Ranbaxy Laboratories will have to undertake a series of initiatives including a third party audit of its facilities in India if it wants the US Food and Drug Administration (FDA) to revoke the ban imposed in 2008.
The Indian drug maker will also have to put in place controls to ensure data integrity in the company's drug applications.
The company has to appoint an individual who will be responsible for all quality assurance and quality control activities to ensure that drugs have the required safety. In addition, Ranbaxy has to establish an Office of Data Reliability to conduct pre-submission audits of all applications submitted from any of its facilities.
This is part of a consent decree signed between the FDA and Ranbaxy on December 20. The contents of the decree have now been made available after the document was filed in the US District Court of Maryland, on Wednesday, by the Department of Justice seeking a permanent injunction against Ranbaxy.
Possible damages
Under the agreement, if Ranbaxy fails to meet conditions imposed by the FDA then it will have to relinquish the 180-day exclusivity that it might have for several generic drug applications.
If the court approves the decree, then Ranbaxy may face liquidated damages for potential violations.
In addition to a provision requiring Ranbaxy to pay $15,000 in liquidated damages for each day of violation, an additional sum of $15,000 for each overall violation has been provided for. Ranbaxy has set aside $500 million for potential penalties imposed by the FDA.
The FDA had banned about 30 drugs manufactured at Ranbaxy's plants in Paonta Sahib, Batamandi and Dewas on grounds that the company did not follow good manufacturing practice (CGMP) and data integrity.
This also included Ranbaxy's wholly owned subsidiary Ohm Laboratories facility located in Gloversville, N.Y. The agreement further requires that Ranbaxy comply with detailed data integrity provisions before FDA resumes reviewing drug applications from these plants.
In addition, the decree prevents Ranbaxy from supplying drugs for the President's Emergency Plan for AIDS Relief Program until drugs can be manufactured in the four facilities in compliance with US 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 Ms Dara Corrigan, FDA associate commissioner for regulatory affairs.
Once Ranbaxy has achieved compliance with the data integrity requirements, a third party expert will conduct audits of the facilities to confirm that compliance is being maintained. The decree also permits FDA to order additional Ranbaxy facilities to be covered by the decree if the agency discovers that the facility is not operating in compliance with the law or has serious data integrity issues.
Reacting to the development, Mr Arun Sawhney, Ranbaxy CEO & Managing Director, said this brings greater predictability to the company's US operations.
“We are pleased with the progress we have made in upgrading and enhancing the quality of our business and manufacturing processes,” he said.