Cloud over US FDA inspection

Two US Congress members have expressed doubts over the quality of inspections conducted by the US Food and Drugs Administration (FDA) on Indian drug manufacturing facilities.

Congressmen John Dingell and Bart Stupak have said the ongoing FDA-Ranbaxy row over alleged supply of "fraudulently approved and manufactured" medicines by Ranbaxy in the US should be seen in the larger context.

Dingell is chairman of the energy and commerce committee, which oversees the FDA, while Stupak chairs its oversight and investigations subcommittee.

In a press release posted on the committee's website, Dingell and Stupak indicated that the committee will soon commence a formal investigation into the Ranbaxy drug approvals.

"We are not aware of any Congressional committee inquiry and have not received any communication in this regard," a Ranbaxy spokesperson said.

"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," Dingell stated.

Now, it appears that India may be another example after China, where FDA found it inconvenient to assure the safety and effectiveness of drugs. If that is the case, this administration should clean up the house at the FDA now,  said Stupak.

Meanwhile, Malvinder Mohan Singh, CMD of Ranbaxy, alleged that a foreign drug multinational was behind the current controversy.

Singh, who had recently agreed to sell majority stake of Ranbaxy to Daiichi Sankyo of Japan, said that the attempt was to derail the Ranbaxy-Daiichi deal. Ranbaxy, along with Daiichi had issued a joint statement yesterday reaffirming their plans to go ahead with the deal.

This is the third consecutive day, Ranbaxy is trying to ward off the "confusion" created by the negative news emanating from the US.

The company's stock prices in the Bombay Stock Exchange (BSE) continued to fall. When the Sensex went up by 3.99 per cent on Friday, Ranbaxy shares were down 3.26 per cent to close at Rs 437.45.