FDA Halts Review of Applications from Ranbaxy's Paonta Sahib Plant

The US Food and Drug Administration charged that Ranbaxy Laboratories’ (Gurgaon, Haryana, India) Paonta Sahib facility falsified data and test results in approved and pending drug applications, according to a press release dated Feb. 25, 2009. To address the falsified data, FDA invoked its Application Integrity Policy (AIP) and stopped all substantive scientific review of new and pending drug-approval applications containing data generated by the facility.

The applications in question are for drugs that fall into the following categories:

• Approved drugs made at the Paonta Sahib site for the US market

• Drugs pending FDA approval that are not yet marketed

• Certain drugs manufactured in the US that relied on data from 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 CDER’s Office of Compliance. “Today’s action reflects the FDA’s continued vigilance and its steadfast commitment to safeguarding the public’s health.”

As part of the AIP, the agency requested Ranbaxy’s cooperation to resolve the questions of data integrity and reliability. Among other measures, Ranbaxy is expected to initiate a corrective action operating plan (CAOP) to certify the integrity and reliability of data from the Paonta Sahib facility. A CAOP includes a third-party independent audit of applications associated with the plant.

FDA is conducting an investigation to ensure the safety and efficacy of marketed drugs associated with the Paonta Sahib site. The agency has no evidence that these drugs fail to meet their quality specifications, nor has FDA identified any health risks associated with currently marketed Ranbaxy products.

Patients are advised to continue their drug therapy to avoid jeopardizing their health. FDA recommends that patients who are concerned about their medications talk with their healthcare professional.

On Sep. 16, 2008, FDA issued two Warning Letters and put an Import Alert in place, thereby barring the entry into the US of all finished drug products and active pharmaceutical ingredients from Ranbaxy’s Dewas, Paonta Sahib, and Batamandi Unit facilities. These measures resulted from violations of US current good manufacturing practices requirements. The Import Alert, which remains in effect, halted the commercial importation of 30 generic drugs into the US.