Ranbaxy used fraudulent data to get FDA’s nod: ex-employee alleges

Ranbaxy used fraudulent data to get FDA’s nod: ex-employee allegesPharmaceuticals giant Ranbaxy Laboratories made use of dishonest means to gain U. S. drugs regulator FDA's approval for its generic drugs, whistleblower Dinesh Thakur alleged.

Thakur, an ex-employee of the Indian drug maker, alleged that the company used "fraudulent" data and faked test results to gain FDA's approval for selling its generic drugs in America.

In a recent interview, Thakur said, "We started getting the files, and, lo and behold, we find that none of that exists in the first place.... It means that we've got approvals from the FDA to sell drugs that were based on no data, or data that was fraudulent."

He added that the FDA or other drugs regulators give drug makers permission to sell their drugs based on information by the drug makers.

In May 2013, Ranbaxy settled 'felony charges' for violating manufacturing norms with the US authorities by agreeing to pay $500 million (nearly Rs 3,000 crore) in penalty. Thakur was awarded $48.6 million by a U. S. court for his role in exposing violations of manufacturing norms in the company.

Ranbaxy has so far made no comment on the allegations slapped by its own former employee.