After its release in Delhi, last month, the Indian Pharmacopoeia 2007 which has many new features to match its counterparts in developed countries and encompassing over 1500 monographs was formally launched in Chennai on Jan 21 through an interactive session with the stake-holders. The new monographs would be made effective from 1st April 2008.
Under the Chairmanship of Debashish Panda, joint secretary, union ministry of health and family welfare, Dr. GN Singh, member secretary-cum-scientific director of Indian Pharmaceutical Commission conducted the interactive session with the stake-holders. Shanthy Gunasekaran, Incharge-CDSCO (south zone), R.S. Anbu Elango, Director of Drugs Control, Tamilnadu, Dr. Murugaesan, incharge-CDTL, Chennai, other senior officials and industry representatives attended the session.
The new edition comes out in 3 volumes with 300 additional monographs has many new features. Besides, the 175 new monographs of chemicals and dosage forms, it has monographs on vaccines, immunosera, herbs, herbal products, blood and blood-related products, biotechnology and veterinary products.
The fifth edition of the standard-setting document has been prepared in accordance with the principles and designed plan decided by the Scientific Body of the Indian Pharmacopoeia Commission. In addition to the past practices of requesting for comments, the contents of revised appendices and monographs have been publicized on the website of the Indian Pharmacopoeia Commission, for collecting comments widely from various institutions and organizations.
The pharmacopoeia standards included in this publication adhere to the concept of harmonization with those used internationally, also keeping in view technological status for manufactures and analysis of different sectors of the industry, without compromising with the quality of the products.
Cross referencing has been avoided and uniformity of presentation of subject matter was kept. Categories of a drug, dosage & usual available strength of dosage forms have been omitted. Classical chemical tests for identification of an article have been almost eliminated & more specific IR & UV spectrophotometric tests have been introduced.
Use of Chromatographic methods has been greatly extended to cope with the need for more specificity in assays and test for pyrogens were virtually eliminated. The BET (bacterial endotoxin test) are going to be applicable to more items.