The President's Emergency Plan for AIDS Relief program has suspended funding for three antiretroviral drugs manufactured by Indian generic drugmaker Ranbaxy that were included in an importation ban imposed by FDA on Sept. 16, Bloomberg reports.
FDA sent letters to the company last week warning of a number of violations at Ranbaxy's manufacturing plants in Paonta Sahib and Dewas, India, including inadequate sterilization processes and inaccurate record-keeping. The agency has banned the importation of more than 30 generic drugs made at those plants, including the three antiretroviral drugs manufactured at the Paonta Sahib plant -- zidovudine, lamivudine and nevirapine. Ranbaxy drugs made in other facilities are not banned. PEPFAR also is suspending funding for the Ranbaxy antiretroviral drugs used overseas to "meet standards equal to those established for patients" in the U.S., a program spokesperson said.
The PEPFAR suspension means the program no longer will support new orders for the three drugs. Last year, PEPFAR provided $8.9 million for antiretroviral drugs made by Ranbaxy. The program plans on providing $1.9 billion to support antiretroviral treatment programs during the next year, according to a PEPFAR spokesperson. In a statement, FDA said that there is no evidence that the banned drugs are harmful, but violations at the plants could lead to defective drugs, Bloomberg reports.
Aurobindo Pharma of Hyderabad and Cipla of Mumbai were cleared by FDA to supply the three AIDS drugs to the program, according to the agency's Web site. The House Energy and Commerce Committee is investigating the safety and effectiveness of Ranbaxy AIDS drugs supplied through PEPFAR. Ranbaxy spokesperson Charles Caprariello said the company is working with the U.S. government "to resolve all of the issues and concerns that have been raised" (Blum, Bloomberg, 9/25).