GLOBAL: India's Hetero Takes AIDS Drugs Off WHO List

Important note: Information in this article was accurate in 2004. The state of the art may have changed since the publication date.

GLOBAL: India's Hetero Takes AIDS Drugs Off WHO List

Reuters (11.19.04) - Friday, November 19, 2004

Today, the World Health Organization said that India's Hetero Drugs has withdrawn all six of its antiretroviral drugs from WHO's list of approved drugs due to concerns about their laboratory tests. It is the third time since June that an Indian company has withdrawn AIDS drugs after a WHO inspection found fault with the bioequivalence tests meant to show the drugs have the same effect as name-brand pharmaceuticals.

WHO spokesperson Iain Simpson said Hetero, based in Hyderabad, has withdrawn the drugs from WHO's prequalified list of generic HIV/AIDS drugs. WHO's list still shows approximately 48 antiretrovirals approved for use. Simpson said Hetero will repeat the studies and hopes to resubmit the results for consideration early next year.

Earlier this month, India's Ranbaxy took its drugs off the WHO list after finding discrepancies in the equivalency tests. Cipla removed two drugs in June due to similar problems. The companies contract independent laboratories to do the bioequivalence testing that is the last stage of the lengthy process of product approval, according to WHO.
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