PHA-Exchange> WHO Drops Two Generic AIDS Drugs

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WHO Drops Two Generic AIDS Drugs
--------------------------------
 
Source: http://www.unwire.org/UNWire/20040616/449_24936.asp
Wednesday, June 16, 2004 
 
The World Health Organization has removed two generic antiretro-
viral drugs from its list of approved AIDS drugs used to treat 
people in the developing world, the New York Times reports to-
day:
http://www.nytimes.com/2004/06/16/health/16aids.html
 
The decision was made after a routine check in May found that 
the manufacturer, the Indian company Cipla, could not document 
that its drugs were biologically equivalent to patented ones.
 
It is the first time the U.N. health agency has pulled any AIDS 
drugs, but the move is not expected to have an effect on its 
initiative to treat 3 million HIV-positive people, mostly in Af-
rica, by next year, said WHO official Lembit Rago.
 
Cipla has been at the forefront of efforts to provide ARVs to 
poor nations. Rago said that despite the investigation's find-
ings, the company's drugs, lamivudine and zidovudine, may still 
be bioequivalent to the patented drugs. The lack of documenta-
tion, however, required their removal, he said.
 
Cipla's chairman, Yusuf Hamied, told the Times that the problem 
was due to poor recordkeeping in the testing laboratory in Bom-
bay. The company said the situation was "on the mend" and it ex-
pected its drugs back on the list in a matter of weeks. 
 
The announcement follows the Bush administration's decision last 
month to allow the purchase of cheaper, generic drugs for Africa 
and the Caribbean through its $15 billion, five-year HIV/AIDS 
program. 
 
Hamied said lamivudine had been tested for bioequivalency in a 
lab in the United States and approved by the Food and Drug Ad-
ministration and that he would send the data to the U.N. agency.
 
He said the testing had been done for the FDA because his com-
pany hopes to sell lamivudine when a U.S. patent, held by 
GlaxoSmithKline of the United Kingdom, expires in 2006 


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