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WHO Takes 3 Of Indian Ranbaxy HIV Drugs Off Approved List




 

GENEVA (AP)--The U.N. health agency has removed three Indian-made generic versions of antiretroviral drugs from its list of approved HIV medicines, saying it's uncertain they're biologically the same as the patented drugs.

The generic drugs, which are manufactured by India's Ranbaxy Laboratories Ltd., will be kept off the World Health Organization's list of approved HIV treatments until the company can submit evidence of new tests that prove the drugs are biologically equivalent to the original medicines, the agency said in a statement Wednesday.

"This effectively means that the medicines may or may not offer the same therapeutic benefits as the originals on which they are based," the WHO explained.

Two of the drugs contain a combination of lamivudine, stavudine and nevirapine in two different strengths. The third is a lamivudine plus zidovudine pill. Ranbaxy will now resubmit the products to a different laboratory, WHO said.

"If and when those products and the laboratories are found to meet the specified requirements, WHO will reinstate them in its list of prequalified products," the agency added.

WHO removed two generic drugs made by Cipla Ltd., another Indian firm, from its list of approved HIV medicines in June, also because tests had not proved that they were the same as the patented versions. The agency is still waiting for Cipla to submit documentation from a new laboratory to prove that its drugs are the same as the patented ones.

In a push to expand treatment, WHO is aiming to put 3 million people in the developing world on HIV drugs by 2005. About 40 million people worldwide are infected with the AIDS virus and 5 million new infections are recorded every year. Sub-Saharan Africa is the worst hit, but the epidemic is now pushing deep into Asia.



 


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Information in this article was accurate in August 4, 2004. The state of the art may have changed since the publication date. This material is designed to support, not replace, the relationship that exists between you and your doctor. Always discuss treatment options with a doctor who specializes in treating HIV.