After its launch in Delhi last month, the Indian Pharmacopoeia (IP) 2007, having many new features to match with its counterparts in developed countries and encompassing over 1500 monographs, was formally released in Chennai on January 21. The new monographs would be made effective from April 2008.
Dr GN Singh of Indian Pharmacopoeia Commission released the massive document, prepared by the Indian Pharmacopoeia Commission. The release function was attended by Debashish Pandy, joint secretary, union ministry of health, Indian Pharmacopoeia Commission deputy director, south zone Shanti Gunasekharan, state drug controller Anbu Elango, other senior officials and industry representatives.
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.
