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Indian firm withdraws all its HIV drugs from WHO list

Indian firm withdraws all its HIV drugs from WHO list

India's Ranbaxy Laboratories is withdrawing all of its generic versions of antiretroviral drugs from the list of HIV medicines approved by the World Health Organization (the United Nations' health agency), as it is uncertain the generics are biologically the same as the patented drugs, WHO said Tuesday. Ranbaxy found "discrepancies in the documentation," which meant that it was unable to prove in studies that its generic HIV treatments are equivalent to the original medicines, WHO said in a statement. A Ranbaxy spokesman said he had no immediate comment. The company has already proposed dates to submit reports on new studies of the drugs, WHO said. The first study is expected to be completed by December. Ranbaxy is withdrawing a total of seven medicines from the WHO list of so-called prequalified drugs. These include Indinavir, Lamivudine, Nevirapine, Stavudine, and Zidovudine tablets as well as two different combinations of Lamivudine and Stavudine, WHO said. In principle, patients should stop using these medicines and switch to other prequalified products, it said. "However, in many cases it will be difficult to find alternative prequalified products immediately," WHO said. In such cases, patients should "continue the use of delisted products, as the risk of withholding treatment is higher" than that of taking the drugs. "A switch to non-prequalified products is not recommended, as their quality has not been documented by WHO," the agency added. Earlier this year WHO removed three other antiretroviral medicines manufactured by Ranbaxy and two more made by Cipla, another Indian firm, from its list of approved HIV treatments. Bioequivalence tests had failed to prove that these were the same as the patented versions. Following the delisting of the products, WHO sent a warning letter to all manufacturers of HIV/AIDS medicines participating in the prequalification project. The agency urged those companies to verify the data they had submitted and to check whether the sites they were using for bioequivalence tests were complying with good medical and laboratory practice. There are still 54 antiretrovirals for the treatment of HIV/AIDS on the WHO prequalified list. In a push to expand treatment, WHO is aiming to put 3 million people in the developing world on HIV drugs by 2005. About 40 million people worldwide are infected with the AIDS virus, and 5 million new infections are recorded every year. Sub-Saharan Africa is the worst hit, but the epidemic is now pushing deep into Asia. The United States announced a change in its AIDS policy earlier this year to help provide cheaper drugs to sufferers in Africa and the Caribbean. That marked a significant shift from U.S. demands for more stringent standards for foreign companies that manufacture low-cost generic versions of anti-HIV drugs and combine them into single pills.

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