Indian Generic Drug Firm Ranbaxy Announces Seven Antiretroviral Drugs Reinstated to WHO-Approved List

Indian generic drug company Ranbaxy on Thursday announced that the World Health Organization has reinstated seven of the company's antiretroviral drugs to its list of prequalified drugs for HIV/AIDS patients after the medications were removed last year because of discrepancies in bioequivalence tests, Reuters reports (Reuters, 8/12). Ranbaxy in November 2004 voluntarily removed its drugs -- including indinavir, lamivudine, nevirapine, stavudine and zidovudine tablets, as well as two combinations of stavudine and lamivudine -- from the WHO list after discovering discrepancies in tests conducted to show whether its generic antiretroviral drugs were equivalent to brand-name versions of the same drugs (Kaiser Daily HIV/AIDS Report, 11/10/04). Ranbaxy said it used globally recognized contract research organizations to conduct the latest bioequivalence studies of its antiretrovirals, which are manufactured at the company's FDA- and WHO-approved plants (Reuters, 8/12). Ranbaxy CEO and Managing Director Brian Tempest said, "This is a significant step forward in Ranbaxy's endeavor to make high-quality, cost-effective ARVs available to HIV patients around the world" (Ranbaxy release, 8/11). Ranbaxy also has sought FDA approval for its antiretroviral drugs in order to qualify them for purchase under the President's Emergency Plan for AIDS Relief. The agency so far has given tentative approval to three of the company's medications (Reuters, 8/12).

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