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www.fdanews.com/articles/67456-nigerian-hiv-aids-groups-fear-threat-from-de-listed-arvs

NIGERIAN HIV/AIDS GROUPS FEAR THREAT FROM DE-LISTED ARVS

January 12, 2005

Groups representing Nigerian HIV/AIDS patients have alleged that the country's Federal Health Ministry may have inappropriately approved medicines removed from the World Health Organisation's list of HIV/AIDS treatments. The claims suggest that despite the de-listing, the government is continuing to distribute the products under its HIV/AIDS subsidized treatment program. The scheme contributes some NGN1,000 (US$7.56) per month for each of the 15,000 Nigerians requiring antiretroviral (ARV) medicines. Further, unattributed sources have accused officials of irregularities in approving several such drugs for use under the scheme.

Last year, the WHO de-listed three generic ARVs produced by Indian drugmaker Ranbaxy, and six manufactured by Hyderabad-based Hetero Drugs. A triple fixed-dose combination manufactured by fellow Indian generics producer Cipla remains on the WHO list. The products' withdrawal resulted from alleged discrepancies between data provided to the organization and results from inspections of contract research organisations that conducted bioequivalence studies on the drugs. Nevertheless, the Nigerian government continues to insist that the de-listed ARVs are safe and effective, claiming a lack of bioequivalence does not necessarily imply any danger to patients.