FDA under probe as Ranbaxy says Daiichi deal is sealed

Mumbai: The US Food and Drug Administration (USFDA), which has charged Ranbaxy with selling unsafe medicines in the country, is itself under Congressional probe for approving those ''substandard'' drugs, even as the Indian drug major said its deal with Japan's Daiichi Sankyo is binding and final.

Ranbaxy, which had accused corporate rivals for its recent stock slump, said its deal with Daiichi would create a complementary business combination, helping sustainable growth by diversification and market expansion.

Ranbaxy had, last month, announced an agreement with Japan's Daiichi Sankyo to sell its entire promoter stake of 34.8 per cent for Rs9,576.14 crore.

''Following intense speculation in sections of the media and the stock market, Daiichi Sankyo and Ranbaxy reiterate that the agreement between Daiichi, Ranbaxy and the Singh family, the promoters of Ranbaxy, is binding and final, subject to regulatory approvals," the companies said in a joint statement.

US media reports said a Congressional committee would examine Ranbaxy's drug approvals in the US and any potential violations of manufacturing regulations. 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 committee "wants to find out whether the FDA knowingly allowed unsafe and ineffective medicine to enter the US,'' the report said.

A US federal court had earlier suspected that there had 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 US department of justice has also cited a failure on the part of Ranbaxy to meet drug specifications and report drug defects in time and has accused the company of concealing violations of good manufacturing practice regulations.

"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 John Dingell, chairman of the House energy and commerce committee, as saying.