Salient Features of the Third Edition of Pharmacopoeia of India (1985)

The new analytical techniques such as Flame Photometry, Flurometry, Electrophoresis and Photometric Haemoglobinometry have been introduced as official method for certain chemical analysis.
Dissolution Test has been introduced in the case of certain tablets.
Disintegration Test has been amended by modifying the design of the apparatus and method of testing.
A microbial limit test has been prescribed for certain pharmaceutical aids and oral liquid preparations.
The Pyrogen Test has been revised to make the test less time-consuming than the previous method.
Gas Liquid Chromatography has been recognized as an alternative method for the determination of alcohol concentration in various preparations.
The test for determination of viscosity has been modified by the introduction of other methods involving the use of Ostwald Viscometer.
The new appendix on “Water for Pharmaceutical Use” use been introduced to clearly indicate the different official standard in respect of purified water, water for injection and sterile water for injection.
Some of the drugs have been renamed in this edition e.g. “Acetylsalicylic Acid” has been changed to “Aspirin”.
Many drugs have been omitted from the third edition and many new drugs have been included in the third edition.
The Government of India, Ministry of Health and Family Welfare vide their resolution No. X19020/1/89-DMS and PFA dated 12th August 1991, reconstituted the Indian Pharmacopoeia Committee for a period of five years for the preparation of the fourth edition of Pharmacopoeia of India. The composition of the committee was as follows:
Chairman
Members – 18 in number representing academic, research and industry
Member – Secretary
Assistant – Secretary
The Committee appointed the subcommittees and working groups in order to expedite the preparation of the new edition of the Indian Pharmacopoeia.
The Monographs, Appendices and General Notes as prepared by the “Working Group” and finalized by the Committee were then published in the form of fourth edition of the Pharmacopoeia of India in 1996 by the Government of India.
      Salient Features of the Fourth Edition of Pharmacopoeia of India(1996)
It contains 1149 monographs and 123 appendices and available in two volumes.
The computer-generated structural formulae have been introduced.
Some titles have been changed to include the more commonly accepted names of India. E.g. Hyoscine Hydrobromide for Scopolamine Hydrobromide
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.
The high performance liquid chromatography (HPLC) has been widely used as a method to analyse many formulations which can otherwise be analysed only by more difficult and less accurate method e.g. biological assay of Insulin has been replaced by HPLC.
The test for bacterial endotoxins as a more suitable substitute for the test for pyrogens has been introduced for some articles.
A quantitative method for determining particulate matter in injectable preparations has been replaced by the quantitative test of the previous edition. The test is applicable solutions that are supplied in containers with 100 ml or more.
The specific biological assays and tests provided for a vaccines; hormones, blood products and enzymes have been transferred from an appendix to the individual monographs.
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.
After the publication of fourth edition of the Indian Pharmacopoeia in 1996, an addendum was published in 2000. Addendum 2002 was published to incorporate the latest developments made in pharmaceutical sciences. The numbering of pages in this Addendum is continuous with that of Volume I and II of Indian Pharmacopoeia 1996 and Addendum 2000. The following changes are made:-
A number of tests and standards in monographs have been amended and replaced with old monographs.
The test on bacterial endotoxins replaces the pyrogen test.
A new appendix on ‘residual solvent’ has been incorporated to monitor the content of organic volatile impurities that are used or produced in the manufacture of an active pharmaceutical substance, excipient or medicinal products.
An appendix on HPLC has been replaced by a revised version covering ion chromatography.
Monographs of a number of antiretroviral activities and their formulations have been introduced in this Addendum.
Monographs on vaccines for Hepatitis B and that for Rabies have been revised.
Government of India has constituted the Indian Pharmacopoeia Commission (IPC) on 22nd March, 2005. The Commission has its headquarters at the Central Indian Pharmacopoeia Laboratory (CIPL). Sector-23, Raj Nagar, Ghaziabad U.P. The Indian Pharmacopoeia Commission has a Governing Body of 8-10 members and Scientific Body of 15-23 members from different related scientific fields. Various expert committees were also made to prepare various monographs.