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AIDS drugs off WHO list

Generic antiretrovirals taken off prequalification list after CROs fail quality standards

Stephen Pincock(Stephenpincock@thescientisteurope.com)

The World Health Organization (WHO) has removed three generic HIV medicines manufactured in India from its prequalification list, which is supposed to help governments and others chose good-quality drugs to use in their public health campaigns.

The three combination antiretrovirals, manufactured by Ranbaxy Laboratories, were taken off the list because a contract research organization (CRO) that had done bioequivalence studies on behalf of Ranbaxy was found to be noncompliant with good clinical and laboratory practices.

"While the three Ranbaxy products to be removed from the list meet quality specifications, proof of bioequivalence is missing in view of noncompliance with good clinical and laboratory practices as well as data-handling requirements found in the contracted laboratory," WHO said in a statement. "This effectively means that the medicines may or may not offer the same therapeutic benefits as the originals on which they are based."

The antiretrovirals in question are triple...

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