Halts review of drug applications from Paonta Sahib, invokes compliance clause

The US Food and Drug Administration (FDA) on Wednesday announced that a facility owned by Ranbaxy Laboratories Ltd falsified data and test results in approved and pending drug applications.

The facility, Paonta Sahib, has been under an FDA import alert since September 2008.

The FDA is continuing to investigate this matter to ensure the safety and efficacy of marketed drugs associated with Ranbaxy’s Paonta Sahib site.

To date, the FDA 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, the regulator said in a press release.

Analysts said the FDA wants to make an example of Ranbaxy so that there is no shortfall whatsoever where the quality of generics are concerned in future.

There is also pressure on the new Obama administration to get such issues addressed in a “deterrent manner”, said an analyst.

In the meantime, the FDA recommended patients not disrupt their drug therapy because this could jeopardise their health.

The affected applications are for 3 categories of drugs:

1. Approved drugs made at the Paonta Sahib for the US market;

2. Drugs pending approval at the FDA; and,

3. Certain drugs manufactured in the US that relied on data from Paonta Sahib facility.

To address the falsified data, the FDA has invoked its Application Integrity Policy (AIP) against 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 Ranbaxy to cooperate with the agency to resolve the questions of data integrity and reliability. This would include implementing a Corrective Action Operating Plan (CAOP) 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 stops all substantive scientific review of any new or pending drug approval pleas.

On September 16, 2008, the FDA issued two warning letters and instituted an import alert barring entry of drugs and APIs from Ranbaxy’s Dewas, Paonta Sahib and Batamandi units.

Our Bureau/ DNA-Daily News & Analysis Source: 3D Syndication