Ranbaxy USA Inc. , a subsidiary of Indian generic drugmaker Ranbaxy Laboratories Ltd., has pleaded guilty and agreed to pay $500 million to settle false claims allegations, current Good Manufacturing Practice violations and false statements to the U.S. Food and Drug Administration, the U.S. Justice Department said Monday.
Ranbaxy pleaded guilty to felony charges relating to the manufacture and distribution of certain adulterated drugs made at two of its plants in Paonta Sahib and Dewas, India.
Ranbaxy also agreed to pay a criminal fine and forfeiture totaling $150 million and to settle civil claims under the False Claims Act and related State laws for $350 million.
This is the largest drug safety settlement to date with a generic drugmaker, the Justice Department said.
The federal government's share of the civil settlement amount is about $231.8 million, and the remaining $118.2 million will go to the states participating in the agreement.
The civil settlement resolves a whistleblower lawsuit filed in U.S. District Court for the District of Maryland. The whistleblower, former Ranbaxy executive Dinesh Thakur, will receive about $48.6 million from the federal share of the settlement amount.
"When companies sell adulterated drugs, they undermine the integrity of the FDA's approval process and may cause patients to take drugs that are substandard, ineffective, or unsafe," said Stuart Delery, Acting Assistant Attorney General for the Civil Division of the Department of Justice. "We will continue to work with our law enforcement partners to ensure that all manufacturers of drugs approved by the FDA for sale in the United States, both domestic and foreign, follow the FDA guidelines that protect all of us."
Ranbaxy had already set aside $500 million to cover potential criminal and civil liability.
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