FDA says Ranbaxy plant falsified data
Washington, February 26, 2009
A plant owned by Indian generic drugmaker Ranbaxy Laboratories falsified data and test results in approved and pending drug applications, US regulators said on Wednesday.
The Food and Drug Administration said it halted reviews of drug applications from Ranbaxy's Paonta Sahib plant in India.
Agency officials said they had not identified any health risks from Ranbaxy drugs on the market but were continuing to investigate products associated with the plant.
"The FDA's investigations revealed a pattern of questionable data raising significant questions regarding the reliability of certain applications," said Deborah Autor, director of compliance in the agency's drug center.
The action "has limited significance for US marketed products" because the FDA banned imports from the facility in September due to manufacturing problems, Autor said.
Patients should not stop taking Ranbaxy drugs but should consult a doctor if they are concerned, FDA officials said.
A Ranbaxy official had no immediate comment.
The FDA said it had asked Ranbaxy to help resolve questions of data integrity and reliability for drugs made at the plant or some that were backed by data from the site. Plans for correcting the problem should include a third-party audit of drug applications linked to the plant, the FDA said.
In September, the FDA banned more than 30 generic drugs from entering the United States that were made at Ranbaxy plants in Paonta Sahib and Dewas, India. The drugs included cholesterol-lowering drugs, AIDS medications and antibiotics.
Japanese drugmaker Daiichi Sankyo holds a controlling stake in Ranbaxy. - Reuters