New Applications from a Ranbaxy Plant Halted by FDA

U. S. health officials said the review of any new drug applications from a Ranbaxy Laboratories plant in India has been halted after it was discovered that scientific data was falsified. 

India's biggest drug maker and one of the largest suppliers of generic drugs to the United States, Ranbaxy's Paonta Sahib plant and another of the companies four factories is said to have falsified data about products' shelf life and due to manufacturing failures have been barred from sending 30 products to the United States since September. 

"Companies must provide truthful and adequate data to FDA and when they do not, there will be serious consequences," said Deborah Autor, director of the FDA's Office of Compliance. Ranbaxy submitted false information about tests to ensure the effectiveness of products, including refrigerating drugs meant to be stored at room temperature to make the shelf life appear longer, Autor said.

The Food and Drug Administration in an e-mail statement said it "has not identified any health risks" linked to the 25 generic drugs that are already approved from the plant and patients should continue taking any drugs. 

Dr. Douglas Throckmorton, deputy director of FDA's Center for Drug Evaluation and Research, during a Wednesday teleconference said, "We took this action after it became apparent that this facility was submitting falsified scientific data in applications for FDA approval of marketed drugs in the United States." 

Falsifying data in drug applications is a "serious breach of integrity -- a breach that must be quickly addressed and corrected," Throckmorton added. He said this is the second action against the Paonta Sahib facility in less than six months. "No other Ranbaxy facilities are directly affected by this action," he said.

The FDA asked Ranbaxy to fix the problems and hire an independent inspector for the plant. Throckmorton said till the problems are resolved, the FDA will stop review of drug applications from the Paonta Sahib plant and the agency will not accept any new applications from this plant.

Once Ranbaxy is able to prove to the agency that all of its data are correct and the FDA no longer has a concern about the data in the applications, the agency would begin reviewing applications again, Autor said.

In a statement Ranbaxy said it would continue to cooperate with the FDA investigation and would "respond appropriately in a timely manner" once it reviews the new restrictions. "The FDA has said it has no evidence the drugs on the market are substandard and also that they comply with specifications upon testing," the company said. Chief Executive Officer Malvinder Singh said last month the company may shift production to the U. S. in response to the FDA ban. 
 

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