Indian Generic Drug Firm Ranbaxy Removes All Its Antiretroviral Drugs From WHO-Approved List

The Indian generic drug company Ranbaxy voluntarily has removed all seven of its antiretroviral drugs from the World Health Organization's approved list of drugs for HIV/AIDS patients, WHO announced on Tuesday, Reuters reports. The company removed its drugs from the WHO list -- which still includes 54 antiretroviral medications -- after discovering "discrepancies" in tests conducted to show whether its generic antiretroviral drugs were equivalent to brand-name versions of the same drugs, according to Reuters (Waddington, Reuters, 11/9). The medications removed from the list include indinavir, lamivudine, nevirapine, stavudine and zidovudine tablets, as well as two combinations of stavudine and lamivudine (Cage, AP/CBSNews.com, 11/9). WHO in August removed three generic Ranbaxy antiretroviral medications -- including a fixed-dose combination of lamivudine, stavudine and nevirapine in two strengths and a lamivudine/zidovudine combination pill -- after inspecting a contract research organization that conducted tests to determine whether the medications were bioequivalent to the patented versions. WHO decided to remove the drugs after determining that the testing lab failed to meet international standards of clinical and laboratory practices (Kaiser Daily HIV/AIDS Report, 10/20). Ranbaxy in September voluntarily recalled all of its HIV/AIDS drugs in South Africa because of problems with the research organization (Kaiser Daily HIV/AIDS Report, 10/28). According to WHO, the company has said it plans to submit new studies of the seven drugs -- which could get them reinstated to the list -- and the first study is expected to be completed by next month, Reuters reports. WHO in a statement said it has urged the manufacturers of all of the prequalified HIV/AIDS-related medicines to check data they have submitted, Reuters reports.

Patient Recommendations, Reaction
WHO has recommended that patients already on the Ranbaxy drugs in question should continue to take them (Reuters, 11/9). Andre van Zyl, a project manager at WHO, said that Ranbaxy's withdrawal does not "necessarily" mean that the drugs are "unsafe" or "ineffective," the Wall Street Journal reports (Whalen/Abboud, Wall Street Journal, 11/10). Daniel Berman, AIDS coordinator for Medecins Sans Frontieres' Access to Essential Medicines program -- which has 23,000 people on HIV/AIDS medications in 27 countries -- said that Ranbaxy's de-listing is "unlikely" to have a "serious affect" on MSF's HIV/AIDS programs, the Washington Post reports. "We are confident in the drugs we are using," Berman said, adding, "We can't make an equation that if a drug is removed from the list that it's not a good drug." Fewer than 10 of the 38 countries in which UNICEF provides HIV/AIDS drugs receive Ranbaxy drugs, Stephen Jarrett, deputy director of UNICEF's supply division, said. However, Paul Lalvani of the Global Fund to Fight AIDS Tuberculosis and Malaria -- which provides money for HIV/AIDS programs in 95 countries, at least 10 of which use Ranbaxy drugs -- said, "It's likely to cause a lot of confusion in countries and ministries of health." He added that Ranbaxy's announcement might cause some countries to question the "confidence that the (WHO) prequalification system was supposed to bring" (Brown, Washington Post, 11/10).

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