Click to play videoNew Delhi: The US Congress is planning to probe the US FDA 's handling of the Ranabaxy case and whether whether it consistently overlooked signs that the drugmaker concealed and forged crucial data.
The committee will also examine Ranbaxy's drug approvals in the US and possible violations of manufacturing guidelines.
The House Energy and Commerce Committee which will head the probe wants to know if the FDA knowingly allowed unsafe medicine to enter the country.
The American health regulator, USFDA, has filed a motion in a US court seeking “certain” documents from Ranbaxy, over doubts that the Indian company indulged in alleged malpractices like concealing and forging crucial data to get marketing approval for its products in the US.
Republican John Dingell who heads the committee said, "If these allegations are true, Ranbaxy has imperiled the safety of Americans in a manner similar to the generic drug (next quote)scandal we uncovered twenty years ago, I would like to know whether FDA officials knew about these allegations and what, if any, action was taken.”
The FDA has declined to comment, saying the case is under investigation.
When contacted by Network 18, Ranbaxy spokesperson declined to comment.
“Ranbaxy have already come under the USFDA. USFDA itself has been probed very deeply on any loophole that may have crept in the drug approval process three to four months ago. The FDA came under US government on having some lapses on approving contaminated Heparin. This probe is concerned with only one manufacturing facility of Ranbaxy. To jump to a conclusion that the entire impact will be felt on Ranbaxy operation in the US will be a little far,” Pharma correspondent Vikas Dandekar said.
Daiichi Sankyo said in a joint statement on Thursday, "Daiichi Sankyo, Ranbaxy and the Singh family stand by the deal and confirm that the terms of the deal remain unchanged.”
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