AIDS drugs off WHO list -- Generics from CROs that fail quality standards

[HuckleB]

AIDS drugs off WHO list -- Generic antiretrovirals taken off prequalification list after CROs fail quality standards

http://www.biomedcentral.com/news/20040805/01

"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 fixed-dose combination pills containing lamivudine, stavudine, and nevirapine in two different strengths, and a lamivudine plus zidovudine tablet. Fixed-dose combinations are cheaper and easier to take than other antiretroviral drugs and are a major part of drug access programs in the developing world."

[madrchsod]

1. get ready folks

this shit will be coming our way in the near future. the drug pushers are already sending r&d to india...

[HuckleB]

2. kick