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1/26/2012
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Ranbaxy face unprecedented injunction after falling standards at US and Indian plants
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Manufacturing violations at Ranbaxy have prompted the US Justice Department to take the unprecedented step of seeking a permanent injunction against the Indian drug manufacturer, in an attempt to force the company to “make fundamental changes” to its two plants.
Fears that falling standards may have compromised the safety of drugs manufactured at the company's bases in the US and India have compelled the Justice Department to act after a request from the US Food and Drug Administration.
The consent decree for the permanent injunction is unprecedented in terms of the range of measures it imposes on Ranbaxy to improve standards and prevent a repeat of violations. The injunction forms part of a settlement with Ranbaxy in which the company must act to correct poor manufacturing standards and problems with submitted data or it will be in contempt of court.
“This action against Ranbaxy is groundbreaking in its international reach; it requires the company to make fundamental changes to its plants in both the United States and India,” said Tony West, assistant Attorney General for the Justice Department's Civil Division.
“Our commitment to ensuring that the drugs the American people rely on are safe, effective and manufactured according to the FDA's standards extends beyond our borders.”
The injunction would prevent Ranbaxy from manufacturing drugs for the US market until the company's facilities have been brought up to US standards. Ranbaxy said it will improve procedures and policies to ensure data integrity as part of the consent decree, which it signed on December 20 last year.
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