Existence of an independent body to review and update the national pharmacopoeia on a regular basis is a fundamental need for any country with a vibrant pharmaceutical industry. Such a body with adequate strength of technically qualified personnel and infrastructure, is responsible to include large number of new drugs and their combinations coming into the market place periodically. This is a practice strictly followed by regulatory authorities in all countries with a developed pharmaceutical industry. But in India, even formation of an independent Pharmacopoeia Commission is yet to take place although Indian pharmaceutical industry is one of the highly developed industry sector of this country. A decision to have an independent Pharmacopoeia Commission was taken by Drug Technical Advisory Body as early as 1982.And the Union health ministry had cleared the proposal in August 2001.Since then for various reasons, constitution of this body is being held up making regular updating of IP a difficult and incomplete job. The updating work is being currently done by the IP committee through sub committees and experts from academia and industry in the absence of the Commission. The latest edition of IP, published in 1996,thus contains a total of 1149 monographs including all anti TB and anti AIDS drugs manufactured in India. Of these,42 mongraphs were added in 2000 and 70 in 2003.
A pharmacopoeia is essentially a compilation of technical information on standards for active pharmaceutical ingredients, drug products and associated testing techniques for the evaluation of quality. And everyone in the drug industry wants the work of updating and reviewing IP to be carried out by a dedicated team of professionals on regular intervals considering fast changing trends in the pharmaceutical industry and science. Some of the important issues to be looked into in this regard are : 1.harmonisation of Indian Pharmacopoeia with international pharmacopoeias but retaining identity of IP as India
has a number of herbal drugs. 2.Impending patent law changes in India and its impact on the pharmaceutical industry.3.Growing number of fixed dose combinations in the market.4.Laboratory corroboration of any technical information by Central Indian Pharmacopoeia Laboratory. In all these areas hardly any serious work has been done by the current IP Committee. Without addressing these and other issues, making IP a perfect document will be impossible. And for that, the IP commission with adequate autonomy should be in place without any further delay. A World Bank funding of Rs.13 crore is already available for the purpose. Then, what is that holding up the officials in the health ministry to give a go ahead to this project.