FDA comes under Congress scanner over Ranbaxy

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Press Trust of India New York
Last Updated : Jan 20 2013 | 9:47 PM IST

Besides, the House Energy and Commerce Committee would also "look at why the FDA continued to approve medicines made by the company and allow shipments into the US while it was questioning Ranbaxy's manufacturing processes," a newspaper reported.      

The report said that the Committee "wants to find out whether the FDA knowingly allowed unsafe and ineffective medicine to enter the US."      

The inquiry stems from a federal court filing by the US Department of Justice, where it has been alleged that there have been "a pattern of systematic fraudulent conduct, including submissions by Ranbaxy to the FDA that contain false and fabricated information about stability and bio equivalence of the company's generic medications."      

The Justice Department has also cited a failure by Ranbaxy to report in a timely fashion it distributed drugs that did not meet proper specifications, and has accused the company of concealing violations of good manufacturing practice regulations from FDA.     

"If these allegations are true, Ranbaxy has imperiled the safety of Americans in a manner similar to the generic drug scandal we uncovered twenty years ago," the newspaper report quoted House Energy and Commerce Committee Chairman John Dingell as saying.

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First Published: Jul 17 2008 | 1:45 PM IST

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