GENEVA (AP)--The U.N. health agency has removed three Indian-made
generic versions of antiretroviral drugs from its list of
approved HIV medicines, saying it's uncertain they're
biologically the same as the patented drugs.
The generic drugs, which are manufactured by India's Ranbaxy
Laboratories Ltd., will be kept off the World Health
Organization's list of approved HIV treatments until the company
can submit evidence of new tests that prove the drugs are
biologically equivalent to the original medicines, the agency
said in a statement Wednesday.
"This effectively means that the medicines may or may not offer
the same therapeutic benefits as the originals on which they are
based," the WHO explained.
Two of the drugs contain a combination of lamivudine, stavudine
and nevirapine in two different strengths. The third is a
lamivudine plus zidovudine pill. Ranbaxy will now resubmit the
products to a different laboratory, WHO said.
"If and when those products and the laboratories are found to
meet the specified requirements, WHO will reinstate them in its
list of prequalified products," the agency added.
WHO removed two generic drugs made by Cipla Ltd.,
another Indian firm, from its list of approved HIV medicines in
June, also because tests had not proved that they were the same
as the patented versions. The agency is still waiting for Cipla
to submit documentation from a new laboratory to prove that its
drugs are the same as the patented ones.
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