Congress men 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 sub-committee.
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 and potential violations of GMP regulations. The members were responding to the information contained in a legal motion moved by US Department of Justice to seek details of Ranbaxy's manufacturing practices.
"We are not aware of any Congressional Committee inquiry and have not received any communication in this regard. 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", 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. I would like to know whether FDA officials knew about these allegations and what, if any, action was taken", Dingell stated.
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"We learned from investigating contaminated heparin that such inspections were dispensed with in the case of the active pharmaceutical ingredient manufactured in China, which resulted in a public health disaster.
Now it appears that such inspections in India - the second largest supplier of drugs to the United States - may be another example in which FDA found it inconvenient to assure the safety and effectiveness of drugs before approving them for marketing to American patients. If that is the case, then the American people should not have to wait until January for change and this Administration should clean house at the FDA now", said Stupak.
Meanwhile, Malvinder Mohan Singh, chairman and managing director of Ranbaxy, alleged that a foreign drug multinational was behind the current controversy. Singh, who had recently agreed to sell majority stakes 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 negative news emanating from the US. The company's stock prices in the Bombay Stock Exchange (BSE) continued to fall. When BSE's bellwether index Sensex went up by 3.99 per cent today, Ranbaxy shares were down by 3.26 per cent to close at Rs 437.45.