Ranbaxy USA Inc., the American subsidiary of Ranbaxy Laboratories Limited, an Indian generic pharmaceutical maker, has agreed to pay $500 million to settle fines related to claims that it made false statements to the FDA about its manufacturing practices abroad and sold substandard medications and pay penalties. The US Justice Department, which announced the terms of this resolution, said that Ranbaxy also pleaded guilty to criminal charges involving federal drug safety violations.
Former Ranbaxy Director (and Global Head, Research & Portfolio Management) Dinesh S. Thankur, who filed the whistleblower lawsuit, is the one who brought forward the allegations that the company violated Good Manufacturing and Laboratory Practices, leading to the making of subpar drugs and the falsification of drug information. He also contends that Ranbaxy submitted false claims for a number of adulterated drugs to government healthcare programs for payment, as well as turned in false information when no tests were conducted while falsifying data about backdating tests.
Thankur alleges that the generic drug manufacturer committed Medicare/Medicaid fraud and pharmaceutical fraud. He said that he was forced to notify healthcare authorities about the violations after his former employer didn’t act when he alerted them to the problems.