WHO Delisting of Ranbaxy AIDS Drugs ‘Created Ripples’ Among International Organizations, Economic Times Reports
The World Health Organization's removal of three generic antiretroviral drugs produced by Indian generic drug manufacturer Ranbaxy from its list of approved HIV/AIDS drugs has "created ripples" among international organizations, India's Economic Times reports (Mukherjee, Economic Times, 8/11). WHO last week removed the three generic drugs -- a fixed-dose combination of lamivudine, stavudine and nevirapine in two strengths and a lamivudine, zidovudine combination pill -- from its list of approved HIV treatments. WHO said that the contract research organization that conducted tests to determine whether the medications were bioequivalent to the patented versions failed to meet international standards of clinical and laboratory practices. In addition, WHO in June removed two generic antiretroviral drugs produced by Indian generic drug manufacturer Cipla from its approved HIV treatment list. However, a WHO inspection of the lab carrying out new bioequivalence studies for Cipla found that the lab was in compliance with international standards, and the products have been placed back on the approved-treatment list (Kaiser Daily HIV/AIDS Report, 8/6). As a result of WHO's actions, South Africa's Medicines Control Council has launched an investigation of Ranbaxy drugs registered in South Africa (Economic Times, 8/11). AIDS treatment initiatives in East Africa, which rely heavily on generic antiretrovirals, could be disrupted by WHO's decision, according to the East African (Kimani, East African, 8/10). Ranbaxy has started conducting new bioequivalence tests and plans to submit the results for relisting on WHO's list of approved medicines, company sources say (Economic Times, 8/11).
Lives 'Hang in Balance' After WHO Decision, Editorial Says
The lives of more than 40,000 HIV-positive people in East Africa "hang in the balance" because of WHO's decision, which will have "far-reaching implications," Kenya's Daily Nation says in an editorial. Although many people "will appreciate the need for antiretrovirals to conform to internationally accepted standards, it is equally important that HIV/AIDS patients should access these life-prolonging drugs at a reasonable cost," the editorial says. WHO's delisting of generic nevirapine is "particularly disturbing, given the important role it plays in protecting children born of HIV-infected mothers," the editorial says. It is crucial that WHO "move with speed" to ensure that the Ranbaxy drugs meet required standards, the editorial says, concluding, "Any delay in expediting this process will mean that the heavy AIDS death toll will go up" (Nation, 8/10).