Addendum to Indian Pharmacopoeia 2008 comes into Force

In a major step towards assuring the health care professionals patients and consumers of the standards of drug in India the Secretary, Ministry of Health & Family Welfare, Shri Naresh Dayal who is also the Chairman of Indian Pharmacopoeia Commission has released the Addendum 2008 to the Indian Pharmacopoeia (IP) 2007 here today. He was chairing the second General Body meeting of the Commission. The Addendum contains amendments to IP 2007 and adds 73 new monographs on different therapeutic groups representing synthetic, herbals and biological drugs. While the amendments to the IP 2007 will come into force with immediate effect, the new monographs will become effective from 1st July 2009.

IP is the official book of standards for drugs included therein terms of the Second Schedule to the Drugs and Cosmetics Act 1940 so as to specify the standards of identity, purity and strength for the drugs imported, manufactured for sale, stocked or exhibited for sale or distributed in India. Compliance with these standards by the industry is thus an assurance to the health care professionals, patients and consumers of their quality. The monographs prescribe the test procedure so as to demonstrate that the article complies with the standards laid down in the Pharmacopoeia. IP 2007 and its addendum will facilitate the manufacturers and other stakeholders to ensure compliance with the technological advancements taken place in the related fields. As India has emerged as one of the developers of generic drugs and also poised for phenomenal growth of pharmaceutical industry, both in terms of volume and value of production, there is an urgent need to frequently upgrade the new monographs by incorporating the changes in the existing analytical procedures. Regular updating of the Indian Pharmacopoeia is the necessity of the day for bringing out an overall improvement in quality drugs in the country. This Addendum is a step in the direction to achieve the said objectives.

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