Associated Press - November 30, 2004

The drugs - lamivudine tablets and a combination of lamivudine and zidovudine, both made by Cipla Ltd. (500087.BY) - are the first of 18 Indian generic drugs that have been removed from the list this year to regain World Health Organization approval.

"Two extremely important drugs are once again on the list and recommended for use by all our U.N. partners in developing countries," said Jim Kim, WHO's AIDS director.

In June, the health agency removed the two Cipla drugs from its list of generic AIDS medicines recommended for use in developing countries, when a random WHO check found tests had failed to prove that the medicines were biologically the same as the patented drugs.

Cipla has now submitted data from new tests which proves the drugs are equivalent to their patented counterparts, WHO said.

"This shows that generic manufacturers are reacting responsibly," said Vladimir Lepakhin, WHO's deputy chief of health technology and medicines.

WHO has said removing medicines from the list doesn't necessarily mean there is something wrong with them, but stressed that manufacturers need to prove that their products work in the same way as the original product.

In principle, patients should stop using medicines which have been removed from the list and switch to others which are still approved for use by WHO. However, if they can't find alternative products immediately they should continue using their old drugs because they're not dangerous, WHO has said.

After WHO withdrew the two Cipla drugs and three others made by Ranbaxy Laboratories (500359.BY), the health agency sent a warning letter to all manufacturers of WHO-approved generic HIV/AIDS medicines, urging them to verify the data they had submitted and to check whether the sites they were using for testing were complying with good medical and laboratory practice.

Since then, Ranbaxy and a third Indian firm, Hetero Drugs, have voluntarily withdrawn all of their other generic AIDS drugs from the approved list. Both firms have submitted new timetables for when they will conduct new tests to prove their drugs are the same as the patented medicines, WHO said.

There are now 50 antiretrovirals for the treatment of HIV/AIDS on the WHO list.

The withdrawal of approval from so many generic AIDS drugs this year should have no impact on WHO's aim of getting 3 million people in the developing world on HIV drugs by 2005, the health agency said.

About 40 million people worldwide are infected with the AIDS virus and 5 million new infections are recorded every year. Sub-Saharan Africa is worst hit, but the epidemic is now moving deep into Asia.

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