: Heparin applied by different importers deferred for submission of clinical data.

Following Heparin Injections applied by below mentioned importers were considered

in 264th meeting of Registration Board and were deferred for the submission of clinical data.

All the formalities and documents as per Form-5A are complete and now the firms have

submitted the clinical data for above products. The details are as follows:

Sr.No.

Name of Importer / Manufacturer


Date of application / Fee status / Packing / MRP

Documentary details

Decision of RB in 264th meeting

Decision

1. M/s Graton PharmaSuit no. 102, The Plaza, Clifton 2 Talwar Karachi.

M/s Tianjin Biochemical Pharmaceutical Co., Ltd.269, South Huanhe Rd, Tianjin Airport Economic Area, Tianjin, 300308, China.

Gratin injection

Each vial containsHeparin Sodium… 5000 IU

Anticoagulant

Shelf life: 3 years

Form 5A

Dy No.973-ADC(BD)01-09-2016Rs.10000013-04-2016

Pack size and price is not provided.

Legalized CoPP No. 2016031 dated 22-08-2016 issued by Tianjin FDA, China.

Heparin Sod. of Wockhort UK(MHRA)

Multiparin Biopharma

Registration Board deferred the above product for submission of clinical trial data.

Approved as per import policy for Finished Drugs and as per valid legalized CoPP.

2. Shamco Traders (Private) Limited, LahoreApproved Manufacturer:M/s MefarIlac San AS RamazanogluMah. Ensar Cad. No: 20 34906 KurtkoyPendik Istanbul Turkey

POLIPARIN 25000 IU/ 5ml IV/ SC Injectable vial

Each 5ml vial contains:Heparin sodium

Form-5A

Dy No. 3120 dated 19-12-16

Rs 100000 dated 15-12-16

Rs. 625/ vial

Legalized CoPP No. 2016/2855 dated21-11-2016

Registration Board deferred above product for submission of clinical trial data.

Registration Board approved product from new manufacturing site i.e. M/s Aroma Ilac San.Ltd. STI. Vakiflar OSB Mahallesi Sanayi Caddesi No. 22/1 Kat.2 Ergene/ TEKIRDAG Turkey as per import policy


New Manufacturing Site:M/s Aroma Ilac San.Ltd. STI. Vakiflar OSB Mahallesi Sanayi Caddesi No. 22/1 Kat.2 Ergene/ TEKIRDAG Turkey.

.25000IU


for Finished Drugs and as per valid legalized CoPP. The previous approval of the registration Board in its 260th for the said product from M/s MefarIlac San AS RamazanogluMah. Ensar Cad. No: 20 34906 Kurtkoy Pendik Istanbul Turkey is cancelled.

Case No.03: Deferred Case of for additional pack size by M/s. Snam Pharma, Lahore.

M/s Snam Pharma, Lahore has requested for the additional pack size of their

already registered drug Biocan R injection (Reg.No. 057167). The case was considered in

264th meeting of Registration Board and Board decided as follows. The firm has submitted the

stability data for above product.

Name of Importer and manufacturer

Name ofProduct/ Reg.No.

Existingpack size

AdditionalPack

RequiredDocumentary detail

Decision of RB in 264th

meeting

Decision

M/s SnamPharma 61-GDefense HousingAuthority, Phase-1, Lahore

Bioveta, a.s.,Komenskeho212,683 23Ivanovicena Hane, CzechRepubic

Biocan R InjectionReg# 057167Composition 1ml :Virus rabiei inactivatum, strainSAD vnukovo-32 min.2 IU

10x5ml.5x20ml

1ml x20single dose

CoPP No. 021/2015Dated 13.1.2015Prod Lic No. 97/086/02-C dated 16-12-2002

Registration Board deferred above product for submission of stability data.

Approved as per import policy for Finished Drugs and as per valid legalized CoPP.


Case No.4: Registration of Drugs for Export Purpose.

M/s The Nextar Pharma (Pvt) Ltd. has requested for registration of following

product for export purpose only:-

Sr. No.



Type of FormDy No & Date of applicationFee submitted

Pack size/

Document details

Remarks

1 The Nextar Pharma Private Limited.Plot No, E-58, North Western Industrial Zone, Port Qasim, Pakistan.

Sea-Tide Injection (Octreotide Acetate 100mcg Pre Filled Syringe.Octreotide as acetate(1.06 ~ 1 ODB 100mcg)

Form 5-D1921/2017(R&I)19-01-2017Rs.50,000/-17/01/20171’s

-DML-Copy of Last inspection Report-Export order

2 The Nextar Pharma Private Limited.Plot No, E-58, North Western Industrial Zone, Port Qasim, Pakistan.

Sea-Tide Injection (Octreotide Acetate) 50mcg Pre Filled Syringe.Octreotide as acetate(1.06 ~ 1 ODB 50mcg

Form 5-D1920/2017(R&I)19-01-2017Rs.50,000/-17/01/20171’s

-DML-Copy of Last inspection Report-Export order

Decision: Registration Board deliberated that as above products are of synthetic origin, therefore the manufacturer will be asked for further confirmation of manufacturing facility.

Case No.05: Imported veterinary biologicals from non-reference countries.

Sr. No.



Type of FormDy No & Date of applicationFee submittedPack size/

Document details

Decision

1 The Marush (Pvt) Ltd K-123 Model Town Lahore.

‘’SHCHELKOVO BIOCOMBINATE’Biocombinat township, SShchelkovskii district, Moscow region, Russian Federation

Cultural monovalent and polyvalent adsorbed inactivated vaccine against foot and mouth disease.

Each dose containAntigen of virus type A (krrasnodarskiy 2013)…….. 10PD50Antigen of virus type O (Pan Asia 2)…….. 6PD50Antigen of virus type Asia1(sindh 08)….. 6PD50

Form 5-A2309/2017(R&I)24-01-2017Rs.100,000/-23/01/2017Multiple pack size:10 DS Vial25 DS Vial50 DS Vial100 DS Vial

Legalized GMP and Legalized Free Sale certificate is submitted

Deferred for evaluation of product by Dr.Qurban Ali, Member Registration Board.


Item No.VI: Quality Assurance & Laboratory Testing.

Case No.01: Manufacture and Sale of Sub-Standard Ascrepe Bandage Batch No.001143 by M/S Asian Fibre, Karachi. F.No. 3-09/2016-QC.

The sample of Ascrepe Bandage Batch No. 001143 By M/S Asian Fibre, Karachi

drawn by FID Karachi from manufacturing premises on 14th December 2015 for test analysis.

The sample was sent to the CDL Karachi for test analysis, however the sample was declared

Substandard vide test report No.KQ.395/2015 dated 12th February 2016. On the explanation

letter to the firm the firm was not challenged the CDL Test report in Appellate Laboratory

NIH Islamabad under Section 22(5) of the Drugs Act 1976. The result of CDL on the basis of

which sample under reference has been declared sub-standard are reproduced as under

Threads per stated length:- Determined: Limits:Wrap: 144.33/cm Not less than 170.0/cm Does not comply Weight per Unit Area: 20.41gm/m2 Not less that 140.0gm/m2 Does not comply

The sample is of “Sub-Standard” quality under the Drug Act 1976.As per procedure show cause notices was issued to the firm and accused persons,

offering opportunity of personel hearing before the Drug Registration Board. They have been

also called for personal hearing.

259th meeting of Registration Board held on 30th & 31th May 2016. Proceedings: Mr.Muhammad Shakir, Director of the M/s Asian Fiber Karachi, appeared before the 259th meeting of Registration Board held on 30th and 31st May, 2016 and pleaded their case.Decision: The Board after detailed discussion, deliberation, considering the facts and legal provision decided as under:-The Board decided to suspend the Registration for six months (06) and to conduct the PSI from the following panel.

i. Director DTL Karachi, ii. Area FID.

The conclusion of PSI report is as under:-

Mr. Najam-Us-Saqib, FID Karachi submitted PSI report conducted on 23rd January, 2017.

Focus of Inspection: Product Root Cause

Ascrepe Bandage(Batch No. 001143)

The product is manufactured by using cotton Yarn and process involved is, weaving, bleaching, slitting and rolling and packaging. Process of manufacturing of ascrerpe bandage involved rather bleaching.The process of manufacturing for this particular product was mostly dependent the manual operations. Panel observed that this may be a major contributing factor as route cause of the shortage of weight and length of the product.Firm has taken remedial measure by incorporating two more machines (Semi-automatic with weight and length measurement operations facility.On the basis of PSI inspection GMP compliance and verification of different related documents, the panel recommends the resumption of the production under strict


compliance of GMP/cGMP guidelines.On the basis of PSI inspection GMP compliance and verification of different related

documents, the panel recommends the resumption of the production under strict compliance

of GMP/cGMP guidelines.

Proceedings and Decision of 266th Meeting:The Board after detailed discussion, deliberation, considering the facts and legal provision decided as under:-

“The Board decided to give resumption of registration of Ascrepe Bandage by M/s Asian Fibre Karachi.”

Case No.02: Manufacture & Sale of Sub-Standard Cotton Bandage BP Batch No. 0815723338 by M/S Asian Fibre, Karachi F. No. 3-04/2016-QC

The sample of Cotton Bandage BP Batch No. 0815723338 By M/S Asian Fibre,

Karachi drawn by FID Karachi from manufacturing premises on 14-12-2015for the test

analysis. The sample was sent to the CDL Karachi, however the sample has been declared

Substandard vide test report No.KQ.400/2015 dated 08th February 2016. On the explanation

letter to the firm by the FID Karachi the firm was not challenged the CDL Test report in

Appellate Laboratory NIH Islamabad under Section 22(5) of the Drugs Act 1976 The result

of CDL on the basis of which sample under reference has been declared sub-standard are

reproduced as under

Threads per 10cm:- Determined: Limits:Wrap/10cm: 124.67 135.0 to 163.0 Does not comply Weft/10cm: 57.71 84.0 to 96.0 Does not comply

The sample is of “Sub-Standard” quality under the Drug Act 1976.

As per procedure show cause notices was issued to the firm and accused persons, offering

opportunity of personal hearing before the Drug Registration Board. They have been also

called for personal hearing.

259th meeting of Registration Board held on 30th & 31th May 2016 Proceedings: Mr. Muhammad Shakir, Director of the M/s Asian Fiber Karachi, appeared before the 259th meeting of Registration Board held on 30th and 31st May 2016 and pleaded their case.Decision: The Board after detailed discussion, deliberation, considering the facts and legal provision decided as under:-

The Board decided to suspend the Registration for six months (06) and to conduct the

PSI from the following panel.


The Firm will recall the batch and the area FID will supervise the destruction. Mr. Najam-Us-Saqib FID Karachi submitted the PSI report conducted on 23rd January, 2017.Minutes for 266th Meeting of Registration Board. 245


Focus of Inspection: Product Root CauseCotton Bandage (Batch No. 0815723338)

The product is manufactured by using cotton Yarn and process involved is, weaving, bleaching, slitting and rolling and packaging. Process of manufacturing of ascrerpe bandage involved rather bleaching.The process of manufacturing for this particular product was mostly dependent the manual operations. Panel observed that this may be a major contributing factor as route cause of the shortage of weight and length of the product.Firm has taken remedial measure by incorporating two more machines (Semi-automatic with weight and length measurement operations facility.On the basis of PSI inspection GMP compliance and verification of different related documents, the panel recommends the resumption of the production under strict compliance of GMP/cGMP guidelines

Proceedings and Decision of 266th Meeting:The Board after detailed discussion, deliberation, considering the facts and legal provision decided as under:-

“The Board decided to give resumption of registration of Cotton Bandage by M/s Asian Fibre Karachi.”

Case No.03: Manufacture & Sale of Sub-Standard Gauze Swab/Sponges BP Batch No. 00511 by M/S Asian Fibre, Karachi. F. No. 3-08/2016-QC

The sample of Gauze Swab/Sponges BP Batch No. 00511 By M/S Asian Fibre,

Karachi drawn by FID Karachi from manufacturing premises on 14-12-2015 for test analysis.

The sample was sent to the CDL Karachi, however the sample of subject cited drug has been

declared Substandard vide test report No.KQ.394/2015 dated 10th February 2016. On the

explanation letter to the firm by the FID Karachi the firm was not challenged the CDL Test

report in Appellate Laboratory NIH Islamabad under Section 22(5) of the Drugs Act 1976.

The result of CDL on the basis of which sample under reference has been declared sub-

standard are reproduced as under:-

Bacterial Sterility Test :- Does not complyProcedure:- Put the content (gauze) of the sample in preterilized thioghycollate medium,

kept in medium flask incubate the same medium flask at 35c for 14 days Acceptance criterion. No growth of micro organism occurs

The sample is of “Sub-Standard” quality under the Drug Act 1976.As per procedure show cause notices was issued to the firm and accused persons, offering opportunity of personal hearing before the Drug Registration Board. They have been also called for personal hearing.

259th meeting of Registration Board held on 30th & 31th May 2016 Proceedings: Mr. Muhammad Shakir, Director of the M/s Asian Fiber Karachi, appeared before the 259th meeting of Registration Board held on 30th and 31st May 2016 and pleaded their case.


Decision: The Board after detailed discussion, deliberation, considering the facts and legal provision decided as under:-The Board decided to suspend the Registration for six months (06) and to conduct the PSI from the following panel.


The conclusion of PSI report is as under:-

Mr. Najam-Us-Saqib FID Karachi submitted the PSI report conducted on 23rd January, 2017.

Focus of Inspection:Product Root Cause

Gauze Swab/Sponges (Batch No. 00511)

The product was declared out of specification on the basis of failure of sterility problem. It was observed that the arrangements were insufficient for conducting sterility of the product. The firm has given undertaking that each batch of the product will be dispatched to the M/S Gamma Radiation Lahore for the sterility of the product.On the basis of PSI inspection GMP compliance and verification of different related documents, the panel recommends the resumption of the production under strict compliance of GMP/cGMP guidelines.

Proceedings and Decision of 266th Meeting:Registration Board deferred the case as the firm has not any sterility facility for

sterile product and the Panel also mentioned that arrangements for conducting the sterility of product was insufficient and they has just given the undertaking regarding the sterility of Product through M/s Gamma Radiation Lahore. The Board after detailed discussion, deliberation, considering the facts and legal provision decided as under:-

“The Board deferred the case as the firm does not have sterility facility for sterile Product. The registration will remain suspended till the firm establishes facility for sterility and intimate the same to the Board for its consideration / decision.”

Case 04: Manufacture & Sale of Sub-Standard Drug-Azofin Suspension (Ibuprofen) Batch No.I-339 By M/S Alkemy Pharmaceuticals Laboratories (Pvt) Ltd Hyderabad.

Brief of the Case.

The sample of Azofin Suspension Batch No. I-339 manufactured by Alkemy

Pharmaceuticals Laboratories Pvt Ltd Hyderabad drawn by FID Hyderabad at Karachi on 15th

September 2015 from manufacture premises for test analysis the Federal Government

Analyst, CDL, Karachi vide which sample of subject cited drug has been declared

Substandard vide test report No.KQ.271/2015 dated 09th November 2015. The result of CDL

on the basis of which sample under reference has been declared sub-standard are reproduced

as under:-


Assay for Ibuprofen.

Determined amount/5ml:- 160.11mg Stated amount/5ml:- 100.0g Percentage:- 160.11%Limits:- 95.0% to 105.0% Does not comply

The sample is of “Sub-Standard” quality under the Drug Act 1976.

On explanation letter issued by the FID, the firm challenged the CDL report and requested for

Appellate testing under Section 22(5) of Drugs Act, 1976. The Appellate Laboratory has also

declared the sample as Substandard vide their test report 02-MNHSR/2016 dated 17 th March

2016.

Assay for Ibuprofen Stated amount Found:- Percentage Limits

100.0g/5ml 104.07mg/5ml 104.07%:- 95-105

Unidentical peaks Nil 40%

Remarks:- Some unidentical peak are also eluted along with principle peak (Ibuprofen) and the sum of these impurities is 40% of principle peak

As per procedure show cause notices was issued to the firm and above named accused persons, offering opportunity of personal hearing before the Drug Registration Board. They have been also called for personal hearing.

258th meeting of Registration Board held on 25th & 26th April 2016

Proceedings: Mr. Asif Najeeb Laghari QC Manager of the firm appeared before the Board and pleaded their case.

Decision: The Board after detailed discussion, deliberation, considering the facts and legal provision decided as under:-The Board decided to suspend the Registration for six months (06) and to conduct the PSI from the following panel:-

i. Dr. Abdul Rashid, Chairman quality Control, ii. Area FID.

The Firm will recall the batch and the area FID will supervise the destruction.The conclusion of PSI report is as under:-

PSI report was received from FID Hyderabad at Karachi Mr. Syed Hakim Masood. The PSI of M/s Alkemy Pharmaceutical Pvt Ltd situated at plot No.P/9, S.I.T.E Hyderabad at Karachi was conducted on 6th December 2016 by Dr. Abdul Rasheed, Additional Director, QA & LT, DRAP, Islamabad, Mr. Faraz Sheikh (M.D), Syed Hakim Masood (Area FID). The conclusion of PSI is as under:-

Observation of the Panel:a. No traceability of raw materials was available. No proper records were available. No

thermometer and hygrometer were found for recording of temperature and humidity in the warehouse.


b. Dispensing area needs renovation and additional calibrated weighing balance required.

c. Old silver son mixers are rusted/ old and required to be replaced with new ones.d. Storage tanks required to be replaced with new ones.e. Floor, walls and ceilings are cracked/old and needs overall, renovation required.f. The rodents’ insects can enter from drainage in the production of syrup section and so

requires better drainage system.g. Vessels need to be replaced.h. Liquid filling machine is old, rusty and must be replaced with semi automatic filling

machine with conveyor belt.i. Water system needs to be upgraded with new one.j. Batch manufacturing instructions were missing from the batch manufacturing records.k. Iron racks are required to be placed in the warehouse. Iron and plastic pallets may

further be added in the warehouse and wooden pellets should be removed from areas.l. There are no racks in the finished goods store and medicines are placed on floor. Few

wooden pellets and plastic pellets are also seen in one room. There is need that iron racks plastic pellets may be provided along with hygrometers to monitor the humidity of the finished goods store. Floors walls and ceiling needs renovation paint and up gradation. Accordingly all the observations were discussed with the management Mr. Faraz

Sheikh (M.D) has submitted an undertaking that management has voluntarily stopped

production in the liquid syrup section for maintenance and renovation and will seek

permission before commencement of production after completion of improvements and

renovation work. The show cause notice and personal hearing may be given for liquid section

for cancellation and suspension of DML.

Proceedings and decision of 266th Meeting:

Additional Director QA & LT who was also the member of panel for PSI, briefed the Board about the non-GMP compliance of the firm particularly regarding liquid section. The Board after detailed discussion, deliberation, considering the facts and legal provision decided as under:-

“The QA section will present the case of non-GMP compliance before Central Licensing Board, and the decision of Central Licensing Board will be presented before Registration Board for consideration / decision. Till that decision, registration of the Azofin Suspension shall remain suspended.”

Case No.05: Manufacture & Sale of Misbranded Inj. Titan -1000 Batch No.4017 By M/S Macter International Ltd, Karachi.

The sample of Injection Titan-1000 batch No. 4017 manufactured by M/S Macter

International Ltd, Karachi drawn by Federal Inspector of Drugs-II on 10-04-2014 from

manufacture premises for test analysis. The Federal Government Analyst, CDL, Karachi vide

which sample of subject cited drug has been declared Misbranded vide test report No.MK-35-


41/2014-FID-II(K) dated 11th April 2014. The result of CDL on the basis of which sample under

reference has been declared misbranded are reproduced as under:-

Remarks:The outer most label does not contain name and address of the manufacturer,

manufacturing license number of Water for Injection (WFI) as required under rule (3) (s) (i) of the drugs (Labeling and Packaging rules 1986 of Drugs Rules 1986 of the Drugs Act 1976. Hence, sample is declared Misbranded under the Drugs Act 1976 and rules framed there under.

The sample is “Misbranded” under the Drug Act 1976.On explanation letter issued by the FID Karachi-II on 20th May, the firm submitted

their reply vide its letter no. Nil dated 26 th June, 2014 and informed that they had already

been incorporated on the label of Primary container of the diluents vial and provided the

required information. M/s Macter International Ltd Karachi violated the section 23 (1) (a)

(iii) of the Drugs Act 1976 and rules framed there under.

As per procedure show cause notices was issued to the firm and accused persons, offering

opportunity of personal hearing before the Drug Registration Board.

They have been also called for personal hearing.

Proceedings and Decision of 266th Meeting: M/S Macter International Ltd, Karachi was called for personal hearing but they did

not appear before the Board. The Board after detailed discussion, deliberation, considering the facts and legal provision decided as under:-

“The Board deferred the case and give last opportunity of personal hearing to the Firm M/S Macter International Ltd, Karachi.”

Case No.06: Manufacture & Sale of Sub-Standard Dekomycin Capsules Batch No. 8110 By M/S Reko Pharmaceuticals Pvt Ltd Lahore.

The sample of Dekomycin Capsules Batch No. 8110, Reg. No.011001, manufactured

by M/s. Reko Pharmacal (Pvt) Ltd, Lahore has been declared Sub-Standard by Federal

Government Analyst vide test report No. LHR.184/2016, dated 28 th April, 2016. The sample

of failed drug was taken by FID Faisalabad at Lahore, on 30-03-2016 from Manufacturer’s

Premises for test/analysis. On explanation letter issued by the FID Faisalabad at Lahore on

06th May 2016, M/s Reko Pharmacal (Pvt) Ltd, Lahore submitted a reply vide its letter

No.MD/01, dated 16th May, 2016, wherein the firm did not challenged the test/analysis report

of CDL Karachi but stated that the test report is not reliable as certificate issued in the report

is regarding capsule having a color “Off white body & yellow hard gelatin capsule”, which is

not their product as their product is orange and off white color gelatin capsule, in reply of

which FID confirmed that samples were drawn from premises (finished goods store) of


manufacturer during inspection on 30-03-2016 so the product belongs to M/s Reko

Pharmacal (Pvt) Ltd, Lahore undoubtedly. The results on the basis of which the subject stated

product was declared substandard are as under;

Sub-Standard with regard to Dissolution Test.

Stage-1

Tablet No. (%)age

01. 35.739

02. 15.619

03. 25.414

04 37.327

05. 31.768

06 15.619

Limits for (Stage-1):- Each unit is not less than Q+5% i.e. 80+5=85%

Stage-2

Tablet No. (%)age

01. 29.385

02. 29.650

03. 22.502

04 36.533

05. 34.150

06 57.976

Average of 12 units= 371.682/12=30.973%

Limits for (Stage-2):- Average of 12 unit (S1+S2) is equal to or greater than Q (80%) and no unit is less than Q-15% (80-15=65%)

Stage 3Limits for (stage-3):- Average of 24 units (S1+S2+S3) is equal to or greater than Q (80%) Not more than 2 Units are less than Q-15 (80-15=65%) & no unit is less than Q-25% (80-25=55%)

Since, all the 11 capsules are below 55% and one capsule below 65% therefore, the sample Does not comply

The FID Faisalabad at Lahore furnished the names of the responsible persons of the firm are as under:-

M/s Reko Pharmacal (Pvt) Ltd, Lahorei Mr. Khalid S. Mian, Managing Directorii. Mr. Muhammad Arif Ghauri Production Mangeriii. Ms. Shehnaz Akhter Quality Control Incharge


In response to show cause notice issued to the firm on 30th December, 2016, the firm

M/s Reko Pharmacal (Pvt) Ltd, Lahore submitted its reply dated 06-01-2017 which stated

that the test report is not reliable as certificate issued in the report is regarding capsule having

a color “Off white body & yellow hard gelatin capsule”, which is not their product as their

product is orange and off white color gelatin capsule and requested to reinvestigate the

matter.

The case was presented in 265th meeting of Registration Board and the accused persons of the firm were called for personal hearing.Decision of the 265th Meeting of Registration Board:The Board decided to defer the case and give last opportunity of personal hearing to the firm in next meeting.Proceedings and decision of 266th Meeting of Registration Board:

The firm requested to adjourn the personal hearing till next meeting of Registration Board because the personal hearing letter was received by the firm on 06-02-2017 late afternoon and did not have sufficient time to compile all the relevant documents. “The Board decided to defer the case and give last opportunity of personal hearing to the firm in next meeting otherwise an ex-parte decision shall be taken by the Registration Board.”

Case No.07: Manufacture and Sale of Substandard Manadol Suspension (Paracetamol) Batch No. 4MD-005 Manufactured by M/s Masfa Industries (Pvt) Ltd Lahore. F.No.3-52/2014-(QC)

The samples of Manadol Suspension (Paracetamol) Batch No. 4MD-005,

Manufactured by M/s Masfa Industrieis (Pvt) Ltd, Lahore drawn by FID- (L-III) Lahore from

manufacture premises on 10-09-2014, was declared Substandard on the basis of assay vide

Test Report No.LHR.230/2014. dated 02-10-2014 by Federal Government Analyst.

Assay forDetermined amount/5ml

Stated amount/5mlPercentage

Paracetamol 84.188 mg 120.0mg 70.15%Limits:- 95.0% to 105.0% Does Not Comply. Remarks:- The sample is of “Sub-Standard” quality under the Drugs Act 1976.On the explanation of FID to the firm the firm made request for Appellate testing to FID. The

Appellate Laboratory vide test report No. 020-MNHSR/2014 Dated 16-12-2014 declared the

sample as substandard on the basis of assay.

Assay for Found Stated Amount/5mlPercentage

Paracetamol 65.64mg/5ml 120mg/5ml 54.7%Limits:- 95.0% to 105.0% Does Not Comply BP 2011 .


Description:- Pink coloured suspension contained in amber colored glass bottle having un-dissolved solid masses which do not disperse even on shaking. (Does not comply with BP-2011 which states that suspension may show a sediment which is readily dispersed on shaking”Remarks:- The sample is of “Sub-Standard” on the basis of tests performed.The firm has violated the Section 23(1)(a)(v) of the Drugs Act 1976, however the names of

the following persons of the firm have been furnished by the FID.

i. M/s Masfa Industrieis (Pvt) Ltd .Lahore, ii. Mr. Mian Muhammad Usman Ghani, (Chief Executive)iii. Mr. Hafiz Abud Bakar (Production Manager) iv. Mr. Hafiz Murtaza (Quality Control Manager)

As per procedure show cause notices were issued to the firm and above named

accused persons, offering opportunity of personal hearing before the Drug Registration

Board.

In the reply of the show cause notice the firm informed that they have tested the reatained samples by their own Lab. and by some other authentic laboratories the most results shown as standard quality. They further stated that they have never been contravened before this. The firm further stated that this is first time so requested to give a chance. The firm has attached some copies of CDL and Provincial Laboratories tests reports of other batches or other products. They were called for personal hearing.Decision of 257th Meeting of Registration Board:-The Board after detailed discussion, deliberation, considering the facts and legal provision decided as under:-The Board decided to suspend the Registration for six months (06) and to conduct the PSI from the following panel:-

a. Director DTL Punjab, Lahoreb. Area FID.c. ADC, Lahore.

Product Specification Inspection (PSI):

In response to the decision of Drug Registration Board in its 257th meeting held on 24-

25th March, 2016, the Product Specific Inspection of firm M/s Masfa Industrieis (Pvt) Ltd,

Lahore was carried out on 30-11-2016 by two panel member i.e. Mr. Munawar Hayat,

Director Drug Testing Laboratory and Ms. Aisha Irfan, Federal Drug Inspector. The Assistant

Drugs Controller was not nominated by the Additional Director (E & M) Lahore.

Focus of Inspection: Product Root CauseManadol Suspension (Paracetamol), Batch No. 4MD-005

The product was declared substandard on the basis ofi. Description: Pink coloured suspension contained in amber colored glass bottle having un-dissolved solid masses which do not disperse even on shaking. (Does not comply with BP-2011 which states that suspension may show a sediment which is readily dispersed on shaking).ii. Assay for Paracetamol: Found percentage was 54.7%. (Does not comply with BP-2011 which states the limit as 95-105%).


Details of Inspection Procedure:

1. PSI report stated that during PSI, the Production Incharge informed that they have changed the formulation of the said product after failed batch, now Methyl Paraben has been replaced by Methyl Paraben Sodium, as salt of sodium is soluble in water and generate less heat during production and the quantity of sucrose has been reduced to 100Kg from 300 Kg per 1500 Liters as crystallization also occurs due to increase amount of sucrose in the product.

2. It was also checked that the paracetamol raw material was purchased from M/s. Zenith Chemical, Lahore and its assay was 99.79 %, hence raw material was of standard quality.

3. The panel observed that test records for HPLC were not saved in HPLC, and column log was also not prepared as approximately 2000 tests can be performed per column.

4. The Production Incharge informed that crystallization of Paracetamol suspension is a very common problem and various factors are involved, especially storage above 40˚C and below 10˚C. The panel asked him to provide reference of this as in Pakistan the temperature is above 40˚C in most of the cities in summer and below 10˚C in winters.

5. The Production Incharge also emphasized that after changing the formulation of the product, they did not face this problem of crystallization again, while the Director DTL, Mr. Munawar Hayat pointed out that their many samples of this product were failed in DTL, Lahore also, which were taken from the medical stores of Multan, Bahawalpur respectively.

6. The manufacturing area was also checked and the firm had installed requisite machineries such as mixing storage tanks, automatic filling machine etc. Supply of R.O water was also provided. However, it was observed that the firm had used the old bottles in their syrup manufacturing instead of new ones, which can also be source of contamination and product degradation as old bottles contain fungus and remnants of other products etc. The firm was directed to immediately curtail this practice. Mr. Abu Bakar, the Production Incharge informed that they would switch to PET bottles in future.

Conclusion of PSI:

The Panel submitted following recommendations:i. The firm M/s Masfa Industries (Pvt) Ltd, Lahore should conduct accelerated

stability studies of at least 05 batches from the retaining samples of Manadol suspension in which the formulation of the product has been altered, in order to determine the outcome of change of formulation.

ii. The firm M/s Masfa Industries (Pvt) Ltd, Lahore should submit the results of stability studies conducted to DRAP for review.

iii. If the registration of the product resumes, then the firm M/s Masfa Industries (Pvt) Ltd, Lahore should intimate the panel after manufacturing first batch, for sampling purpose. Regular production of the product would depend upon the results obtained by CDL, Karachi.

iv. The firm M/s Masfa Industries (Pvt) Ltd, Lahore should immediately curtail the practice of using old bottle in syrup section.


v. Moreover it is also a question mark that as informed by Production Incharge that the product cannot remain stable above 40˚C and below 10˚C then how it can be delivered to hot or cold climate areas in Pakistan. Hence, the panel concludes that first the firm conduct the accelerated stability studies of Manadol Suspension of minimum five batches of Quality Control retaining samples and submit its data to Registration Board for further consideration in the matter.

The case was presented in 266th meeting of Registration Board dated 07th February, 2017.Proceedings and Decision of 266th Meeting of Registration Board:

Registration Board after thorough discussion, deliberation and in the light of PSI report decided the case as under:

i. QA Division should consider the GMP issues of the firm M/s Masfa Industries (Pvt) Ltd, Lahore, like use of old bottles in syrup manufacturing instead of new ones as it is violation of GMP.

ii. The firm M/s Masfa Industries (Pvt) Ltd, Lahore, shall submit accelerated and real time stability studies of 03 batches for 06 months of the product Manadol Suspension.

iii. The registration of the product Manadol Suspension, Reg. No. 071558 will remain suspended till the submission of stability studies by firm M/s Masfa Industries (Pvt) Ltd, Lahore, for consideration of Registration Board.”

Case No.08: Miscellaneous ItemFollowing functions/powers may be delegated as follows:-In order to facilitate timely disposal of routine cases relating to Quality control section

following consideration is submitted which is in already in practice for the appraisal of the

Board.

Sr.No.

Power/Function Of The Secretary Registration Board Delegated/permitted to

1 To convey the decision, minutes, approved Show Cause Notices and miscellaneous directions etc. on behalf of Board.

Deputy Director And Assistant Directors in QC

The case was presented in 263rd meeting of Drug Registration Board held on 29-30th

November, 2016. Decision of 263rd Meeting of Registration Board:Registration Board Deliberated that any officer authorized by Director QA/LT can convey the decision of the Board.

The matter is again placed for consideration of Board so that the routine matters be

expeditiously processed.

Decision of 266th Meeting of Registration Board:“Registration Board deliberated the case and decided that any officer of the QA&LT Division (Additional Director, Deputy Director, Assistant Director), as authorized by Director QA/LT can convey the decision of the Registration Board.”


Additional Agenda:

A. Medical Device & Medicated Cosmetics Division.

Case No.01: Fresh Applications for registration of Medical Devices for import.

Following importing firms have submitted their registration applications of medical

devices for import. Status of each application is mentioned against each.

A. Catheters. S.N Name of

Importer and Manufacture/

Exporter.


Price & Pack size

Shelf life

Remarks Decision

1. M/s Surgi World,303 Mohammadia Plaza, College Road,Rawalpindi

Manufactured by:M/s Medcomp , 1499 Delp Drive Harleys Villa, USA.

Titan HD Long Term Dialysis Catheter(All sizes Straight & Precurved)

Decontrolled 5 years

Applied on 17-11-2011. Shortcoming Letter Issued 18-9-2013. Reminders issued11-7-2013 and31-7-2013,4-3-2015 and 3-2-2017.No reply received till date.


PKR.35,000/-,b. Application on

Form 5A as Duly signed and stamped.






2. M/s Surgi World,303

Hemo-Flow Long Term Dialysis


Applied on 17-11-2011.



Mohammadia Plaza, College Road, Rawalpindi.Manufactured byM/s Medcomp , 1499 Delp Drive Harleys Villa, USA.

Catheter(All sizes Straight & Precurved)

Shortcoming Letter Issued 18-9-2013. Reminders issued 11-7-2013 and 31-7-2013,4-3-2015 and 3-2-2017.

shortcomings:a. Differential fee







3. M/s Surgi World,303 Mohammadia Plaza, College Road, Rawalpindi.Manufactured byM/s Medcomp , 1499 Delp Drive Harleys Villa, USA.

Duo-Flow ® Side Xside Short Term Dialysis Catheter(All sizes Straight & Precurved)


Applied on 17-11-2011. Shortcoming Letter Issued 18-9-2013. Reminders issued 11-7-2013 and 31-7-2013,4-3-2015 and 3-2-2017.





d. Approval of shelf life from regulatory authority or Stability data to





4. M/s. Ontech Corporation, M-02 Mezzanine Floor ,Lakhani corner block -13-A, Gulshan e Iqbal,Karachi.Manufactured byM/s. Ameco Medical Industries, Industrial Zone, Ramadan City, Egypt.

Urodynamic Cathethers


05 year

s

Applied on 05-4-2011Letter issued on 6-12-2013. Reminder issued on 7-10-2016(Telephonically communicated on10-10-2016 and then20-01-2017, But no reply yet received.)




c. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board .



Copy Valid Drug Sale License,

5. M/s. Ontech Corporation, M-02 Mezzanine Floor ,Lakhani corner block -13-A, Gulshan e Iqbal,Karachi.

Manufactured by

Ureteric Cathether


05 year

s

Applied on 5-4-2011Letter issued on6-12-2013Reminder issued on 7-10-2016(Telephonically communicated on





M/s. Ameco Medical Industries, Industrial Zone, Ramadan City, Egypt.

10-10-2016 and then20-01-2017, But no reply yet received.)




Copy Valid Drug Sale License,

6. M/s. Ontech Corporation, M-02 Mezzanine Floor ,Lakhani corner block -13-A, Gulshan e Iqbal,Karachi.

Manufactured byM/s. Ameco Medical Industries, Industrial Zone, Ramadan City, Egypt.

Peritoneal Dialysis Catheters Kit


05 year

s

Applied on 5-4-2011Letter issued on 6-12-2013Letter issued on 7-10-2016(Telephonically communicated on 10.10.2016 and then 20.01.2017, But no reply yet received.)







f. Copy Valid Drug


Sale License,7. M/s. Ontech

Corporation, M-02 Mezzanine Floor ,Lakhani corner block -13-A, Gulshan e Iqbal,Karachi.


Precautaneous Nephrostomy Catheter

Decontrolled

03 year

s

Applied on 5-4-2011Letter issued on 6-12-2013Reminder issued on 7-10-2016








8. M/s 4S International, Suit No.205, 2nd Floor, Al Fiza Glass Tower, Rashid Minhas Road, Block-10-A, Gulshan-e-Iqbal, Karachi, PakistanManufactured By:M/s Balton Sp. Z o.o. Ul. Nowy swiat 7/ 14, 00-496 Warsaw, Poland.Manufacturing Site.

Introducers Sets to Introduce and Exchange Catheters and Endovavitary Electrodes with Hemostasis Valve


1’s

4 years & 11

months


Shortcoming Letter issued on19-01-2017.


authorization letter/sole agency agreement from manufacturer as decided above by Registration Board


c. Approval of shelf life from regulatory authority or


Ul. Modlinska 294 02-156 Warsaw, Poland

Stability data to support claimed shelf life.

d. Clarification as brand name is different on Form 5A.

9. M/s Hashir Surgical Services (Pvt) Ltd,1st Floor, House No.16, Street 1, Sector F-2, Phase-6, Hayatabad, PeshawarManufactured By:M/s Intra Special Catheter GmbH, Oststrasse 2, 66780 Rehlingen-Siersburg, Germany

Duocath Hemodialysis Catheter 2-Lumen.

Sizes: 12FLength (cm): 13, 16, 20, 24.


Board/ Federal

Government

5 years

Applied on 2-5-2016

Shortcoming Letter Issued on26-10-2016.Reminders issued6-12-2016 and28-12-2016.




10. M/s. ACP System,13-23, Naval Fleet Club, Iqbal (S.J) Shaheed Road,Karachi.Legal Manufacturer:M/s Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN 55432, USA.Manufacturing Site:M/s Medtronic Vascular, 37A Cherry Hill Drive, Danvers, MA 01923, USA.

Export Advance Aspiration Catheter



Policy Board/ Federal

Government

2 years


Shortcoming letter issued on18-1-2017. Reminder issued on 3-2-2017.


authorization letter/sole agency agreement from manufacturer as decided above by Registration Board .


B. STENTS

S.No


Exporter.


Price & Pack size

Shelf life

Remarks Decision

1. M/s Allmed Solutions, Karachi.

Manufactured by:Not provided

Esophageal Stents


Board/Federal

Government

Not mentioned

Applied on7-6-2012Shortcoming

letter issued on28-10-2013Reminder

issued on 2-3-2015. No reply received till date.

Following shortcomings:-

a. Application Form not provided

b. Differential fees

c. Complete specifications with details of analytical procedures

d. Details of manufacture and QC

e. Stability studies

f. Clinical data

g. FSCh. Sole

agency certificate, duly notarized.

i. Credentials of the company duly notarized.

j. GMP/ISO 13485 certificate

k. Valid drug Sale Licence

l. Clarification of product sizes and codes

m. Last inspection report.



b. Form 5-A and all other relevent documents required according to form 5-A, Free sale certificate, sole agency agreement and credentials of manufacturer etc.

(According to manufacturing site decision of Registration Board for related documents will be applicable.)

2. M/s. Ontech Corporation, M-02

Double Loop Stent

Decontrolled

03 years

Applied on5-4-2011Letter issued on



Mezzanine Floor ,Lakhani corner block -13-A, Gulshan e Iqbal,Karachi.


6-12-2013Letter issued on7-10-2016(Telephonically communicated on 10-10-2016 & then 20-01-2017, But no reply yet received.)Following deficiencies;1. Differential fee not paid.2. Form 5-Aduly signed and stamped.3. Equipment detail for manufacturing and QC.4. Components and composition of device.5. Specification of devices with detail of analytical procedure.6. Description and method of manufacturing.7. QMS/ ISO 13485 expired.8. Drug Sale License expired.9. Free sale certificate expired.10. Sole agency agreement, duly notarized.11. Clinical data.12. Stability data.

shortcomings:a. Differen

tial fee PKR.35,000/-,






g. Copy Valid Drug Sale License

3. M/s. SES Associates,61-Bank Square Market, Model Town, Lahore.

Navalis Peripheral Vascular Self Expending Stent System

Decontrolled till policy decision by Policy Board/ Federal

3 years Applied on11-12-2012Shortcoming Letter issued on24-4-2013. Reminder issued on 2-3-2015.


a. Original and valid Free Sale Certificate


Manufactured byM/s. QualiMed Innovative Medizinproduket GmbH, BoschstraBe 16, D-21423, Winsen, Germany.

Stent Length (mm);20,40, 60, 80, 100, 120, 150.

Stent Dia (mm):6,7,8,9,10,11.

Usable catheter length:80cm, 120cm.

Government

1’s

as decided above by Registration Board.



d. Copy of valid drug sale licence.

Case No.02: Registration applications of Medical devices for local manufacturing.

S.N Name of Manufacture

Name of Medical Device (s)

price & Pack size

Shelf life

Remarks Decision

1. M/s. Silver Surgical Complex Pvt Ltd, C-40 SITE-2, Super Highway Industrial Area Scheme No.33, Karachi.

Silver I.V Cath (Intravenous Catheter Straight Type)16G, 18G, 20G, 22G, 24G


decision by the Policy Board/ Federal Govt.

5 years

Applied on 3-12-2015.Shortcoming letter issued on 2-2-2017 and 3-2-2017.Provided undertaking for stability and clinical data after registration.

Approved with 02 years shelf life.

Case No.03: Inspection of Manufacturer abroad M/s Yangzhong Jinxiang Emulsion Products Co. Ltd, China.

The Registration Board in its 244th meeting held on 22nd & 23rd July, 2014

considered and approved the following medical devices of M/s Ghazali Brothers, Karachi

subject to inspection of manufacturer abroad, verification of storage facilities, etc as per

policy:-

S.# Name of Importer and Manufacturer/Exporter


Demanded price & Pack size

Shelf Life

1. M/s Ghazali Brothers, Hospital & Homecare Decontrolled till 5 years


1st Floor Azzainab Court, Campbell Street, Karachi.Manufactured by:M/s Yangzhong Jinxiang Emulsion Products Co. Ltd, No.88 Daqiao Road, Yangzhong, Jiangsu, China.

Latex Foley Catheter(1 way, 2way & 3 way)

(6G,8G,10G,12G, 14G, 16G,18G, 20G,22G,

24G,26G)

policy decision by the Policy Board/Federal Government

Inspection of manufacturer abroad has been carried out by the panel comprising Dr.

Amanullah Khan, Director, DTL, Quetta and Mr. Zaheeruddin M Babar, Deputy Drugs

Controller (Reg-I), DRAP, Islamabad on 7th & 8th March, 2016. The panel did not

recommend the above product for registration due to the following observations:-

“Production area is located in a big hall and shared with production line of gloves and catheters both without any partitioning. No production of catheter was going on at the time of visit and the management informed that the area is under maintenance. The overall condition of production area was unsatisfactory. The area was not specifically designed for the purpose. Environment control was not appropriate. The floor and machines were dirty. Waste matter was found abundantly on the floor and machines. The machines were rusty. The clean room for packing area was though designed properly with appropriate ducting etc but the procedures for maintenance of environment are properly followed and entrance & exit gate to and from is not restricted through change room. The raw material store was badly managed and without proper environment monitoring. The storage tank is not properly covered. The ETO sterilization plant included an area which appears to be bath/wash room previously and some modifications were made to cover the chemicals. The firm’s management could not produce a number of documents. Furthermore, it is highly recommended that the products of this manufacturer shall be banned in the country unless in future the manufacturer is not inspected by DRAP.”

Case was placed before the Registration Board in its 261st meeting and Board

discussed the inspection report of M/s Yangzhong Jinxiang Emulsion Products Co. Ltd,

No.88 Daqiao Road, Yangzhong, Jiangsu, China in detail and keeping in view the nature of

the observations, being critical, rejected the above application for registration due to above

recorded reason as reported by panel.

Registration Board also advised Medical Device and PE&R Divisions to present

details of already registered drugs/products of same manufacturer for consideration.

As per available computer record of MDMC Division and PE&R Division, no

medical device/drug has been registered with Drug Regulatory Authority of Pakistan from the

above said manufacturer.

Decision: Registration Board noted the information.

Case No.04: Cancellation of Sole Agency Certification.

Registration Board in its 236th meeting held on 20th November, 2012 considered

and approved the following medical devices of M/s Intra Health, Karachi subject to Minutes for 266th Meeting of Registration Board. 266

recommendations of ECMD, inspection of manufacturer abroad, local storage facilities etc as

per policy:-

S. # Name of Importer and Manufacturer / Exporter.


DemandedPrice & Pack Size.

Shelf Life

1. M/s Intra Health, 56-A, Unit No.1, Justice Inamullah Road, Block 7/8 KCHS, Karachi.Manufactured byM/s Uro Technology Sdn. Bhd., Malaysia.

Pro Care Foley Balloon Catheters.

(Latex Foley Catheter Silicon Coated)

Decontrolled

Different types i.e 2way, 3way with different product

codes

5 years

The ECMD in its 1st meeting held on 13th December, 2012 recommended the above

product. The registration certificates of above mentioned products could not be issued as the

inspection of manufacturing facility in Malaysia could not be conducted. In the meanwhile,

the Principal manufacturer has sent a letter dated 12-01-2016, wherein they have confirmed

that they have an exclusive contract with M/s Life Cares, Karachi for the exclusive sales and

distribution of whole range of Chroma Foley Catheters and that they will not pursue the

registration of their product Foley Catheter with MOH Pakistan applied by M/s Intra Health,

Karachi.

In this regard M/s Intra Health, Karachi was asked through a letter dated 22nd June,

2016 to confirm their status as being sole agent of M/s Uro Technology Sdn. Bhd., Malaysia

for above mentioned medical device or otherwise within 10 days for further processing the

case.

M/s Intra Health, Karachi has informed vide letter dated 29-06-2016 that they are the

exclusive agent for Procare Foley Balloon Catheters, manufactured by M/s Uro Technology

Sdn. Bhd. Malaysia. The firm has submitted a colored copy of authorization letter/sole

agency agreement from principal manufacturer and requested not to consider any application

as the agreement is still valid. Authorization letter/sole agency agreement was issued on 1 st

April, 2015 for 03 years i.e. till 31st May, 2018. However, the authorization letter/sole agency

agreement in favor of M/s Life Cares, Karachi was issued on 12-01-2016.

Case was placed before the Registration Board and Registration Board

discussed the case and decided to issue show cause notice to M/s Intra Health, Karachi that

why their application may not be rejected due to the aforementioned reasons. The Board also

decided to call the firm representative for personal hearing in the next meeting of the Board.

Accordingly decision of the Board was conveyed to M/s Intra Health, Karachi. In

reply the firm has informed as below:-

(i) Our application has been submitted with the Ministry since 17-10-2011 which gives us the benefit of applying fist and also entitled to the registration of our PROCARE Brand.


(ii) Our supplier has been providing us all the documents since the day applied and fulfilled all the requirements for this registration. This shows his willingness to get this registration for the PROCARE brand through our company. We have been consistently making efforts to get this brand registered since the last five years.

(iii) We had provided the registration fee as well as the balance fee vide our letter dated 08-03-2013 which makes our file complete in all aspects.

(iv) The exclusive letter provided by the manufacturer is still valid and gives us the benefits of being the rightful applicant for the brand PROCARE in the Pakistani market.

Decision: Registration Board decided to call the firm for hearing in the next meeting of registration Board.


Case No.05. Cancellation of Sole Agency Certification.

Registration Board in its 241st meeting held on 23rd December, 2013 considered and

approved the following medical devices of M/s. Cardiac Care, Lahore subject to inspection of

manufacturer abroad, verification of local storage facility etc as per policy:-

S.No. Name of Importer and Manufacturer/ Exporter.

Name of Medical Device. Shelf life

1. M/s Cardiac Care, 848-C, Shadman-I, Lahore.Manufactured byM/s CID SPA Strada Crescentino snc, 13040, Saluggia (VC) Italy.

ProHp Pegaso PTCA Balloon Catheter.

Balloon Length (mm): 10,15,20, 30.

Balloon Dia (mm):1.5, 2.0, 2.25, 2.75,3.0,3.25, 3.50, 3.75, 4.0.

36 months

2. -do- Brio Pegaso-SCRX PTCA Balloon Catheter.Balloon Length (mm): 10,15,20, 30.Balloon Dia (mm): 1.5, 2.0, 2.5, 3.0,3.5, 4.0.

36 months

3. -do- Cre8 Amphilimus Eluting Coronary Stent.Stent Length (mm): 12,16,20, 25,31.Stent Dia (mm): 2.50, 2.75, 3.0, 3.50, 4.00, 4.50.

18 months

4. -do- Avantgarde Chrono Carbostent(Coronary carbofilm coated bare metal stent)Stent Length (mm): 7, 8,12,16,20, 24, 25,31.Stent Dia (mm): 2.25, 2.50, 2.75, 3.0, 3.50, 4.00, 4.50.

36 months

5. -do- Chrono Carbostent(Coronary carbofilm coated Cobalt Chromium stent)Stent Length (mm): 7, 8,12,16,20, 24, 25,31.Stent Dia (mm): 2.25, 2.50, 2.75, 3.0, 3.50, 4.00, 4.50.

36 months

6. -do- Janus Optima Tacrolimus Eluting Carbostent(Coronary carbofilm coated drug eluting stent)Stent Length (mm): 11,15,19, 25,31.Stent Dia (mm): 2.50, 2.75, 3.0, 3.50, 4.00.

18 months

The registration certificates of above mentioned products could not be issued due to

clarification regarding the countries located in erstwhile Western Europe and erstwhile

Eastern Europe in import policy approved by the Policy Board in its 4th meeting which was

later on revised and clarified by the Policy Board in its 14 th meeting. In the meanwhile,

authorization issued by the Principal manufacturer M/s CID SPA, Italy in respect of M/s

Cardiac Care, 848-C, Shadman-I, Lahore, submitted in registration application dossiers, was

expired. The Principal manufacturer M/s CID SPA Strada Crescentino s/n, 13040, Saluggia

(VC) Italy has now sent a letter to DRAP submitting that the agreement between CID and

M/s Cardiac Care, 848-C, Shadman-I, Lahore, Pakistan has been terminated on 31st

December, 2015 and M/s Atco Laboratories Ltd., with its office located in B-18, S.I.T.E,

Karachi has now been appointed a sole agent to act as distributor in Pakistan and to attain

Regulatory Approvals for the following products through the local authorities:-

(i) ProHP Pegaso PTCA Balloon Catheter.(ii) Brio Pegaso SCRX PTCA Balloon Catheter.(iii) Cre8 Amphilimus Eluting Coronary Stent.


(iv) Avantgarde Chrono Carbostent (Coronary carbofilm coated bare metal stent)

M/s CID SPA, Italy has requested the DRAP to issue registration of above listed

products to Atco Laboratories Ltd., having the marketing authorization in Pakistan.

In this regard M/s Cardiac Care, 848-C, Shadman-I, Lahore was asked to confirm

their status as being sole agent of M/s CID SPA, Italy for above mentioned medical devices

within 10 days for further processing the case. Letter was issued on 17 th May, 2016 but no

response received till date.

The case was placed before the Registration Board in its 261st meeting wherein the

Board once again directed the firm for personal hearing in the subject matter in the next

meeting of the Board.

Decision: M/s Cardiac Care submitted written statement that they are not representing the principal that is M/s CID, Itlay and do not intend to further proceed its product line registration. Therefore the Registration Board rejected the above mentioned six applications.

Case No.06. Request for approval of change of address. M/s Kohsar Distributors, Rawalpindi has informed that they have changed their

premises from 3-Khurshid Plaza, Naya Mohallah, Rawalpindi to Hill View Block, Lower

Basement, Block No.516 to 523, Pakistan Town, Islamabad. The detail of their registered

imported medical devices/drugs is as under:-

S.No. Reg.No. Name of medical device/drug

Pack Size

1. 069511 Paramount Syringes 1ml, 2ml, 5ml, 10ml, 20ml2. 069512 Paramount Syringes 30ml, 50ml

2. The firm has submitted the following documents:-

(i) Fee challan of Rs.5000/-.(ii) Copy of registration letter.(iii) Copy of new Drug Sale License.

Decision: Registration Board approved the request of the firm for change of above mentioned address subject to verification of local storage facility by the area FID.

Case No.05: Transfer of Registration.

M/s Asto Life Sciences Private Limited, Lahore has requested for transfer of

following registered imported drugs (Medical Devices) from the name of M/s Becton

Dickinson Pakistan (Private) Limited, Lahore to their name:-

S.# Regn.No. Brand Name of Medical Device

Packing Shelf Life Name of Manufacturer

(i) 074663 BD SoloShot TM Mini Auto Disable

0.5 ml(23G, 24G &

5 years M/s Becton Dickinson, S.A. Ctra, Mequinenza,


Syringe 25G)0.05 ml

(27G X 3/8)

Fraga (Huesca), Spain.

(ii) 074685 BD Emerald TM Pro (Reuse Prevention) Luer Slip Syringes

2ml, 5ml & 10ml

5 years -do-

(iii) 059218 BD Disposable Syringes

3ml, 5ml, 10ml, 20ml

5 years(Confirmation of renewal status)

M/s Becton Dickinson Medical (Singapore) Tuas Avenue, Singapore.

(iv) 059219 BD Venflon TM Pro IV Cannulas

G16, G18, G20 & G22.

5 years(Confirmation of renewal status)

-do-

2. The firm has submitted following documents:-(i) Application dossier alongwith Form 5-A for each product.(ii) Fee of Rs.100,000/- for each product.(iii) Letters of Authorization regarding above products from the foreign

manufacturer (legalized from High Commission of Pakistan/Embassy) wherein it has also been mentioned that M/s Asto Life Sciences (Private) Limited is authorized to submit the application for transfer of registration in their name to the Drug Regulatory Authority of Pakistan.

(iv) Original NOC from M/s Becton Dickinson Pakistan (Private) Limited, Lahore regarding transfer of registration of above products.

(v) Change of address of M/s Becton Dickinson Pakistan (Private) Limited from 19 D/1, Gulberg-III, Lahore to 202-B, 2nd Floor, City Towers 6-K Main Boulevard, Gulberg-II, Lahore.

It is submitted that as per Free Sale Certificate of BD Venflon TM Pro IV Cannula,

product owner is Becton Dickinson Infusion Therapy AB Florettgatan 29C, PO Box 631, SE-

251 06, Helsingborg, Sweden while manufacturing site is Becton Dickinson Medical (s) PTE

Ltd, 30 Tuas Avenue 2, Singapore.

Decision: Registration Board deferred the case till next meeting for detail discussion.

Case No. 06: Correction of Brand Name on Registration Letter.

M/s Becton Dickinson Pakistan (Private) Limited, Lahore has informed that their

following product manufactured by M/s Becton Dickinson and Company, USA has been

registered as per detailed below:-

S.No. Reg.No. Product Name Packing MRP Shelf Life

1 059212 BD Ultra-Fine TM Insulin Syringe

0.5ml1ml

De-controlled 05 Years

The firm has submitted that product actual name is BD Ultra-Fine II Insulin Syringe

and requested to issue new registration letter with correct name of the product. Product was

approved in 221st meeting of the Registration Board held on 6th November, 2009 wherein

following product descriptions was mentioned:-

“BD Ultra-Fine TM, Ultra-Fine TM I, Ultra-Fine TM II Insulin Syringe”


In this regard, it is submitted that RRR Section have informed that Registration

Board in its 263rd meeting considered case for renewal of registration for this product and

decided as under:-

“During meeting RRR Section informed Registration Baord that in addition to verification of fee challan by the Budget & Account Division and by R&I Section, original application has been traced later on. Thus the Board granted the renewal till 22-11-2019. Inspection of manufacturing site will be conducted as per import policy for finished drugs.”

Decision: Registration Board deferred the case for till next meeting for detail discussion.

Case No.07. Cancellation of Agency Agreement.

M/s Hope Pharma, Lahore have informed that M/s Delta Med, Italy IV

Catheter/Canula was registered in Pakistan under brand Name “Delta Ven” for M/s Intra

Health, Karachi under registration Nos.071613, 071614 & 071615. The Principal

manufacturer did not want to continue their business with their present distributor M/s Intra

Health, Karachi. In this regard the principal manufacturer has terminated the distribution

agreement of Intra Health, Karachi on 12-07-2016 mentioning all products in the territory of

Pakistan due to the total lack of business provided in year 2015 and 2016 (Termination letter,

Embassy attested). M/s Delta Med also nominated Hope Pharma, Lahore as their Sole Agent

and distributor in registering, importing and selling of IV Cannula and accessories range in

Pakistan (Embassy attested letter of authorization).

Decision: Registration Board decided that showcause notice be issued to M/s Intra Health, Karachi that why there Registration may not be cancelled due to termination of their distribution agreement by the principal manufacturer.

Case No.08. Local storage facility of M/s Johnson & Johnson Pakistan (Pvt) Ltd, Karachi.

Registration Board in its 253rd meeting held on 5th & 6th October, 2015 approved the

new address of M/s Johnson & Johnson Pakistan (Pvt) Ltd i.e. Fl-19, Sub-Plot F-1,

Kehkashan Scheme No.5 Main Boat Basin, Clifton, Karachi-75600 subject to verification of

local storage facility.

Later on M/s Johnson & Johnson Pakistan (Pvt) Ltd, Karachi has informed that

under the revised Business Model in Pakistan, they have appointed M/s Pak Punjab Cardex

Medical System situated as 257-K-Block, DHA, Lahore Cantt holding License

No.21-A/Cantt/11/2015 as Authorized Distributor who is responsible for import, store, sale


and exhibit for sale. This process is fully in accordance with Drug Import Rule 3 by issuance

of NOC/Indent to the designated distributor.

M/s Johnson & Johnson Pakistan (Pvt) Ltd, Karachi has also submitted following documents:-

i) Copy of Drug Sale License of M/s Pak Punjab Cardex Medical System Lahore Cantt.

ii) NOC for import authorization in respect of M/s Pak Punjab Cardex Medical System, Lahore Cantt

M/s Johnson & Johnson Pakistan (Pvt) Ltd, Karachi has requested that the local

storage condition of their designated warehouse (M/s Pak Punjab Cardex Medical System

situated at 257-K-Block, DHA, Lahore Cantt) may kindly be verified.

Case was placed before Registration Board in its 256 th meeting and the Board allowed

to verify the local storage conditions of M/s Pak Punjab Cardex Medical System, 257-K-

Block, DHA, Lahore Cantt with the direction to bring the case alongwith the inspection

report in the next meeting of Registration Board.

In this regard, it is submitted that local storage facility of M/s Pak Punjab Cardex

Medical System, 202, Eden Heights, Jail Road, Lahore has been verified and recommended

by the Area FID.

Decision: Registration Board deliberated that as products are registered for M/s Johnson & Johnson Pakistan (Pvt) Ltd, Karachi and firm wants to use M/s Pak Punjab Cardex Medical System, 257-K-Block, DHA, Lahore Cantt as its storage site, who itself is an importer. The Board advised M/s Johnson & Johnson Pakistan (Pvt) Ltd, Karachi to develop its own storage site and inform DRAP for confirmation of storage facility.

Case No.09. Clarification of Product.It is submitted that the application of Magma Rapamycin-Eluting Coronary Stent

System manufactured by QualiMed Innovative Medzinproduckte, GmbH, Boschstr. 16, D-

21423, Winsen, Germany was approved in 265th meeting of Registration Board. It is further

submitted that Itrix Rapamycin-Eluting Coronary Stent Implantation System is already

registered with registration No. 082015 on 30 th September, 2016 in the name of M/s

Cardiovascular medical system, Lahore. In this case the owner/legal manufacturer is M/s amg

international GmbH, lohnfield, Winsen-Luhe, Germany and manufactured by QualiMed

Innovative Medzinproduckte, GmbH, Boschstr. 16, 21423, Winsen, Germany.

Decision: Registration Board decided that registration certificate for Magma Rapamycin-Eluting Coronary Stent System shall not be issued till clarification of product similarity with already registered Itrix Rapamycin-Eluting Coronary Stent Implantation System from both the applicant and status of sole agent by the manufactuer M/s QualiMed Innovative Medzinproduckte, GmbH, Boschstr. 16,D-21423, Winsen, Germany.


B. Biological Drugs Division:i. IV Globulin SN Inj. applied by M/s Hi-Warble Pharmaceuticals (Pvt.) Ltd.,

Lahore deferred in 264th meeting of Registration Board.Following product of M/s Hi-Warble Pharmaceuticals (Pvt.) Ltd., Lahore was

deferred in 264th meeting of Registration Board for the submission of clinical trial data. The

detail of the product is as follows:

The firm has submitted the periodic safety update report for the period from 01 st

January 2010 to 30th November 2010. The firm has also submitted the Multi center, single-

arm, phase-IV study to evaluate the efficacy and safety of the combined therapy of aspirin

and high-dose “IVIG-SN” for paediatric patients with Kawasaki disease.

The clinical trial was conducted in accordance with the Korean Good Clinical Practice

regulations and 45 subjects were selected for this trial. The conclusion of the trial is as

follows:

“This clinical trial showed that incidence of coronary artery lesions was 2.38% when IVIG-SN was used in paediatric patients diagnosed with Kawasaki disease. This was lower than the 15% set as the standard in the protocol and the difference was statistically significant. The efficacy of the product was clinically confirmed as well. Moreover, no major issues were discovered in terms of safety. IVIG-SN is believed to be a product that can be used as safely and effectively as previous IVIG agents. Submitted for the consideration of board please.

S. #.






Decision of RB in 264th

meeting

Decision

1 M/s Hi Warble Pharmaceuticals Pvt Limited Lahore.

M/s Green cross Corporation, 586, Gwahaksaneop 2-ro, Ochang-eup, Chenongwon-gu, Cheoangju-si, Chungcheongbuk, do, Republic of Korea.

I.V. Globulin SN injSolution for injection

Each ml contains:Human normal immunoglobulinG……50mg

Plasma derivative

Form 5-ADy. No 224 dated 12-08-16

Rs.100,000/-dated 11-08-16

Rs. 9,500 per 10mlRs.18,000 per 20mlRs.35,000 per 50 mlRs.66,500 per 100ml

Legalized valid CoPP No: 2016-A1-0427 dated31-03-2016

Intrabolulin of biotest Germany registered with M/s Eastern trade

Flebogamma DIF 50 mg/ml of Grifols UK Ltd. (UK)

Deferred for submission of clinical trial data.

Registration Board approved product as per import policy for finished drugs and as per valid legalized CoPP.


ii. Imported veterinary biologicals from non-reference countries.S.#. Name of

Importer & Manufacturer


Type of Form

Dy. No & Date of application

Fee submitted




Decision

1 Marush (Pvt) Ltd K-123 Model Town Lahore.

‘’SHCHELKOVO BIOCOMBINATE’’, Biocombinat township, SShchelkovskii district, Moscow region, Russian Federation

Cultural monovalent and polyvalent adsorbed inactivated vaccine against foot and mouth disease.Each dose contains:Antigen of virus type A(Iran 05)…….. 10PD50Antigen of virus type O ( Pan Asia 2)…….. 6PD50Antigen of virus type Asia1( sindh 08)…….. 6PD50Shelf Life: 18 months

Dy No. 2872/2017(R&I) 30-01-2017Rs.100,000/- 23-01-2017Pack Size:10 DS vial25 DS vial50 DS vial100 DS vial

Legalized GMP certificate No. 01026 dated 29-01-2016

Legalized FSC certificate issued by Ministry of Agriculture of Russian Federation, Federal State Enterprise.

Deferred for evaluation of product by Dr. Qurban Ali, Member Registration Board.

iii. Imported human biologicals from non-reference countries.

S.#.





Remarks Decision

1 RG Pharmaceutica (Pvt.) Ltd. Suit #703 progressive square block 6, P.E.C.H.S Shahrah-e-Faisal, Karachi-75400, Pakistan

North China Pharmaceutical Co. Ltd. No. 115 Hainan Road, Economic &

Freclot Injection 25000IU/5mlEach ml contains: Heparin sodium ….5000 IU

Anti-coagulantShelf Life: 36 months

Dy No. 2524/2017(R&I) 25-01-2017Rs.100,000/- 11-01-2017Pack Size: 5ml x 10vials

Valid Legalized CoPP No. 20150854 dated 18-01-2016

As per submitted CoPP the product is not registered for sale in the market of country of origin.Stability data provided is of 24 months while claimed shelf life is 36 months.Under clinical trial data, the firm has submitted abstracts of three articles instead of complete articles.

Deferred for clarification of following:a. As per submitted

CoPP the product is not registered for sale in the market of country of origin.

b. Stability data provided is of 24 months while claimed shelf life is 36 months.

c. Under clinical trial data, the firm has submitted abstracts of three


Technological Development Zone, Shijiazhuang, China

articles instead of complete articles.

2 M/s Getz Pharma (Pvt.) Ltd, 29-30, Sector-27, Korangi Industrial area,Karachi.

M/s Biocon Limited, Special Economic Zone, Plot Nos. 2,3,4 & 5 Phase-IV, Bommasandra Post,Bangalore-560099,India

TRAVIA 440MG VIALEach vial contains:Trastuzumab(rDNA Origin)…440mgAnti-neoplasticShelf Life: 4 years

Dy No. 1626/2017(R&I) 17-01-2017Rs.100,000/- 12-01-2017Pack Size: 1s vial(440mg)/ Rs.100,000

CoPP No. DCD/CR-1849/Spl.Cell-I/2015-16 dated 07-12-2016

CoPP and Sole agent certificates are photocopied.

Stability data provided for finished product is of 18 months while proposed shelf life is 4 years.Diluent is a part of pack presentation; therefore separate application on Form-5A along with fee for diluent is required.It is pertinent to mention that M/s AGP has already applied the same product from same manufacturer i.e. M/s Biocon Limited, India through M/s Mylan Pharmaceuticals Private Limited, India.Biosimilarity data is submitted which needs evaluation.

Deferred for clarification of following:a. CoPP and Sole

agent certificates are photocopies. Original legalized CoPP and sole agency agreement is required.

b. Stability data provided for finished product is of 18 months while proposed shelf life is 4 years.

c. Diluent is a part of pack presentation; therefore separate application on Form-5A along with fee for diluent is required.

d. M/s AGP has already applied the same product from same manufacturer i.e. M/s Biocon Limited, India through M/s Mylan Pharmaceuticals Private Limited, India.


C. Pharmaceutical Evaluation & Registration.

Case No.01: Approved cases in previous meetings of Registration Board.

a) Products of M/s Warafana approved in 234th Meeting of Registration Board.

Registration Board in its 234th meeting approved the following product of M/s

Warafana Pharmaceuticals, Islamabad subject confirmation of source, GMP Stability and fee

Rs.15000/-. The decision of Registration Board was confirmed from the original minutes.

Sr.No.

Name of firm Name of Composition of product

Pack Size

Demanded price

Date of application

Evaluation by the Section

1. M/s Warafana Pharmaceuticals,Islamabad

Rabe-10 CapsuleEach capsule contains:-Rabeprazole as Sodium(enteric coated pellets 8.5%)….10mg

1x10’s As per SRO 01-06-2011 Approved in FDA

Now, the firm has submitted the information regarding source as M/s Vision

Pharmaceuticals, Islamabad alongwith GMP, stability studies and COA. Regarding fee the

firm has submitted evidence of photocopy of Rs.15000/- and original Challan of Rs.5000/-

(F.N.1-11/2011-Reg.III).

Decision: Registration Board deferred the above product Rabe-10 Capsule for verification of me-too status.

b) Products of M/s Warafana approved in 238th Meeting of Registration Board.Registration Board in its 238th meeting approved the following product of M/s

Warafana Pharmaceuticals, Islamabad subject to condition mentioned in 2nd last column. The

decision of Registration Board was confirmed from the original minutes.

S. No.

Brand Name / Label Claim

Demanded Pack

Size

Demanded

Price

Date of Submissio

n

Decision of Registration Board of meeting-

238th

Evaluation by the section.

1. Clinda CreamEach gm contains:-Clindamycin as Phosphate (USP……….20mg(Gynaecological Anti-Infective)

20gm As Per SRO

06-06-2011

Dy.No.1349-R&I

Fee Rs.8,000(Original Challan)25-07-2013

ApprovedHowever

Registration Board

advised the Registration sections to

again review the

Registration

Approved in USFDA

Dossier is not signed by the

quality control manager and production manager


Dy.No.1832-R-III

Rs.12,000/-

(Original Challan)

Dossiers before

issuance of Registration

letters

2. Feri InjectionEach ampoule contains:-Iron as Iron Sucrose ….100mg(Haematinic)

5mlx5’s As Per SRO

06-06-2011

Dy.No.1324-R&I

Fee Rs.8,000(Original Challan)25-07-2013

Dy.No.1831-R-III

Rs.12,000/-

(Original Challan)

-Do- Approved in USFDA as vial and in

UK as ampoule.

Dossier is not signed by the

quality control manager and production manager

3. Cepha-500 CapsulesEach capsule contains:-Cefadroxil as Monohydrate USP……. 500mg(Anti-Biotic, 1st Generation)

2x6’s As Per SRO

22-06-2011

Dy.No.2671-R&I

Fee Rs.8,000(O

riginal Challan)25-07-2013

Dy.No.1833-R-III

Rs.12,000/-

(Original Challan)

-Do- Approved in UK

The firm mentioned Dry suspension in

the dosage form in form-5 and the dossier is not signed by the quality

control manager and production manager

4. Wefdox100 CapsulesEach capsule contains:-Cefpodoxime (as Proxetil) USP………..100mg(Anti-Biotic, 3rd Generation Cephalosporin)

1x5’s As Per SRO

25-07-2013

Dy.No. 1843Fee

Rs.20,000(Original)

-Do- Not approved in USFDA & UK in capsule dosage form.

5. Waraxim-200 1x5’s As Per 25-07- -Do- Not approved Minutes for 266th Meeting of Registration Board. 278

CapsulesEach capsule contains:-Cefixime (as Trihydrate) USP………..200mg(Anti-Biotic, 3rd Generation Cephalosporin)

SRO 2013Dy.No. 1842Fee

Rs.20,000(original)

in UK &USA (instead as

400mg capsule in FDA)

Now, the firm has requested for grant the registration of above product as they have

deposited the balance fee as per detail mentioned in 3rd last column.

Decision: Registration Board approved products at s. no.1, 2 and 3 while deferred the product at s. no. 4 and 5 for confirmation of approval of formulation in the reference agencies.

Case No.02: Deferred cases in previous meetings of Registration Board.

a) Products Deferred in previous meeting.Registration Board in its 248th meeting approved 07 products of M/s Wenovo

Pharmaceuticals, Taxila except the following while considering these products which were deferred in 244th and 246th meetings for confirmation of availability of TOC analyzer and liquid Particle Counter.

Now, the firm has requested to approve the above product since the same formulation

has been found approved in Lithuania, Poland & Lativa as intramuscular injection instead of

Germany as indicated in the minutes of 261st meeting.

Decision: Registration Board approved WENOFEN 2 ml Injection.


Sr.No. Brand name and composition Type of FormInitial date, diary

Fee including differential fee

Demanded Price / Pack size

Decision of M-246th

meeting of Registration Board

1. WENOFEN InjectionEach 2 ml of amberglass ampoule contains:Diclofenac Sodium….75mgLidocaine HCl…..20 mgAnalgesic, Local anestheticManufacturer

Form-5Dy No: 1272dated 23-10-201420,000/-As per policyof MOHPack of 5’s & 10’s

Deferred forconfirmationof installationand operationalqualificationsof TOC analyser &liquid ParticleCounter byArea FID.

Case No.03: Registration for export purpose.Registration Board in its 262nd meeting deferred the following products of M/s

Hudson, Karachi for the reason stated in the last column. Now the firm has provided

international availability as per following details:

S.# Name of Applicant

Name of product(s) Date of application, Diary No. & Form

Decision of Registration Board in 262nd Meeting

Approval status in reference regulatory agencies or evidence of registration in the country of importer.

1. M/s Hudson Pharma, Karachi

Resprixo 0.5mgEach 2ml ampoule contains:Fluticasone Propionate…….0.5mg

15.09.20161198Rs. 50,000/-

Deferred for confirmation of approval status by reference regulatory authorities and importing country

FDA ApprovedFLONASE ALLERGY RELIEF spray, metered, nasalGSK CONS

2. -do- Actonide 0.5mgEach ampoule contains:Budesonide BP…….0.5mg(BP Specification)

15.09.20161199Rs. 50,000/-


MHRA approved as Budesonide 0.5 mg Nebulizer SuspensionBreath Limited UK

3. -do- Formotol 20mcgEach ampoule contains:Formoterol Fumarate ….20mcg(Manufacturer’s Specification)

15.09.20161203Rs. 50,000/-


FDA ApprovedPERFORMIST,Solution;InhalationMYLAN SPECLT

4. -do- Deeferol Injection 200,000IUEach ampoule contains:Cholecalciferol BP………5mg(Manufacturer’s Specifications)

15.09.20161189Rs. 20,000/-


Me too formulation

Decision: Registration Board approved the grant of registration of above mentioned products to M/s Hudson Pharma, Karachi for export purpose.


D. Quality Assurance & Laboratory Testing Division.

Case No.01: Manufacture & Sale of Sub-Standard Drug-Beflam 75mg Tablets (Diclofenac Potassium) Batch No.3827 By M/S Batala Pharmaceutical Gujranwala.

The sample of Beflam 75mg Tablets Batch No. 3827 manufactured by M/s Batala

Pharmaceuticals Gujranwala, was drawn by FID Lahore from the manufacturing premises on

16-06-2015 and sent to the CDL, Karachi for test/analysis. The Federal Government , CDL

Karachi vide test report No LHR-156/2015 dated 31st July 2015, declared the sample of

Beflam 75mg Tablets as of Substandard quality under the Drugs Act, 1976. . The result of

CDL on the basis of which sample under reference was declared sub-standard are reproduced

as under:-

Sub-Standard with regard to Dissolution Test.Stage-1

Tablet No. (%)age.01. 52.08202. 28.43503. 48.06404 48.79805. 28.43506 48.98Average % (S1) 254.794/6=42.465

Limits for (Stage-1):- Each unit is not less than Q+5% i.e. 75+5=80%Stage-2

Tablet No. (%)age01. 72.01902. 31.29803. 38.19704 48.46205. 38.02906 35.505Average % (S2) 263.5/6=43.918

Average of 12 units = 254.794+262.51=517.304517.304/12=43.191%

Limits for (Stage-2):- average of 12 units (S1+S2) is equal to or greater than Q(75%) and no unit is less than Q-15% (75-15=60%)

Stage-3Limits for (Stage-3):- Average of 24 units (S1+S2+S3) is equal to or greater than Q(75%). Not more than 2 Units are less than Q-15 (75-15=60%) & no units is less than Q-25% (75-25=50%)

Since, 01 tablet is below 60% and 10 tablets are already below 50% therefore, the sample Does not comply with USP 37.

Remarks:- The sample is of “Sub-Standard” quality under the Drug Act 1976.


On explanation letter issued by the FID, the firm challenged the CDL report and

requested for Appellate testing under Section 22(5) of Drugs Act, 1976. However Appellate

Laboratory declared the sample as Substandard vide their test report 031-MNHRS&C/2015

dated 08th January 2016. The result of Appellate Laboratory on the basis of which sample

under reference has been declared sub-standard are reproduced as under:-

Sub-Standard with regard to Dissolution Test:-

Dissolution: Determined: 54.193% Limit: Not less than 75% of the labeled amount.

Does not comply with USP-32

The names of the following persons of the firm were furnished by the FID. i. Rana Muhammad Yousaf (Chief Executive), M/s Batala Pharmaceuticals.ii. Muhammad Umar Shakir Production Manager.iii. Hafiz Shabir Ahmed Quality Control Manager

As per procedure show cause notices were issued to the firm and above named accused persons, offering opportunity of personal hearing before the Drug Registration Board.

258th meeting of Registration Board held on 25th & 26th April 2016

Proceedings: No representative of M/s Batala Pharmaceuticals Gujranwala appeared before the Board. The Firm submitted the request for giving opportunity to next meeting due to some emergency in the family of the concerned personals.

Decision: Registration Board after detailed discussion, deliberation, considering the facts and legal provision decided as under:-

“Deferred the case and given last opportunity to the M/s Batala Pharmaceuticals Gujranwala if they want to avail personal hearing before the Registration Board. In case of failure of the firm to appear before the Board in its next meeting of Registration Board, the Board will take ex-parte decision.”

259th meeting of Registration Board held on 30th & 31th May 2016

Proceedings: Mr. Hafiz Shabir Ahmad, Quality Control Manager of the M/s Batala Pharmaceutical Gujranwala appeared before the 259th meeting of DRB held on 30-31st May 2016 and pleaded their case.Decision: Registration Board after detailed discussion, deliberation, considering the facts and legal provision decided as under:-“The Board decided to suspend the Registration for six months (06) and to conduct the PSI from the following panel:

i. Director DTL Lahore.ii. Mr. Muhammad Adnan Faisal Saim, (DDC- QC-I & II).

iii. Area FID.The Firm will recall the batch and the area FID will supervise the destruction.”


Product Specific Inspection Report:

With reference to the decision of Registration Board in its 259th meeting held on 31-

05-2016, the above constituted panel visited the firm on 21-11-16 to conduct Product Specific

Inspection and concluded as under:-

Focus of Inspection: Product Root Cause

Beflam 75 mg Batch no. 3827

The product was declared substandard on the basis ofi. Dissolution: Determined was 54.193%. (Does not comply with USP-32 which states the limit as not less than 75% of the labeled amount.)

Details of Product Specific Inspection:The panel scrutinized the documents regarding sub-standard product [Beflam 75 mg

Tablets (Diclofenac Potassium)] including the Batch Manufacturing Record, standard manufacturing procedures, standard testing procedures, testing methods, pharmacopoeial specifications etc. The panel noted that batch of the product was manufactured as per standard procedures, and the released certificate was issued by the Quality Control Department. The firm also issued letters for recall to the distributors. The panel also checked the documents and record. After the detailed discussion and investigation of the record, the panel reached to the conclusion that registration of the product, Beflam 75 mg, may be restored with the directions to the firm to keep strict control and observations on the product by conducting real time stability study and monitoring from the market on regular basis.

Conclusion:After thorough investigations and observations of record, the panel observed that the

firm was not getting calibration of some of their equipment from external source timely. It is directed to the management to get calibrated all of their equipment from the external sources on regular basis well before their next due date. It is also directed to ensure the testing of the product as per current Pharmacopoeial requirements, so the panel recommends that the production may be restored of drug Beflam 75mg tablets (Diclofenac Potassium) as the period of more than six months of suspension of registration of the drug has already been completed, as per the decision of Drug Registration Board.

The case was presented in 266th meeting of Registration Board dated 07th February, 2017.

Proceedings and Decision of 266th Meeting:

Registration Board after detailed discussion, deliberation, considering the facts and in the light of Product Specific Inspection report decided the case as under:-

“The Board decided to give resumption of registration of Beflam 75 mg Tablets (Diclofenac Potassium) Reg. No. 031128 by M/s. Batala Pharmaceuticals, Gujranwala.”

Meeting ended with a vote of thanks to and from the chair.

End of Document
