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Issue dated - 22nd August 2002

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IP to publish monographs of 12 antiretroviral drugs
A Special Correspondent - Mumbai

The Indian Pharmacopoeia is in the process of publishing an addendum to include monographs of 12 antiretroviral bulk actives and their 20 dosage forms before the end of 2002 calender year.

The bulk actives for which monographs are being designed include didanosine, efavirenz, indinavir sulphate, lamivudine, nelfinavir mesylate, nevirapine, ritonavir, sequinavir mesylate, stavudine, zidovudine, abacavir and lopinavir. The dosage forms include tablets, capsules, delayed-release and oral suspensions of the 12 bulk actives.

The move to list monographs of antiretroviral drugs is the first step towards upgrading the the IP monographs to international standards, say IP Committee members. They informed that Dr Nitya Nand, chairman of the IP Committee, plans to form small sub-groups of scientists in different areas of expertise to bring about a total upgradation in the IP monographs on par with international standards. In other words, the IP Committee is in the process of a major revamp and reconstitution to include experts with current knowledge in newer technologies to update the monographs.

A three-member working group has been formed to design the monographs for antiretroviral drugs. They include Dr V G Nayak of Cipla, Dr T G Chandrashekhar from Ranbaxy Laboratories, and Dr K M Thomas from Aurobindo Pharma. It is interesting to note that the members are the representatives of three major Indian companies, which incidently are fierce competitors of anti-HIV therapies in the domestic as well as international markets.

The decision to design antiretroviral monographs crystallised following the meeting of DCGI and Dr Nitya Nand alongwith the members of IP Committee with Dr Kopp Kubel of International Pharmacopoeia and WHO representative Andre Van Zyl. It may be mentioned that Cipla had already submitted ten monographs of anti-HIV drugs last year to the International Pharmacopoeia.

This joint meeting was soon followed up with a meeting of the IP Committee with the USP representatives for collaborative work to develop monographs for inclusion in the USP (EPP 1 August, 02). A joint working group has been set up comprising of Dr Roger Williams and Dr Srinivasan from USP and Dr Ajit Dangi (OPPI), Dr V G Nayak (BDMA) and Dr Milind Joshi (IDMA).

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