The FDA has accused Ranbaxy of submitting falsified stability data in abbreviated new drug applications (ANDAs), which include information generated from the company's plant in Paonta Sahib, India. The agency said that new and pending applications referencing information from the facility will not be reviewed until the suspect data are validated.
The agency said it is invoking its application integrity policy for Ranbaxy drug applications containing data from the plant.
The affected applications are for drugs that fall into three categories:
- Approved drugs made at the Paonta Sahib site for the U.S. market;
- Drugs pending approval at the FDA that are not yet marketed; and
- Certain drugs manufactured in the U.S. that relied on data from the Paonta Sahib facility.
To address the falsified data, the FDA has invoked its Application Integrity Policy (AIP) against the Paonta Sahib facility. The AIP is invoked when a company's actions raise significant questions about the integrity of data in drug applications. This AIP covers applications that rely on data generated by the Paonta Sahib facility only.
Under the AIP, the FDA has asked the New Delhi, India-based Ranbaxy to cooperate with the agency to resolve the questions of data integrity and reliability. This would include implementing a Corrective Action Operating Plan (COAP) to provide assurance of the integrity and reliability of data from the Paonta Sahib facility. A CAOP includes, but is not limited to, conducting a third-party independent audit of applications associated with Paonta Sahib.
When the AIP is implemented, the FDA will stop all substantive scientific review of any new or pending drug approval applications that contain data generated by the Paonta Sahib facility.
"The FDA's investigations revealed a pattern of questionable data raising significant questions regarding the reliability of certain applications, and this warrants applying the Application Integrity Policy," said Deborah Autor, director of the Office of Compliance within the Center for Drug Evaluation and Research at the FDA.
In the meantime, the agency has recommended that "patients not disrupt their drug therapy because this could jeopardize their health."
In September 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 unit facilities due to violations of U.S. current good manufacturing practices requirements. That action barred the commercial importation of 30 different generic drugs into the United States and remains in effect.