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Seven Indian AIDS Drugs Reinstated

August 19, 2005

GENEVA (AP) _ The U.N. health agency said Friday it has reinstated seven Indian-made generic drugs to its list of approved HIV/AIDS medicines for use in developing countries after the manufacturer was able to prove they were the same as the patented versions.

The World Health Organization removed three of the drugs _ made by Ranbaxy Laboratories Ltd. _ from its list of generic AIDS medicines recommended for use in developing countries in August 2004. A random check had found that tests failed to prove that the medicines were biologically the same as the patented drugs.

Ranbaxy later withdrew the other four drugs, saying it was uncertain they were biologically the same as the patented drugs. But the company has now submitted data from new tests that proves that the drugs are equivalent to their patented counterparts, WHO said.

``Subsequently, WHO ran the full range of quality, safety and efficacy checks on the medicines as well as thorough inspections of the new laboratories,″ the health agency said in a statement. ``The products and laboratories were all found to be satisfactory.″

Two of the drugs contain a combination of lamivudine and stavudine in different strengths; another two are combinations of lamivudine, stavudine and nevirapine; one is lamivudine; one is zidovudine; and the seventh is a combination of lamivudine and zidovudine.

WHO also said it has added three new antiretroviral medicines, made by India’s Aurobindo Pharma Ltd., to its approved list.

Two of these are lamivudine tablets in different strengths and the third is zidovudine.

``The addition of 10 medicines will benefit existing AIDS programs and procurement schemes,″ WHO said.

About 6.5 million people in low and middle income countries are in need of antiretroviral treatment, according to the health agency.

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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