Date:14/03/2006 URL: http://www.thehindubusinessline.com/2006/03/14/stories/2006031403180700.htm

Back Concern over different quality criteria for AIDS drugs

P.T. Jyothi Datta

The tender did not insist on WHO pre-qualification

Governments use the WHO pre-qualification list to guide procurement, assuming that safety and efficacy have been established.

Mumbai , March 13

Despite Indian drug-makers supplying AIDS medicines to the world, concerns are emerging back home on why the quality yardstick for selling drugs internationally is not followed when procuring AIDS medicines for local supply.

The trigger for this debate is a recent contract, estimated at Rs 65 crore, to supply AIDS drugs to the National Aids Control Organisation (NACO).

Two tenders were floated by the Centre to procure anti-AIDS drugs for an existing national programme where medicines are given free to people with HIV/AIDS.

But the quality criteria differed in the two supply contracts, though medicines were being procured for the same NACO programme, a drug-company official told Business Line.

The World Health Organisation's (WHO) pre-qualification was a requirement for the larger contract, which was to be funded by the Global Fund for AIDS, tuberculosis and malaria. But the "smaller" tender, to be funded by Government resources, did not insist on WHO pre-qualification, though it too was procuring medicines for the same NACO programme, the official said.

Despite repeated attempts, NACO was not available for comment.

WHO PRE-QUALIFICATION

A WHO pre-qualification is a virtual endorsement of the drug. Governments use the list to guide procurement, assuming that safety and efficacy have been established.

India is home to Cipla, Ranbaxy, Hetero and Matrix, who make or supply ingredients to companies that make products that feature on the WHO quality list. But newer entrants like Emcure, for instance, sell AIDS drugs in India and abroad, though they are yet to feature on WHO's pre-qualification list.

An Emcure executive said they were in the process of getting the WHO stamp of approval. But, it is not fair to treat the absence of the same as a handicap, he said, as the company had approvals from the Indian drug regulatory authority.

A non-profit organisation representative working with AIDS-patients said India needed to benchmark against the WHO pre-qualification standards.