WHO Removes Three Ranbaxy AIDS Drugs From Approved Treatment List
The World Health Organization has removed three generic antiretroviral drugs produced by Indian generic drug manufacturer Ranbaxy from its list of approved HIV treatments, Dow Jones/Wall Street Journal reports (Dow Jones/Wall Street Journal, 8/5). WHO inspected the contract research organization that conducted tests to determine whether the medications -- including a fixed-dose combination of lamivudine, stavudine and nevirapine in two strengths and a lamivudine, zidovudine combination pill -- were bioequivalent to the patented versions (Business Standard, 8/5). WHO decided to remove the drugs from their list of approved treatments after determining that the testing lab failed to meet international standards of clinical and laboratory practices (Reuters/CNN.com, 8/5). "While the three Ranbaxy products to be removed from the list meet quality specifications, proof of bioequivalence is missing in view of [the] noncompliance ... in the contracted laboratory," a WHO release said, adding, "This effectively means that the medicines may or may not offer the same therapeutic benefits as the originals on which they were based" (WHO release, 8/4). Ranbaxy now must submit new studies providing "unequivocal evidence" of bioequivalence, the Press Trust of India/Hindustan Times reports (Press Trust of India/Hindustan Times, 8/4). The company in a statement said it had suspended business with the lab in question and already had started conducting new bioequivalence studies (Reuters/CNN.com, 8/5).
The decision marks the second time this year WHO has removed generic AIDS medications from its list of prequalified drugs, a move that "is likely to lead to renewed criticism of the agency's efforts to evaluate the safety and efficacy of drugs," the Financial Times reports (Dyer, Financial Times, 8/5). WHO in June removed two generic antiretroviral drugs produced by Indian generic drug manufacturer Cipla from its approved HIV treatment list. Dr. Lembit Rago, WHO's coordinator for quality assurance and safety of medicines, said that Cipla's versions of lamivudine and zidovudine were removed from the list because of problems detected during a similar inspection of an independent laboratory that Cipla had hired to conduct its bioequivalence studies (Kaiser Daily HIV/AIDS Report, 6/16). However, a WHO inspection of the lab carrying out the new bioequivalence studies for Cipla found that the lab was in compliance with international standards. The products now will be placed back on the approved treatment list, according to the Business Standard (Business Standard, 8/5).