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Department of Justice files consent decree of permanent injunction against Ranbaxy
Date:1/25/2012

he affected facilities;

(2) implement procedures and controls sufficient to ensure data integrity in the company's drug applications; and

(3) withdraw any applications found to contain untrue statements of material fact and/or a pattern or practice of data irregularities that could affect approval of the application. 

In addition, the consent decree prevents Ranbaxy from manufacturing drugs for introduction to the U.S. market and for the President's Emergency Plan for AIDS Relief (PEPFAR) Program at the Paonta Sahib, Batamandi, Dewas, and Gloversville facilities until drugs can be manufactured at such facilities in compliance with U.S. manufacturing quality standards. 

"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."

Under this agreement, once Ranbaxy has achieved compliance with the data integrity requirements, a third party expert must conduct audits of the facilities to confirm that compliance is being maintained.  The company must authorize an individual to be responsible for all quality assurance and quality control activities to ensure that drugs have the required safety, identity, strength, quality, purity, and potency and are in compliance with the law and the decree.  In addition, they must establish an Office of Data Reliability to conduct pre-submission audits of all applications submitted from any facility after entry of the decree.

Ranbaxy has agreed to relinquish any 180-day marketing exclusivity that it might have for three pending generic drug applications, and the firm has further agreed to relinquish any 180-day marketing exclusivity that i
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SOURCE U.S. Food and Drug Administration
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