India’s largest drug manufacturer, Ranbaxy Laboratories and its U.S. subsidiary, Ranbaxy Inc., and the U.S. Justice Department, and the U.S. Food and Drug Administration have reached an agreement over allegations that the company was selling potentially unsafe drugs in the United States.
Three of Ranbaxy’s Indian facilities and a facility in Gloversville, N.Y. (now closed), have been under FDA import alert since 2008 and it has banned the company from bringing 30 different drugs to the United States. The ban does not include Ranbaxy’s generic version of the cholesterol pill Lipitor. In a press release issued by the FDA, the agency said that the U.S. public should not be concerned that any of the questionable drugs from these facilities are currently in the U.S. market.
In its consent decree, filed in the U.S. District Court for the District of Maryland, the U.S. government said its investigations of Ranbaxy uncovered problems in the drug company’s drug manufacturing and testing in India and in its Gloversville facilities. Those problems included a failure to keep written records showing that drugs had been manufactured properly and to adequately keep the manufacture of penicillin and non-penicillin drugs separate. The U.S. government said Ranbaxy also did not have adequate procedures to prevent contamination of sterile drugs and did not conduct adequate testing of drugs to make sure their strength and effectiveness was retained through their expiration date.
“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 in a statement about the settlement.
The consent decree, filed Wednesday, requires that Ranbaxy
- hire a third party to conduct internal reviews at its facilities and to audit applications containing data from the facilities in question;
- implement procedures and controls sufficient to ensure data integrity in the company’s drug applications;
- 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;
- relinquish any 180-day marketing exclusivity that it might have for certain pending generic drug applications.
The decree also stipulates the FDA may order more of the company’s facilities to be covered by the decree if it finds, through an inspection, that those facilities are not operating in compliance with the law and/or have data integrity issues.
“Today’s announcement is the next step in the process of finalizing our agreement with the FDA to resolve this legacy issue,” said Arun Sawhney, Ranbaxy CEO and managing director in a statement released by the company on Wednesday. “We are pleased with the progress we have made in upgrading and enhancing the quality of our business and manufacturing processes and remain committed to ensuring that all of our facilities and products meet the high standards that patients, prescribers and the public have come to expect from Ranbaxy.”
The decree is subject to court approval.
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