An Indian pharmaceutical company has voluntarily withdrawn its anti-retroviral drugs from World Health Organization approval amid concerns about the drugs’ quality, a move that officials said could affect the supply of ARVs to Cambodian AIDS patients.
Ranbaxy Laboratories Ltd, India’s largest pharmaceutical company and one of the world’s biggest producers of generic ARVs, is pulling seven of its ARVs from WHO prequalification, the stamp of approval the world body gives to drugs that meet international standards, according to a WHO statement Tuesday.
WHO removed three Ranbaxy ARVs from its prequalification list in August, after finding “serious discrepancies” between the drug’s original lab analyses and the results presented to the WHO, the statement said.
“The fact is that Ranbaxy’s decision to withdraw all its products makes some difficulties,” Dr Massimo Ghidinelli, HIV/AIDS adviser to the WHO in Cambodia, said Thursday.
Ideally, patients should stop taking Ranbaxy drugs and switch to other brands, the WHO statement said. But since many of those likely taking Ranbaxy’s generics are patients in developing countries with limited access to other products, it is safer to continue taking the de-listed drugs than to stop treatment altogether, the WHO and doctors said.
In places like Cambodia, “the number of sources you can switch to is limited,” said Dr Richard Veerman, head of mission of Medecins Sans Frontieres-Belgium. Patients who stop taking the drugs can become resistant to them, he said.
MSF-Belgium, which supplies ARVs to about 1,300 AIDS patients, canceled an order with Ranbaxy after its first de-listing in August and has found an alternate supplier, Veerman said.
It was unclear Thursday how the Ministry of Health’s ARV supply would be affected. As policy, the ministry uses only WHO prequalified drugs.
Before its de-listing, Ranbaxy was bidding to supply ARVs to the National Center for HIV/AIDS, Dermatology and STI, and has supplied NCHADS in the past, Deputy Director Ly Penh Sun said. He said he did not know more about Ranbaxy’s de-listing or its future with the ministry.