Ranbaxy settles row with USFDA; to upgrade plants in India and US
New Delhi, Saturday, Januray 28, 2012: Ranbaxy Laboratories has agreed to make significant changes in its manufacturing facilities in India and the US as part of a settlement that seeks to end wide-ranging investigations against the drug maker by the US regulatory authorities.

A consent decree, signed between Ranbaxy and the US Food and Drug Administration (FDA) last month and filed in a US court on Wednesday, extends the ban on supply of drugs from four plants to the US market until the Indian drug maker resolves the problems at these facilities, dashing hopes of the embargo being lifted immediately after the settlement.

The US Department of Justice (DoJ), which filed the consent decree at the request of the FDA, said Ranbaxy had not kept written records, not prevented contamination of sterile drugs at its facilities, inadequately tested drugs, and submitted false data to the FDA. The company made adulterated and potentially unsafe drugs that were illegal to sell, it claimed.

Ref: ET