The US Food and Drug Administration announced on Wednesday, 25th February, that a plant belonging to India’s largest pharmaceutical company, Ranbaxy Laboratories, falsified data and test results in approved and pending applications of generic drugs for the US market.
The FDA said it was halting review of drug applications from Ranbaxy’s Paonta Sahib Plant in India due to evidence of falsified data and was invoking powers under the Application Integrity Policy (AIP). This plant, and two others at Dewas and Batamandi, have been under an FDA Import Alert since September last year in respect of 30 different generic drugs, said the announcement.
The drugs affected by this move fall into three categories:
- Drugs approved by the FDA for the US market that are made at the Paonta Sahib plant.
- Drugs made at the plant that are not yet marketed in the US and are pending FDA approval.
- Some drugs made in the US that relied on results provided by the plant.
While the FDA continues to investigate the matter, they assured they have no evidence that the drugs don’t meet their quality specifications or of any health risks linked to products from the company that are currently sold in the US.
The agency’s advice to patients currently taking drugs made by Ranbaxy is not to disrupt their therapy as this could be risky to their health; anyone worried about their medication should talk to their doctor.
The AIP covers applications that rely on information coming only from the Paonta Sahib factory, said the FDA, who raise the policy only when they are significantly concerned about the integrity of data provided with a drug application.
Under the policy, Ranbaxy is required to put in place a Corrective Action Operating Plan (CAOP) and show that the data from the plant is accurate and reliable. This includes for example allowing a third party to audit applications linked to data from the plant.
Director of the FDA’s Center for Drug Evaluation and Research (CDER), Dr Janet Woodcock, told the press that:
“Companies must provide truthful and accurate information in their marketing applications.”
Director of CDER’s Office of Compliance, Deborah Autor said they applied the AIP because:
“The FDA’s investigations revealed a pattern of questionable data raising significant questions regarding the reliability of certain applications.”
She said that the “action reflects the FDA’s continued vigilance and its steadfast commitment to safeguarding the public’s health”.
Sources: FDA.
Written by: Catharine Paddock, PhD