‘Ranbaxy got USFDA nod with fudged data’

Nov 08 2013, 08:31 IST
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SummaryFraudulent data was used to get USFDA nod to sell its generic drugs.

Ranbaxy Laboratories used “fraudulent” data to get USFDA nod to sell its generic drugs, according to whistleblower Dinesh Thakur, who has also accused the drug-maker of faking test results.

In a interview to CBS News, he said: “The data is important because the FDA or other agencies globally look at that information to give you marketing authorisation to sell the drug.”

An ex-employee of the company, Thakur, who was tasked with investigations of alleged malpractices in Ranbaxy, 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 gotten approvals from the FDA to sell drugs that were based on no data, or data that was fraudulent.”

Pointing out how test results were allegedly manipulated, he said: “When you find a blood sample rework for one patient copied 23 times because there are 24 patients needed to prove bioequivalence, that’s not an error.”

Ranbaxy spokespersons could not be reached for comments. Elaborating how the company’s drug failed to provide relief, he said: “The expectations is the drug is supposed to work as intended ... What we saw in this particular case is that trust was broken.”

Recounting an incident where his son was prescribed a Ranbaxy antibiotic for a fever, Thakur said: “He (son) kept getting worse, so we got another company’s formulation and the fever went away.”

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