Seven Indian AIDS Drugs Reinstated

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Seven Indian AIDS Drugs Reinstated

The Associated Press: Friday, August 19, 2005; 7:50 PM

GENEVA -- The U.N. health agency said Friday it has reinstated seven Indian-made

generic drugs to its list of approved HIV/AIDS medicines for use in developing

countries after the manufacturer was able to prove they were the same as the

patented versions.

The World Health Organization removed three of the drugs _ made by Ranbaxy

Laboratories Ltd. _ from its list of generic AIDS medicines recommended for use

in developing countries in August 2004. A random check had found that tests

failed to prove that the medicines were biologically the same as the patented

drugs.

Ranbaxy later withdrew the other four drugs, saying it was uncertain they were

biologically the same as the patented drugs. But the company has now submitted

data from new tests that proves that the drugs are equivalent to their patented

counterparts, WHO said.

" Subsequently, WHO ran the full range of quality, safety and efficacy checks on

the medicines as well as thorough inspections of the new laboratories, " the

health agency said in a statement. " The products and laboratories were all found

to be satisfactory. "

Two of the drugs contain a combination of lamivudine and stavudine in different

strengths; another two are combinations of lamivudine, stavudine and nevirapine;

one is lamivudine; one is zidovudine; and the seventh is a combination of

lamivudine and zidovudine.

WHO also said it has added three new antiretroviral medicines, made by India's

Aurobindo Pharma Ltd., to its approved list.

Two of these are lamivudine tablets in different strengths and the third is

zidovudine.

" The addition of 10 medicines will benefit existing AIDS programs and

procurement schemes, " WHO said.

About 6.5 million people in low and middle income countries are in need of

antiretroviral treatment, according to the health agency.

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.

Source:

http://www.washingtonpost.com/wp-dyn/content/article/2005/08/19/AR2005081900452.\

html

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Chritsy <christya@...>

The following is the list of seven Ranbaxy Anti Retroviral formulations are now

pre-qualified by WHO. The products pre-qualified are:

- Lamivudine 150mg+Nevirapine 200mg+Stavudine 40mg tablets

- Lamivudine 150mg+Nevirapine 200mg+Stavudine 30mg tablets

- Lamivudine 150mg+Stavudine 40mg tablets

- Lamivudine 150mg+Stavudine 30mg tablets

- Lamivudine 150mg+Zidovudine 300mg tablets

- Lamivudine 150mg tablets, and

- Zidovudine 300mg tablets