New Delhi, May 15: Recently, Indian generic drugmaker Ranbaxy Laboratories Ltd pleaded guilty to felony charges related to drug safety and will pay $500 million in civil and criminal fines under the settlement agreement with the U.S. Department of Justice. The settlement is its largest-ever with a generic drugmaker over drug safety, according to the U.S. government. It includes $150 million in payments for a criminal fine and forfeiture and $350 million in payments for civil claims.
And it was Dinesh Thakur who served as the whistleblower in this case who was the former Ranbaxy Director and Global Head, Research Information & Portfolio Management. Thakur will receive Rs 244 crore for blowing the whistle against Ranbaxy.
Thakur joined Ranbaxy from US drug maker Bristol-Myers Squibb in 2003. Thakur, now a US citizen, co-founded Sciformix Corporation, a scientific process outsourcing organisation, in the US, which is focused on drug safety and regulatory writing. He was recruited by the Indian drugmaker's then R&D head, Rashmi Barbhaiya, a former BMS executive himself.
Thakur gave evidence to the US authorities about the company falsifying drug data and violating good management practices, which triggered an investigation leading 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.
Thakuar now will receive about Rs 244 core from the Federal share of the settlement that Ranbaxy has agreed to pay.
Sources who have worked with Thakur at Ranbaxy said he was hired with three or four people from foreign-based multinational companies. "This team was in a way part of Ranbaxy's ambitious overseas plans at that point in time. However, quite ironically, most of them left in a huff within a short time," a former executive of Ranbaxy said.
Thakur in his statement claimed he had notified the company's management about the problems, but after he found the status-quo, he had no choice but to alert the healthcare authorities.
Thakur began probing the processes followed by company in 2004-05. According to him, he checked 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.
The generic drugs at issue were manufactured at Ranbaxy's facilities in Paonta Sahib and Dewas in India and included acne drug Sotret, epilepsy and nerve pain drug gabapentin and antibiotic ciprofloxacin.
Thakur's website said he quit in 2005 after reporting the fraud to the management. However, reports suggest that he was asked to go, for disciplinary reasons. During this period, Brian Tempest was the managing director of the company and Malvinder Singh was its president. Ranbaxy was sold by Singh to Japan's DaiichiSankyo in 2008.
After returning to the US, he co-founded a life-sciences KPO, Sciformix Corporation in 2007. He remained CEO of the company till last year, says his website. However, he kept on working 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.
