Ranbaxy whistleblower Thakur richer by Rs 266cr; speaks out

  (1 ) Money Control :May 14, 2013, 12.04 PM IST

Dinesh Thakur served as the whistleblower in this case and is the former Ranbaxy Director and Global Head, Research Information & Portfolio Management.

Thakur is entitled to Rs 266 crore as the whistleblower in the case, the US Justice Department said.



The US government has fined Ranbaxy USD 500 million after its subsidiary pleaded guilty to sale of adulterated drugs manufactured in India. The adulterated drugs were made in Ranbaxy's plants in India and were sold in the US in 2005-2006.

Dinesh Thakur served as the whistleblower in this case and is the former Ranbaxy Director and Global Head, Research Information & Portfolio Management. Thakur is entitled to USD 48.6 million (Rs 266 crore with $1=Rs. 54.80) as the whistleblower in the case, the US Justice Department said.

Here is what Dinesh Thakur said,

"I am relieved that the government's investigation has concluded. I am thankful for the remarkable effort of United States Food and Drug Administration, Department of Justice, United States Attorney's Office for the District of Maryland, USAID, and State Medicaid Fraud Control Units. Their work has been tireless and dedicated.

"Eight years ago, as the Director of Project & Information Management at Ranbaxy, I discovered that the company falsified drug data and systemically violated current good manufacturing practices and good laboratory practices. Ranbaxy's 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.

"I worked with U.S. 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. Along the way, the government barred the importation of Ranbaxy drugs, held the company accountable for its data fraud under FDA's Application Integrity Policy, and required it to implement corrective measures to prevent the problems from recurring.

"As a senior pharmaceutical executive, I understand the importance of regulatory oversight in ensuring drug quality and safety. There are unique challenges in a global drug market, which is highly dependent on international manufacturing and distribution. In fact, approximately 78 percent of prescription drugs dispensed in the United States are generic, and a growing percentage of drugs both generic and name brand is manufactured overseas. This case highlights the need for effective regulation that applies to drugs sold in the United States, regardless where they are manufactured.

I would like to thank FDA's Office of Criminal Investigation, United States Attorney's Office for the District of Maryland, Department of Justice, USAID, and Andrew M. Beato , Bob Muse , and Rory Kelly of Stein Mitchell Muse & Cipollone LLP. I hope that our actions and this case have helped to improve the quality and safety of drugs in the United States and abroad."

 (2) FP Staff May 15, 2013

Dinesh Thakur, the whistleblower in Ranbaxy Laboratories’ US drug safety case, has made a killing by blowing the lid off the dubious manufacturing practices of the pharma major that has pleaded guilty to the sale of adulterated drugs manufactured in India.

An ex-Ranbaxy Director and Global Head, Research Information & Portfolio Management, Thakur played a key role in providing evidence to the US FDA about the company falsifying data and violating ethical management practices.

“Eight years ago, as the Director of Project & Information Management at Ranbaxy, I discovered that the company falsified drug data and systemically violated current good manufacturing practices and good laboratory practices. Ranbaxy’s 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,” Thakur said in a statement.

Reuters

According to a report in theEconomic Times, he has claimed that senior company executives ordered destruction of evidence when they were alerted to data fudging, misbranding and adulteration in drugs.

Thakur joined Ranbaxy in November 2002. After working with US drugmaker Bristol-Myers Squibb. A year later he was relocated to Gurgaon from the US. At the time, he was reporting to Rajinder Kumar, the then head of R&D at Ranbaxy where he found that the firm was making false claims on drugs data to US regulators.

With the backing of Kumar, Thakur launched an internal probe in August 2004 on HUV drugs data and uncovered slips ups ans data fudging after which he widened the investigation to cover other generic drugs where he found even more lapses.

“The problems…implicated the quality of hundreds of generic drugs sold by Defendants, including the following fraudulent practices violating cGMP requirements and rendering the drugs adulterated,” the report quotes Thakur as saying.

After reporting the fraud to the management, Thakur quit Ranbaxy in 2005 but continued to help the the US  FDA for the next two years to expose the fraud and file a lawsuit to hold Ranbaxy accountable.

“I 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. Along the way, the government barred the importation of Ranbaxy drugs, held the company accountable for its data fraud under FDA’s Application Integrity Policy, and required it to implement corrective measures to prevent the problems from recurring,” he said in a statement.

In 2007, Thakur co-founded Sciformix Corporation, a scientific process outsourcing organsiation in the US which focussed on drug safety and regulatory writing, reported theBusiness Standard.

Now a US citizen, Thakur said as a senior pharma  executive, he understood the importance of regulatory oversight in ensuring drug quality and safety.