US regulator charges Ranbaxy of falsifying data, test results
The US health regulator FDA said Indian pharma major Ranbaxy has falsified data and test results in its drug applications, prompting it to take necessary actions.business Updated: Feb 26, 2009 07:54 IST
The US health regulator FDA on Wednesday said Indian pharma major Ranbaxy has falsified data and test results in its drug applications, prompting it to take necessary actions.
The US Food and Drug Administration (FDA) said in a statement that it has taken “new regulatory action against Ranbaxys Paonta Sahib Plant in India” and has halted review of drug applications from plant due to evidence of falsified data.
“The facility, Paonta Sahib, has been under an FDA import alert since September 2008,” FDA said, adding that it was “continuing to investigate this matter to ensure the safety and efficacy of marketed drugs associated with Ranbaxys Paonta Sahib site.”
Any comment from Ranbaxy, which was sold to Japan’s Daiichi by its then Indian promoters last year, on the latest FDA action could not be obtained immediately.
“To date, FDA has no evidence that these drugs do not meet quality specifications and has not identified any health risks associated with currently marketed Ranbaxy products. “In the meantime, the FDA recommends that patients not to disrupt their drug therapy because this could jeopardize their health. Individuals who are concerned about their medications should talk with their health care professional,” the regulator noted.
First Published: Feb 25, 2009 22:50 IST