WHO Reinstates to Approved Drug List Two Antiretrovirals From Indian Generic Drug Manufacturer Cipla

Two generic antiretroviral drugs manufactured by the Indian generic drug maker Cipla have been reinstated to the World Health Organization's approved list of medications for HIV/AIDS patients, WHO officials said on Tuesday, Reuters reports (Reuters, 11/30). WHO in June removed 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 tests to determine whether the generic drugs are equivalent to brand-name versions. 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. The Indian generic drug company Hetero Drugs also withdrew all six of its antiretroviral drugs from the WHO list earlier this month because of deficiencies in the data submitted and because the laboratories it was using to conduct bioequivalence tests were not compatible with current standards. 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, 11/22). The two drugs -- lamivudine and lamivudine combined with zidovudine -- returned to the list after inspections proved they were bioequivalent to their brand-name counterparts, Jim Yong Kim, director of WHO's Department of HIV/AIDS, said during a news briefing. The WHO list now includes 50 antiretroviral medications (Reuters, 11/30).

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"This is extremely good news," Daniel Berman, HIV/AIDS coordinator for the Campaign for Access to Essential Medicines -- a project of Medicins Sans Frontieres -- said, adding, "It shows that although there have been problems, the WHO is raising the bar and companies are responding in improving quality" (Fak et al., Financial Times, 12/1). "It could be seen as a short-term pain, but I think it will be outweighed by a long-term gain," Lembit Rago, WHO coordinator for essential medicines and drugs, said. He added, "The whole pre-qualification process has in a way been a turning point ... in terms of putting much more emphasis on the quality of drugs than has been done before" (Agence France-Presse, 11/30).