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Ranbaxy (Generics) to resubmit dropped AIDS drugs by year-end
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LONDON (Reuters) - India's Ranbaxy Laboratories Ltd will resubmit three generic HIV/AIDS drugs dropped from the World Health Organisation's approved list by the end of 2004, the firm's chief executive said on Monday.
The company also expects to file for U.S. regulatory approval for the antiretroviral combination pills this year.
The U.N. agency removed the medicines from its approved list in August amid concerns over their safety, after finding the independent laboratory used by Ranbaxy to prove they were equivalent to brand-name drugs did not meet international standards.
"What happened was unfortunate and we are re-doing all the bioequivalence studies around the world and we will be filing with the WHO and the FDA (U.S. Food and Drug Administration) by the end of the year," Brian Tempest told Reuters.
The WHO's decision was a blow to the rollout of cheap generic HIV/AIDS drugs in the developing world.
It was the second time this year that the WHO was forced to axe Indian generics from its approved drugs list because of concerns over testing procedures, after similar action against Cipla Ltd in May.
But Tempest, in London for an industry conference, said the setback had limited financial impact for India's largest drug maker by sales.
"We make a profit but we don't make a big profit on HIV products," he said.
"We are in the HIV products really because, being part of the developing world, we think this is something we should accomplish."
AIDS activists have been pushing hard for developing countries to use generic AIDS drugs, which can cost less than half as much as patented products.
The U.S. government, however, has so far refused to buy such drugs under its $15 billion emergency AIDS plan, arguing that that FDA, and not the WHO, should assess the quality of medicines.
Ranbaxy is now seeking FDA approval in order to qualify for inclusion in U.S. programmes. If it gets the green light, its drugs could be distributed by U.S.-backed agencies in Africa and other poor countries. But they would not be sold in the United States, due to patent protection.
The Ranbaxy antiretrovirals pulled from the WHO approved list are a triple-combination pill containing lamivudine, stavudine and nevirapine in two different strengths and a tablet of lamivudine plus zidovudine.
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