By Arun Kumar, IANS,
Washington : The US Food and Drug Administration (FDA) has halted review of drug applications from Indian drug major Ranbaxy’s Himachal Pradesh plant, alleging that it falsified data and test results in approved and pending drug applications.
Announcing the action Wednesday, the FDA said it is continuing to investigate the matter to ensure the safety and efficacy of marketed drugs associated with Ranbaxy’s Paonta Sahib site, which has been under an FDA import alert since September 2008.
The agency said that to date it has no evidence that these drugs do not meet their quality specifications and has not identified any health risks associated with currently marketed Ranbaxy products.
In the meantime, the FDA recommended that patients not disrupt their drug therapy because this could jeopardise their health. Individuals who are concerned about their medications should talk with their health care professional, it said.
The affected applications are for drugs that fall into three categories: Approved drugs made at the Paonta Sahib site for the US market; drugs pending approval at the FDA that are not yet marketed; and certain drugs manufactured in the US that relied on data from the Paonta Sahib facility.
“Companies must provide truthful and accurate information in their marketing applications. The American public expects and deserves no less,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research (CDER).
On Sep 16, 2008, the FDA issued two warning letters and instituted an Import Alert barring the entry of all finished drug products and active pharmaceutical ingredients from Ranbaxy’s Dewas, Paonta Sahib and Batamandi facilities due to violations of current US Good Manufacturing Practices requirements.
That action barred the commercial importation of 30 different generic drugs into the US and remains in effect.
In a press statement, Ranbaxy Laboratories said it will analyse the letter from the FDA informing it about action against the Paonta Sahib facility, placing it under a policy entitled Application Integrity Policy (AIP), and “respond appropriately in a timely manner”.
The FDA has said it has no evidence that the drugs on the market are substandard and also that they comply with specifications upon testing and no products from Ranbaxy’s other manufacturing facilities are included in the AIP, it noted.
Ranbaxy will continue to co-operate with the FDA, it said. Further, no effort or action will be spared to timely protect key drug applications from Paonta Sahib, which include some First to File applications.