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.

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.

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.

"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."