The Indian Pharmacopoeia (IP) 2007, having many new features to match with its counterparts in developed countries and encompassing over 1500 monographs, was today released. The new monographs would be made effective from April 2008.
Union health minister Dr Ambumani Ramadoss released the massive document, prepared by the Indian Pharmacopoeia Commission. The function at the Central Indian Pharmacopoeia Laboratory at Ghaziabad near New Delhi, was attended by his deputy in the cabinet Panabaka Lakshmi, senior officials, scientists 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 standards of this pharmacopoeia are authoritative, legally enforceable and intended to help in the inspection and licensing of manufacturing and distribution of drugs and pharmaceuticals,'' officials behind the effort said.
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. All the feedback and inputs have been reviewed by the relevant Expert Committee to ensure the feasibility and practicability of the standards and methods revised in this edition of the Pharmacopoeia, as well as the principle of "openness, justice and fairness" has been kept in mind during compiling and editing, according to the officials.
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.
The IPC had published IP Addendum 2005 to IP 1996 with amendments in existing monographs and adding 46 new monographs and it was made effective from June 30, 2006. The 1996 edition had 1250 monographs. Ever since, the IPC secretariat has been on the huge task of bringing out the new edition in a comprehensive and more user-friendly format.