Navigation Links
Statement By Dinesh Thakur Regarding US Government's Case Against Ranbaxy
Date:5/13/2013

WASHINGTON, May 13, 2013 /PRNewswire-USNewswire/ -- 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

MEDIA INQUIRIES

For media inquiries, please contact media@gloverparkgroup.com or 202-337-0808; for inquiries from India media, Indianmedia@gloverparkgroup.com


'/>"/>
SOURCE Dinesh Thakur
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Icahn Issues Statement Regarding Amylin Pharmaceuticals
2. American Society of Hematology Statement on Senate Passage of Prescription Drug User Fee Act (PDUFA)
3. American Society of Hematology Statement on House Passage of Prescription Drug User Fee Act (PDUFA)
4. Millennium Laboratories Wins Lawsuit: Ameritox Advertisements Regarding Rx Guardian and Rx Guardian CD Contain Literally False Statements
5. Statement from the Cystic Fibrosis Foundation on Passage of the EXPERRT Act in House of Representatives
6. Lilly Statement on PDUFA Vote by Senate
7. Statement from the Cystic Fibrosis Foundation on Passage of the EXPERRT Act in the U.S. Senate
8. Lilly Statement on Affordable Care Act Ruling by Supreme Court
9. Statement from Mary Vogt, President of Home Access Health Corporation, manufacturer of the Home Access HIV-1 test system, the only over-the-counter HIV test previously approved by the FDA for at-home use.
10. CRE Statement on "Inherent Reasonableness" for Retail Pharmacy Diabetic Supplies
11. Johnson Health Tech Statement on Lance Armstrong
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/29/2017)... March 29, 2017 Transparency ... which provides an exhaustive study of the U.S. substance ... 242 companies are functional in this market at ... the leading companies, such as GlaxoSmithKline Plc., Pfizer ... aggressively on various marketing strategies to increase their ...
(Date:3/29/2017)... 2017 Research and Markets has announced the ... 2023" report to their offering. ... The ablation device global market is expected ... by 2023. Ablation is the minimally invasive therapeutic ... cancerous or diseased tissue removal, to the removal of abnormally conducting ...
(Date:3/29/2017)... 29, 2017   Dynatronics Corporation (NASDAQ: ... of Cynthia L. McHenry (Cyndi) as ... for leading Dynatronics manufacturing, distribution, and purchasing operations ... Dynatronics, CEO Kelvyn H. Cullimore, Jr. ... search process conducted by the company as it ...
Breaking Medicine Technology:
(Date:3/29/2017)... ... March 30, 2017 , ... Sublime Naturals and its ... Life" or "Wonder Spice", it has been used for thousands of years. , "The ... says Heshelow, author of " Turmeric: How to Use it For Your Wellness. Overcome ...
(Date:3/29/2017)... ... March 29, 2017 , ... AngioGenesis Labs sold 300 ... Mississippi. AngioGenesis Labs, makers of HeartBoost, BrainBest and BeautyBest, achieved these results while ... HeartBoost, an over the counter heart healthy drink, can reduce Arterial Plaque, Lower ...
(Date:3/29/2017)... OK (PRWEB) , ... March 29, 2017 , ... ... now receive FASTBRACES® in Carnegie, OK, from Dr. Jamie Cameron, with ... straighten teeth efficiently, compared to traditional orthodontic treatment. Depending on each patient’s case, ...
(Date:3/29/2017)... ... March 29, 2017 , ... How big ... outpatient facilities, and who are the most active developers? , In the ... Healthcare Real Estate Insights (HREI) found that outpatient medical real estate development projects ...
(Date:3/29/2017)... ... 2017 , ... An inventor from Raynham, Mass., knows the ... conjunction with my braces always rubbed against the inside of my cheeks, causing ... problem." The O.B.S. was the result of his brainstorming. , This patent-pending invention ...
Breaking Medicine News(10 mins):