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This is an archive article published on May 15, 2013

Whistleblower: Ranbaxy systemically violated good manufacturing practices

Thakur is set to receive around 48.6 million from the 500 million that Ranbaxy agreed to pay to settle allegations that the company sold adulterated drugs manufactured at its Paonta Sahib and Dewas facilities.

Dinesh Thakur,the whistleblower in the case that eventually forced Ranbaxy Laboratories to plead guilty on Monday to felony charges related to drug safety in the US,has alleged that the pharma major systemically violated good manufacturing practices. Thakur,currently based in New Jersey,said he hoped his crusade against his former employer would help improve the quality and safety of drugs in the US and abroad.

Thakur is set to receive around 48.6 million from the 500 million that Ranbaxy agreed to pay to settle allegations that the company sold adulterated drugs manufactured at its Paonta Sahib and Dewas facilities.

In a statement issued after Ranbaxys settlement with the US Department of Justice,Thakur said that eight years ago,as the Director of Project and Information Management at Ranbaxy,he discovered that the company falsified drug data and systemically violated current good manufacturing practices and good laboratory practices.

Thakur claimed Ranbaxys management was notified of these widespread problems. When they failed to correct the problems,it left me with no choice but to alert healthcare authorities.

An ex-colleague,who worked with Thakur in Ranbaxy eight years back,recalls that Thakur was forced to quit the pharma firm in an unceremonious manner after spending a couple of years with the company.

Thakur,in his statement,indicated that in 2005,he discovered that the company falsified drug data and systemically violated current good manufacturing practices and good laboratory practices and subsequently notified Ranbaxys management of these widespread problems.

Later that year,Thakur reportedly left Ranbaxy. In 2007,Thakur filed a whistleblower lawsuit in the US District Court of Maryland under the False Claims Act FCA detailing Ranbaxys violations.

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The lawsuit alleged that Ranbaxy caused false claims for payment to be submitted to US government healthcare programmes for numerous adulterated drugs as well as falsifying information about the drugs.

The FCAs qui tam provisions allow whistleblowers to report fraud on a government programme with the protection of a court-ordered seal and confidentiality,and receive a percentage of the amount recovered in a successful case.

Beato,head of the FCA and Whistleblower Practice Group at Stein Mitchell Muse amp; Cipollone LLP and counsel to Thakur,said,This case was fueled by the extraordinary courage of Dinesh Thakur.

A questionnaire sent to a public relations agency representing Thakur said it was assessing Dineshs schedule and that it would get back with the responses to the queries.

 

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