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WHO pulls three Ranbaxy generics from AIDS drugs list
  By Ben Hirschler
LONDON (Reuters) - The World Health Organisation said on Wednesday it was removing three generic HIV/AIDS drugs made by India's Ranbaxy Laboratories Ltd from its recommended list, over concerns about quality.
Ranbaxy has not proved that the medicines are biologically equivalent to patented drugs, the Geneva-based U.N. agency said in a statement.
India's largest drug maker by sales said it was working to address the issue by carrying out new tests. Ranbaxy and another Indian firm, Cipla Ltd, have pioneered the supply of generic versions of such pills in poor countries, particularly Africa, to cheers from AIDS activists, who see them as a cheap alternative to branded medicines.
But Western drug makers and U.S. government officials have questioned whether such products are necessarily of the same standard as the originals.
The WHO decision is a setback for Ranbaxy, which announced plans at the weekend to file its anti-AIDS drugs with the U.S. Food and Drug Administration under a new fast-track approval scheme before the end of 2004.
The WHO'S so-called prequalification list, which currently includes some 60 life-saving antiretrovirals, was set up two years ago to guide procurement by aid agencies battling the epidemic in African and Asian countries. It contains both generic and patented products.
The WHO has launched a campaign to get antiretrovirals to 3 million people in the developing world by the end of 2005. As of June 30 this year, however, only 440,000 were receiving them.
The WHO said it was dropping the three Ranbaxy products because the laboratory, which had carried out bioequivalence studies, did not meet international standards of good clinical and laboratory practices.
The antiretrovirals in question are a triple-combination pill containing lamivudine, stavudine and nevirapine in two different strengths, and a tablet of lamivudine plus zidovudine.
The move follows similar action in late May against two drugs made by Cipla. Cipla's three-in-one pill, however, did meet equivalence standards and will continue to be listed.
The three medicines from Ranbaxy will not be reinstated until the company submits data from new studies providing "unequivocal evidence" of bioequivalence with the originals, the WHO said.
The company, in a statement issued in New Delhi, said it had already started new equivalence studies and had suspended business with the independent laboratory that carried out the original tests.
(Additional reporting by Rosemary Arackaparambil in Bombay).



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