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WHO Bans 3 AIDS Medicines As part of its continuous effort to monitor the quality of drugs for priority diseases such as AIDS, the World Health Organisation (WHO) has ordered the withdrawal of three anti-retrovirals manufactured by Ranbaxy Pharmaceuticals for its failure to comply with international standard of good clinical laboratory practices. A release from WHO headquarters in Geneva said the organisation recently carried out systematic inspections of contract research organisations which have done bioequivalence studies for prequalified medicines. The antiretrovirals in question are the triple fixed-dose combination pill containing lamivudine, stavudine and nevirapine in two different strengths and a lamivudine plus zidovudine tablet. The recent inspections follow another inspection which took place in late May when similar non-compliance was found at a laboratory contracted by CIPLA to do bioequivalence studies of two AIDS medicines. However, another WHO inspection of a contract research organisation has found that the bioequivalence tests for triple fixed-dose combination lamivudine, stavudine and nevirapine tablet manufactured by CIPLA were carried out properly in compliance with requested standards. This product will therefore continue to be included in the list of WHO prequalified products. While the three Ranbaxy products to be removed from the list meet quality specifications, proof of bioequivalence is missing in view of non-compliance with good clinical and laboratory practices as well as data handling requirements found in the contracted laboratory. This effectively means that the medicines may or may not offer the same therapeutic benefits as the originals on which they are based. Bioequivalence tests are conducted on volunteers whose blood are tested after receiving the test medicines, to determine whether the concentration of the test medicine (generic medicine) is similar to that of the innovator or patented medicine). Who Are We ? | About THISDAYOnLine.com | THISDAY People | Contact Us © Copyright 2000 Leaders & Company Limited

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