2. • The term Pharmacopoiea is derived from Greek word “Pharmakon means
Drug” and “Poiein means to make”.
• It is issued under the authority of respective country.
• IP is the standard book of Govt of India and also been recognised by Drugs
& Cosmetics Rules.
• It comprises list of pharmaceutical substances, formulae along with their
description and standards.
• All Pharmacopoeias consist of the three main Section
a) Introduction b) Monographs of the official drugs c) Appendices
• The word monograph implies the written study of a subject.
3. History
• In pre-independence days, British Pharmacopeia was used in India.
• The colonial addendum of BP 1898 was published in 1900 appeared as
Government of India edition in 1901.
• In 1946 Government of India issued one list known as “The Indian
Pharmacopoeial list”
• Committee under chairmanship of Sir R. N. Chopra along with other nine
members prepared “The Indian Pharmacopoeial list”.
• It was prepared by Dept. of Health, Govt. of India, Delhi in 1946.
• In 1948 Government of India appointed an Indian Pharmacopeia committee
for preparing “Pharmacopeia of India”
• Tenure of this committee was five years.
4. Introduction
• The Indian Pharmacopoeia (IP) is a compilation of official standards for drugs
manufactured in India.
• Addenda or Supplements to the pharmacopoeia will be numbered with
additional characters starting with 1
– e.g. Indian Pharmacopoeia 6.1 or IP 6.1 for the first addendum or supplement, Indian
Pharmacopoeia 6.2 or IP 6.2 for the second addendum, and so on.
• A Pharmacopoeial monograph provides a reliable basis for making an
independent and objective judgement as to the quality of a pharmaceutical
substance.
• As IP standards are statutory, it is important that the contents of
monographs are unambiguous, acceptance criteria are clearly spelt out and
the methods of evaluation provide all the details for carrying out the tests
and assays, including the equipment, reagents and other ancillary materials
that are to be used.
• Standards in the IP are expressed in the form of specifications and test
methods for determining compliance with such standards.
5. Contents of the Pharmacopoeia
• The technical part of the pharmacopoeia shall be broadly divided into the
following sections:
• 1. Introduction
• 2. General Notices
• 3. Monographs
• 4. Test methods
• 5. Reagents and Solutions
• 6. General Texts
• 7. Index
6. The Indian Pharmacopoeia editions are as follows:
Indian Pharmacopoeia 1955 - First edition, followed by supplement in 1960;
Indian Pharmacopoeia 1966 - Second edition, followed by supplement in 1975;
Indian Pharmacopoeia 1985 - Third edition, followed by its addendum in 1989 and
1991;
Indian Pharmacopoeia 1996 - Fourth edition, followed by its addendum 2000,
supplement 2000 for Veterinary Products, addendum 2002 and addendum 2005;
Indian Pharmacopoeia 2007 - Fifth edition, followed by addendum 2008;
Indian Pharmacopoeia 2010 - Six edition with DVD followed by its addendum
2012;
Indian Pharmacopoeia 2014 – Seventh edition with DVD followed by its
addendum 2015 and addendum 2016;
Indian Pharmacopoeia 2018 with DVD - Eighth edition
Indian Pharmacopoeia 2022 - Ninth edition
7. IP 2022 contains information of
a total of 92 new monographs including 60 Chemical, 21 Vitamins, Minerals, Amino
acids, Fatty acids etc.,
3 Biotechnology-derived Therapeutic Products,
4 Human Vaccines,
2 Blood and Blood Related Products,
2 Herbs and Herbal Related Products, and
7 Phytopharmaceutical Ingredient Category monographs.
This has led to the total number of 3152 monographs in the current edition
of IP. In additions, 12 new general chapters have also been introduced. Several
monographs and general chapters have also been revised to update them as per
current global requirements and to harmonize with other pharmacopoeias like USP,
BP, EP, etc. The harmonization of standards with global standards is expected to help
IP getting recognized and accepted in foreign countries.
