Indian firm withdraws its HIV drugs from World Health Organization list.

2004 DEC 1 - (NewsRx.com & NewsRx.net) -- India's Ranbaxy Laboratories is withdrawing all of its generic versions of antiretroviral drugs from the World Health Organization (WHO)'s list of approved HIV medicines, saying it is uncertain they are biologically the same as the patented drugs.

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, the U.N. health agency said in a statement.

In India, 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 comprise 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 de-listed products, as the risk of withholding treatment is higher" than that of taking the drugs.