Ranbaxy withdraws Its HIV Drugs From WHO List

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Indian Co Withdraws Its HIV Drugs From WHO List

Associated Press - November 9, 2004

GENEVA (AP) - India's Ranbaxy Laboratories (500359.BY) is

withdrawing all of its generic versions of antiretroviral drugs

from the U.N. health agency's list of approved HIV medicines,

saying it is uncertain they are biologically the same as the

patented drugs, the World Health Organization said Tuesday.

Ranbaxy found " discrepancies in the documentation, " which meant

it was unable to prove in studies that its generic HIV treatments

are equivalent to the original medicines, WHO 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.

" A switch to non-prequalified products is not recommended as

their quality has not been documented by WHO, " the agency added.

Earlier this year, WHO removed three other antiretroviral

medicines manufactured by Ranbaxy and two more made by Cipla

(500087.BY), another Indian firm, from its list of approved HIV

treatments. Bioequivalence tests had failed to prove these were

the same as the patented versions.

Following the de-listing of the products, WHO sent a warning

letter to all manufacturers of HIV/AIDS medicines participating

in the prequalification project. The agency urged those companies

to verify the data they had submitted and to check whether the

sites they were using for bioequivalence tests were complying

with good medical and laboratory practice.

There are still 54 antiretrovirals for the treatment of HIV/AIDS

on the WHO prequalified list.

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

into Asia.

The U.S. announced a change in its AIDS policy earlier this year

to help provide cheaper drugs to sufferers in Africa and the

Caribbean. That marked a significant shift from U.S. demands for

more stringent standards for foreign companies that manufacture

low-cost generic versions of anti-HIV drugs and combine them into

single pills.

041109> AP041121

http://www.aegis.org/news/ap/2004/AP041121.html

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