Drug firm agrees to pay $500 million fine

WASHINGTON - The Associated Press

Ranbaxy-manufactured products are stacked on the counter. A subsidiary of Ranbaxy, Ranbaxy USA, will pay a fine for selling adulterated drugs. AFP photo

A subsidiary of India’s largest pharmaceutical company has agreed to pay a record $500 million in fines and penalties for selling adulterated drugs and lying to federal regulators in a case that is part of an ongoing crackdown on the quality of generic drugs flowing into the U.S.

Federal prosecutors said on May 14 the guilty plea by Ranbaxy USA represents the largest financial penalty against a generic drug company for violations of the Federal Food, Drug and Cosmetic Act, which prohibits the sale of impure drugs.

The Food and Drug Administration had earlier barred from Ranbaxy from importing more than 30 different drugs made at factories in India and, in 2011, struck a deal that required the company to ensure that data on its products is accurate, undergo extra oversight from a third-party and improve its drug making procedures.

It admitted as part of the deal that it sold impure drugs developed at two manufacturing sites in India. Prosecutors said the batches of adulterated drugs included generic versions of an antibiotic and other medications used to treat a severe type of acne, epilepsy and nerve pain.