Ranbaxy to pay $500m in US lawsuit settlement

Pleading guilty to “felony charges” relating to manufacture and distribution of certain adulterated drugs made at two India units, the US subsidiary of Ranbaxy on Monday agreed to pay $500 million — the largest settlement with 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 on Monday 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 totalling $ 150 million and to settle civil claims under the False Claims Act and related State laws for $350 million.”

Ranbaxy USA pleaded guilty to three felony counts under Federal Food Durg and Cosmetics Act, 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.

As part of the case’s resolution, the whistle-blower, a former Ranbaxy executive Dinesh Thakur will receive about $ 48.6 million from the Federal share of the settlement amount.