HISTORY OF PHARMACOPOEIA. DETAIL DISCUSSION OF INDIAN PHARMACOPOEIA

1. BY
PROF. TAUFIK MULLA
ASST. PROFESSOR
SPBC COLLEGE OF PHARMACY

2.  According to the latest index given by the World Health Organization (WHO), there are as many as 40
pharmacopoeias published around the world.
 60 active pharmacopoeia commissions who carry out the work for developing and maintaining these
pharmacopoeias.
 Pharmacopoeia: the word derives from the ancient Greek word Pharmakon means Drug & Poeia means
to make.
 It is a legally binding collection, prepared by a national or regional authority & contains list of medicinal
substances, crude drug & formulas for making preparation from them.

4. The pharmacopoeia contain-:
 List of drug and other related substances
 Sources
 Description
 Tests
 Formulas for preparation actions
 Uses
 Doses
 Storage conditions

5.  International Pharmacopoeia
 United States Pharmacopoeia (USP)
 European Pharmacopoeia
 Indian Pharmacopeia(ip)
 Pharmacopoeia Of The People's Republic Of China(pprc)
 German Pharmacopeia
 British Pharmacopoeia (BP)
 Portuguese Pharmacopoeia
 Mexican Pharmacopoeia
 French Pharmacopoeia
 Japanese Pharmacopoeia (JP)
 Argentinean Pharmacopoeia

6.  Indian Pharmacopoeia Commission (IPC) is an autonomous institution of the Ministry of Health and
Family Welfare which sets standards for all drugs that are manufactured, sold and consumed in India
 The set of standards are published under the title Indian Pharmacopoeia (IP)
 Vision: The IPC is committed to the promotion of the highest standards for drugs for use in the
prevention and treatment of diseases in human beings and animals keeping in view the special features
of the pharmaceutical industry in India.

7.  The first official pharmacopoeia of india appeared in 1868 which was edited by Edward John Waring. (before
Independence) (British Pharmacopoeia)
 The process of publishing the first Pharmacopoeia started in the year 1944 under the chairmanship of R. N.
Chopra
 In 1948 government of India appointed an Indian Pharmacopeia committee to prepare ‘Pharmacopeia of India
 1st edition I. P. 1955 was published in the official gazette. Dr. B. N. Ghosh, Chairman – Supplement 1960
 2nd edition I. P. 1966, Dr. B. Mukherji, Chairman, Shankar S. – Supplement 1975
 3rd edition I. P. 1985, Dr. Nityanand, Chairman – I Addendum/Supplement 1989 – II Addendum/Supplement
1991

8.  4th Edition I. P. 1996 Dr. Nityanand, Chairman - III Addendum/ Supplement 2000 / IV Addendum/
Supplement 2002
 5th Edition I. P., 2007, Dr. Nityanand, Chairman
 6th Edition I. P., 2010
 7th Edition I. P. 2014 - V Addendum/Supplement 2015
 8th Edition I. P. 2018 - IV Volumes

10.  The Indian Pharmacopoeia is the official book of standards and medicines which produced in India and
it must comply with the specified standards.
 Pharmacopeial standards and acceptance criteria are set with the intention that they be used only as
compliance requirements and not as requirements to guarantee total quality assurance.
 Pharmacopeial standards are the minimum ones with which a manufacturer must comply before release
of a product for sale or distribution in market.
 It is recognized that changes in quality may occur during storage and distribution and the pharmacopeial
requirements are set to define acceptable levels of change and to reject materials or products showing
unacceptable levels

11.  It is the responsibility of the manufacturer to ensure that the product is manufactured in accordance
with current Good Manufacturing Practices and that sufficiently control limits of acceptance are applied
at the time of release of a batch of material or product so that the standards are met until the expiry
date under the storage conditions specified.
 Pharmacopeial requirements for drug substances have been drawn up to provide appropriate limits for
potential impurities rather than to provide against all possible impurities and adulterants.
 Material found to contain an impurity that cannot be detected by means of the prescribed tests is to be
considered as not of pharmacopeial quality if the nature or amount of the impurity found is not
compatible with good manufacturing practices.