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This is an archive article published on January 26, 2012

US seeks injunction against Ranbaxy

Consent decree to prevent Ranbaxy to stop manufacturing drugs for US until they conform to standards.

In an unprecedented move,the US Justice Department has sought a permanent injunction against Ranbaxy as part of a proposed settlement with the Indian drug major filed in a court that will require the firm to make fundamental changes to its plants.

The Justice Department cited violations of manufacturing standards and problems with submitted data in a consent decree for permanent injunction filed in court against the company. 8220;This action against Ranbaxy is groundbreaking in its international reach 8212; it requires the company to make fundamental changes to its plants in both the United States and India,8221; said Tony West,Assistant Attorney General for the Justice Department8217;s Civil Division,after it filed the consent decree at the request of the Food and Drug Administration FDA.

8220;Our commitment to ensuring that the drugs the American people rely on are safe,effective and manufactured according to the FDA8217;s standards extends beyond our borders,8221; West said.

The consent decree filed is unprecedented in its scope,and requires Ranbaxy to take a wide range of actions to correct its violations and ensure that they do not happen again,said the Justice Department.

Among other things,the consent decree seeks to prevent Ranbaxy from manufacturing drugs for the US market at certain of its facilities until those facilities can do so according to US standards.

Once the settlement is approved by the court,it becomes a court order with which Ranbaxy must comply or face contempt.

In a statement,Ranbaxy said that under the terms of the consent decree,which it signed on December 20 last year,the pharma company has committed to further strengthen procedures and policies to ensure data integrity and to comply with current good manufacturing practices.

 

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