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US files consent decree of permanent injunction against Ranbaxy

Maryland, Jan 26 (): The Department of Justice, on behalf of the U.S. Food and Drug Administration, has filed a consent decree of permanent injunction against generic drug manufacturer Ranbaxy in the U.S. District Court of Maryland for failing to meet US safety guidelines.  Ranbaxy Laboratories, Ltd., an Indian corporation; its subsidiary Ranbaxy Inc., headquartered in Princeton, N.J. Ranbaxy Labs.’ Dale Adkisson, senior vice president, head of global quality, and Arun Sawhney, chief executive officer and managing director, and Ranbaxy, Inc.’s Venkatachalam Krishnan, regional director Americas, were also named as defendants.

The filing of decree against Ranbaxy to stop selling drugs made at four of its manufacturing plants until it remedies deviations from current good manufacturing practices could trigger multi-million-dollar repercussions. The consent decree also 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.

“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, after it filed the consent decree at the request of the Food and Drug Administration (FDA).

“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.

“Because this company continued to violate current good manufacturing practice regulations and falsify information on drug applications, the FDA took these actions in an effort to protect consumers,” said Dara Corrigan, FDA associate commissioner for regulatory affairs. “The FDA continues to be committed to protecting consumers from potentially unsafe products that may be offered on the market.”

If and when the decree is approved by the court, “it becomes a court order with which Ranbaxy must comply or face contempt,” the Justice Department said. The Justice Department listed several problems, including “inadequate testing of drugs to ensure that they kept their strength and effectiveness until their expiration date.” In addition, “Ranbaxy submitted false data in drug applications to the FDA, including the backdating of tests and the submitting of test data for which no test samples existed,” it added.

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