ANNUAL REPORT 2015-16

Pharmacopoeia Commission For

Indian Medicine & Homoeopathy

PLIM Campus, Kamla Nehru Nagar

Ghaziabad

CONTENTS

1. BACKGROUND 1

2. MANAGEMENT 5

2.1 General Body 5

2.2 Standing Finance Committee (SFC) 5

2.3 Scientific Body 6

2.4 Organizational Setup 7

2.5. Execution of Pharmacopoeial Work 8

2.5.1 Pharmacopoeial Committees 8

2.5.2 Pharmacopoeial Laboratory for Indian Medicine (PLIM) 9

2.5.3 Homoeopathic Pharmacopoeial Laboratory (HPL) 9

3. TECHNICAL ACCOMPLISHMENTS 11

3.1. Publication and revision of Ayurvedic, Siddha, Unani and Homoeopathic Formularies/ Pharmacopoeia/Codex and supplementa ry compendia

11

3.2. Development of Phytochemical Reference Standards (PRS) repository 12

3.3. Development of Botanical Reference Standards (BRS) repository 13

3.4. Harmonization of various pharmacopoeias 15

3.5. Consolidation of various pharmacopoeial volumes 19

3.6. Survey and Collection Tour programme 19

3.7. Gearing up Development of Pharmacopoeial standards and allied works through a new Scheme to be operational in project mode

20

3.8. Seminars/Workshops/Conferences/Training programmes 20

3.8.1 APC - Industry Interactive workshop for states of southern region 20

3.8.2 Brain Storming Session on revisiting of NFUM and UPI 22

3.8.3 Capacity Building Training Programmes for Regulatory authorities 23

3.8.4 Participation in seminars 23

3.9. Organization of Hindi Pakhvada 23

3.10. Renewal of Registration 24

3.11. Achievements of Pharmacopoeia Committees 24

3.11.1 Ayurvedic Pharmacopoeia Committee (APC) 24

3.11.2 Siddha Pharmacopoeia Committee (SPC) 26

3.11.3 Unani Pharmacopoeia Committee (UPC) 27

3.11.4 Homoeopathic Pharmacopoeia Committee (HPC) 29

3.12. Coordinated activities with Pharmacopoeial laboratories 31

3.13. Meetings Held 34

4. FINANCIAL STATEMENTS 35

4.1. Budget Estimate 35

4.2. Statement of Expenditure 36

4.3. Audited Accounts 36

Annexure I 39

Annexure II 43

Annexure III 48

Annexure IV 49

Annexure V 56

Annexure VI 57

1

1. BACKGROUND

Pharmacopoeia Commission for Indian Medicine & Homoeopathy (PCIM&H) is an

autonomous organization under Ministry of AYUSH, Govt. of India with a primary

mandate to develop pharmacopoeial standards for drugs/formulations used in

Ayurveda, Siddha, Unani (ASU) and Homoeopathy (ASU&H) systems of Medicine.

It serves as an umbrella organization for Ayurvedic Pharmacopoeia Committee (APC),

Siddha Pharmacopoeia Committee (SPC), Unani Pharmacopoeia Committee (UPC)

and Homoeopathic Pharmacopoeia Committee (HPC) with Pharmacopoeial Laboratory

for Indian Medicine (PLIM) and Homoeopathic Pharmacopoeia Laboratory (HPL) as

its supporting structures.

The Government of India set up APC, SPC, UPC and HPC in the years 1962, 1975,

1964 & 1962 respectively. These Committees were supported technically by the PLIM

and HPL which are the apex laboratories dedicated to develop Pharmacopoeia l

standards for respective systems of Medicine. These Pharmacopoeia Committees have

been publishing standards on Ayurveda, Siddha, Unani and Homoeopathic Single drugs

and Formulations alongwith respective Formularies. Ayurvedic Formulary of India

(Part I-III) consists of 985 Formulations, Siddha Formulary of India (Part I-II) consists

of 399 Formulations and National Formulary of Unani Medicine (Vol. I-VI) consists of

1229 Formulations. So far monographs on 645 Single drugs and 152 Formulations of

Ayurveda, 139 Single drugs of Siddha, 298 Single drugs and 150 Formulations of Unani

and 1117 drugs of Homoeopathy have been published. Detailed information on

volumewise distribution of pharmacopoeial monographs alongwith other supporting

publications is given vide Annexure I.

The Pharmacopoeias are official documents and are widely used all over the India.

These are the compendia of quality standards to ensure the Identity, Purity and Strength

of the drug imported, manufactured for sale, stocked or exhibited for sale or distributed

in India. However, to give credence to these pharmacopoeias, it was felt that an

independent/autonomous Pharmacopoeia Commission for Indian Medicines on the

lines of the Indian Pharmacopoeia Commission (IPC) for Allopathic medicines

(established in the year 2004) may be set up. It was expected that a non-Governmenta l

Autonomous Commission undertaking the standardization of the ASU drugs would

have much better credibility rather than the Standing Committees. Presently,

2

Pharmacopoeia Commissions exist in countries like United States of America (USA),

United Kingdom (UK), China and Japan. This measure would enable networking with

similar Commissions elsewhere on an equal footing which will lead to mutua l

agreement on standards & facilitate better coordination and exchange of information.

Pharmacopoeia Commission would further boost the development of AYUSH sector in

the country. The Steering Committees constituted by the Planning Commission for the

AYUSH Sector for 11th Plan also recommended the constitution of a Pharmacopoeia

Commission for Indian Medicine (PCIM).

The Commission was initially established as Pharmacopoeia Commission for Indian

Medicine (PCIM) in the year 2010. However, in pursuance to the decision of Central

Government (dated 20th March 2014), Homoeopathy was incorporated and the

Commission was renamed as Pharmacopoeia Commission for Indian Medicine &

Homoeopathy (PCIM&H). Amendments in three-tier governing structure of the

Commission have also come in effect with this restructuring. The Commission is re-

registered under Societies Registration Act, 1860 on 25th June 2014 with its new name

and revised Memorandum of Association.

Main Aims and Objects of PCIM&H

1. Publication and revision of the Ayurvedic, Siddha, Unani and Homoeopathy

Pharmacopoeia of India at suitable intervals and of such addenda or supplementary

compendia during the intervening periods as may be deemed necessary; releasing

the publications for public use from a date when they are to become official

2. Publication and revision of the Ayurvedic, Siddha and Unani Formularies of India,

Homoeopathic pharmacopoeia as well as Homoeopathic Pharmaceutical Codex at

regular intervals with a view to make it an authentic source of information on rational

combination and use of medicines including their methods of preparation,

therapeutic indications, adverse reactions, contra-indications, drug-drug interactions

and similar issues concerning Indian medicines for safe use in humans and animals.

Identification of ASU Formulations and Homoeopathic pharmacopoeia as well as

Homoeopathic Pharmaceutical Codex with a view to develop their quality standards

and to ensure quality and safety of ASU&H medicine.

3

3. To nurture and promote awareness of quality in ASU drugs formulations, Homoeopathic

pharmacopoeia as well as Homoeopathic Pharmaceutical Codex and drug research on

ASU products and publish regularly or at suitable intervals other related scientific

information as authorised under the rules and procedures of the Commission.

4. Exchange information and interact with expert committees of the World Health

Organization and other international bodies with a view to harmonise and develop

the ASU & H Pharmacopoeial standards to make those internationally acceptable.

5. Arranging studies either under its own auspices or through collaboration with other

institutions to develop standards and quality specifications for identity, purity and

strength of raw materials and compound formulations and to develop SOPs for the

process of manufacture included or to be included in the Ayurvedic, Siddha, Unani

and Homeopathic Pharmacopoeia/formulary and its addenda or supplementary

compendia or other authorized publications.

6. Maintain National repository of authentic reference raw materials used in the

manufacture of Ayurveda, Siddha, Unani and Homeopathy medicines for the

purpose of reference and supply of reference standards to the stake holders at a price.

7. To assign responsibilities described for PLIM and HPL under the Drugs &

Cosmetics Act, 1949 (D&C Act) - as soon as the both the institutes become part of

the Commission.

8. Generate and maintain repository of chemical reference marker compounds of the plants

or other ingredients used in standardizing Ayurveda, Siddha, Unani and Homeopathy

medicines and supply them as reference standards to the stake holders on price.

9. Furtherance of the provision of Chapter IVA of D&C Act in case ASU drugs & 4A

of Schedule II of D&C Act in case of Homoeopathy medicine and rules there under

related to ASU drugs and Homoeopathy medicine respectively.

10. Acting as a coordinating centre for analytical laboratories, industry and academia

by encouraging exchange of scientific and technical information and staff and by

undertaking sponsored funded research as well as consultancy projects.

11. Organising national/international symposia, seminars, meetings and conferences in

selected areas from time to time and to provide updated regular training to the

regulatory authorities and stake holders.

4

5

2. MANAGEMENT

The Commission was initially established as Pharmacopoeia Commission for Indian

Medicine (PCIM) in the year 2010. However, in pursuance to the decision of the Central

Government dated 20th March 2014, Homoeopathy was incorporated and the

Commission was renamed as Pharmacopoeia Commission for Indian Medicine &

Homoeopathy (PCIM&H). Amendments in three-tier governing structure of the

Commission have also come in effect with this restructuring of PCIM as PCIM&H. The

Commission is re-registered under Societies Registration Act, 1860 on 25th June 2014

with its new name and Memorandum of Association. It has been principally accepted

that Sowa-Rigpa also has to be a part of Commission; however, its actual incorporation

will take place at a later stage when its Pharmacopoeial institutions are set up.

The structural pattern as in enforcement is described below.

The Commission consists of:

(a) General Body (GB)

(b) Standing Finance Committee (SFC)

(c) Scientific Body (SB)

2.1 General Body

The General Body is the Apex body and is responsible for overall governance of the

Commission.

Composition: The composition of the General Body during the reported period is

attached vide Annexure II(A).

2.2 Standing Finance Committee

All matters with respect to financial approvals are dealt by SFC. SFC is responsible for

screening/appraising/evaluating the projects/works etc. of the Commission and

recommends for the approval of these projects/works by the General Body.

Composition: The composition of the Standing Finance Committee during the reported

period is attached vide Annexure II(B).

6

2.3 Scientific Body

The Scientific Body is responsible for designing/preparing and according technica l

approval for all the scientific & technical works/projects and execution of these

works/projects through different Pharmacopoeia Committees/other agencies,

publication of validated Pharmacopoeias/Formularies/Pharmaceutical Codex and other

publications after obtaining the approval of the General Body. The Scientific Body is

headed by an eminent Scientist, nominated by the Central Government.

Composition: The composition of the Scientific Body during the reported period is

attached vide Annexure II(C).

7

2.4

Org

aniz

atio

nal S

etup

The

gove

rnin

g str

uctu

re o

f Com

miss

ion

along

with

san

ctio

ned

staff

stren

gth

durin

g th

e re

porti

ng p

erio

d is

sche

mat

ically

rep

rese

nted

belo

w.

Th

e de

tails

of e

xistin

g sta

ff str

engt

h of

the

Com

miss

ion

as o

n 31

st M

arch

201

6 ar

e at

tach

ed v

ide

Ann

exur

e III

.

Gen

eral

Bod

y

Dir

ecto

r

Join

t Dir

ecto

r

Tec

hnic

al

PSO

(Ayu

rved

a) SO(A

yurv

eda)

2

post

s

SO

(Sid

dha)

SO

(Una

ni)

SO

(P'c

olog

y)

PSO

(P'c

ogno

sy)

SO(P

'cog

nosy

)

RA

(Mus

eum

&

Her

bari

um)

2 po

sts

RO

(M

icro

biol

ogy)

PSO

(Phy

toch

em.)

SO(P

hyto

chem

.)

PSO

(Ino

rg. C

hem

.)

SO (

Inor

g.

Che

m.)

Adm

inis

trat

ive

PS2

post

sA

dmin

istr

atio

n of

fice

r

Ass

ista

nt2

post

s

Juni

or

Tec

hnic

ian

Stor

e of

fice

rA

ccou

nts

offi

cer

Lib

rary

Inf

o.O

ffic

er

Scie

ntif

ic B

ody

Stan

ding

Fin

ance

C

omm

itte

e

Lege

nds:

PS

O :

Prin

cipa

l Sci

entif

ic O

ffice

r SO

:

Scie

ntifi

c Offi

cer

RO

: Re

sear

ch O

ffice

r RA

:

Rese

arch

Ass

istan

t PS

:

Pers

onal

Secr

etor

y

8

2.5. Execution of Pharmacopoeial Work

2.5.1 Pharmacopoeial Committees

The Scientific and technical work of the Commission is being executed through various

committees of respective system of medicine under the supervision of the Scientific

Body. The four Pharmacopoeia committees are as below:

i. Ayurvedic Pharmacopoeia Committee (APC)

ii. Siddha Pharmacopoeia Committee (SPC)

iii. Unani Pharmacopoeia Committee (UPC)

iv. Homoeopathic Pharmacopoeia Committee (HPC)

Each Pharmacopoeia Committee comprises of 15 to 20 experts from related disciplines

of science and technology connected with Pharmacopoeial standards. Composition of

all pharmacopoeia committees is attached vide Annexure IV(A-D).

Functions of the Pharmacopoeia Committees:

To prepare official Formularies and Pharmacopoeias, Pharmaceutical Codex of

single drugs and compound formulations and other technical documents related to

standards for drugs

To provide standards for drugs and medicines of therapeutic usefulness or

pharmaceutical necessity sufficiently used in the ASU & Homoeopathy practice

To lay down testing protocols & methodologies for identity, quality and purity of

drugs

To ensure as far as possible uniformity, physical properties and active constituents

of drugs

To provide all other scientific information regarding the distinguishing

characteristics, methods of preparation, dosage forms, mode of administration etc.

of drugs

Pharmacopoeial Laboratory for Indian Medicine (PLIM) and Homoeopathic

Pharmacopoeial Laboratory (HPL), permanent supporting structures to the PCIM&H

also contribute to pharmacopoeial work.

9

2.5.2 Pharmacopoeial Laboratory for Indian Medicine

Pharmacopoeial Laboratory for Indian Medicine (PLIM) was established in 1970 under

the then Ministry of Health & Family Welfare, Govt. of India. The laboratory has the

mandate to develop Pharmacopoeial standards and draft monographs and amendments

alongwith standardization methods, for the ASU drugs and to act as Central Appellate

Drug Laboratory for testing of ASU drugs under Rule 163A of Drugs & Cosmetics

Rules, 1945 (D&C Rules).

The laboratory primarily under the directives of PCIM&H acts to lay down standards

for single drugs as well as compound formulations of ASU systems to be incorporated

in respective pharmacopoeias. Apart from it, the laboratory also houses Herbarium and

Museum for preserving standard and authentic specimen of crude drugs. Towards

dissemination of knowledge and ensuring enforcement of D&C, Training Programmes

for Scientists working in the Pharmaceutical Industry of ISM and Orientation Lecture

Programmes for Drugs Inspectors/Drug Analysts are also organized. Survey tours are

also conducted to collect the genuine samples of crude drugs from different agro-

climatic zones of the country for developing Pharmacopoeial Standards.

2.5.3 Homoeopathic Pharmacopoeial Laboratory

Homoeopathic Pharmacopoeial Laboratory (HPL), established in 1975 under the then

Ministry of Health & Family Welfare, Govt. of India, is a permanent supporting

structure to the PCIM&H. It is the Central Standards Setting cum Drugs Testing

Laboratory for Homoeopathic medicines established under Section 6 of the Act and

Rule 3A and Sub-Rule 7 of D&C Act.

The laboratory lays down standards for Homoeopathic drugs to be incorporated in the

Homoeopathic Pharmacopoeia of India. The laboratory houses a well-mainta ined

Herbarium and Museum for preserving standard and authentic specimen of crude drugs

and undertakes survey tours to collect genuine samples of crude drugs from different

parts of the country for developing Pharmacopoeial Standards. Herbal garden is also

maintained to grow exotic Homoeopathic medicinal plants. Orientation lecture

programmes for Drugs Inspectors/Drug Analysts are organized by the laboratory

towards dissemination of knowledge and ensuring enforcement of D&C Act and Rules.

10

11

3. TECHNICAL ACCOMPLISHMENTS

3.1. Publication and revision of Ayurvedic, Siddha, Unani and Homoeopathic

Formularies/ Pharmacopoeia/Codex and supplementary compendia

Three new publications regarding pharmacopoeias of ASU&H have been brought out

by PCIM&H (details as below). These documents prescribe requisite standards for

drugs for the regulatory authorities, different groups of stakeholders and drug

manufacturers/ academia/ researchers in the field of ASU&H and also provide

associated guidelines.

As a part of Digital India campaign and to ensure dissemination of knowledge to

maximum end users, as a landmark in the history of pharmacopoeias, these publicat ions

are made openly available on the website of Ministry of AYUSH.

i. Ayurvedic Pharmacopoeia of India, Part-I, Vol. IX

The present volume comprises of 45 monographs on frequently used plant drugs with

standards on source plant, hydro-alcoholic extracts and water extracts. Each of these

Monographs covers vital information regarding analytical parameters for ascertaining

Identity, Purity & Strength of the drug alongwith diagnostic pharmacognostic features,

Assays and High Performance Thin Layer Chromatography (HPTLC)/ Liquid

Chromatography (LC) profiles etc.

ii. Thin layer Chromatography (TLC) Atlas of API, Part-I, Vol. III

Thin layer Chromatography (TLC) Atlas are the supportive documents to the published

pharmacopoeial volumes which provide additional useful information about the drugs

apart from the prescribed regulatory standards. Coloured plates depicting the plant in

its natural habitat and part used thereof alongwith detailed TLC profile are described in

the Atlas for identification and phyto-chemical analysis of the drugs. This publicat ion

covers 99 plant drugs from Ayurvedic Pharmacopoeia of India, Part-I, Volume-III.

iii. Unani Pharmacopoeia of India, Part-II (Formulations), Vol. III

Unani Pharmacopoeia of India, Part-II series prescribes pharmacopoeial standards for

the classical formulations in Unani system of Medicine. This volume consists of

pharmacopoeial standards for 50 widely used Unani formulations selected from

National Formulary of Unani Medicine. The classical formulations covered in this

volume of pharmacopoeia are based on various Unani dosage forms viz. Arq, Habb,

12

Jawarish, Majoon, Raughan, Sufoof etc. Each of these Monographs spells out vital

information regarding Formulation composition, Method of preparation, Quality

Parameters for ascertaining Identity, Purity & Strength of the formulation, Assays and

Ultra-violet (UV) - Visible Spectrophotometric patterns etc.

3.2. Development of Phytochemical Reference Standards (PRS) repository

Generating and maintaining repository of chemical reference marker compounds of the

plants and other ingredients used in standardizing ASU&H medicines is one of the key

objectives of the Commission. Keeping in line with this and in order to secure the

isolated phyto-compounds and associated scientific data in such a manner that

facilitates their appropriate usage towards development of pharmacopoeial standards

and other research of national importance, Commission has entered a Memorandum of

Understanding (MoU) with ICMR on 10th April 2015. The venture has resulted in

securing 120 PRS samples with associated scientific data for the repository.

Dignitaries of PCIM&H and ICMR exhibiting MoU documents

Counting together other exercises in this regard, Commission has altogether secured

124 PRS samples during the reporting period. An inventory of 225 PRS markers has

been prepared recording their source of availability.

13

3.3. Development of Botanical Reference Standards (BRS) repository

The Commission, as one of its mandates, has to maintain a National repository of

authentic reference raw materials used in the manufacture of ASU&H medicines for

the purpose of reference and supply of reference standards to the stake holders.

Plant/Herbal origin drug substances being a major component of the raw materials used

in ASU&H medicines, a dedicated Botanical Reference Standards (BRS) repository is

being developed and maintained.

Botanical Reference Standards mainly comprise of crude drugs of plant origin whose

botanical identity and genuineness are well authenticated upto the species level. These

can be used as reference materials for comparison while confirming the identity of the

commercial supplies. Compliance to the tests related to identity, purity and strength

using pharmacognostic features (macroscopic and microscopic), various physico-

chemical parameters of analysis, chromatographic (TLC/HPTLC/LC/GC)

fingerprinting, assays and other specified tests can be substantiated involving use of

these BRSs. The BRS samples generally have a shelf life of about 2 years, as far as

intact shade dried mature plant parts are concerned.

The development of BRS repository is being exercised. An inventory on drugs covered

in different pharmacopoeias i.e. Ayurvedic Pharmacopoeia of India (API), Siddha

Pharmacopoeia of India (SPI), Unani Pharmacopoeia of India (UPI), Homoeopathic

Pharmacopoeia of India (HPI) is being compiled and authentic raw material samples

for the repository are being collected/procured for the museum as well as for supply to

stake holders as reference standards. Genuine samples collected from habitat during

surveys as well as procured otherwise are duly authenticated and added to the

repository. Each of the BRS samples is supported with requisite documentation data.

The data covers Basic information such as ID code, names according to various

pharmacopoeias, botanical name, vernacular names, source, date of collection, storage

conditions etc.; Pharmacognostic details such as morphological part, organoleptic

characters, macro & microscopic diagnostic characters etc. and analytical profile as

prescribed by the pharmacopoeia. 35 authentic samples (details as below), all supported

with detailed passport data have been added to the BRS repository.

14

Sl. No. Botanical Name Part used 1. Abrus precatorius L. Seed 2. Abutilon indicum (L.) Sweet Root 3. Achyranthes aspera L. Whole plant 4. Aegle marmelos (L.) Correa Stem bark 5. Alstonia scholaris (L.) R. Br. Stem bark 6. Azadirachta indica A. Juss. Leaf 7. Azadirachta indica A. Juss. Stem bark 8. Barleria prionitis L. Whole plant 9. Boerhaavia diffusa L. Whole plant

10. Bombax ceiba L. Stem bark 11. Calotropis procera (Aiton) Dryand. Leaf 12. Calotropis procera (Aiton) Dryand. Root 13. Cannabis sativa L. Leaf 14. Cassia fistula L. Stem bark 15. Cynodon dactylon (L.) Pers. Whole plant 16. Evolvulus alsinoides Kuntze Whole plant 17. Ficus arnottiana (Miq.) Miq. Stem bark 18. Ficus racemosa L. Stem bark 19. Justicia adhatoda L. Leaf 20. Lawsonia inermis L. Leaf 21. Melia azedarach L. Stem bark 22. Melia azedarach L. Seed 23. Murraya koenigii (L.) Spreng. Leaf 24. Neolamarkia cadamba (Roxb.) Bosser Stem bark 25. Ocimum tenuiflorum L. Whole plant 26. Oxalis corniculata L. Whole plant 27. Pongamia pinnata (L.) Pierre Stem bark 28. Punica granatum L. Fruit rind 29. Ricinus cummunis L. Leaf 30. Senna occidentalis (L) Link Seed 31. Tamarindus indica L. Leaf 32. Terminalia arjuna (Roxb. ex DC.) Wight & Arn. Stem bark 33. Tinospora cordifolia (Wild.) Miers. Stem 34. Vitex nigundo L. Leaf 35. Ziziphus jujuba Mill. Stem bark

15

3.4. Harmonization of various pharmacopoeias

APC, SPC, UPC and HPC earlier used to publish the standards individually for the

drugs identified according to the respective systems of medicine. Many of the drugs,

especially the crude single ones are common among these systems. However, as all

pharmacopoeia committees were functioning independently, parallel monographs with

variations in the standards prescribed were being published. Now, with establishment

of PCIM&H which is an umbrella organization for all four ASU&H Pharmacopoeia

committees, it is pertinent that all these pharmacopoeia committees coordinate with

each other and publish unanimous standards for the drugs in common. In this

connection, the Commission has taken up the task to harmonize all the monographs

published/ being published through API, SPI, UPI, HPI and also the Indian

Pharmacopoeia (IP). The data from relevant monographs are being referred for this

work, compared meticulously and revised content for the harmonized monographs is

being drafted. These harmonized draft monographs will be finalized in consultat ion

with all four pharmacopoeia committees and will be taken into account while publishing

the revised versions of pharmacopoeias. Harmonization of Botany portion from 121

monographs on 50 single plant drugs has been carried out during the reporting period.

List of the plant drugs taken up is as given below:

Sl. No.

Name of plant Part used Pharmacopoeial Reference

1. Abrus precatorius Linn. Seed

API-I Abrus precatorius L. SPI-I Abrus precatorius Linn. HPI-IX

2. Abrus precatorius Linn. Root

API-II Abrus precatorius Linn. UPI-IV

3. Acacia leucophloea Willd. Stem bark

API-II Acacia leucophloea Willd. UPI-VI

4. Acalypha fruticosa Forsk. Root

API-VI Acalypha fruticosa Forssk. SPI-II

5. Acalypha indica L. Whole plant

API-VI Acalypha indica L. SPI-II Acalypha indica Linn. HPI-VIII

6. Achyranthes aspera Linn. Whole plant API-II Achyranthes aspera L. SPI-I

16

7. Achyranthes aspera Linn. Root

API-III Achyranthes aspera Linn. UPI-IV

8. Aconitum chasmanthum Stapf. ex Holmes Root

API-II Aconitum chasmanthum Stapf. ex Holmes UPI-IV

9. Aconitum heterophyllum Wall. ex. Royle Root

API-I Aconitum heterophyllum Wall. ex. Royle SPI-I Aconitum heterophyllum Wall ex. Royle UPI-I

10. Acorus calamus Linn. Rhizome

API-II Acorus calamus Linn. UPI-V

11. Adhatoda vasica Nees. Leaf

API-I Justicia adhatoda L. SPI-I Adhatoda vasica Nees. UPI-VI Adhatoda vasica Nees. HPI-I

12. Adhatoda vasica Nees. Root

API-IV Justicia adhatoda L. SPI-I

13. Aegle marmelos Corr. Root

API-III Aegle marmelos (L.) Corr. SPI-I

14. Aegle marmelos Corr. Fruit pulp

API-I Aegle marmelos Corr. UPI-I Aegle marmelos (Linn.) Corr. HPI-VI

15. Aerva lanata (L.) Juss. Whole plant

API-V Aerva lanata (L.) Juss. ex Schult. SPI-I

16. Allium sativum Linn. Bulb

API-III Allium sativum Linn. UPI-V Allium sativum Linn. HPI-I

17. Aloe barbadensis Mill Dried juice of leaves

API- I Aloe barbadensis Mill. UPI - I

18. Alpinia galanga Willd. Rhizome

API-V Alpinia galanga Willd. SPI-I Alpinia galangal (Linn.) Sw. UPI-II

19. Alstonia scholaris (Linn.) R.Br. Bark

API-I Alstonia scholaris R.Br. HPI-IV

20. Alternanthera sessilis (Linn.) R.Br. Whole plant

API-II Alternanthera sessilis (L.) R.Br. ex DC. SPI-I

21. Althaea officinalis Linn. Root

API-V Althaea officinalis Linn. UPI-V Althaea officinalis Linn. HPI-VII

17

22. Althaea officinalis Linn. Seed

API-V Althaea officinalis Linn. UPI-V

23. Amomum subulatum Roxb. Seed

API-II Amomum subulatum Roxb. UPI-IV

24. Anacyclus pyrethrum DC. Root

API-II Anacyclus pyrethrum DC. UPI-II Anacyclus pyrethrum DC. SPI-II

25. Anethum sowa Roxb. ex Flem. Seed/Fruit

API-II Anethum sowa Roxb. ex Fleming UPI-VI

26. Angelica archangelica Linn. Root

API-V Angelica archangelica Linn. HPI-IX

27. Apium graveolens Linn. Seed/Fruit

UPI-II Apium graveolens Linn. HPI-II

28. Aquilaria agallocha Roxb. Heart wood

API-IV Aquilaria agallocha Roxb. UPI-VI

29. Areca catechu Linn. Seed

API-I Areca catechu Linn. UPI-I Areca catechu Linn. HPI-IX

30. Aristolochia bracteata Retz. Leaf

API-VI Aristolochia bracteolata Lam. SPI-II

31. Aristolochia indica Linn. Root

API-III Aristolochia indica Linn. UPI-V

32. Asparagus racemosus Willd. Tuberous root

API-IV Asparagus racemosus Willd. SPI-II Asparagus racemosus Willd. UPI-VI

33. Asteracantha longifolia Nees Whole plant

API-II Asteracantha longifolia Nees HPI-IX

34. Asteracantha longifolia Nees Seed

API-II Asteracantha longifolia Nees. UPI-III

35. Azadirachta indica A. Juss. Leaf

API-II Azadirachta indica (L.) A. Juss SPI-II Azadirachta indica A. Juss. UPI-IV

36. Azadirachta indica A. Juss. Stem Bark API-II Azadirachta indica A. Juss. SPI-I Azadirachta indica A. Juss. UPI-IV Azadirachta indica A. Juss. HPI-VIII

18

37. Azadirachta indica A. Juss Fruit API-V Azadirachta indica A. Juss. SPI-I Azadirachta indica A. Juss. UPI-V

38. Azadirachta indica A. Juss Flower API-V Azadirachta indica A. Juss. SPI-I Azadirachta indica A. Juss. UPI-V

39. Azadirachta indica A. Juss Root bark API-V Azadirachta indica A. Juss. UPI-V

40. Bacopa monnieri (Linn.) Wettst. Whole plant API-II Bacopa monnieri (L.) Wettst. SPI-I Bacopa monnieri Linn. UPI-IV Bacopa monnieri (Linn.) Wettst. HPI-IX

41. Balsamodendron caudata Mauch. Leaf API-VI Balsamodendron caudata Mauch. SPI-II

42. Barringtonia acutangula (Linn.) Gaertn. Fruit API-III Barringtonia acutangula Linn. UPI-VI

43. Benincasa hispida (Thunb.) Cogn. Fruit API-IV

Benincasa hispida (Thunb.) Cogn. SPI-II

44. Berberis aristata DC Stem API-II Berberis aristata DC var. aristata SPI-I Berberis aristata DC UPI-IV

45. Betula utilis D.Don Stem bark API-V Betula utilis D.Don UPI-V

46. Boerhaavia diffusa Linn. Whole plant API-I Boerhaavia diffusa L. SPI-I Boerhavia diffusa Linn. HPI-I

47. Bombax ceiba Linn. Stem bark API-III Bombax ceiba Linn. UPI-V

48. Borago officinalis Linn. Leaf UPI-II Borago officinalis Linn. HPI-VIII

49. Brassica campestris L. Seed API-III Brassica campestris Linn. UPI-V

50. Buchnania lanzan Spreng. Seed API-II Buchnania lanzan Spreng. UPI-IV

19

3.5. Consolidation of various pharmacopoeial volumes

Pharmacopoeial committees used to allot drugs and formulations to various working

laboratories and the finalized monographs have been published in series of volumes in

order of the output obtained. Scientific Body of PCIM&H has now desired that the

monographs randomly scattered through various published volumes of the

pharmacopoeias should be consolidated and segregated in a systematic manner. The

Single drug monographs from each of the pharmacopoeia are to be segregated and

rearranged together systematically as per the alphabetical order of the title of drugs. The

Formulation monographs from each of the pharmacopoeia are to be segregated and

rearranged together systematically as per the dosage form and to be divided under three

major categories namely solid, liquid and semisolid dosage forms of the formulations.

The exercise will be taken into account while publishing the revised versions of

pharmacopoeias.

During the reporting period, 600 monographs from API, Part I and 152 monographs

from API, Part II have been segregated for this purpose.

3.6. Survey and Collection Tour programme

Survey and collection tours are conducted to collect the genuine samples of crude drugs

from different agro-climatic zones of the country. These collected samples are

authenticated, analysed as per protocol and duly processed so as to add/update them to

the museum, herbarium and/or BRS repository as well as for developing

Pharmacopoeial Standards. Commission independently as well as in coordination with

PLIM and HPL regularly conducts such tours.

Sl. No. Survey Area Date

1. Mawana (Dist. Meerut) 29th May 2015

2. Shukratala (Dist. Muzaffarnagar) 23rd July 2015

3. Meerut & Nearby area 18th August 2015

4. Sohna (Gurgaon), Haryana 15th September 2015

5. Brij Ghat, Dist. Ghaziabad 11th December 2015

6. Masoori, Murad Nagar and Upper Ganga Canal 22nd March 2016

20

3.7. Gearing up Development of Pharmacopoeial standards and allied works

through a new Scheme to be operational in project mode

It was desired that work on development of monographs of single drugs / compound

formulations / Extracts / Atlas may be allotted to the Research Councils’ Institutes /

AYUSH institutions preferably. However, these institutes not being in a position to

deliver the work in sufficient quantum, it may be outsourced in a Task Force mode to

selected academic/research institutes of repute with necessary infrastructure and

expertise / approved analytical laboratories / institutions or industries having required

infrastructure and instrumentation/equipment with firm commitments of timely

deliverables. Duly constituted Task Force will make selection of the

Institute/laboratory/industry (preferably having earlier experience in the field) with well

reputed, experienced & committed Principal Investigator for Pharmacopoeial work.

The Task Force will also be responsible for evaluating & monitoring the assigned work.

The Scheme sketched out by Commission was duly approved by the General Body

during the reporting period. A call for expression of interest has also been floated

through websites of all four Research Councils under Ministry of AYUSH and also

through newspaper advertisements. The proposals received will be scrutinized in due

course and action will be taken accordingly.

3.8. Seminars/Workshops/Conferences/Training programmes

Two interactive workshops were organized to receive feedback on relevance of

Pharmacopoeias of AYUSH systems and challenges faced while enforcing the

standards prescribed thereof.

3.8.1 APC - Industry Interactive workshop for states of southern region

APC had resolved that regional level consultative workshops are to be organized in

various parts of India. These workshops are to be aimed at gathering feedback from

Ayurveda drug industry regarding their views on enforcement/implementation of

standards as well as norms prescribed by Ayurvedic Pharmacopoeia of India (API). The

difficulties faced at the level of procurement of raw materials, mass/bulk production as

well as at commercial levels are to be understood.

21

A first workshop in this series, named “APC - Industry Interactive workshop for states

of southern region” was organized at National Research Institute for Panchakarma

(CCRAS), Cheruthuruthy, Kerala on 24th January, 2016.

The Workshop was attended by four APC members, Officials from CCRAS, Ministry

of AYUSH, PCIM&H, Drug Control authority, Karnataka as well as 30 industry

representatives from the states of Kerala, Tamil Nadu, Karnataka, Andhra Pradesh,

Telangana and Union Territory of Puducchery.

The Industry representatives put forth their queries and problems faced from both

manufacturing as well as quality control points of view. The experts, in turn, gave

necessary clarifications and guidelines as per the context.

Dignitaries of PCIM&H, APC and AYUSH at the inaugural of workshop

Felicitation of Director, PCIM&H at the inaugural of workshop

22

3.8.2 Brain Storming Session on revisiting of NFUM and UPI

A Brain Storming Session on revisiting of NFUM and UPI was organized through

Secretariat of UPC i.e. CCRUM on 29th August 2015 at Jamia Hamdard, New Delhi.

Experts from various disciplines related to Unani medicine and pharmacopoeia

participated in the session.

It was stressed that revisiting and updating NFUM & UPI is necessary as it provides

opportunity to rectify the errors and incorporate new developments/advancements.

A detailed discussion on each document was held and it was resolved that each

document namely; NFUM Part - I to VI, UPI Part - I Vol. I to VI and UPI Part - II

Vol. I and II are to be revisited in harmony with the classical literature in order to

upgrade the documents.

View of the Brainstorming Session

23

3.8.3 Capacity Building Training Programmes for Regulatory authorities

Towards dissemination of knowledge and ensuring appropriate enforcement of D&C,

Capacity Building Training Programmes for Scientists working in the Pharmaceutical

Industry of ISM&H and Drug Inspectors/Drug Analysts/Quality Control personnel from

State/Central Drug Control Authorities are organized in co-ordination with PLIM and HPL.

Five workshops, as a part of this programme were conducted at PLIM during the reporting

period. Dr. Rajeev Kr. Sharma, Director and Dr. (Ms.) Nitin Rai, Scientific Officer

(Pharmacognosy), on behalf of PCIM&H, were involved in these workshops as expert

speakers to deliver lectures to the trainees. Details of the Training programmes are as follows:

Starting Date

Number of days

Target Area

Target Group

18-05-2015 5 ASU Quality Control Personnel

25-08-2015 3 ASU Drug Enforcement officials/Drug Inspectors

14-10-2015 3 ASU Induction training of Central officers

02-11-2015 5 ASU Quality Control Personnel

24-02-2016 3 ASU Drug Enforcement officials/Drug Inspectors

3.8.4 Participation in seminars

Apart from organizing the Seminars/Workshops by its own, Commission also involves

in various similar programmes organized by other reputed organizations to represent

the Government stake in pharmacopoeia as well as for enrichment of knowledge of its

staff. Details of such participations are attached vide Annexure V.

3.9. Organization of Hindi Pakhvada

Hindi Pakhvada was observed in the Commission during 14th September to

30th September 2015 to promote use of Hindi as Official language. Various

competitions like Debate, Noting & Drafting, General Knowledge Quiz and Essay

Writing were held for the staff to increase awareness about Hindi language and

encourage them for use of Hindi in day-to-day communications to a maximum possible

extent. The programme was inaugurated during a formal function chaired by Director,

PCIM&H on 14th September 2015 and concluded with a valedictory ceremony in the

gracious presence of Chief Guest Sh. R. C. Srivastava, Former Library and Information

Officer, HPL, Ghaziabad dated 30th September 2015.

24

3.10. Renewal of Registration

The Commission was initially established as Pharmacopoeia Commission for Indian

Medicine (PCIM) in the year 2010 and was registered under Societies Registration Act,

1860. The Registration of PCIM&H under Societies Registration Act, 1860 was

renewed on 7th October 2015 for a period of 5 years with effect from 31st August 2015.

3.11. Achievements of Pharmacopoeia Committees

Progress of work done by various Pharmacopoeia Committees during the reporting

period is described below.

3.11.1 Ayurvedic Pharmacopoeia Committee (APC)

Contributing to development of pharmacopoeial standards for single drugs, data

was compiled/generated for 25 monographs on drugs of plant/animal origin.

Sl. No.

Name Botanical name/English equivalent Part used

1. Ahiphena Papaver somniferum L. Exudate 2. Aja dugdha Goat milk - 3. Amlavetasa Hippophae tibetana Schlecht. Fruit 4. Arimeda Sara Acacia leucophloea (Roxb.) Willd. Heart Wood 5. Babbula Acacia nilotica subsp. indica (Benth.)

Brenan Leaf

6. Chincha Tamarindus indica L. Kshar 7. Chincha Tamarindus indica L. Stem bark 8. Eranda Ricinus communis L. Oil 9. Gangeru Grewia tenax (Forssk.) Fiori Root 10. Goksura Tribulus terrestris L. Seed 11. Guduchi Tinospora cordifolia (Wi1ld.) Miers Satva 12. Hapusha Juniperus communis L. Root 13. Jufa Hyssopus officinalis L. Fruit 14. Kamal Nelumbo nucifera Gaertn. Seed 15. Lajjalu Mimosa pudica L. Root 16. Padmaka Prunus cerasoides D. Don Stem 17. Prishniparni Uraria picta (Jacq.) DC. Root 18. Pundrahva Saussurea obvallata S.O. (D.C.) Edgew. Flower 19. Rasna Pluchea lanceolata Oliver & Hiern Whole plant

25

20. Shringataka Trapa natans L. var. bispinos (Roxb.) Makaino

Fruit pulp

21. Unnao Zizyphus vulgaris Lam. Fruit 22. Gomutra Urine of cow (Muslin cloth filtered ) - 23. Vanphasha Viola odorata L. Flower 24. Vamshlochana Bambusa bambos (L.) Voss

syn. B. arundinacea Willd. Bamboo manna

25. Vriddhadaruka Argyreia nervosa (Burm. f.) Bojer Seed

Under the programme to develop and standardize method of preparation,

pharmacopoeial standards and shelf life studies for compound formulations, data

on 31 Ayurvedic formulations were thoroughly reviewed during this period and

monographs for the same are about to be finalized.

1. Abhraka Bhasma

2. Amla Curna

3. Amrta (Giloy) Curna

4. Asvagandha Curna

5. Candanasava

6. Dadimashtak Curna

7. Dasamula kvatha Curna

8. Eladi Curna

9. Eranda taila

10. Jaha mohra Pishti

11. Jatyadi ghrta (Non-murchita)

12. Jatyadi Taila (Non-murchita)

13. Kankayana Vati

14. Khadirdi Vati (Mukha loga)

15. Kutajaghan Vati

16. Lagu Sutasekhara rasa

17. Loadhrasava

18. Maharasnadi kvatha Curna

19. Mulethi Curna

20. Pashanabhedadi kwath Curna

21. Phalatrikadi kvatha Curna

22. Punanarnava Curna

23. Sankha Bhasma

24. Sarasvatarista

25. Satavari Curna

26. Shuddha Gairika

27. Shuddha Sphatika (Bhasma)

28. Shuddha Tankana

29. Trikatu Curna

30. Triphala Curna

31. Vishagarbha Taila

The Committee has taken note of Sugandha Dravyas (aromatic drugs) being

marketed where their volatile fractions are taken away without inducing any

physical damage to the materials. In this background, committee has felt need of

authentic data on volatile oil content in Sugandha Dravyas used in classical

26

Ayurvedic formulations. Estimation of volatile oil content in genuine samples of

such identified drugs has been taken up and the data generated is being monitored.

Preparation of a document on Ayurvedic Veterinary Formulations is continued

from previous years and more formulations were identified for incorporation.

Requisite data on the identified formulations is being compiled so as to present it

in the pattern of Formulary.

3.11.2 Siddha Pharmacopoeia Committee (SPC)

Siddha Formulary of India

Identification of classical formulations and deciphering their composition and

ingredients is the prime task as basis to develop the pharmacopoeias. Formularies are

developed by the Pharmacopoeia Committees for this purpose.

The Siddha Formulary of India, Part I [Revised edition (Tamil)] comprising of 248

classical Siddha formulations encompassing 22 pharmaceutical forms has been

brought to shape. The document is under review and finalization for printing at

Commission’s end.

Drafting of Siddha Formulary of India, Part III (Tamil) is under progress.

Revision of Siddha Formulary of India, Part I (English version) and translation of

Siddha Formulary of India, Part II (Tamil to English) are also under progress.

Draft of Siddha Pharmacopoeia of India, Part-I, Vol. III has been almost worked

out and will soon be ready for submission to the Commission.

Development of pharmacopoeial monographs

Contributing to development of pharmacopoeial standards for single drugs,

monographs for 11 drugs of plant origin have been prepared.

1. Kasthuri manjal Curcuma aromatica Salisb. Rhizome 2. Kuppaimeni elai Acalypha indica Linn. Leaf 3. Mudakkatran elai Cardiospermum halicacabum L. Leaf 4. Nalvelai ver Cleome gynandra L. Root 5. Pulankilanku Kaempferia galanga L. Tuber 6. Sirukanchori ver Tragia involucrata L. Root 7. Sirukanchori elai Tragia involucrata L. Leaf 8. Sirupeelai ver Aerva lanata (L.) Juss. Root

27

9. Thippili kattai Piper longum L. Stem 10. Vellai kungiliyam Shorea robusta Gaertn. Resin 11. Viluthi elai Cadaba fruticosa (L.) Druce Leaf

Under the programme to develop and standardize method of preparation and

pharmacopoeial standards for compound formulations, data generation is under

progress for following 32 Siddha formulations.

1. Amukkara churanam

2. Suvasa kutori mattirai

3. Elathi curanam

4. Ilanir kuzhampu

5. Kalnar parpam

6. Karunai ilakam

7. Kazharchi churanam

8. Kunkiliya parpam

9. Mekanata kulikai

10. Nilavakai churanam

11. Parankippattai churanam

12. Talisathi churanam

13. Tetrankottai ilakam

14. Tirikatuku churanam

15. Venpusani ilakam

16. Annapethi chenturam

17. Balasanjeevi mattirai

18. Brahmananda bairavam

19. Gandhaga rasayanam

20. Impural vatakam

21. Kachukkatti churanam

22. Kapa curak kutinir hcuranam

23. Murukkan vithai mattirai

24. Pancha deepakkini churanam

25. Pungampoo churanam

26. Seenthil churanam

27. Vasantha kusumakaram

28. Sanku parpam

29. Silacattu parpam

30. Cundai vatral churanam

31. Nilavempu kutinir

32. Tiripalai churanam

3.11.3 Unani Pharmacopoeia Committee (UPC)

Work on Development of pharmacopoeial standards for 10 single drugs which are

occurring as ingredients of formulations selected from National Formulary of

Unani Medicine (NFUM) was carried out. The list is as follows:

1. Gul-e-Dhawa Anogeissus latifolia Wall. Flower 2. Sammunder Sokh Argyreia nervosa (Burm.f.) Bojer Seed 3. Dandi Harsinger Nyctanthus arbor-trystis L. Stem 4. Gul-e-Sadberg Tagetus minuta L. Flower 5. Shagufa-e-Babool Acacia arabica

= A. nilotica (Lam.) Willd. Inflorescence

28

6. Narkachoor Zingiber zerumbet Rosce. Rhizome 7. Shagufa-e-Anar Punica granatum L. Inflorescence 8. Satt-e-Pudina Mentha arvensis L. Extract (Menthol) 9. Shibb-e-Yamani Alum 10. Gul-e-Gurhal Hibiscus rosa-sinensis L. Flower

Under the programme to develop and standardized method of preparation and

pharmacopoeial standards of compound formulations included in various parts of

NFUM and also the Essential Drugs List – Unani (2008), work was carried out in

respect of monographs on 47 formulations. The formulations are from various

dosage forms like Habb, Sharbat/Sikanjbeen, Zimad/Marham, Sunoon/Sufoo f,

Majoon/Qairooti/Murabba, Muffarreh etc. List of the formulations worked out

during reporting period is as follows:

1. Akleen 2. Habb-e-Anar 3. Sunoon-e-Mukhrij-e-Ratubat 4. Sunoon-e-Zard 5. Sikanjabeen Sada 6. Sikanjabeen Buzoori Motadil 7. Sufoof-e-Mulaiyyin 8. Sharbat-e-Nilofar 9. Sharbat-e-Zoofa Murakkab 10. Sharbat-e-Toot Siyah 11. Murabba-e-Halela 12. Murabba-e-Belgiri 13. Gulqand-e-Gulab 14. Gulqand-e-Gurhal 15. Sharbat-e-Anar Shirin 16. Sharbat-e-Buzoori Motadil 17. Sharbat-e-Gurhal 18. Sharbat-e-Khaksi 19. Zimad-e-Tehal 20. Marham-e-Kafoori 21. Marham-e-Quba 22. Zimad-e-Mohallil 23. Murabba-e-Gazar 24. Qairooti-e-Aarad-e-Karsana

25. Marham-e-Gulabi 26. Majoon-e-Saalab 27. Mufarreh-e-Azam 28. Mufarreh-e-Yaqooti Motadil 29. Habb-e-Bawasir Badi 30. Habb-e-Bawasir Khooni 31. Habb-e-Irqun Nisa 32. Habb-e-Muqawwi-e-Khas 33. Habb-e-Mushil 34. Habb-e-Narkachoor 35. Habb-e-Sadar 36. Habb-e-Nishat Jadeed 37. Habb-e-Sara Khas 38. Habb-e-Mulayyin 39. Habb-e-Muqil Jadeed 40. Habb-e-Yarqan 41. Muneish 42. Qalbeen 43. Imsakeen 44. Kundri 45. Majoon Nishat Angaiz 46. Majun Pnmba Dana 47. Nawed-e-Nau

29

Draft of Part II, Vol. IV comprising of 50 monographs has been almost worked out

and is in the final stage.

National Formulary of Unani Medicine, Part I to VI have been taken up for revision

as per resolution of Brain-storming session held on 29th August 2015. All the

documents have been reviewed and suggestions for corrections wherever

necessary have been summarized. The suggested corrections will be incorporated

to revise the documents after due vetting and approval by UPC.

UPI, Part-I, Vol. I to VI and UPI Part-II, Vol. I-II are also being revised as per

resolution of Brain-storming session held on 29th August 2015.

3.11.4 Homoeopathic Pharmacopoeia Committee (HPC)

Pharmacopoeial standards for following six Homoeopathic drugs have been

developed through units/laboratories of CCRH.

1. Corchorus Capsularis

2. Abroma Augusta

3. Solanum Surattense

4. Quartz

5. Trimethyl Aminum

6. Zincum Arsenicosum

Revision/Updating of published Pharmacopoeial monographs, is one of the

continued processes of the HPC. Different expert groups / sub-committees

constituted for the purpose are holding their meetings to prepare and finalize

respective portion for the revised drafts. Work regarding following 97 monographs

was taken ahead during the reporting period.

1. Acetanilidum

2. Achillea Millefolium

3. Acidum Aceticum

4. Acidum Benzoicum

5. Acidum Gallaicum

6. Acidum Hydrofluoricum

7. Acidum Lacticum

8. Acidum Nitricum

9. Acidum Phosphorium

10. Acidum Picricum

11. Acidum Sulphuricum

12. Acidummuriaticum

13. Aconitum Napellus

14. Allium Sativum

15. Aloe Succotrina

16. Alumina

17. Ammonium Muricatum

18. Ammonium Carbonium

19. Amyl Nitrosum

20. Antimonium Crudum

21. Antimonium Tertaricum

22. Apis Mellifera

23. Aralia Racemosa

24. Arentum Nitricum

30

25. Argentum Metallcum

26. Arnica Montana

27. Arsenicum Album

28. Arsenicum Sulphuratum Flavum

29. Arsenticum Iodatum

30. Atropa Belladonna

31. Aurum Muriaticum

32. Aurum Muriaticum Natronatum

33. Bartya Muricata

34. Baryta Carbonica

35. Baryta Iodata

36. Berberis Aquifolium

37. Berberis Vulgaris

38. Blatta Orientalis

39. Borax

40. Bromium

41. Bryonia Alba

42. Calcarea Arenicosa

43. Calcarea Carbonica

44. Calcarea Fluorica

45. Calcarea Hypophophorosa

46. Calcarea Iodta

47. Calcarea Picrata

48. Calcarea Slicata

49. Calcarea Sulphurica

50. Calendula Officinalis

51. Capsella Bursa-Pastoris

52. Carbo Animals

53. Carboneum Sulphuratum

54. Carcareaphophorica

55. Causticum

56. Chrysarobinum

57. Coffea Arabica

58. Conium Maculatum

59. Croton Tiglium

60. Eucalyptus Globulous

61. Ferula Asafoetida

62. Ficus Indica/ F. Benghalensis

63. Ficus Religiosa

64. Frigeron Candanses

65. Hydrocotyle Asiatica

66. Justicia Adhatoda

67. Kali Chloricum

68. Lathyrus Sativus

69. Leucas Aspera

70. Lithium Carbonicum

71. Magnesia Carbonica

72. Magnesia Sulphurica

73. Magnesium Muriaticum

74. Magniesium Phosphoricum

75. Mercurius Iodatus Rubber

76. Natrum Carbonicum

77. Natrum Muriaticum

78. Natrum Sulphuricum

79. Nicotiana Tobacum

80. Nyctanthes Arbor-Tristis

81. Ocimum Sanctum

82. Petroselinum Crispum

83. Psoralea Corylifolia

84. Raphanus Sativus

85. Rauwolfia Serpentina

86. Rhus Toxicodendron

87. Rumex Crispus

88. Sambucus Nigar

89. Silybum Marianum

90. Sulphur

91. Symphytum Officinale

92. Terminalia Chebula

31

93. Thiosinaminum

94. Tinospora Cordifolia

95. Tribulus Terrestris

96. Vitex Agnus-castus

97. Withania Somnifera

3.12. Coordinated activities with Pharmacopoeial laboratories

Contributing to the development of pharmacopoeial standards for single drugs,

API monographs for 14 drugs of plant origin are being developed at PLIM.

Sl. No. Name of the drug Botanical name Part used

1. Arimeda Sara Acacia leucophloea (Roxb.) Willd.

Heart Wood

2. Babbula Acacia nilotica Subsp. indica (Benth.) Brenan

Leaf

3. Guduchi Tinospora cordifolia (Wi1ld.) Miers

Sattva

4. Padmaka Prunus cerasoides D.Don. Stem

5. Putikaranja Caesalpinia crista L. Leaf

6. Rasna Pluchea lanceolata Oliver & Hiern.

Root

7. Snuhi Euphorbia neriifolia L. Root

8. Somavalli Root

9. Svarnakshiri Euphorbia thomsoniana Boiss Root

10. Vamsalochana Bambusa bambos (L.) Voss syn. B. arundinacea Willd.

Silicaceous Concretion

Herbarium maintained at PLIM is updated regularly by addition of new sheets as a

continuous process. Seven herbarium sheets were added during the reporting period.

1. Convolvulus pluricaulis Choisy

2. Momordica charantia L.

3. Psoralia corylifolia L.

4. Salvadora persica L.

5. Solanum nigrum L.

6. Terminalia arjuna W & A

7. Triticum aestivum L.

32

PLIM also maintains a Crude drugs museum which is updated on regular basis.

The specimens in the museum are updated regularly as a continuous process.

APC has taken up the work to determine range/limits for volatile oil content in

Sugandha dravyas (aromatic drugs) to be prescribed as pharmacopoeial standard.

This work is being carried out at PLIM. 93 samples of 42 selected drugs were

analysed during reporting period. The reports are under scrutiny by the APC.

Sl. No. Plant name Part used No. of samples

1. Aguru Heart Wood 3

2. Ajamoda Fruit 2

3. Ardraka Rhizome (Fresh) 1

4. Chandana Heart Wood 2

5. Choraka Root stock 1

6. Dhanyaka Fruit 3

7. Harenuka Seed 1

8. Haridra Rhizome 5

9. Jatamansi Rhizome 3

10. Jatipatri Aril 2

11. Jatiphala Seed 3

12. Krishnajiraka Fruit 2

13. Kushtha Root 3

14. Lavanga Flower bud 3

15. Maricha Fruit 3

16. Mishreya Fruit 1

17. Musta Rhizome 3

18. Padmaka Heart Wood 2

19. Pippali Fruit 2

20. Priyala Seed 1

21. Priyangu Fruit 2

22. Pushkara Root 2

23. Sala Heart Wood 2

24. Sarala Root 1

25. Sarala Exudate 1

26. Shatapushpa Fruit 1

33

27. Shunthi Rhizome 2

28. Shvetajiraka Fruit 2

29. Sthauneya Leaf 1

30. Sthulaila Fruit 2

31. Sukshmaila Fruit 4

32. Tagara Rhizome 3

33. Talisa Leaf 4

34. Tulasi Leaf 1

35. Tulasi Seed 2

36. Tumburu Fruit 1

37. Tumburu Stem Bark 1

38. Tvak Stem Bark 5

39. Tvakpatra Leaf 4

40. Ushira Root 1

41. Vacha Rhizome 3

42. Yavani Fruit 2

34

3.13. Meetings Held

List of meetings of various Bodies/Committees of Commission held during reporting

period is as follows:

Sl. No. Name of the Body/Committee Date

1. Homoeopathic Pharmacopoeia Committee 18-19 May 2015

2. Ayurvedic Pharmacopoeia Committee (subcommittee meeting)

1-2 July 2015

3. Standing Finance Committee 2 July 2015

4. Homoeopathic Pharmacopoeia Committee DS Special Committee meeting

23 September 2015

5. Ayurvedic Pharmacopoeia Committee 28-29 October 2015

6. General Body 11 January 2016

7. Siddha Pharmacopoeia Committee 19 January 2016

8. Homoeopathic Pharmacopoeia Committee (Chemistry expert group)

28-29 January 2016

9. Homoeopathic Pharmacopoeia Committee (Botany expert group)

3-4 February 2016

10. Scientific Body 5 February 2016

11. Ayurvedic Pharmacopoeia Committee 24-25 February 2016

12. Homoeopathic Pharmacopoeia Committee (Zoology expert group)

4 March 2016

13. Siddha Pharmacopoeia Committee (subcommittee meeting)

7 March 2016

35

4. FINANCIAL STATEMENTS

4.1. Budget Estimate

Budget estimate for the period under review was as denoted below.

Budget Estimate 2015-2016

Pharmacopoeia Committee on ASU and Strengthening of Pharmacopoeia Commiss ion of Indian Medicine (PCIM)

Plan Non-Plan Total

Salaries 0 55,20,000.00 55,20,000.00

Medical Treatment 0 0 0

Domestic Travel Expenses 0 20,80,000.00 20,80,000.00

Office Expenses 0 0 0

Grant- in-Aid-General 1,20,00,000.00 0 1,20,00,000.00

Grant- in-Aid-Salaries 2,50,00,000.00 0 2,50,00,000.00

Other Charges 0 5,00,000.00 5,00,000.00

Total 3,70,00,000.00 81,00,000.00 4,51,00,000.00

36

4.2. Statement of Expenditure Income Expenditure Account for the Period/Year Ended on 31-03-2016

(A) Income Schedule Current Year Previous Year

Grant/Subsidies 1 1,57,15,595.00 -

Interest Earned - -

Other Income - -

Total 1,57,15,595.00 -

(B)Expenditure

Plan

Establishment Expenses 2 82,30,911.00 32,53,036.00

Other Administrative Expenses 3 34,15,615.00 24,58,253.00

Expenditure on Grants Subsidies - -

Depreciation 2,74,569 -

Total 1,19,21,095.00 57,11,289.00

Balance being excess of Income over Expenditure (A-B)

37,94,500.00 (57,11,289.00)

Balance being surplus/(deficit) carried to corpus/capita fund

37,94,500.00 (57,11,289.00)

4.3. Audited Accounts Audit for Accounts of the Commission by the Comptroller and Auditor General is

awaited. The unaudited accounts duly verified by the Chartered Accountant appointed

by Commission are attached at Annexure VI.

37

ANNEXURES

38

39

Annexure I

Annexure I (A): Publications related to Ayurvedic Pharmacopoeia

Document Part & Year of publication No. of Formulations

Ayurvedic Formulary of India

Part I, 2003 (Second edition) 444

Part II, 2000 191

Part III, 2011 (Bilingual) 350

Total 985

Document Part Volume & Year of publication No. of Monographs

Ayurvedic Pharmacopoeia of India

Part I (Single Drugs)

Vol. I, 1986 80

Vol. II, 1999 78

Vol. III, 2001 100

Vol. IV, 2004 68

Vol. V, 2006 92

Vol. VI, 2008 101

Vol. VII, 2008 (Minerals & Metals)

21

Vol. VIII, 2011 (Aqueous & Hydro-alcoholic extracts)

60

Vol. IX, 2016 (Aqueous & Hydro-alcoholic extracts)

45

Total 645

Part II (Compound Formulations)

Vol. I, 2007 50

Vol. II, 2008 51

Vol. III, 2010 51

Total 152

Vol. I, 2011 (Hindi Ed.) 50

Vol. II, 2011 (Hindi Ed.) 51

Supporting Pharmacopoeial Publications

Thin Layer Chromatography (TLC) Atlas

API Drugs Pt. I, Vol. I, 2009 80

API Drugs Pt. I, Vol. III, 2016 99

Macroscopy and Microscopy Atlas

API Drugs Pt.-I Vol. V, 2009 92

API Drugs Pt.-I Vol. I, 2011 80

40

Annexure I (B): Publications related to Siddha Pharmacopoeia

Document Part & Year of publication No. of Formulations

Siddha Formulary of India

Part I (Tamil), 1984 248

Part II (Tamil), 2011 151

Total 399

Part I (English), 1992 248

Document Part Volume & year of publication No. of Monographs

Siddha Pharmacopoeia of India

Part I (Single Drugs)

Vol. I, 2008 73

Vol. II, 2011 66

Total 139

41

Annexure I (C): Publications related to Unani Pharmacopoeia

Document Part & Year of publication No. of Formulations

National Formulary of Unani Medicine

Part. I, 1981 441

Part II, 2007 202

Part III, 2007 103

Part IV, 2006 166

Part V, 2008 178

Part VI, 2011 139

Total 1229

Document Part Volume & year of publication No. of Monographs

Unani Pharmacopoeia of India

Part I (Single Drugs)

Vol. I, 1998 45

Vol. II, 2007 50

Vol. III, 2007 53

Vol. IV, 2007 50

Vol. V, 2008 52

Vol. VI, 2009 48

Total 298

Part II (Compound Formulations)

Vol. I, 2009 50

Vol. II, 2010 50

Vol. III, 2016 50

Total 150

42

Annexure I (D): Publications related to Homoeopathic Pharmacopoeia

Document Volume & year of publication No. of Monographs

Homoeopathic Pharmacopoeia of India

Vol. I, 1971 180

Vol. II, 1974 100

Vol. III, 1978 105

Vol. IV, 1984 107

Vol. V, 1987 114

Vol. VI, 1990 104

Vol. VII, 1999 105

Vol. VIII, 2000 101

Vol. IX, 2006 100

Vol. X, 2016 101

Total 1117

43

Annexure II

Annexure II(A): Composition of General Body

1. Secretary, Ministry of AYUSH Sh. Nilanjan Sanyal until 31st August, 2015; Sh. Ajit M. Sharan from 1st September, 2015

Chairman

2. Joint Secretary, Ministry of AYUSH Sh. Anurag Srivastav until 1st November, 2015 Sh. Jitendra Sharma from 2nd November, 2015

Vice-Chairman - 1

3. Chairman, SB Prof. S. S. Handa

Vice-Chairman - 2

4. Secretary and Director General, Indian Council of Medical Research (ICMR) Dr. Soumya Swaminathan

Member

5. Chairman, Confederation of Indian Industry (CII) or his nominee Sh. Sumit Mazumder

Member

6. Chairman, Federation of Indian Chambers of Commerce & Industry (FICCI) or his nominee Mr. Harshavardhan Neotia

Member

7. Drugs Controller General (India) Dr. G. N. Singh

Member

8. Central Drug Controller (AYUSH)* Member 9. Adviser (Ayurveda), Ministry of AYUSH

Dr. Manoj Nesari Member

10. Adviser (Unani), Ministry of AYUSH Prof. Rais-Ur-Rahman

Member

11. Adviser (Homoeopathy), Ministry of AYUSH Dr. N. Radha

Member

12. Eminent ASU&H experts (one from each system) i. Dr. Vaidya Balendu Prakash (Ayurveda Expert)

Turner Road, Dehradun, Uttarakhand ii. Dr. V. Arunachalam (Siddha Expert)

Dean, Santhigiri Health Care & Research Organization, Santhigiri Ashramam, Santhigiri P.O, Thiruvanathapuram-695589, Kerala

iii. Dr. Mohd. Khalid Siddique (Unani Expert) Former DG, CCRUM, Jamia Hamdard Enclave, New Delhi

iv. Dr. S. P. Singh (Homoeopathy Expert) Former Adviser (Homoeopathy), SRB, 68-C Shipra Riviera, Indirapuram, Ghaziabad-201014

Members

* Will be included after approval of the concerned proposal under consideration

44

13. One representative each of ASU&H Drug Manufacturers i. Mr. Pramod Sharma (Ayurveda Industry)

Managing Director, Shree Baidyanath Ayurvedic Bhawan (P) Ltd. Patna 800001. Bihar

ii. Dr. M. K. Thyagarajan (Siddha Industry) IMPCOPS, Adayar, Chennai-600020

iii. Dr. Ajmal K. P. (Unani Industry) Hermas Herbal Unani Pharmaceuticals, Chennamangallur, (PO) Mukkam, Kozhikode-673602

iv. Dr. P. N. Verma (Homoeopathy Industry) Scientific Advisor, Dr. Willmar Schwabe India Pvt. Ltd, Noida-201307

Members

14. Director, PCIM&H Dr. Rajeev Kr. Sharma

Member Secretary

45

Annexure II(B): Composition of Standing Finance Committee

1. Joint Secretary, Ministry of AYUSH Sh. Anurag Srivastava until 1st Nov., 2015 Sh. Jitendra Sharma from 2nd Nov., 2015

Chairman

2. Chairman, SB Prof. S.S. Handa

Vice-Chairman

3. Financial Adviser, M/o Health &Family Welfare Smt. Vijaya Srivastava

Member

4. Central Drug Controller (AYUSH)* Member 5. Director, PCIM&H

Dr. Rajeev Kr. Sharma Member

Secretary * Will be included after approval of the concerned proposal under consideration

46

Annexure II(C): Composition of Scientific Body

1. Eminent Scientist or an ASU&H Expert with significant experience in Pharmacopoeial work Prof. S. S. Handa

Chairman

2. Chairman, IPC or his nominee Dr. G. N. Singh

Member

3. Chairman, APC Prof. V. K. Joshi

Member

4. Chairman, SPC Dr. G. Veluchamy

Member

5. Chairman, UPC Dr. G. N. Qazi

Member

6. Chairman, HPC Dr. C. Nayak

Member

7. Director General, ICMR or his nominee (ASU Drugs Expert) Dr. Soumya Swaminathan

Member

8. Director General, Council for Scientific & Industrial research (CSIR) or his nominee (ASU Drugs Expert) Dr. Girish Sahni

Member

9. Director General, Central Council for Research in Ayurvedic Sciences (CCRAS) Prof. K. S. Dhiman

Member

10. Director General, Central Council for Research in Siddha (CCRS) Prof. R. S. Ramaswamy

Member

11. Director General, Central Council for Research in Unani Medicine (CCRUM) Prof. Rais-Ur-Rahman

Member

12. Director General, Central Council for Research in Homoeopathy (CCRH) Dr. R. K. Manchanda

Member

13. Central Drug Controller (AYUSH) Member 14. Adviser (Ay.), Ministry of AYUSH

Dr. Manoj Nesari Member

15. Adviser (Unani), Ministry of AYUSH Prof. Rais-Ur-Rahman

Member

16. Adviser (Homoeopathy), Ministry of AYUSH Dr. N. Radha

Member

17. Dy. Adviser (Siddha), Ministry of AYUSH Dr. K. Ravi (Joint Adviser)

Member

18. Professional expert drawn one each from ASU&H industry i. Dr. K. Anil Kumar, Managing Director,

Kerala Ayurveda Pharmacy Ltd. (KPL), Athani-683585, Aluva, Kerala

ii. Dr. A. Jaheer Hussain, Siddha Physician, QC Section, TAMPCOL, Alathur, Dist. Kanchipuram

Members

47

iii. Sh. Kafeel Ahmed, Manager, Tibbiya College Dawakhana, Aligarh Muslim University, Aligarh

iv. Dr. Nishant Tripathi, General Manager, M. Bhattacharya & Co. Pvt. Ltd. 73, N. S. Road, Kolkata-700 001

19. One expert each from ASU&H Academia and Regulatory Bodies i. Dr. G. S. Badesha, Director (Ayurveda),

Govt. of Chattisgarh, Raipur, Chattisgarh. ii. Dr. N. Kabilan, Associate Professor,

The Tamil Nadu Dr. M. G. R Medical University, Anna salai, Guindy, Chennai-600 032

iii. Prof. Yashmin Shamsi Faculty of Unani Medicine, Jamia Hamdard University, Delhi

iv. Dr. S. K. Nanda, Director, National Institute of Homoeopathy, Kolkata-700106

Members

20. Director, PCIM&H Dr. Rajeev Kr. Sharma

Member Secretary

48

Annexure III

Annexure III(A): Staff Strength (Permanent)

Sl. No. Name Designation

1. Dr. Rajeev Kr. Sharma Director

2. Dr. M. B. Shankar Joint Director

3. Dr. S.C. Verma Principal Scientific Officer (Phyto-chemistry)

4. Dr. (Mrs.) Jayanthy A. Principal Scientific Officer (Pharmacognosy)

5. Dr. Anupam Maurya Scientific Officer (Phyto-chemistry)

6. Dr. (Ms.) Nitin Rai Scientific Officer (Pharmacognosy)

7. Dr. V. Vijayakumar Scientific Officer (Siddha)

8. Dr. Nikhil Jirankalgikar Scientific Officer (Ayurveda)

9. Dr. Vijay Gupta Scientific Officer (Ayurveda)

10. Dr. Ramachandran S. Scientific Officer (Pharmacology)

11. Sh. Pankaj Nagdeve Store Officer

12. Sh. Jeetendra Kumar Vaishya Research Assistant (M & H)

13. Sh. Suman Halder Research Assistant (M & H)

14. Sh. Sanjay Singh Rawat Junior Technician

Annexure III(B): Staff Strength (Contractual)

1. Sh. Afzal Hashmi Senior Research Fellow (Chem.)

2. Sh. Ganga Sharan Consultant (Accounts)

3. Sh. Arya Bandhu Consultant (Administration)

4. Sh. Ashish Kumar Data Entry Operator

5. Sh. Sunil Dahiya Data Entry Operator

6. Sh. Rajpal Multi-tasking Staff

49

Annexure IV Annexure IV(A): Composition of Ayurvedic Pharmacopoeia Committee

1. Dr. V. K. Joshi B-6, New Medical Enclave, Nariya, Banaras Hindu University, Varanasi-221005

Chairman

Official Members: 2. Adviser (Ay.)

Ministry of AYUSH, New Delhi- 110023 Member

3. Director, PLIM Kamla Nehru Nagar, Ghaziabad- 201002

Member

4. Director General, CCRAS 61-65, Institutional Area, Opp. ‘D’ Block, Janakpuri, New Delhi- 110058

Member Secretary

5. Prof. V. K. Kapoor 1473, Pushpak Complex, Sector-49 B, Chandigarh- 160047

Member

6. Dr. Roopak Kumar Vice President, Multani Pharmaceuticals Ltd. Analytical Division, Khasra No. 37, Village:- Makkanupur, MehmoodAlam, Pargana-Bhagwanpur, Tehsil- Roorkee, Distt- Haridwar- 237891

Member

7. Prof. Karan Vasishth Former Head, University Institute of Pharmaceutical Science (UIPS), Chandigarh – 160014

Member

8. Ms. S. Satakopan 7/4 Padmam Flats, 7th street Nanaganallur, Chennai - 600061

Member

9. Dr. Malati Chauhan IPGTRA, GAU, Jamnagar, Gujarat

Member

10. Dr. J. L. N. Sastry Head, Dabur Research & Development Center (DRDC), Dabur India Limited 22, Site IV, Sahibabad (UP)

Member

11. Dr. K. N. Dviwedi Head, Deptt. of Dravyaguna, I.M.S., Banaras Hindu University, Varanasi- 221005

Member

12. Dr. S. K. Dixit B-3/402, Shivala, Varanasi-221005

Member

50

13. Dr. S.S. Savrikar Prof. & HOD Rasashastra& Bhaishajya Kalpana Govt. Ayurvedic College & Hospital (GAC), Solapur Road, Madhuban, Osmanabad, Maharashtra- 413501

Member

14. Dr. C. K. Katiyar CEO Technical, Emami HCD, Emami Towers, 5th Floor, 687, Anandapur, E.M. Bypass, Kolkata – 700107

Member

15. Dr. P.M. Variar Arya Vaidya Sala, Kottakkal, Malappuram, Kerala-676503

Member

16. Dr. Aditya Kaushik Head – Medical Regulatory Affairs Glaxo SmithKline Consumer Healthcare Ltd. Plot No. 67, Sector 32, Gurgaon 122001, Haryana

Member

17. Dr. Shailesh Nadkarni Dhootapapeshwar, 135, Nanubai Desai Road, Khetwadi, Mumbai- 400004

Member

18. (Late) Sh. J. K. Dhing Ex-Manager, Hindustan Copper Ltd. Udaipur. SF-8, Gayatri Nagar, Sec.-5, Hiran Magri, Udaipur, Rajasthan-313002

Member

51

Annexure IV(B): Composition of Siddha Pharmacopoeia Committee 1. Dr. G. Veluchami

24, Chokkanathar Street, Karthikeyan Nagar, Maduravoyal, Chennai-600095

Chairman

Official Members: 2. Deputy Adviser (Siddha)

Ministry of AYUSH, New Delhi- 110023 Member

3. Director, PLIM Kamla Nehru Nagar, Ghaziabad- 201002

Member

4. Director General, CCRS SCRI, Anna Hospital Campus, Arumbakkam, Chennai-600106

Member Secretary

5. Dr. Sharada Vasanth Rtd. Research Officer (Chem.), SCRI, Chennai-600106

Member

6. Dr. K. Balakrishna Rtd. Research Officer (Chem.), SCRI, Chennai-600106

Member

7. Prof. V. Gopal Principal, Govt. College of Pharmacy, Mother Teresa PG Research Institute of Health Sciences, Puducherry-605006

Member

8. Dr. Sasikala Ethiraju Research Officer (Pharmacognosy), SCRI, Chennai-600106

Member

9. Dr. P. Jayaraman (Ret., Prof. of Botany), Presidency College, Chennai

Member

10. Dr. (Prof.) I. Sornamariammal Retd. Joint Director of Indian Medicine, Chennai

Member

11. Dr. P. Kumar Drug License Issuing Authority for ISM, Anna Hospital Campus, Arumbakkam, Chennai

Member

12. Prof. Jayprakash Narayanan Former Vice- Principal, Old NO. 55, New No. 70, Panchaliamman Koil Street Arumbakkam, Chennai-600106

Member

52

13. Dr. Kumaravel No. 25, II Street Ram Nagar, North Extension Vijayanagar, Velacherry, Chennai

Member

14. Dr. V. Kalidass Proprietor, Raja Siddha Marunthagam, 1/3, Dhermathupatty, Madurai- 625008

Member

15. Dr. K. Vasanthira Prof. of Pharmacology, Stanley Medical College, Chennai

Member

16. Dr. G. Thiyagarajan Former Joint Director of ISM, 19/5, Arunachalapuram, Street, Sandopalayam, Aminjikarai, Chennai

Member

17. Dr. T. Anandan 75, O- block, Ganapathy Colony, Anna Nagar (E), Chennai

Member

53

Annexure IV(C): Composition of Unani Pharmacopoeia Committee 1. Dr. G. N. Qazi,

Vice Chancellor, Jamia Hamdard University, Mehrauli Road, New Delhi- 110062

Chairman

Official Members: 2. Adviser (Unani)

Ministry of AYUSH, New Delhi- 110023 Member

3. Director, PLIM Kamla Nehru Nagar, Ghaziabad- 201002

Member

4. Director General, CCRUM 61-65, Institutional Area, Opp. ‘D’ Block, Janakpuri, New Delhi- 110058

Member Secretary

5. Dr. Rahul Singh Head, CQA Healthcare Products, Emami Group of Companies, Emami Towers, 5th Floor, 687, Anandapur, E.M. Bypass, Kolkata – 700107

Member

6. Dr. Arshad Khuroo, Plot GP-5, Sector-18, Udyog Vihar Industrial Area, Gurgoan-122001

Member

7. Prof. Maninder Kaur UIPS, Punjab University, Chandigarh

Member

8. Dr. Deepak M (Ph.D. Pharmacognosy) Sr. Manager, Natural Remedies, Plot No. 5B, Veersanda Indl. Area, 19th K.M. Stone, Hosur Road, Bangalore- 560100

Member

9. Prof. Kunwar Mohammad Yusuf Amin MBBS, MD (Pharmacology), Deptt. of Ilmul Advia, AMU, Aligarh

Member

10. Dr. Santosh Joshi Head R&D, Hamdard Laboratories. B-1/2/3, Industrial Area, Meerut Road, Ghaziabad- 201010

Member

11. Prof. Tajuddin Former Dean, Deptt. of Saidla, Faculty of Unani Medicine, AKTC, AMU, Aligarh.

Member

12. Prof. M. Idris Head, PG Deptt. of Ilmul Saidla, A&U Tibbia College, Ajmal Khan Road, Karol Bagh, New Delhi. 110005

Member

54

13. Dr. Asad Mueed Director, Hamdard (Wakf) Laboratories, Hamdard Building, 2A/3 Asaf Ali Road, New Delhi- 110002

Member

14. Dr. M. U. R Naidu Plot No. 176/B 2, House No. 1-241, Santh Nagar Co. H. Society, Motinagar, Hyderabad- 500018

Member

15. Prof. Zillur Rehman Former Dean Faculty of Unani Medicine, AMU, Aligarh

Member

16. Dr. Absar Ahmad Principal Scientist, Biochemical Division, National Chemical Laboratory, Dr. Homi Bhabha Road, Pune-411008

Member

55

Annexure IV(D): Composition of Homoeopathic Pharmacopoeia Committee 1. Dr. C. Nayak,

Ex-Director General, CCRH, New Delhi. House No. 55-B, Block No. C- 4-D Janakpuri, New Delhi -110058

Chairman

Official Members: 2. Adviser (Homoeopathy)

Ministry of AYUSH, New Delhi- 110023 Member

3. Director, HPL Kamla Nehru Nagar, Ghaziabad- 201002

Member

4. Director General, CCRH 61-65, Institutional Area, Opp. ‘D’ Block, Janakpuri, New Delhi- 110058

Member Secretary

5. Dr. B. N. Suhagia, Dean Faculty of Pharmacy, Dharamsinh Desai University, Nadiad. Gujarat. 387001

Member

6. Dr. Dilip Pannakadda, Head, Department of Pharmacy, National Institute of Homoeopathy Block - GE, Sector - III, Salt Lake, Kolkata- 700 106. West Bengal

Member

7. Dr. (Mrs.) Shanta Mehrotra, Ex-Emeritus Scientist, NBRI, HIG-91, Aliganj Extension, Sector –E, Lucknow – 226 024

Member

8. Dr. P. V. Santhosh Managing Director, Kerala State Co-operative Homoeopathic Pharmacy, XII/37 to 39, Mararikulam South, Pathirappally P.O., Alappuzha - 688 521

Member

9. Mohd. Faiyaz Alam, Technical Manager, SBL. Pvt. Ltd. A/3, Site -4, Indl. Area Sahibabad, U.P.

Member

10. Dr. Sohan Singh, Ex-Vice Principal, JSPS Homoeopathic Medical College, Hyderabad. House No 8-3-248/B/23/1, Opposite Times of India, Road No 3, Journalist Colony, Banjara Hills, Hyderabad – 500034

Member

56

Annexure V Participation in Seminars/Workshops/Conferences/Training programmes

Sl. No. Date Name Organizer Participant(s)

1. 26 February 2016

National symposium on quality, safety and rational use of medicine

Indian Pharmacopoeia Commission

Dr. S.C. Verma, Dr. Jayanthy A., Dr. Ramachandran S.

2. 29 March 2016

Consultative workshop on Sustainable Trade, Standards and Certification Schemes in Medicinal and Aromatic Plants in India

TRAFFIC India & Applied Environmental Research Foundation

Dr. Rajeev Kr. Sharma Dr. Nitin Rai

57

Annexure VI Unaudited Accounts

58

59

60

61

62

63

64

65

66