This document provides an introduction to Indian pharmacopoeias and their history and development. It discusses that the Indian Pharmacopoeia is the official book that contains standards for drugs and related substances in India. It must be complied with by manufacturers. The document outlines the various editions of the Indian Pharmacopoeia published since 1955 and describes the typical contents and structure of monographs in the publications. It also provides a brief introduction to the National Formulary of India and its editions.

1. INTRODUCTION TO INDIAN
PHARMACOPOEIAS
Mr. Ajay Kumar Dubey, Assistant Professor, Institute of Pharmacy
Subject- Inorganic Pharmaceutical Chemistry (BP104T)
Email- a84dubey@gmail.com
Dr. Manju Pandey, Director, Institute of Pharmacy
Email- director.pharma@srmu.ac.in
Shri Ramswaroop Memorial University, Barabanki-225003

2. Indian Pharmacopoeia
• Under the Drugs and Cosmetics Act 1940 , The Indian
Pharmacopoeia is an official book that 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 .
• 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 .

3. History of development of Indian Pharmacopoeia
• The government of India published the Indian pharmacopoeial
list in 1946, as a supplement to the British Pharmacopoeia.
• Indian Pharmacopoeial List contain list of drugs both included
and not included in the British Pharmacopoeia along with
standards to secure their usefulness, tests for identity and
purity.
• The Govt. of India constituted a permanent Indian
Pharmacopoeia Committee in 1948 .
• This committee was assigned the task of preparing Indian
Pharmacopoeia and to keep it up-to-date.

4. Editions of Indian Pharmacopoeia 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 , followed by its addendum 2012
• Indian Pharmacopoeia 2014 with DVD - Seventh edition
• Indian Pharmacopoeia 2018 with DVD - Eighth edition

5. Number of volumes in each edition of IP
• IP 1955, 1965 and 1985 was published in 1
volumes
• IP 1996 was published in 2 volumes
• IP 2007 and 2010 was published in 3 volumes
• IP 2014 was published in 4 volumes
• IP 2018 was published in 4 volumes

6. Contents of the IP 2014 Volume-1
• Introduction General Chapters
• General Notices
• Test Methods
• Apparatus
• Biological Methods
• Chemical Methods
• Physical and Physicochemical Methods
• Pharmaceutical Methods
• Tests on Herbal Products
• Tests on Vaccines
• Tests on Blood and Blood Blood-related Products
• Reference Data
• Reagents and Solutions
• General Tests
• Containers
• Tables

7. Contents of the IP 2014 Volume-2
• General Notices General Monographs on
Dosage Forms Monographs on Drug
substances, Dosage forms and Pharmaceutical
Aids
• Monographs A to M

8. Contents of the IP 2014 Volume-3
• General Notices
• Monographs on Drug substances,
• Dosage forms and Pharmaceutical aids
• Monographs N to Z
• Monographs on Vaccines and Immunosera for
Human Use
• Monographs on Herbs and Herbal Products
• Monographs on Blood and Blood Blood related
Products
• Monographs on Biotechnology Products

9. Contents of the IP 2014 Volume-4
• Monographs on Veterinary Products o
• Non Non-Biological
• Biological
• Diagnostics Index

10. MONOGRAPH
Title of the Monograph : The main name of the substance (The
International Non-proprietary Name (INN) approved by the World
Health Organization (WHO )).
Subsidiary or abbreviated title or synonym : The common name(s), if
any, of the substance.
Chemical formula and Molecular Weight of the substance : If
necessary, its I.U.P.A.C. chemical name and/or its chemical structure
is also given .
Standards: Prescribes the standards of purity and strength e.g. Sodium
bicarbonate IP contains not less than 99.0 % and not more than
100.5 % of NaHCO3.
Description : A brief description of the physical form of the material,
including colour, texture, whether hygroscopic, odour, if readily
apparent, and any other characteristic

11. MONOGRAPH
Solubility :
Identification : At least two or three identification tests, starting with
physical and instrumental tests and ending with general chemical
reactions is given.
Tests of purity: These tests include melting point, boiling point, weight
per ml, limit tests for chloride, sulfates , iron, heavy metals, lead and
arsenic, specific optical rotation, sulfated ash, loss on drying, pH of
solution, etc. as may be applicable for the substance.
Method of Assay: The term ‘Assay’ is used in pharmacopoeias for
quantitative determination of principal ingredients of the official
substances and of their preparations.
Storage : Prescribes some conditions for the storage of some official
substances which are likely to deteriorate if not properly stored.

12. NATIONAL FORMULARY OF INDIA
• The National Formulary of India would prove to be the
authoritative guide to prescribing, dispensing and
administering medicines for all healthcare professionals.
The National Formulary of India editions are as follows: -
• National Formulary of India 1960 -The first edition of NFI
• National Formulary of India 1966 -The Second edition of NFI
• National Formulary of India 1979 –The Third edition of NFI
• National Formulary of India 2011- Fourth Edition It contains
information about drug interaction, resistance, cumulative
effects, drug dependence, prescription writing etc.

13. CONTENTS OF NATIONAL FORMULARY OF INDIA
• List of Medicines in NFI
• Common Abbreviations
• General Advice to Prescribers
• Alphabetical listing of different classes of drugs with Indications .
• Availability
• Dose .
• Contraindications
• Precautions
• Adverse effects
• Storage
• Appendices
• Index

14. THANK YOU
REFERENCES-
https://en.wikipedia.org/wiki/Indian_Pharmacopoeia
https://www.slideshare.net/
 https://www.pharmtech.com/