Document Version- Mfg-02

RUG SALE LICEN

SE

MANUFACTURING LICENCE

STANDARD DOCUMENTS

AND

APPLICATION GUIDELINES

AND APPLICATION

Preface

Food and Drug Administration, Maharashtra State is presenting the guideline Manual for the easy understanding of processing of various applications through online system. Though the system is in service since 2015, from 25th January, 2016, it is made completely paperless. This effort is to bring transparency and uniformity in processing of various applications. The Manual is available in Marathi and English. All the stakeholders are requested to read it properly and follow the online paperless system.

General Instructions to applicants for Licence for manufacturing of Drugs and Cosmetics through online application software

1. All the documents should be scanned in 150 dpi, gray scale/Black &

White, and then should be uploaded at relevant space provided.

2. Please show all the original documents to the inspector at the time of

inspection.

3. Please be sure that, all the information is filled precisely for respective

application mentioned under standard document and only then e-send the

application. In case of rejection of your application for incomplete

information, the fees once paid will be forfeited.

4. If necessary, the licensing authority may ask for any other relevant

documents.

5. These guidelines are subject to change as and when necessary and will be

updated from time to time.

6. Every application needs to be ‘e-send’, otherwise it will not be forwarded

to the office.

7. In case of Change in Constitution, (Change in partner, proprietor, Pvt.

Ltd. to Ltd, etc.), except in case of death of proprietor, applicant is

required to obtain a fresh Licence.

8. These are only guidelines. For clarity please refer to the provisions of

Drugs and Cosmetic Act 1940 and Rules 1945, whichwill always

prevail.

9. Fees for Licence is as per table given below

Fees applicable in the State of Maharashtra

Appl Form

Lic Form

Fresh Appl Ren / RetAppl Late Fee / month

Duplicate Copy fee

Addl Prod /

Drug Lic Fee

Insp Fee Lic Fee

Insp Fee

24 25 3000 750 3000 750 1500 750 750 24A 25A 3000 750 3000 750 1500 300 750 24B 25B 600 300 600 300 300 150 250 24C2 25C 240 60 240 30 90 45 15 24C3 25C 120 30 120 15 90 30 15 24C4 25C 120 30 120 15 45 30 15 24D 25D 400 200 400 200 200 100 100 24E 25E 400 200 400 200 200 100 100 24F 25F 6000 1500 6000 1500 3000 1500 750 27 28 4500 1500 4500 1500 1500 600 1250 275 28 1800 12006 1800 12006 900 300 125 (Max

1500) 27A 28A 4500 1500 4500 1500 1500 600 1250 27B 28B 7500 1500 7500 1500 3600 1200 1250 27C 28C 6000 1500 6000 1500 1000 1000 300 27D 28D 1800 12006 1800 12006 900 600 125 (Max

1500) 27DA 28DA 6000 1500 6000 1500 1000 1000 300 27E 28E 6000 1500 6000 1500 1000 1000 300 27F 28F 6000 1500 6000 1500 1000 1000 300 30 29 150 31 32 3000 1200 3000 1200 1200 600 750 317 32 1200 300 1200 150 600 150 12.50 31A 32A 3000 1200 3000 1200 1200 300 750 36

37 (Sch C &

C1)

4500 4500 3000 4500 (for Addl

category ) 36

37 (Other than C &

C1)

2700 2700 1500 2700 (for Addl

category) 47 48 6000 6000 1000

1. In case of itinerant vendor or applicant who desires to establish a shop in town or village having population 10000 or less.

2. Fees for manufacture of homoeopathic mother tinctures and potentised preparations. 3. Fees for manufacture of homoeopathic potentised preparations only. 4. Fees for manufacture of homoeopathic potentised preparations from back potencies by

Pharmacies. 5. For Allergens only. 6. For first inspection and fee of Rs 600/- for subsequent inspection. 7. For odoriferous substances (Aromatic products).

NDPS Transport permit 10 Licence I / II (grant or

renewal) per year 20

Poisons Licence 500 Blood Storage Centre Approval 2000 (for WHB) + 200 (per product) Competent Person Approval

Interview 1000

Individual Certificate 500 Upto 1 cr 1 to 5 cr More than

5 cr Plan Approval One Section Fresh 1000 2000 5000 Modification 500 1000 2500 More than 1 section Fresh 2000 5000 10000 Modification 1000 2500 5000 Blood Storage Centre 1000 General GMP 500 + 2500

(Insp fee) 1000 + 2500 (Insp fee)

Capacity certificate 500 + 2500 (Insp fee)

1000 + 2500 (Insp fee)

Performance certificate

2000 (for 10 prod) 1000 for additional 10 products

Free sale certificate 1000 (for 10 prod) 500 for additional 10 products

No conviction 1000 Any other certificate (Validity, Neutral Code) 1000 WHO GMP Fresh WHO-GMP

Certificate – Inspection fee (Own)

5000/- for each section

Fresh WHO-GMP Certificate – Inspection fee (Loan)

2000/- for each section

Unit WHO-GMP Certificate 1000 for every 10 products First time COPP with

Annexure (with Validation & Stability)

1500/-

First time COPP (with Validation & Stability)

1000/-

COPP with any type of Annexure

1000/-

COPP (if WHO – GMP Cert. or COPP already granted)

500/-

Statement of Licensing status

1000 for every 10 products

STEPS FOR GRANT OF MANUFACTURING LICENCE BY APPLICANT

AFTER PAYMENT OF FEES, THROUGH GRAS SYSTEM, PRINT PAYMENT RECEIPT AND UPLOAD THE SAME IN SYSTEM.

APPLICATION IS RECEIVED BY CONCERNED ASSISTANT COMMISSIONER.

APPLICANT APPLY FOR PASSWORD AND USER ID THROUGH ONLINE SYSTEM

AFTER RECEIPT OF PASSWORD AND USER ID, APPLICANT UPLOAD NECESSARY DOCUMENTS.

PAY PRESCRIBE FEES THROUGH GRAS SYSTEM (GOVERENMENT RECEIPT ACCOUNTING SYSTEM)

ALLOTMENT OF APPLICATION.

AFTER RECEIPT OF APPLICATION, ASSISTANT COMMISSIONER ALLOCATES IT TO THE CONCERN DRUGS

INSPECTOR.

INSPECTION STAGE. AFTER RECEIPT OF APPLICATION AREA INSPECTOR

ALONG WITH CDSCO DRUGS INSPECTOR, JOINT INSPECTION CARRIED OUT RELATED TO THE PREMISES

AND FACILITY.

VERIFICATION OF UPLOADED DOCUMENTS BY INSPECTORS

INSPECTOR WILL FORWARD REPORT TO ASSISTANT COMMISSIONER WITH RECOMMENDATION. ASSISTANT

COMMISSIONER WITH HIS REMARK AND RECOMMENDATION FORWARD TO LICENSING

AUTHORITY FOR FURTHER ORDERS.

INSPECTOR MAKE ENTRIES RELATED TO INSPECTION REPORT

LICENSING AUTHORITY WILL VERIFY ENTRIES, UPLOADED DOCUMENTS AND INSPECTION REPORT OF

INSPECTOR.

LICENSING AUTHORITY WILL MAKE NECESSARY REMARKS REGARDING GRANT OR REJECTION OF

APPLICATION.

DRAFT COPIES OF LICENCES VERIFIED BY LICENSING AUTHORITY BEFORE FINAL ORDER OF GRANT OR

REJECTION OF APPLICATION.

FINAL ORDER OF GRANT OR REJECTION OF APPLICATION BY LICENSING AUTHORITY.

SYSTEM GENERATED SMS WILL FORWARD TO APPLIACNT

FINAL PRINT OUT OF LICENCES CAN TAKE OUT BY APPLICANT WITH IN THREE DAYS FROM THE GRANT OF

LICENCES/ PERMISSION

Step 1. HOW TO OBTAIN LOGIN ID AND PASSWORD

Approval of plan For Own Manufacturer.

(All documents which are to be uploaded should be in PDF format)

Hard copy is required to be submitted to office only once at initial stage. (Due to logistic constraint for approved plan, Article of Association and Memorandum of Association, Agreements, etc.)

S. No Document type Format Copy 1 Covering letter (with brief of

company, categories of products, dosage forms proposed to manufacture)

Hard copy Soft copy

01 01

2 GRN generated by payment of fees through https://gras.mahakosh.gov.in/echallan/ Upload in MFW module.

Hard copy Soft copy

01 01

3 Site Plan and layout of the building with name, address, scale, measurements of the Area as per Schedule- T requirement (For Ayurvedic, Siddha, and Unani)& as per Schedule- M requirement (Allopathic Medicines)& as per Schedule- M - II requirement (For

Hard copy Soft copy (A4 size PDF)

03 01

Steps Action

1. Visit https://fda.maharashtra.gov.in/Home.aspx web site. Use Google Chrome OR Mozilla Browser.

2. Click on XLN Manufacturing Website link on home page

3. Popup tab will take yu the site or alternatively you can visit https://xlnindia.gov.in/login.aspx?ST=6j4eq4PwS%2fg%3d&XLNMFG=MFGweb site.

4. Click for Mfg ID & password.

5. Enter your firm’s details precisely & upload Company or Proprietor’s Pan Card in JPEG File Format within file Size – 75 KB. SELECT OWN OR LOAN AS APPLICABLE

6. Wait for 24 hrs to receive ID and password on the mobile number provided.

Cosmetics) 4 Self attested copies of documents

pertaining to the possession of premises such as, Register ownership /rent / lease/ allotment letter/ Possession Letter, Tax Receipt,(Documents should be Registered with appropriate Authority)

Hard copy Soft copy

01 01

5 Consent to establish from Maharashtra Pollution Control Board.

Hard copy Soft copy

01 01

6 List of Directors, Partners, Trustees, along with AOA and MOA submitted to ROC, LLP, HUF, Registered Partnership deed, Trust deed, etc. (As applicable)

Soft copy

Information of Directors, Partners, Trustees, proprietor should be in Format as follows.

Sr No.

Name Educational Qualification

Designation PAN No. &Adhar No.

Residential Address

Mob. No. & Ph. No.

Email ID

Date OF Joining

This format should be signed by responsible person and then it should be uploaded

DOCUMENTS FOR GRANT OF LICENCE

(All documents should be in PDF format)

S. No Document type Format 1 A) APPLICATION IN FORM 24 & 27 (FOR

ALLOPATHIC MEDICINE) Soft copy

B) APPLICATION IN FORM 24-B (FOR LICENCE TO REPACK)

Soft copy

APPLICATION IN FORM 24D (FOR AYUVERDIC MEDICINE)

Soft copy

APPLICATION IN FORM 31 (FOR COSMETICS) Soft copy Application In Form 24c (For Homoeopathic Medicine) Soft copy 2 Challan Of Fees Paid To Be Upload In MFW Module Soft copy

3 Specific Power Of Attorney In FavorAuthorized Signatory For Submitting Application On Behalf Of The Company

Soft copy

4

List Of Competent Technical Staff, With Their Qualification, Registration, Experience, Previous FDA Approvals, Etc. TO BE UPLOADED AT MFT MODULE

Soft copy

5 Appointment/Acceptance Letter Of Competent Technical Staff Of Manufacturing Section. TO BE UPLOADED AT MFT MODULE

Soft copy

6 Appointment/Acceptance Letter Of Competent Technical Staff Of Testing Section. TO BE UPLOADED AT MFT MODULE

Soft copy

7 Section Wise List Of Plant And Machineries Soft copy 8 Plan Layout Of The Premises Approved By The Licensing

Authority Soft copy

9 Consent To Establish & Consent To Operate From Maharashtra State Pollution Control Board.

Soft copy

10 Noc of Department Of Industrial Safety & Health Soft copy 11 Details Of Manufacturing Process, Process Flow Chart

(For Bulk Drug) Soft copy

12 AHU Installation And Validation Certificate (Wherever Necessary)

Soft copy

13 Water System Installation And Validation Certificate (Wherever Necessary)

Soft copy

DOCUMENTS FOR GRANT OF LICENCE FOR THE DRUGS TO BE CERTIFIED BY CENTRAL LICENSING APPROVING AUTHORITY

(FOR LVP/SERA & VACCINES/rDNA derived drugs)

S. No Document type Format 1 Application In Form 27 Soft copy 2 Challlan Of Fees Paid To Be Upload In MFW Module Soft copy 3 Copy Of Joint Inspection Report Along With Its

Compliance Soft copy

4 Specific Power Of Attorney In FavorAuthorized Signatory For Submitting Application On Behalf Of The Company

Soft copy

5 List Of Competent Technical Staff, With Their Qualification, Registration, Experience, Previous Fda Approvals, Etc. To Be Uploaded At MFT Module

Soft copy

6 Appointment/acceptance letter of Competent Technical Staff of manufacturing section. TO BE Uploaded At MFT Module

Soft copy

7 Appointment/acceptance letter of Competent Technical Soft copy

Staff of testing section. To Be Uploaded At MFT Module 11 Section wise list of Plant and machineries Soft copy 12 Plan layout of the premises Approved by the Licensing

Authority Soft copy

13 Consent to establish & consent to operate from Maharashtra State Pollution Control Board.

Soft copy

14 NOC of Department Of Industrial Safety & Health Soft copy 15 Details Of Manufacturing Process, Process Flow Chart &

Stability Data Soft copy

16 Copy Of New Drug Permission In Form 46/46a Soft copy 17 AHU Installation And Validation Certificate Soft copy 18 Validated Water System Installation Certificate Soft copy

DOCUMENTS FOR GRANT OF LOAN LICENCE

S. No Document type Format 1 Application In Form 24A& 27AProforma-1/2/3/4/D (For

Allopathic Medicine) Soft copy

2 Application In Form 24E, Proforma- 1/2/3/4/D (For Ayuverdic Medicine)

Soft copy (A4 size PDF)

3 Application In Form 31A,Proforma- 1/2/3/4/D (For Cosmetics)

Soft copy

4 Challlan Of Fees Paid To Be Upload In MFW Module Soft copy 5 Specific Power Of Attorney In FavorAuthorized Signatory

For Submitting Application On Behalf Of The Company Soft copy

6 Details Of Manufacturing Process, Process Flow Chart (For Bulk Drug)

Soft copy

7 List Of Directors, Partners, Trustees, Along With ROC Copy Registered Partnership Deed, Trust Deed (As Applicable)

Soft copy

8 Proof Of Establishment (For Allopathic Licence Copy In 20B& 21B)

Soft copy

Information of Directors, Partners, Trustees, proprietor should be in Format as follows.

Sr No.

Name Educational Qualification

Designation PAN No. & Aadhar No.

Residential Address

Mob. No. & Ph. No.

Email ID

Date OF Joining

This format should be signed by responsible person and then it should be uploaded

HOW TO GET USER ID & PASSWORD Go to website Visit https://fda.maharashtra.gov.in/Home.aspx preferably in Google chrome / Mozilla Firefox or internet explorer version 8 and above. Popup blocker should be allowed.

Click on XLN Manufacturing Website link on home page

Popup tab will take yu the site or alternatively you can visit https://xlnindia.gov.in/login.aspx?ST=6j4eq4PwS%2fg%3d&XLNMFG=MFGweb site.

Click for Mfg ID & password.

Enter your firm’s details precisely & upload Company or Proprietor’s Pan Card in JPEG File Format within file Size – 75 KB. SELECT OWN OR LOAN AS APPLICABLE

Wait for 24 hrs to receive ID and password on the mobile number provided.

HOW TO MAKE PAYMENT IN GRAS

1ST STEP

https://gras.mahakosh.gov.in

2ND STEP

Payment of fees - After every inward application wherever fees are applicable, ‘make payment’ tab will appear after inward application is completed. Click on this option. Then new window will appear click on ‘make a new payment’ tab. It will redirect to ‘Gras’ site of Government of Maharashtra. All the payments must be paid through GRAS SYSTEM ONLY

After paying the fees through GRAS, please fill all the details in the following screen. The GRN number, amount paid should be very accurately filled otherwise the payment will not be certified.

Then select as follows – Department: Food & Drugs Administration Payment Type: select menu e.g. Drugs sale Licence etc. Scheme name: will come automatically District: select district where Licence premises is existing Office name: Select from drop down Period (Year): current financial year and select – one time / adhoc payment. Form ID: write Licence Form No.

Then select the payment option from three radio buttons – i) e-payment, ii) payment across the bank counter, iii) SBI payment gateway.

Fill all the details and take a printout of Challan. Use this Challan for your Inward Application.

HOW TO ADD CHALLAN IN E-WALLET MODULE

Enter your login credentials

After logging in go to MFW tab

Click on Make a Payment

Click on button “new”, add details and save

AFTER E WALLET PAYMENT, APPLICATION CAN BE MADE EITHER FOR NEW LICENCE OR ADDITIONAL PRODUCTS OR FOR RETENSION OF LICENCES.

AFTER LOG IN,CLICK ON MFA, PLACE ON MENU BAR

CLICK ON PREPARE/EDIT ONLINE APPLICATION.

CLICK ON ADD NEW APPLICATION.

COMPLETE THE APPLICATION BY FILLING NECESSARY INFORMATION ON CATEOGRY, INWARD TYPE, LICENCE TYPE, APPLICATION REMARKS

SAVE THE INFORMATION.

CONFIRMATION OF APPLICATION.

UNDERTAKING/ CHECK LIST

UNDERTAKING

ESIGN

GO TO APPLICATION AGAIN

ENTER THE PRODUCT / CATEGORIES DETAILS

SAVE THE INFORMATION.

ENTER COMPOSITIONS AND UPLOAD METHOD OF ANALYSIS

CHECK THE FEES AND ENTER RELEVANT REMARKS

ESEND THE APPLICATION

APPLICATION IS RECEIVED BY CONCERNED AREA ASSISTANT COMMISSIONER.

Note. Query is raised by Inspector or / and Licensing Authority/ Assistant Commissioner in case of incomplete / inadequate information. Applicant receives the application back along with an SMS. Application should be resubmitted by taking corrective actions by the Applicant.

ALLOTMENT OF APPLICATION. AFTER RECEIPT OF APPLICATION, ASSISTANT COMMISSIONER ALLOCATES IT FOR INSPECTION TO THE DRUGS INSPECTOR.

INSPECTION STAGE AFTER RECEIPT OF APPLICATION, AREA INSPECTOR CARRIES OUT INSPECTION / JOINT INSPECTION FOR GRANT OF NEW LICENCE OR ADDITIONAL PRODUCT FOR VERIFICATION OF THE REQUIREMENTS AS PER PROVISIONS OF RULES SUCH AS INFRASTRUCTURE, STAFF, FACILITY, DOCUMENTATION, ETC. IN CASE OF NON COMPLIANCES QUERY IS RAISED TO MANUFACTURER FOR CORRECTIVE ACTION AND SUBMISSION OF COMPLIANCE REPORT. PROCESSING BY DRUGS INSPECTOR

SELECT APPLICATION IN CHRONOLOGICAL ORDER (RED MARK APPLICATION TO BE DISPOSED OFF ON PRIORITY BASIS)

INSPECTOR SCRUTINISES APPLICATION FOR APPLIED PRODUCTS, LICENCE DETAILS, STAFF, MANUFACTURING FACILITY, ETC.

SUBMMISSION OF APPLICATION WITH REMARKS AND RECOMMENDATION TO ASSISTANT COMMISSIONER.

BEFORE SENDING APPLICATION TO ASSISTANT COMMISSIONER, INSPECTOR HAS TO e-sign THE APPLICATION

AFTER RECEIPT OF APPLICATION FROM ASSISTANT COMMISSIONER, LICENSING AUTHORITY MAKES FINAL DECISION ON THE SAID APPLICATION

PRODUCT PERMISSION / APPLICANT DETAILS, UPLOADED DOCUMENTS CAN BE VERIFIED, BEFORE GRANT

REMARKS OF LICENSING AUTHORITY

FINAL ORDER OF LICENSING AUTHORITY REGARDING GRANT OR REJECTION OF APPLICATION.

PRINTING OF LICENCE/ PERMISSION/ CERTIFICATES BY APPLICANT ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

After grant or rejection of application, applicant will receive an SMS about the same.Take a print out of the approval / rejection from MFR and ‘certificate / permit printing’ option for new Licence and retention, product permission, certificates within three days. Applicant will receive Licences /approvals with the valid e-signature and official seal.

COVERING LETTER AND LICENCE WITH AADHAAR AUTHENTICATED eSIGNATURE OF LICENSING AUTHORITY HAVING THIRD PARTY APPROVAL VERIFICATION (TPAV) NUMBER.