The document provides an overview of pharmacopoeias and details the history and development of the Pharmacopoeia of India. It discusses how the Indian Pharmacopoeial List was first published in 1946, followed by the Indian Pharmaceutical Codex in 1953. The first edition of the Pharmacopoeia of India was then published in 1955. Subsequent editions in 1985, 1996, 2010, and 2014 introduced new analytical techniques, testing methods, and drug standards. The document outlines some key features and changes between editions, such as introducing dissolution testing, additional identification tests, and recognizing new analytical methods like HPLC and infrared spectroscopy.

1. Introduction to
Pharmacopoeias
Mr. G.A.Shete

2.  Pharmacopoeia:
 Pharmakon means “a drug” and poein means “to make”. Pharmacopoeia is defined as a compressive
book which is issued under the authority of government and contains a list of drug and formulae used
for medicinal preparation with description and the tests for those substances and the standards to
which they must confirm.
 Example of different Pharmacopoeias : I.P., B.P., USP, European Pharmacopoeia, etc.
Sr No Edition Year of publication
1 1st 1955
2 2nd 1966
3 3rd 1985
4 4th 1996
5 5th 2007
6 6th 2010
7 7th 2014

3.  Brief the history of the ‘Pharmacopoeia of India’
 The government of India directed the Drugs Technical Advisory Board to list the drugs that are used
in India, which are not mentioned in British Pharmacopoeia and also recommend the standards to
be prescribed to maintain uniformity and the chemical tests to be used to establish identity and
purity. The Government of India published the Indian Pharmacopoeial List in 1946 as a supplement
to British Pharmacopoeia. The term list in the title was ‘misleading’ in that, the book not only
contained a list of drugs which were of substantial medicinal value but also laid down standards.
 The Indian Pharmacopoeial List contained about 180 monographs and a number of appendices
prepared on the lines of the British Pharmacopoeia. Approximately 100 monographs were on
vegetable drugs growing in India and on their galenicals. `The drugs of plant origin such as
artemesia, bael, berberis, cannabis, ispaghula, kaladana, kurchi, myrobalan,picrorhiza,
punarnava, rauwalfia, vasaka etc.were included in it. Similarly several oils such as ajowan,cassia,
chaulmoogra, neem and pudina were included it. The appendices gave detail for a number of
determinations referred to in the monographs.
 The Pharmaceuticals and Drugs Research Committee of the Council of Scientific and Industrial
Research decided in February 1947to compile a ’Brochure’ to highlight the information and clinical
users of the important indigenous drugs of India. Later on it was decided to prepare a ’Codex’
instead of Brochure on the lines of the British Pharmaceutical Codex. The first Indian
Pharmaceutical Codex published in 1953.The Codex consisted of two parts. The part carried about
190 general monographs on natural product and drugs of vegetable and animal origin, and a few
chemicals. The second part consisted of formulary of galenicals and other preparations.

4.  After the publications of the Indian Pharmacopoeial List the Government of India, constituted an
eleven member Indian Pharmacopoeial Committee in 1948, in their notification No. F.1-1/48-DS
dated 23rd November, 1948, for preparing the Pharmacopoeia of India. The tenure of the office of
the members of the Committee was five years. It was extended by one year vide Government
notification no F.6- 10/53-DS34 dated 21st November 1953. In compiling the monographs of the first
Pharmacopoeia of India, help was taken from all available established scientific data in the modern
Pharmacopoeia, such as British Pharmacopoeia, the United States Pharmacopoeia, and the
international Pharmacopoeia and from scientific institutions interested in drugs and Pharmaceuticals
products. The first edition of Pharmacopoeia of India was compiled and then published in 1955.

5.  Salient Features III Edition of I.P.:
i. New analytical techniques such as flame photometry, Flurometry, have been introduced as official
method for certain chemical analysis.
ii. Dissolution test has introduced in the case of certain tablets.
iii. Disintegration Test has been amended by modifying the design of apparatus and method of
testing.
iv. A microbial limit test has been prescribed for certain pharmaceutical aid & oral liquid preparation.
v. Pyrogen test has been revised to make the test less time consuming than the previous method.
vi. Gas liquid chromatography has been recognized as an alternative method for the determination of
alcohol concentration in various preparations.
vii. Test for determination of viscosity has been modified by introduction to other method involves.
viii. The new appendix on water for pharmaceutical use” has been introduced to clearly indicate the
different official standard in respect of purified water.
ix. Some of the drugs have been renamed in this edition.
x. Many drugs have been omitted from the third edition and many new drugs have been included in
the third edition.
xi. It provides the official standard to the new drug which came into use after the publication of first
addendum to third edition.

6.  Salient Features IV Edition of I.P.:
i. It contains 1149 monographs and 123 appendices and available in two volumes
ii. The computer generated structural formula have been introduced
iii. Some titles have been changed to include the more commonly accepted names in India eg. Hyoscin hydro
bromide for scopolamine hydro bromide
iv. Infra-red and ultra-red absorption spectrophotometric tests for identification of drug substance have been
introduced as alternative tests to the classical chemical tests. The infra-red reference Spectra of a number
of drug substances has been included in an appendix.
v. The high performance liquid chromatography (HPLC) has been widely used as a method to analyze many
formulation which can otherwise be analyzed only by more difficult and less accurate method Eg. Biological
assay of insulin has been replaced by HPLC.
vi. The test for bacterial endotoxins as a more suitable substitute for the test for pyrogens has been
introduced for some articles
vii. A number of general monographs. Eg. Eye drop, eye ointment, nasal preparation, oral liquids,
viii. A quantitative method for determining particulate matter in injectable preparation has been replaced by
the qualitative teat of the previous edition. The test is applicable to injectable solutions that are supplied
in container with 100 ml or more.
ix. The specific biological assay and tests provided for vaccines; hormones, blood products and enzymes have
been transferred from an appendix to the individual monographs.
x. In the monographs for oral rehydration salts (ORS), ORS- bicarbonate formula has been dropped due to its
stability problem, whereas ORS-citrate formula recommended by WHO is retained