Indian Generic Drug Company Hetero Takes Six Antiretroviral Drugs Off WHO Pre-Approved List
The Indian generic drug company Hetero Drugs has withdrawn all six of its antiretroviral drugs from the World Health Organization's approved list of medications for HIV/AIDS patients, WHO announced Friday, the AP/Seattle Post-Intelligencer reports. The company removed its drugs from the WHO list -- which still includes 48 antiretroviral medications -- because the laboratories it was using to conduct tests to determine if its generic antiretroviral drugs were equivalent to brand-name versions "were not compatible with the current standards" of testing and there were "deficiencies in the data submitted," according to WHO, the AP/Post-Intelligencer reports. The medications removed from the list include generic versions of indinavir, lamivudine and zidovudine; two different doses of stavudine; and a combination of lamivudine and zidovudine (Cage, AP/Seattle Post-Intelligencer, 11/19). WHO in June removed Indian generic drug manufacturer Cipla's versions of lamivudine and zidovudine from its approved HIV treatment list because of problems detected during an inspection of an independent laboratory that Cipla had hired to conduct its bioequivalence studies (Kaiser Daily HIV/AIDS Report, 10/20). The Indian generic drug company Ranbaxy earlier this month removed all seven of its generic antiretroviral drugs from the WHO list after discovering discrepancies in bioequivalence tests. WHO has said it has urged the manufacturers of all of the pre-qualified HIV/AIDS-related medicines to check data they have submitted (Kaiser Daily HIV/AIDS Report, 11/10).
Recommendations and Reaction
WHO on Friday restated its advice that countries should stop using delisted drugs and switch to other prequalified drugs. However, WHO said that if prequalified drugs could not be substituted "immediately," patients should continue using the delisted drugs, according to Reuters. "The risk of withholding treatment is higher than that of providing medicines whose bioequivalence is not proven but which have demonstrated quality and safety," WHO said in a statement (Nebehay, Reuters, 11/19). WHO spokesperson Iain Simpson added, "It is clear that these are quality medicines; they are not dangerous medicines. However, the last stage is to show that these products are equivalent in the way they actually work with the original product." In response to the recent delisting of antiretroviral drugs from Hetero, Cipla and Ranbaxy, Lembit Rago, coordinator of WHO's quality and safety of medicines division, said, "Our findings, and the companies' admission of responsibility by withdrawing their products, show that (laboratory) inspections are necessary." He added, "Current WHO procedures are ultimately improving medicines monitoring mechanisms which will, in the long term, ensure better quality treatment for patients" (AP/Seattle Post-Intelligencer, 11/19).