India's largest pharmaceutical-maker lied about test results for more than 20 of its generic drugs, U.S. regulators said yesterday.
The Food and Drug Administration is stopping any consideration of new drugs from Ranbaxy Laboratories' Paonta Sahib plant, saying that officials there falsified data on drugs submitted to the agency.
The action comes six months after the FDA closed U.S. borders to more than 30 generic drugs made at that plant and at another Indian plant where inspectors found manufacturing problems.
Regulators said they have been investigating the testing violations for years but only recently had enough evidence to begin rejecting new drug submissions.
Federal investigators found that the company did not properly test the shelf-life and other safety aspects of its drugs, and then lied about the results. In one instance, company officials refrigerated drugs, then indicated that they had been stored at room temperature. At other times, the company lied about the number and frequency of safety tests conducted.
Twenty-five drugs affected by the problems probably reached the United States, regulators said, though the September import ban means it has been months since most of the pills reached pharmacy shelves.
Three drugs tested at the Paonta Sahib plant are still in U.S. circulation because they are manufactured at the company's New Jersey plant. Those drugs are a generic decongestant and generic versions of Merck & Co. Inc.'s Zocor and Bristol-Myers Squibb's Pravachol. Both are widely used cholesterol drugs.
Those drugs probably underwent new testing when they were transferred to the United States for production, regulators said.
A spokesman for Ranbaxy, Chuck Caprariello, said that the company "will continue to cooperate" with the FDA and plans to respond "in a timely manner." The company's U.S. operations are based in Princeton, N.J.
Despite the fraudulent data, regulators said, they have no evidence that the drugs are dangerous and recommended that patients continue taking their prescriptions.
"We've not uncovered any harm associated with Ranbaxy products currently marketed in the U.S.," FDA Deputy Director Douglas Throckmorton said. "We feel comfortable leaving those products on the market at this time."
Ranbaxy has three other plants in India that export drugs to the United States, such as low-cost versions of popular cholesterol drugs and antibiotics. The FDA said it has inspected Ranbaxy's plants more than 20 times in the past four years without finding similar problems. Officials did not specify how many drug applications that Ranbaxy had pending review at the FDA, but the FDA said it uncovered false information in those applications as well.
"Companies must provide truthful and accurate information to the FDA, and when they don't, there will be serious consequences," said Deborah Autor, the director of drug compliance.
India has become one of the world's leading suppliers of generic drugs in recent years, with such companies as Ranbaxy and Dr. Reddy's Laboratory able to undercut prices from U.S. competitors.
Source : Journalnow.com