India's largest drug manufacturer, Ranbaxy Laboratories, had falsified data and test results of medicines manufactured at its Himachal Pradesh facility to obtain marketing approval in the United States, says the US Food and Drug Administration.
The FDA disclosure marks completion of the first phase of a probe it had begun soon after Japanese drug major Daiichi Sankyo entered into an agreement with Ranbaxy's promoters to acquire majority shares in the company for over $4 billion. Ranbaxy became a Daiichi subsidiary in November 2008.
In an announcement made on Wednesday, the FDA said the falsification happened in the case of both approved and pending drug applications. The US drug regulator had stopped all new approvals from the facility in Paonta Sahib, Himachal Pradesh, and had banned the sale of medicines produced from the facility in September 2008. This is the first such charge by the US drug regulator against an Indian pharmaceutical company.
Ranbaxy officials were not available for comments.
The applications that were found to have falsified records include medicines approved from the Paonta Sahib site for the US market, drugs for which applications are pending with the agency and certain medicines manufactured in the US based on the data generated from this facility.
On September 16, 2008, the FDA had 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 alleged violations of US current Good Manufacturing Practices requirements. That action barred the commercial importation of 30 different generic drugs into the United States and remains in effect.
The agency is continuing its investigation to find if the medicines marketed by using approvals generated through falsified data have any implications for safety and efficacy. To date, the FDA has no evidence that these drugs do not meet its quality specifications and has not identified any health risks associated with currently marketed Ranbaxy products, the agency said.
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. Under it, the FDA has asked Ranbaxy to cooperate in resolving the questions on 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 Paonta Sahib. A CAOP includes, but is not limited to, conducting a third-party independent audit of applications associated with Paonta Sahib.
"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 in the FDA's Center for Drug Evaluation and Research. "Today's action reflects the FDA's continued vigilance and its steadfast commitment to safeguarding the public's health."
