New Delhi/Washington: US health regulator Food and Drug Administration has said it may seek third-party audit for drug applications from Ranbaxy’s Paonta Sahib plant in Himachal Pradesh, as it has found evidence of falsified data and test results in them.
Five months after banning import of Ranbaxy’s 30 drugs to the US, the regulator said in a statement late Wednesday that it was taking “new regulatory action against Ranbaxy’s Paonta Sahib Plant in India” and has halted review of drug applications from the plant due to evidence on falsified data.
“To address the falsified data, the FDA has invoked its Application Integrity Policy (AIP) against the Paonta Sahib facility,” it said.
Under AIP, the regulator may implement a Corrective Action Operating Plan (CAOP), which FDA said, might include seeking a third-party independent audit of drug applications associated with the plant.
The AIP is invoked when a company’s actions raise significant questions about the integrity of data in drug applications. Under the AIP, FDA has asked Ranbaxy to cooperate with the agency in resolving the questions of data integrity and reliability.
Ranbaxy said separately in a statement that it would continue to cooperate with the USFDA.
The company added that it would “analyse the letter (from FDA) and other information fully and respond appropriately in a timely manner”.
The company, however, added quoting FDA that the regulator has no evidence that the drugs in the market are sub-standard and also that they comply with specifications upon testing.
“...no effort or action will be spared to timely protect key ANDAs (Abbreviated New Drug Applications) from Paonta Sahib, which includes some First to File applications,” US FDA said.
First to File applications are for the first generic versions of a drug after expiry of patents and gives the company exclusive rights for the six months.