Ranbaxy woes deepen
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18/07/2008
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Asian Age (New Delhi)
It seems that Ranbaxy's troubles will not end soon. A US congressional committee is launching an investigation into the US Food and Drug Administration's role in handling the allegations that Ranbaxy sold potentially adulterated medicines, said a US media report.
The House Energy and Commerce Committee has said that it wants to find out whether the FDA knowingly allowed unsafe and ineffective medicine to enter the United States, said the news report. The committee said its inquiry stems from justice department filings in federal court in Maryland. About two weeks back, federal prosecutors had told a local court that they are investigating Ranbaxy for allegedly falsifying records that resulted in the production and sale of generic medicines in the United States that did not meet US quality standards. These allegations has been denied by the Ranbaxy.
"If these allegations are true, Ranbaxy has imperilled the safety of Americans in a manner similar to the generic drug scandal we uncovered twenty years ago," the newspaper quoted Mr John Dingell, the committee chairman as saying. "I would like to know whether FDA officials knew about these allegations and what, if any, action was taken," he further said.
FDA spokeswoman, Ms Julie Zawisza declined comment, saying the Ranbaxy case is the subject of an open federal investigation, said the news report.
Meanwhile, Ranbaxy in a statement said that it is not aware of any Congressional Committee inquiry and have not received any communication in this regard. "Ranbaxy is a highly regarded company that has always believed in upholding the highest standards of quality. All the company's plants are CGMP compliant and produce medicines that meet global norms," said the company. Ranbaxy said that it will continue to fully cooperate with the USFDA and the department of justice (DOJ) in all respects. During the past three years, the FDA has gathered over 200 random samples of various products marketed by the company in the US.' These products have been independently tested by the USFDA and were found to be complying with all the specifications as per the filing, said the company. Ranbaxy is in the process of submitting supporting documentation for its ANDA applications to DOJ and believes that this will demonstrate no wrong doing on its part. Ranbaxy's shares ended nearly 4 per cent down on BSE on Thursday. Daiichi Sankyo and Ranbaxy on Thursday again reiterated that the agreement between Daiichi Sankyo, Ranbaxy and the Singh family, the largest controlling shareholders of Ranbaxy, is binding and final.
"Daiichi Sankyo, Ranbaxy and the Singh family remain committed to the transaction and to the vision of creating a complementary business combination that provides sustainable growth by diversification and an enhanced global reach," said the statement from Ranbaxy.