WASHINGTON: Pleading guilty to “felony charges” relating to manufacture and distribution of certain adulterated drugs made at two India units, the US subsidiary of Ranbaxy has agreed to pay USD 500 million – the largest settlement by a generic medicine maker till date.
The US Justice Department said in a statement: “In the largest drug safety settlement to date with a generic drug manufacturer, Ranbaxy USA, a subsidiary of Indian generic pharmaceutical manufacturer Ranbaxy Laboratories, pleaded guilty to felony charges relating to manufacture and distribution of certain adulterated drugs made at two of Ranbaxy’s manufacturing facilities in India.”
“Ranbaxy also agreed to pay a criminal fine and forfeiture totaling USD 150 million and to settle civil claims under the False Claims Act and related State laws for USD 350 million.”
Ranbaxy USA pleaded guilty to three felony counts under Federal Food Drug and Cosmetics Act (FDCA), and four felony counts of knowingly making materially false statements to the Food and Drug Administration (FDA).
The generic drugs at issue were manufactured at Ranbaxy’s facilities in Paonta Sahib and Dewas in India.
“Under the plea agreement, the company will pay a criminal fine of USD 130 million, and forfeit an additional USD 20 million,” the Justice Department said.
As part of the case’s resolution, the whistle-blower, a former Ranbaxy executive Dinesh Thakur will receive about USD 48.6 million from the Federal share of the settlement amount.
“While we are disappointed by the conduct of the past that led to this investigation, we strongly believe that settling this matter now is in the best interest of all of Ranbaxy’s stakeholders. The conclusion of the DOJ investigation does not materially impact our current financial situation or performance,” Ranbaxy Laboratories CEO & Managing Director Arun Sawhney said. -PTI
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