WHO drops two generic AIDS drugs
The World Health Organization has removed two generic antiretroviral drugs from its list of approved AIDS drugs used to treat people in the developing world, the New York Times reported 16 June 2004.
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 Africa, 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 findings, the company's drugs, lamivudine and zidovudine, may still be bioequivalent to the patented drugs. The lack of documentation, 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 Bombay. The company said the situation was "on the mend" and it expected 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 Administration and that he would send the data to the U.N. agency.
He said the testing had been done for the FDA because his company hopes to sell lamivudine when a U.S. patent, held by GlaxoSmithKline of the United Kingdom, expires in 2006 (Altman/McNeil, New York Times, June 16).