Indian pharma major Ranbaxy faces the possibility of a permanent injunction which requires it

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to make fundamental changes to its plants both in the US and India and would prevent it from manufacturing drugs at certain facilities in the US.

This follows the US Justice Department's unprecedented action in filing a groundbreaking consent decree in a court in Maryland at the request of the Food and Drug Administration.

"This action against Ranbaxy is ground-breaking in its international reach -– it requires the company to make fundamental changes to its plants in both the US 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," West said

The consent decree filed yesterday 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 decree seeks to prevent Ranbaxy from manufacturing drugs for the US market at certain of its facilities until they can do so according to US standards.

Meanwhile, Ranbaxy in a statement in New Delhi said that under the terms of the consent decree, which it signed on December 20 last year, it is committed to further strengthening procedures and policies to ensure data integrity and to comply with current good manufacturing practices.

"Today's announcement is the next step in the process of finalising our agreement with the FDA to resolve this legacy issue," Ranbaxy CEO and Managing Director Arun Sawhney said in the statement.