BUSINESS

FDA under lens over Ranbaxy issue

Source:PTI
July 17, 2008 14:21 IST

The US drug regulator FDA, which has charged Ranbaxy with selling unsafe medicines in America, has come under the parliamentary scanner and will be probed for its conduct in approving the Indian pharma major's products and other potential violations in the matter.

A congressional committee has said that it would examine Ranbaxy's drug approvals in the United States and potential violations of manufacturing regulations, a media report said.

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,' the Star Ledger 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 Star Ledger report quoted House Energy and Commerce Committee chairman John Dingell as saying.

Source: PTI
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