Statement by Dinesh Thakur Regarding US Government’s Case Against Ranbaxy

FOR IMMEDIATE RELEASE – Washington, D.C. (May 13, 2013)

Today, the United States government brought to a conclusion an eight-year criminal and civil investigation of Ranbaxy Laboratories Limited, India’s largest generic drug company, and Ranbaxy, Inc., Ranbaxy Pharmaceuticals, Inc., Ranbaxy Laboratories, Inc., Ranbaxy USA, Inc., and Ohm Laboratories, Inc. (“Ranbaxy”). Ranbaxy has agreed to pay $500 million to resolve allegations of falsifying drug data and systemic manufacturing violations. Ranbaxy USA Inc. has pleaded guilty to multiple criminal violations. Dinesh Thakur served as the whistleblower in this case and is the former Ranbaxy Director and Global Head, Research Information & Portfolio Management.

Statement by Dinesh Thakur:

“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.”

FOR MORE INFORMATION
Please visit www.dineshthakur.com

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18 thoughts on “Statement by Dinesh Thakur Regarding US Government’s Case Against Ranbaxy

  1. We are proud of people like you who show us that corporate might cannot throttle the voices of the ethical crowd.

    Regards

  2. I feel proud that I have worked with you. You inspire us who work in drug safety environment. God Bless!

  3. You have always been a source of inspiration for us. You have once again proved that time is always right to do what is right. Congratulations !

  4. FIRST OF ALL CONGRATULATIONS SIR FOR WINNING YOUR BATTLE. SIR WHEN COMPANIES LIKE RANBAXY ARE NOT FOLLOWING THE GMP AND GLP GUIDELINES AND ARE CAUGHT FOR SUCH BY USFDA THEN OTHER INDIAN COMPANIES MIGHT NOT BE FOLLOWING GMP GLP GUIDELINES IN INDIA. THESE COMPANIES ARE SHOWING THEIR LOGOS LIKE CARING FOR LIFE BUT ACTUALLY THEY JUST WANT TO MAKE MONEY. INDIAN REGULATORY BODIES LIKE DCGI CDSCO ARE ALSO TAKING BRIBES FOR THE APPROVAL OF MANUFACTURING PLANT . I REQUEST YOU HELP PUNISH ALL THOSE WHO ARE JUST INTERESTED IN MAKING MONEY NOT FOR THE BETTERMENT OF PEOPLES LIFE.

    A WELL WISHER OF INDIA

  5. I finished reading the CNN report moments ago.

    Shocking, and inspiring at the same time.

    CNN also talks about how Ranbaxy tried to “fix” the whistleblower using dirty tactics, planting false evidence on the computer etc. This seems to be a regular practice ! But surprisingly a pioneering one as it happened in 2005 much before other companies discovered that the Information Technology Act (IT Act) is their friend in “handling” whistleblowers. Whistleblowers at other companies have been successfully suprressed with such dirty tactics. I can share this based on first hand experience, and I hope your success will be a beacon of light.

    The CNN report also says how the company painted itself as a victim of corporate saboteurs: “… A multinational and a leading Indian company are working in concert to bring our share price down,” he said, without specifying the names. Despite the investigation, he said, “our business in the U.S. continues as normal…” which is again a very revelatory of the fundamental nature of corporate culture.

    Generics R&D will certainly benefit the global and indian humanity but I hope some attention will also be drawn to the importance of whistleblower protection. Thank you for walking the right path even in the face of severe adversity. I hope this will inspire a thousand other men and women to stand upright.

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  8. Dear Mr. Thakur,

    We in India want to take up same issues in a big way as it affects common man and it has now been established that Drug Controller of India Officers are hand in glove with pharma companies. Even Indian Parliamentry Committee report has said so.

    How do we get in touch with you ? This is important . Kindly visit our web site to know more about us and what we are doing to clean up Indian system

    Vinay Kumar Mittal
    Researxh Volunteer
    Aam Aadmi Party

  9. it is really a good one . someone like you helped in unraveling the mystery surrounding the MNCs in the pharma industry.can we have a central regulatory organisation on the lines of RBI in the coming days?in India to do justice to the common man and the poor people

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