Generic drugmaker in India pays $500 million to U.S. to settle whistleblower False Claims Act case–largest payment of its kind

Ranbaxy Laboratories Ltd. India’s largest generic drug manufacturer has agreed to pay $500 million to the United States and individual states to resolve allegations brought forth by whistleblower Dinesh S. Thakur that the company falsified drug data and systematically violated Good Manufacturing and Laboratory Practices resulting in substandard and unapproved drugs. The Settlement is the largest of its kind for a drug manufacturer abroad. Mr. Thakur, former Director and Global Head, Research & Portfolio Management alleged that Ranbaxy caused false claims for payment to be submitted to government healthcare programs for numerous adulterated drugs. He also alleged that the falsified information included backdating tests and submitting false data where no tests were performed. The pervasive violations are alleged to have adulterated dozens of generic drugs purchased by government healthcare programs such as Medicare and Medicaid as well generic antiviral drugs purchased by the U.S. under the President’s Emergency Plan for AIDS Relief. Mr. Thakur will receive 21 percent of the federal and Medicaid States civil recoveries. Presently nearly 80 percent of the generic drugs taken by American consumers trace to overseas manufacturing facilities. Jeffrey Newman represents whistleblowers.