Seven Indian AIDS Drugs Reinstated

On Friday, the World Health Organization reinstated seven generic HIV/AIDS drugs made by Ranbaxy Laboratories Ltd. to its list of medicines approved for use in developing nations. WHO made the move after finding the Indian firm's drugs were equivalent to the patented medicines. In addition, WHO added three new antiretroviral drugs made by Indian firm Aurobindo Pharma Ltd. to its list.

In August 2004, WHO delisted three Ranbaxy AIDS medicines after a random check found that tests failed to prove the drugs' bioequivalence. Ranbaxy later removed four other HIV/AIDS drugs, citing similar uncertainties. Ranbaxy now has submitted data from new tests proving the drugs are bioequivalent to patented drugs, said WHO.

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

Back on WHO's approved HIV/AIDS drugs list are Ranbaxy's two different doses of lamivudine and stavudine combinations; another two combining lamivudine, stavudine and nevirapine; one is lamivudine; one is zidovudine; and the seventh is a lamivudine and zidovudine combination. The Aurobindo drugs are two different strengths of lamivudine and the third is zidovudine.

"The addition of 10 medicines will benefit existing AIDS programs and procurement schemes," said WHO, whose goal is to treat 3 million HIV/AIDS patients in poor nations with antiretroviral drugs by 2005.

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