India drug firm pulls antiretrovirals from WHO list
The World Health Organisation (WHO) said on Tuesday that Indian drug maker Ranbaxy had voluntarily withdrawn all of its antiretroviral AIDS drugs from the U.N. health agency’s approved list.
The Geneva-based agency had already announced that it was dropping three generic HIV/AIDS drugs produced by the firm, India’s largest pharmaceutical company by sales.
“Ranbaxy Laboratories Limited has informed the World Health Organisation this it is voluntarily withdrawing all its antiretrovirals,” WHO said in a statement.
The Indian company took the step after finding discrepancies in documents submitted to prove the generic products’ bioequivalence to brandname drugs, the WHO said.
But it added that Ranbaxy had already presented it with a plan for submitting new studies of the drugs, with the first such study expected to be finished by next month.
The U.N. agency said that it had written to all manufacturers of HIV/AIDS medicines on its recommended list, urging them to check the data they submitted.
In August, the agency dropped three Ranbaxy drugs after finding that the independent laboratory used by the company to verify their equivalence to patented drugs did not meet international standards.
It also struck off two antiretrovirals from rival Indian concern Cipla in May.
The decisions were seen as a setback to hopes to make cheap generic HIV/AIDS drugs available throughout the developing world, particularly in Africa.
Revision date: July 8, 2011
Last revised: by Jorge P. Ribeiro, MD