courtesy aids-india
---------------------

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
_________________________________________
Chritsy <[EMAIL PROTECTED]>

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









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