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NEW DELHI: DineshThakur, the former Ranbaxy executive who pocketed Rs 244 crore ($48 million) for blowing the whistle on the dubious manufacturing practices of the country's largest drug maker, has made some of his peers and ex-colleagues turn green with envy.
"I worked for the company for almost two decades. In all these years, my cumulative paycheck was nowhere near what Dinesh has got from the settlement," remarked a former Ranbaxy executive, wryly.
But then Thakur, a former director of project and information management at Ranbaxy, has pulled off what very few corporate executives dare to do. He gave evidence to the US authorities about the company falsifying drug data and violating good management practices, triggering a massive investigation that resulted in the drugmaker pleading guilty to felony charges related to the manufacture and distribution of certain adulterated drugs made at two of its plants in India. The company has agreed to pay $500 million to resolve false claim allegations.
This is the largest financial penalty paid by any generic drugmaker in the US for violating the provisions of the federal Food, Drug and Cosmetic Act (FDCA).
Thakur will receive his money from the US government's share of the settlement. He has been awarded this sum as part of the civil settlement lawsuit under the qui tam, or whistleblower, provisions of the False Claims Act, which allow private citizens to bring civil actions on behalf of the US and share in any recovery, a US Department of Justice statement said on Monday.
In a statement issued by Thakur on Monday, the former Ranbaxy executive claimed he had notified the company's management about the problems, but when they failed to correct them, he had no choice but to alert the healthcare authorities. In an earlier testimony to the US district court of Maryland in June 2012, he had alleged that when his boss had complained about instances of wrongdoing to the Ranbaxy management, he was told to destroy the evidence of the fraud.
On Monday, Thakur said he had worked with US regulatory authorities for two years to expose the fraud. "In furtherance of this effort, I filed a lawsuit to hold Ranbaxy accountable. It took us eight years to help government authorities unravel a complicated trail of falsified records and dangerous manufacturing practices that threatened to compromise the quality and safety of Ranbaxy drugs," he said.
Thakur has worked with Infosys Technologies in the past, and was hired by Ranbaxy in November 2002 from Bristol-Myers Squibb (BMS), where he was employed for 11 years and served as director of discovery informatics. He was recruited by the Indian drugmaker's then R&D head, Rashmi Barbhaiya, a former BMS executive himself.
From 2004-05, Thakur reported to Barbhaiya's successor, Rajinder Kumar, and it was during this period that he began probing the processes followed by the company. In his testimony to the Maryland court last year , he said he began checking whether some of the contract research organisations hired by Ranbaxy had falsified data for HIV and some non-HIV drugs to gain approvals for marketing them in the US and other markets.
Subsequently, he widened the scope of investigation to include all generic products being sold by Ranbaxy. That is when, he alleges, other regulatory issues - violation of good manufacturing practices at its select facilities and instances of adulterated and misbranded drugs - came to fore.
Thakur left the company in 2005. His website said he quit after reporting the fraud to the management. But two former executives said he was asked to go, ostensibly for disciplinary reasons. "Thakur was a soft spoken, gentle person. But he was upset about the circumstances of his departure and felt the company's leadership did not treat him well. Probably, this made him bitter, and he spilt the beans," said an ex-Ranbaxy executive. In 2005, Brian Tempest was the managing director of the company and Malvinder Singh was its president. Singh sold Ranbaxy to Japan's DaiichiSankyo in 2008.
Subsequently, Thakur returned to the US, and in 2007, co-founded a life-sciences KPO, Sciformix Corporation. The company is a scientific processing outsourcing organisation that delivers services in the areas of drug safety, biometrics, medical and regulatory writing, and clinical operations. He remained CEO of the company till last year, says his website. Simultaneously, he worked with the US authorities for eight years on the Ranbaxy investigations, which have finally culminated in a $500-million fine for the company and a $46-million payout for him.
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