Indian Pharmacopoeia 2018

600 Pages·2018·299.793 MB·English

by  The Indian Pharmacopoeia Commission

DIAN
RMACOPOEIA
2018
Volume I
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Ainisgry 411C Meal amity Welfare
g'Vi3LUSHEI) BY
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Authenticity Certificate
Book Number
0524
IP 2018
Indian Pharmacopoeia-2018
A publication of the
Indian Pharmacopoeia Commission
Ministry of Health & Family Welfare
Government of India
This certificate hearing the IPC Seal and a unique
book number is an assurance that this is an
authentic and official print version of
IP-2018
INDIAN PHARMACOPOEIA 2018
INDIAN
PHARMACOPOEIA
2018
Volume I
UM(cid:9) 1
Government of India
Ministry of Health & Family Welfare
Published by
2018, Indian Pharmacopoeia Commission
Application for reproduction should be made to Notices
The Secretary-cum-Scientific Director
INDIAN PHARMACOPOEIA COMMISSION
Sector-23, Raj Nagar, Legal Notices Scientific Director is authorised to issue such amendments.
Ghaziabad-201 002, India
Whenever such amendments are issued, the Indian
Tel: (91-120) — 2783401 In India, under the Drugs and Cosmetics Act 1940, the current
Pharmacopoeia would be deemed to have been amended
Fax: (91-120)— 2783311 edition of Indian Pharmacopoeia is a book of standards for
accordingly.
Website: www.ipc.gov.in drugs included therein and the standards as included in the
E.mail: ipclab(a vsnl.net Indian Pharmacopoeia would be official. Also, in several other Patents and Trade Marks
laws of India, the Indian Pharmacopoeia is recognised as the
ISBN 978-93-81238-15-8 (Volume I) standard book. It is expedient that enquiry be made in each In the Indian Pharmacopoeia, certain drugs and preparations
ISBN 978-93-81238-19-6 (Set) case in order to ensure that the provisions of any such law are have been included notwithstanding the existence of actual
being complied with. In general, the Drugs and Cosmetics or potential rights in any part of the world. In so far as such
Act, 1940, the Narcotic Drugs and Psychotropic Substances substances are protected by Letters Patent their inclusion
Act, 1985, the Poisons Act, 1919 and the rules framed in the Indian Pharmacopoeia neither conveys, nor implies,
IP 2018
thereunder should be consulted. These statutes empower licence to manufacture without due permission, authority,
Eighth Edition the Government agencies to enforce the law using this Or licence from the person or persons in whom such
compendium. The monographs of the Indian Pharmacopoeia rights exist.
Effective from 1 St January, 2018
' should be read subject to the restriction imposed by those
The titles given under the individual monographs are public
laws which are applicable.
property. These titles cannot be patented as trade marks and
(cid:9) If considered necessary, the standards included in Indian no person is permitted to patent any trade mark devising the
On behalf of : Government of India
Pharmacopoeia can be amended and the Secretary-cum- root of these titles.
Ministry of Health & Family Welfare
Designed, produced & published by : The Indian Pharmacopoeia Commission
Indian Pharmacopoeia Laboratory
Govt. of India, Ministry of Health & Family Welfare
Sector 23, Raj Nagar, Ghaziabad-201 002
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Information Resources, Vigyan Sanchar Bhawan,
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Price per set: Inland 50000
Foreign S (cid:9) 2200
£ (cid:9) 1400
(Plus GST as applicable)
ISBN No. 978-93-81238-15-8
9 7 8 9 3 8 I 2 3 8 1 5 8 08
Preface
The Eighth edition of the Indian Pharmacopoeia (IP 2018) is Active Pharmaceutical Ingredients (APIs) and the dosage
published by the Indian Pharmacopoeia Commission (IPC) on forms produced. This totally transformed the profile of the
behalf of the Ministry of Health & Family Welfare, Government Indian Pharmaceuticals market and Indian Pharma industry
of India. The Indian Pharmacopoeia (IP) is published in emerged as one of the important global suppliers of
fulfilment of the requirements of the Drugs and Cosmetics pharmaceutical products, both to the developed and
Act, 1940 and Rules thereunder. It prescribes the standards developing countries. These developments posed major
for drugs produced and/or marketed in India and thus challenges for the IP to reflect the quality standards of the
contributes to the control and assurance of the quality of the marketed drugs, which the subsequent editions and
medicines. The standards of this pharmacopoeia are supplement of IP tried to address.
authoritative and legally enforceable. It intends to help in the
In view of these rapid advances, it was decided to publish a
licensing of manufacturing, inspection and distribution of
new edition of the Pharmacopoeia and its Addenda at regular
medicines. IP is published in continuing pursuit of the mission
and shorter intervals for which the Indian Pharmacopoeia
of IPC to improve the health of the people through ensuring
Committee was reconstituted in 1978. Third edition of Indian
the quality, safety and efficacy of medicines. The Commission
Pharmacopoeia in 1985, its Addenda 1989 and 1991
has been receiving significant inputs from regulatory, industrial
respectively, inclusion of traditional system of drugs was
houses, academic institutions, national laboratories, individual
limited. However, most of the new drugs manufactured and/or
scientists and others. Publication of IP at regular and shorter
marketed were included, while only those herbal drugs which
intervals is one of the main mandates of the Commission.
had definitive quality control standards had got place in it.
Indian Pharmacopoeia contains procedures for analysis and In view of the continuing rapid increase in the range of drugs
specifications for the determination of quality of produced in India, the forth edition of IP 1996, its Addendum
pharmaceutical substances, excipients and dosage forms. 2000, Supplement 2000 for Veterinary Products and Addendum
IP monograph for an official substance or preparation includes 2002 were published. The Addendum 2005 was published by
the article's definition, description, identification, specific the IPC which included a large number of antiretroviral drugs
tests, assays, packaging, storage, labelling specifications and and raw plants commonly used in making medicinal products
impurities profile, one or more analytical procedures for each not covered by any other pharmacopoeias, which attracted
test, acceptance criteria and other requirements. much global attention. The IP Committee decided to delete
The history of the IP began in the year 1833 when a Committee the obsolete or less used product monographs and added
of the East India Company's Dispensary recommended the monographs based on the therapeutic merit, medical need
publication of a Pharmacopoeia and Bengal Pharmacopoeia and extent of use of such articles in the country.
and General Conspectus of Medicinal Plants were published The Indian Pharmacopoeia Commission was established in
in 1844, which mainly listed most of the commonly used
year 2005. It provided systematic approach and practices for
indigenous remedies. This was followed by IP 1868, which
publication of fifth edition of IP 2007 containing 271 new
covered both the drugs of British Pharmacopoeia (BP) 1867 monographs with focus on those drugs and formulations that
and indigenous drugs used in India, with a Supplement covered the National Health Care Programmes and the National
published in 1869 incorporating the vernacular names of
Essential Medicines and Addendum 2008 to the IP 2007
indigenous drugs and plants. However, from 1885 the BP was containing 72 new monographs.
made official in India. A Drugs Enquiry Committee appointed
The sixth edition of IP 2010 contained monographs on
in 1927 by the Government recommended the publication of a
antiretroviral, anticancer, antituberculosis and herbal drugs.
National Pharmacopoeia.
It further emphasized on biological monographs such as
After independence, the Indian Pharmacopoeia Committee was
Vaccines, Immunosera for human use, Blood products,
constituted in 1948 for publication of IP as its main function,
Biotechnological and Veterinary (Biological and
which published the first edition of IP in 1955, followed by a
non-biological) preparations. Addendum 2012 to the IP 2010
Supplement in 1960. This Pharmacopoeia contained both
was published which had taken care of the Amendments to
western and traditional system of drugs commonly used in
IP 2010 and also incorporated 52 new monographs.
India and the same policy continued while preparing the
second edition of Indian Pharmacopoeia in 1966 and its The seventh edition of Indian Pharmacopoeia was published
Supplement 1975. There had been a phenon*RitiMwth and in thee3tear 21114 which incorporated 577 monographs
development of the Indian Pharma i.94*try Since consisting -4 APIs, excipients, dosage forms,
independence, especially from early 1970, both i e range of radiopharmaceuticals, herbal and veterinary products.
-`-
PREFACE (cid:9) (cid:9) (cid:9) PREFACE
IP 2018 IP 2018
Addendum 2015 and Addendum 2016 to the 1P 2014 were The IPC Secretariat and Indian Pharmacopoeia Laboratory In addition, emphasis has been put to bring out harmonisation Volume III: General Notices; Drug Substances, Dosage
published which had taken care of the Amendments to IP 2014 (IPL) staff, with the support of different advisory Expert in Appendices to establish a sound connection between Forms and Pharmaceutical Aids (N to Z);
and also incorporated 82 new monographs in Addendum 2015 Committee and Expert Members of the Scientific Body have individual monographs and the relevant appendices, so as to Vaccines and Immunosera for Human Use;
and 89 new monographs in Addendum 2016 respectively. Herbs and Herbal Products; Blood and
examined the suitability of the standards. In order to make make this edition precise and well structured. Number of
The Eighth edition of Indian Pharmacopoeia (IP 2018) is IP 2018 user friendly, the existing formatting pattern has been monographs and appendices are expanded further to Blood-related Products; Biotechnology Derived
published in accordance with the principles and designed suitably revised. The standards prescribed in this edition are incorporate the latest technological advancement and Therapeutic Products, Allergen Products and
plan decided by the Scientific Body of the IPC. To establish encouraged to adhere with the concept of harmonization, regulatory compliance. Constant efforts have been made to Radiopharmaceutical Preparations.
transparency in setting standards for this edition, the contents keeping in view the technological status for manufacture and unify the National Drug Standards and to bring them in line Volume IV: General Notices; Notices; Veterinary Products
of new monographs, revised appendices and other information analysis of drugs and pharmaceuticals in the country without with the International Standards progressively by addition of and Index.
have been publicized on the website of the IPC, besides compromising with the quality of the products. It strives to monographs of fixed dose combination drugs and adopting
The Standards prescribed in the Indian Pharmacopoeia are
following conventional approach of obtaining comments. update the existing monographs as well as incorporating the current methodology and constantly advancing technological
to establish the compliance with regulatory requirements on
The feedback and inputs have been reviewed by the relevant new monographs of drug substances based on clinical use of standards.
an article. The criteria to be adhered to are:
Expert Committee to ensure the feasibility and practicability medicines in India and improving their test protocols. IPC provides the official Indian Pharmacopoeia Reference
of the standards and methods revised. The principle of The IP 2018 has been considerably revised and improved in Substances (IPRS) as primary reference standards and impurity (i) The interpretation of a monograph must be in accordance
"openness, justice and fairness" is kept in mind during respect of the requirements of monographs, general chapters, standards to the stakeholders as per the requirements of with all the general requirements, testing methods, texts
compiling and editing the contents of this edition. monographs of dosage form and testing protocols by monographs and the list of available IPRS and impurity and notices pertaining to it, in the IP.
Public Review and Comment Process for standards introducing advanced technology. The contents of general standards is updated from time to time on the official website (ii) A product is not of standard quality unless it complies
development related to this edition of the Indian chapters and monographs of dosage forms are by and large of IPC (www.ipc.gov.in). with all the requirements of the monograph.
Pharmacopoeia has given special attention to incorporate revised in consonance with those adopted internationally.
This is the Eighth edition of the Indian Pharmacopoeia. The IP 2018 incorporates additional 391 monographs inclusive
comments from stakeholders. The methodology adopted is The monographs of combined dosage forms widely marketed
It comprises of four volumes. Each volume has got different of 82 monographs of IP Addendum-2015, 89 monographs of
appended below: in India have been given special attention.
features. IP Addendum-2016 and newly added 220 monographs ofAPI's,
Preparation of Initial List of New and Revision of Volume I: (cid:9) Notices; Preface; About Indian Pharmacopoeia excipients, dosage forms, radiopharmaceuticals, herbs and
existing IPMonographs on the basis of Commission; Acknowledgements; herbal products, blood and blood related products,
Inclusion and Exclusion Criteria Introduction; General Notices; General Chapters biotechnology derived therapeutic products and veterinary
— - J Reference Data and Index. products etc. It is intended that this edition would play a
significant role in improving the quality of medicines which in
Volume II: General Notices; Dosage Forms (General
turn will promote public health and accelerate the growth and
Acquisition of Monographs Quality Specification Monographs); Drug Substances, Dosage Forms
development of pharma sector.
and Pharmaceutical Aids (A to M).
IPC Drafts and Reviews the Monograph, after
Consultation with Experts and Uploading on the
Website for Stakeholders comments
egulatory
IP Ye
rAiircp
Expert Committees review comments and make
A.ca(cid:9)dem_.i..c..-s- ,) Appropriate Change in Monographs, if applicable,
and Uploading on the website (www.ipc.gov.in)
r
Revision Needed 1- No Further Revision Needed
Approval by Scientific Body and Secretary-cum-Scientific Director
of IPC then Published in Indian Pharmacopoeia
`)/
Release of IP
Process of IP Development
•
Indian Pharmacopoeia Commission
The Indian Pharmacopoeia Commission (IPC) has been formed • To take note of the different levels of sophistication in
as an autonomous institution under the Ministry of Health analytical testing/ instrumentation available while framing
and Family Welfare's Resolution bearing even no. dated 6th the monograph.
May, 2008 published in the Official Gazette, the Government
• To accelerate the process of preparation, certification and
of India. It is a three-tier structure comprising of the Governing
distribution of IP Reference Substances, including the
Body of 14 members, General Body of 26 members and Scientific
related substances, impurities and degradation products.
Body of 15-23 members from different related scientific fields.
• To collaborate with Pharmacopoeias like the Ph Eur, BP,
The Secretary, Ministry of Health and Family Welfare, is the
USP, JP, ChP and International Pharmacopoeia with a view
Chairman and the Chairman-Scientific Body is the Co-Chairman
to harmonizing with global standards.
of the Commission. The Secretary-cum-Scientific Director is
the Chief Scientific and Executive Officer of the Commission. • To review existing monographs periodically with a viev,
to deleting obsolete ones and amending those requiring
!Governing Body] upgrading /revision.
I PC E1t.1 General Body
• To organize educational programs and research activities
Scientific Body I
for spreading and establishing awareness on the need
(cid:9) and scope of quality standards for drugs and related
II PC Secretariat) IPL
articles /materials.
IPC-Structure • To publish the National Formulary of India for updating
The primary responsibility of the Scientific Body is to provide medical practitioners and health professionals.
guidelines for standards development related to the • To act as a National Coordination Centre for
Indian Pharmacopoeia with the assistance of its Expert Pharmacovigilance Programme of India.
Committees.
The Indian Pharmacopoeia is published in continuing pursuit The Governing Body
of the Mission, Vision and Objectives of the IPC.
The composition of the Governing Body is given below:
Mission Chairman The Secretary (Health &Family Welfare)
(ex-officio) Government of India
To promote public and animal health in India by bringing out
Ministry of Health & Family Welfare
authoritative and officially accepted standards for quality of
Nirman Bhawan
drugs including active pharmaceutical ingredients, excipients
New Delhi-110 011.
and dosage forms, used by health professionals, patients and
consumers. (Shri C. K. Mishra)
Co- The Chairman, Scientific Body, IPC
Vision
Chairman Former Director General, ICMR
To promote the highest standards of drugs for use in human C-191, 9th Floor, City View Apartment
and animals within practical limits of the technologies available Plot No. 199, Sector-35
for manufacture and analysis. Noida-201 301.
(Professor N. K. Ganguly)
Objectives
Member The Director General (DGHS)
• To develop comprehensive monographs for drugs to be
(ex-officio) Ministry of Health & Family Welfare
included in the Indian Pharmacopoeia, including active
Nirman Bhawan
pharmaceutical ingredients, pharmaceutical aids and
New Delhi-110 011.
dosage forms as well as medical devices and to keep
(Dr. Jagdish Prasad)
them updated by revision on a regular basis.
• To develop monographs for herbal drugs, both raw drugs Member The Additional Secretary & D.G. (CGHS)
and extracts/formulations therefrom. (ex-officio Ministry of Health & Family Welfare
an Bhawan
• To accord priority to monographs of dru
w Delhi-110 011.
National List of Essential Medicines
dosage forms. . R. K. Vats)
INDIAN PHARMACOPOEIA COMMISSION IP 2018 IP 2018 (cid:9) INDIAN PHARMACOPOEIA COMMISSION
Member (cid:9) The Additional Secretary & Finance Advisor Member The Secretary-cum-Scientific Director Member (cid:9) The Deputy Secretary (Drugs) Member (cid:9) Prof. (Dr.) Lal Ji Singh
- (cid:9)
(ex-officio) Ministry of Health & Family Welfare Secretary Indian Pharmacopoeia Commission (ex-officio) Ministry of Health & Family Welfare Former Vice-Chancellor
Nirman Bhawan Banaras Hindu University
Nirman Bhawan (ex-officio) Sector-23, Rajnagar
New Delhi-110 011. Varanasi-221 005.
New Delhi -110 011. Ghaziabad-201 002.
(cid:9)
(Ms. Vijaya Srivastava) (Dr. G N. Singh) (Shri D. N. Sahoo) Member The President
Member (cid:9) The Drugs Controller General (I) (ex-officio) Indian Drug Manufacturers Association
Member (cid:9) The Joint Secretary (Regulation)
The General Body (ex-officio) Directorate General of Health Services (IDMA)
(ex officio) Ministry of Health & Family Welfare
- Ministry of Health & Family Welfare 102-B, Poonam Chambers, 'A' Wing'
Nirman 13hawan The composition of the General Body is as follows:
Dr. Annie Besant Road, Worli
FDA Bhawan, Kotla Road
New Delhi-110 011. Chairman The Secretary (Health & Family Welfare) New Delhi-110 002. Mumbai — 400 018.
(Mr. Sudhir Kumar) (ex-officio) Government of India (Mr. S. V. Veerramani)
(Dr. G N. Singh)
Joint Secretary Ministry of Health & Family Welfare (cid:9)
(cid:9) Member The President
Nirman Bhawan Member The Director
Member (cid:9) The Joint Secretary (ex-officio) Organization of Pharmaceutical Producers of
New Delhi-110 011. (ex-officio) National Institute of Biologicals
(ex-eicio) Department of Pharmaceuticals India (OPPI),
A-32, Sector-62, Institutional Area
Ministry of Chemicals and Fertilizers (Shri C. K. Mishra) Peninsula Chambers, Ground floor
Noida-201 309.
Shastri Bhawan, New Delhi-110 011. Co- (cid:9) The Chairman, Scientific Body, IPC Ganpat Rao Kadam Marg, Lower Parel
(Dr. Surinder Singh)
Mumbai- 400 013.
(Shri Sudhanshu Pant) Chairman Former Director General, ICMR (cid:9)
C-191, 9th Floor, City View Apartment Member The Director (Dr Shailesh Ayyangar)
Member (cid:9) The Deputy Secretary (Drugs) Plot No. 199, Sector-35 (ex-officio) Central Drugs Laboratory (cid:9)
Member The President
(ex officio) Ministry of Health & Family Welfare 3, Kyd Street, Kolkata-700 016.
- Noida-201 301. (ex-officio) Indian Pharmaceutical Alliance (IPA)
Nirman Bhawan
(Dr. Hariharan)
(Professor N. K. Ganguly) Mumbai.
New Delhi-110011.
(cid:9)
(Shri D. N. Sahoo) Member (cid:9) The Director General (DGHS) Member From Regulatory Bodies (Dr. Rao V. S. V. Vadlamudi)
(ex-officio) Central Drugs Standard Control Organisation (cid:9)
(ex-officio) Ministry of Health & Family Welfare Member The President,
Member (cid:9) The Drugs Controller General (I) Directorate General of Health Services
Nirman Bhawan (ex-officio) Pharmacy Council of India
(ex officio) Directorate General of Health Services FDA Bhawan, Kotla Road,
- New Delhi-110 011. Combined Councils' Building
Ministry of Health & Family Welfare New Delhi-110 002.
(Dr. Jagdish Prasad) Kotla Road, Aiwan-E-Ghalib Marg
FDA Bhawan, Kotla Road
(cid:9) Member (cid:9) The Director New Delhi-110 002.
New Delhi-110 002. Member The Additional Secretary & D.Q (CGHS)
(ex-officio) Ministry of Health & Family Welfare (ex-officio) National Institute of Pharmaceutical Education (Professor B. Suresh)
(Dr. G N. Singh) and Research (NIPER) (cid:9)
Nirman Bhawan Member Dr. Kiran Mazumdar Shaw
Sector 67, SAS Nagar
Member (cid:9) The Director NewDelhi-110011. Mohali-160 062. C&MD,
(ex officio) National Institute of Biologicals Biocon Ltd.
- A-32, Sector-62, Institutional Area (cid:9) (Dr. R. K. Vats) (Dr. USN Murty, Officiating Director) 20th KM, Hosur Road
Noida-201 309. Member The Additional Secretary & Finance Advisor Member (cid:9) Commissioners in-charge of Drug Control Electronics City
(Dr. Surinder Singh) (ex-officio) Ministry of Health & Family Welfare (ex-officio) (cid:9) Administration. Andhra Pradesh Bangalore- 560 100
Nirman Bhawan (cid:9) (cid:9)
Member (cid:9) Professor (Dr.) Lal Ji Singh New Delhi -110 011. Member (cid:9) Commissioners in-charge of Drug Control Member- The Secretary-cum-Scientific Director
Former Vice Chancellor (ex-officio) Administration, Gujarat Secretary Indian Pharmacopoeia Commission
(Ms. Vijaya Srivastava)
Banaras Hindu University (cid:9) (ex-officio) Sector-23, Rajnagar
(cid:9) Member Commissioners in-charge of Drug Control
Varanasi-221 005. Member The Joint Secretary (Regulation) (cid:9) Ghaziabad-201 002.
(ex-officio) Administration, Himachal Pradesh
(ex-officio) Ministry of Health & Family Welfare (Dr. G. N. Singh)
Member (cid:9) The President, (cid:9)
Nirman Bhawan Member Commissioners in-charge of Drug Control
(cid:9)
Pharmacy Council of India
New Delhi-110 011. (ex-officio) Administration, Sikkim
Combined Councils' Building (cid:9) The Scientific Body
(Mr. Sudhir Kumar) Member Commissioners in-charge of Drug Control
Kotla Road, Aiwan-E-Ghalib Marg (cid:9)
Joint Secretary (ex-officio) Administration, Uttar Pradesh The composition of the Scientific Body is given below:
Post Box No. 7020, New Delhi-110 002.
(cid:9) Chairman Dr. (Prof.) N. K. Ganguly
(Professor B. Suresh) Member The Joint Secretary Member Dr. C. Adithan
Former Director General, ICMR
(ex-officio) Department of Pharmaceuticals (ex-officio) Director-Professor, Dept. of Pharmacology
Member (cid:9) Dr. Kiran Mazumdar Shaw Ministry of Chemicals and Fertilizers Jawaharlal Institute of Postgracigate Medical ,. _.._-... C-191, 9th Floor
C&MD _Shastri Bhawan Education and Research 4,9 View Apartment
Biocon Ltd. 20th KM, Hosur , of No. 199, Sector-35
7 New Delhi-110 011. Pondicherry-605 006.
ida-201 301.
Electronics City, Bangalore- 56 -!--'--.--i._.,r;_,_•_--•, ,,,:)-. `
--s, $hri Sudhanshu Pant)
(cid:9) „...._.,. ..,
(cid:9) (cid:9) (cid:9)
INDIAN PHARMACOPOEIA COMMISSION IP 2018 IP 2018 INDIAN PHARMACOPOEIA COMMISSION
Member (cid:9) Dr. Nitin Bhatia Member (cid:9) Dr. D. Srinivasa Reddy Member (cid:9) Shri Salim A. Veljee Anti-Cancer Drugs
Sr. General Manager (Tech. & Regulatory) Senior Scientist Director
Dr. K.V. Jogi (Chair), Dr. B. Nagaraju, Dr. N. Padmaja and
Intas Animal Health Division of Organic Chemistry Directorate of Food & Drugs Administration
Mr. Mohan Jain.
Intas Pharmaceuticals Ltd. National Chemical Laboratory (NCL) Dhanwantari', Opp. Shrine of the Holy Cross
44th Floor, Premier House Dr. Homi Bhabha Road Bambolim Anti-Retroviral Drugs
Opposite Gurudwara, S. G. Road, Pune- 411008. Goa 403202.
Dr. Manish Gangrade (Chair), Dr. Antony Raj Gomes,
Bodakdev,
Member (cid:9) Dr. V. Satyanarayana Member (cid:9) Dr. Ram A. Vishwakarma Ms. Rashmi Srivastava and Dr. Suryanarayana Muluktla.
Ahmedabad (Gujarat).
Managing Director, Director Radiopharmaceuticals
Member (cid:9) Prol(Dr.)Vmod Kumar Dixit M/s. Sipra Labs Ltd. Indian Institute of Integrative Medicine
Former Dean, Faculty of Pharmacy & 7-2-1813/5/A Industrial Estate Post Bag No. 3 Dr. Rakesh Kumar Sharma (Chair), Dr. M.G. R. Rajan,
Dr. Anil Kumar Mishra, Dr. Grace Samwel, Dr. N. Shivaprasad,
Retired Professor of Pharmacognosy Sanath Nagar Canal Road
Dr. Aruna Korde and Dr. Sanyog Jain.
Dr. Hari Singh Gour University Hyderabad.-500 018. Jammu-180001.
(formerly University of Sagar.) Member (cid:9) Dr. Hemant Kumar Sharma Member (cid:9) Prof. Naveet Wig Biologics
Sagar,
Associate President Professor of Medicine Dr. Surinder Singh (Chair), Dr. Anurag S. Rathore and
Madhya Pradesh.
Research & Development All India Institute of Medical Sciences Dr. S.S. Jadhay.
Member (cid:9) Dr. Nitya Gogtay APL Research Centre II Ansari Nagar
Blood and Blood related Products
Associate Professor in Clinical Pharmacology (A Division ofAurobindo Pharma Limited) New Delhi.
Department of Clinical Pharmacology Survey No. 71&72, Indrakaran (V) Dr. R.K. Chaudhary (Chair), Dr. Kabita Chatterjee.
Member- Dr. G N. Singh
KEM and Seth G S. Medical College Sangareddy (M) Dr. Debasish Gupta, Dr. J.P. Prasad and Mrs. Kanchan Ahuja
Secretary Secretary-cum-Scientific Director
Mumbai. Medak District
(ex-officio) Indian Pharmacopoeia Commission Excipients
Telengana-502 329.
Sector-23, Rajnagar
Member (cid:9) Dr. Shahid Jameel (cid:9) Dr. P.V. Kanitkar (Chair), Mr. Subodh Priolkar,
CEO, Wellcome Trust, DBT India Alliance Member Dr. Raman Mohan Singh Ghaziabad-201 002. Dr. D.B.A. Narayana and Dr. Shailesh Nagarsenkar.
1110 DLF Tower B Director,
Jasola Central Drugs Testing Laboratory General Chapters
Previous Scientific Body
New Delhi-110 025. Zonal FDA Bhawan, Bellasis Road Dr. V.G. Nayak (Chair), Dr. Raman Mohan Singh,
Govt. Medical Stores Depot Compound Indian Pharmacopoeia Commission also acknowledges Dr. Sunil Nadkrani, Mr. Antony R. Gomes, Dr. Vinay Aroskar,
Member (cid:9) Dr. Praveen Khullar Mumbai Central contribution of previous Scientific Body Members of IPC for Dr. Pramod Dalvi, Dr. Sunder Kalyana Balaji, Mr. Kundan D. Patil,
Sr. Director Development Centre Goa & Mumbai-400 008. their valuable inputs in upgrading and publication of IP 2018. Mr. Deepak Jakate, Dr. Sheetal Pise, Mr. Sanjay Deshpandey,
Regional Co-ordinator APJ Generics BU
(cid:9) Dr. V. B. Malkar, Mr. Mohan Jain, Dr. Luis Countinho.
Sanofi Synthelabo (India) Pvt. Limited Member Prof.(Dr.) Sanjay Singh Prof. B. Suresh (Chair), Prof. Praveen Aggarwal, Mr. Vinod
L-121, Phase III A, GIDC Professor, Department of Pharmaceutics Arora, Dr. Manish Gangrade, Prof. Y. K. Gupta, Dr. S. S. Jadhav, General Chapters on Dosage Forms
Verna Industrial Estate Indian Institute of Technology Dr. Prasad V. Kanitkar, Dr. H. G. Koshia, Dr. J. P. Mehta,
Mr. Vinod Arora (Chair), Dr. Prashant Dixit.
Verna, Goa-403722. (Banaras Hindu University) Dr. S. M. Mudda, Dr. D. B. Anantha Narayana, Dr. Vinay G Nayak,
Varanasi-221 005 Dr. S. Y. Pandey, Dr. G N. Qazi, Dr. Anurag S. Rathore, Herbal Products
Member (cid:9) Dr. Arun Kumar Mishra Uttar Pradesh. Prof. Rakesh Kumar Sharma, Prof. Lalji Singh, Mr. R. Sridharan,
Executive Vice President (cid:9) Dr. N. Udupa, Dr. P. V. Venugopal and Prof. M. R. Yaday. Dr. D.B.A. Narayana (Chair), Dr. Amit Agrawal,
GSK Consumer Health Care Ltd. Member Dr Rakesh Narayanrao Tirpude Dr. George. Patani, Dr. Pulok K. Mukherjee, Dr. C.K. Katiyar,
Assistant Commissioner Dr. Nancy Pandita, Dr. Reema Shree, Dr. Benna Bhatt,
DLF Phase-5, Golf course Road
Gurugram. Food & Drugs Administration Expert Working Groups Dr. Vidhu Aeri, Mr. Ravikanth Kotagiri and Dr. Sanjeev Tripathi.
Maharashtra State
Sub-group on Essential Oils
Member (cid:9) Dr. Amulya K. Panda Mumbai-51. Review of IP Work
Scientist (Biotechnology) Presently In-charge Mr. J.L. Sipahimalani (Chair), Mr. R. Raghunandanan. Dr. Ramakant Harialkha, Mr. B. Murali, Dr. Rahul Singh,
Product Development Cell Assistant Director Mr. R. Sridharan. Ms. Bhuvana Nageswaran and Dr. Hema Lohani.
National Institute of Immunology Food and Drugs Control Laboratory
Sub-Group for Reviewing IP Work Inhalation Products
Aruna Asaf Ali Marg Food & Drugs Administration, Mumbai
New Delhi —110 067. Maharashtra. Dr. R.A. Singh, Mr. Arvind Kukrety, Mr. Gaurang Oza and Mr. R. Sridharan (Chair), Mr. Satish Sharma, Mr. Sanjay Gupta,
Mr. S.L. Jat Mr. Nagesh Shenoy, Mr. Ganadish Kamat, Mr. Amit Sule and
Member (cid:9) Shri A. K. Pradhan Member (cid:9) Dr. Anil Kumar Tyagi Mr. S.G Belapure.
Deputy Drugs Controller (I) CSO, R&D Department IPRS Review Committee
CDSCO (NZ) AtanIcind Pharma Ltd. Dr. V. G. Nayak (Chair), Dr. Raman
Kamla Nehru Nagar, Hapur C Okhla Industrial Estate, Phase III Dr. P. K. Guha, Dr. K. V. Jogi, Prof. Sanjay Sin , Dr. Hitendra Sahu, Mr. Prakash Bachani,
Ghaziabad. New Delhi — 110020. Dr. Girish Juneja and Dr. S. K. Mishra. r. Ajai Shahi, Mr. Sempal, Dr. Satyanarayan.
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