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PHARMACOPOEIA
• Derived from Greek word ‘Pharmakon’ means drug and ‘Poiea’ means to make. Literally it means that it is a
list of medicinal substances, crude drugs and formulae for making preparations from them
• It is a legal and official book issued by recognized authorities usually appointed by Government of each
country.
• It comprises list of pharmaceutical substances, formulae along with their description and standards.
• The books containing the standards for drugs and other related substances are known as pharmacopoeia
and formularies - collectively these books are known as the drug compendia.
• The pharmacopoeias or formularies contain a list of drugs and other related substances regarding their
source, Monographs (means collection of detailed information on a drug), standards, tests, formulae for
preparing the same, action and uses, doses, storage conditions etc.
• These books are prepared under the authority of the Government of the respective countries.
• These books are revised from time to time so as to introduce the latest information available as early as
possible after they become established.
• In order to keep the size of book within reasonable limit it becomes necessary to omit certain less frequently
used drugs and pharmaceutical adjuvants(गुणवर्धक औषधर्) from each new edition of the book. Therefore, in
each new edition of these books certain new monographs are added while the older ones are deleted.
• For the preparation of these books the expert opinion of medical practitioners, teachers and pharmaceutical
manufacturers are obtained.
➢ CLASSIFICATION
• The drug-compendia are classified as:
(i) Official compendia
(ii) Non-official compendia

i) OFFICIAL COMPENDIA
• Official compendia are the compilations of drugs and other related substances which are recognized as legal
standards of purity, quality and strength by a government agency of respective countries of their origin.
• e.g. British Pharmacopoeia (BP), British Pharmaceutical Codex (BPC), Indian Pharmacopoeia (IP), United
States Pharmacopoeia (USP) , National Formulary (NF) , The State Pharmacopoeia of USSR and
Pharmacopoeias of other countries
ii) NON-OFFICIAL COMPENDIA
• The book other than official drug compendia which are used as secondary reference sources for drugs
and other related substances are known as non-official drug compendia.
• e.g. Merck Index, Extra Pharmacopoeia (Martindale) , United States Dispensatory etc.
➢ List of Pharmacopeias:
1. Argentine 10. German 19. Nordic
2. Austrian 11. Hungarian 20. Polish
3. Belgian 12. Indian 21. Portuguese
4. Brazilian 13. International 22. Rumanian
5. British 14. Italian 23. Russian
6. Chinese 15. Japanese 24. Spanish
7. Egyptian 16. Yugoslavian 25. Turkish
8. European 17. Mexican 26. United state
9. French 18. Netherlands

❖ INDIAN PHARMACOPOEIA (IP)

➢ Introduction to IP-
• The Indian Pharmacopoeia (IP) is published in fulfilment of the requirements of the, Drugs and
Cosmetics Act, 1940 and Rules thereunder. It prescribes the standards for drugs produced and/or
marketed in India and thus contributes in the control and assurance of the quality of the medicines.
The standards of this pharmacopoeia are authoritative and legally enforceable. It intends to help in
the licensing of manufacturing units, inspection and distribution of medicines.
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•For the preparation of Pharmacopoeia of India, the pharmacopoeias of other countries, like British,
Europe, United States, USSR, Japan, the National Formulary (USA) and Merck Index were consulted.
• The persons working in pharmaceutical industry, drug control laboratories, research and teaching
institutions take participation in the preparation of IP.
• Under the Drugs and Cosmetics Act 1940, the Indian Pharmacopoeia is an official book which
contains the standards for drugs and other related substances included in the pharmacopoeia. The
drugs and other related substances prepared by pharmaceutical manufacturers must comply with
these standards.
➢ History-
• The historical developments of Pharmacopoeia in India traces back to 1563 and the credit goes to
Garcia da Orta a Portugese physician-cum-teacher.
• The idea of indigeneous Indian Pharmacopoeia was concieved in 1837 and this idea take shape in
1841 in the form of Bengal Pharmacopoeia and Conspectus of Drugs(दवाओं का सवेक्षण).
• The hindustani version in Bengali and Hindi of London Pharmacopoeia was made available in India
from 1901 onwards.
• The Indian Pharmacopeial List, published in 1946 formed the seeding for the true Official Indian
Pharmacopoeia published in 1955.
• The first edition of Indian Pharmacopoeia was published in 1955, but actually the process was started
as early as 1944. In 1944 Government of India asked the Drugs Technical Advisory Board to prepare
the list of drugs used, in India, having sufficient medicinal value to justify their inclusion in official
pharmacopoeia.
➢ The Indian Pharmacopoeial List, 1946.
• The list contain both, drugs included and not included in the British Pharmacopoeia along with
standards to secure their usefulness, tests for identity and purity was prepared by the committee and
was published by the Government of India under the name ‘The Indian Pharmacopeial List 1946’.
• The committee constituted under the chairmanship of Col. Sir R.N.Chopra along with other nine
members, prepared the list of drugs with the following details:
i) Substances included in the British Pharmacopoeia for crude drugs, chemicals and their
preparations.
ii) Substances not included in the British pharmacopoeia
a) Drugs of plant origin
b) Drugs of animal origin
c) Biological products
d) Insecticides
e) Colouring agents
f) Synthetics
g) Miscellaneous
h) Drugs for veterinary use.
• The Indian Pharmacopeial List 1946 was prepared by Department of Health, Govt. of India

➢ The Eight edition of Indian Pharmacopoeia was published in 2018 by the Indian Pharmacopoeia
Commission(IPC) on behalf of the Ministry of Health and Family Welfare, Government of India.
 Salient features Indian Pharmacopoeia 2018 –
• 220 New monographs
• 170 New chemical monographs
• 15 Herbal Monographs
• 03 Monographs on Radiopharmaceutical
• 14 New veterinary Non-biological monographs.
• 18 New Biological monographs
• 02 Monographs on Vaccines and Immunosera for human use
• 06 Monographs on Biotechnology derived therapeutic products.
• 10 Monographs on Blood and Blood related products.
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• General Chemical tests & Thin Layer Chromatography (TLC) for identification of an article
have been almost eliminated; and more specific infrared, ultraviolet spectrophotometer and
HPLC tests have been emphasized.
• The use of chromatographic methods has been extended to cope with the need for more
specificity in assays and in particular, in assessing the nature and extent of impurities in
ingredients and products.
• Most of the existing Assays and Related Substances Test methods have been upgraded by
liquid chromatography to harmonize with other International Pharmacopoeias.
• Pyrogen test has been replaced by Bacterial Endotoxin test (BET) in parenteral preparations
and other monographs.
• For ease of access to make Pharmacopoeia more user-friendly, an Index has been
incorporated in Volume-I along with the already existing one in Volume-IV of IP.
• 53 New Fixed Dose Combination (FDCs) monographs have been included, out of which 25
FDC monographs are not available in any Pharmacopoeia.
• General Chapters on Volumetric Glassware, Conductivity, Dissolution test, Disintegration
test, Dimensions of Hard Gelatin Capsule Shells etc. have been revised.

Edition Year Vol. Addendum/Supplement Chairmaship Features

1st 1955 1 Supplement 1960 Dr. B.N. Ghosh 986 Monographs
Supplement 1975 (126 new Dr. B. Mukherjee 274 Monographs deleted 93 new added
2nd 1966 1 added 250 amended, Cholera
vaccine deleted)
Addendum 1989(46 added 126 Dr. Nityanand 261 Monographs added 450 deleted
3rd 1985 2 amended)
Addendum 1991 (62 added 110
amended)
Addendum 2000(42 new added) 1149 total Monographs
Vet supplement 2000 (208 Dr. Nityanand 294 Monographs new 110 deleted
4th 1996 2 added
Addendum 2002
Addendum 2005
Vol-1 contain general notices and
general chapters
5th 2007 3 Addendum 2008 Dr. Nityanand Vol-2&3 contains general monographs
on drug substance, dosage form and
pharmaceutical aids.
Vol-1 contains- the notice preface, the
structure of the IPC,
Acknowledgements, introduction and
the general chapters.
Vol-2 contains the general notice,
General monographs on dosage forms
6th 2010 3 Addendum 2012 Shri. K.Chandramouli and monographs on drug substances,
dosage form and Pharmaceutical aids(A
to M)
Vol-3 contains- monographs on dosage
forms and monographs on drug
substances, dosage form and
Pharmaceutical aids(N to Z)

The IP 2014 incorporates 2550

Addendum 2015 Nabi Azad (Health minister) monographs of drugs out of which 577
7th 2014 4 Addendum 2016 are new monographs consisting of APIs,
excipients, dosage forms and herbal
products etc

8th 2018 4 Addendum 2019 DR. C.K.MIshra Salient features See above