In a setback to Indian pharmaceutical giant Ranbaxy, the US has prohibited it from producing and distributing "substandard quality" drugs for the American market from its Toansa facility in Punjab.
In an order, the Food and Drug Administration on Thursday prohibited Ranbaxy from distributing in the US the drugs manufactured using active pharmaceutical ingredients (API) in Toansa, including drugs made by Ranbaxy's Ohm Laboratories facility in New Jersey.
Ranbaxy has also been prohibited from manufacturing API at its Toansa facility for FDA-regulated drug products; exporting API from Toansa to the US for any purpose; and providing API from Toansa to other companies, including other Ranbaxy facilities, making products for American consumers.
"We are taking swift action to prevent substandard quality products from reaching US consumers," said Carol Bennett, acting director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research. "The FDA is committed to ensuring that the drugs American consumers receive no matter where they are produced meet quality standards and are safe and effective," he said.
In a statement, FDA said it exercised its authority under a provision in the consent decree which permits the agency to extend the decree's terms to any Ranbaxy-owned or operated facility if an FDA inspection finds the facility in violation of the Federal Food, Drug, and Cosmetic Act or FDA regulations, including CGMP requirements.
CGMP requirements serve as the primary regulatory safeguard over drug manufacturing and must be followed by companies to ensure manufacturing quality.
The FDA also acted under a separate provision in the decree which permits the agency to order additional corrective actions that FDA determines are necessary to achieve compliance with the law or the decree, it said.
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