In a major setback to Ranbaxy Laboratories, the US Food and Drug Administration has prohibited the import of products manufactured at its facility in Toansa, Punjab, allegedly for violation of current good manufacturing practices.
Indian drug regulatory authorities said Indian drug standards and good manufacturing practices are different from those of the USFDA. A decision on whether the company can continue to distribute products from Toansa in India would be taken after an inspection by a team from the drug controller general of India and the state drug controller.
The USFDA said that during an inspection completed on January 11, its inspectors found Toansa staff retesting raw materials, intermediate drug products and finished active pharmaceutical ingredients (APIs) that had failed analytical testing and specifications, in order to produce acceptable results. The earlier failures were neither reported nor investigated, it said.
Ranbaxy said the company had voluntarily and proactively suspended API shipments from Toansa to the US market in early January when it received the inspection findings.
“This development is clearly unacceptable and an appropriate management action will be taken upon completion of the internal investigation,” Arun Sawhney, CEO and managing director, said in a statement.
Toansa joins Ranbaxy facilities in Paonta Sahib, Batamandi and Dewas in the list of facilities whose products or data will not be admissible for USFDA drug applications until pending issues are addressed.
Ranbaxy is required to hire a third-party expert to thoroughly inspect the Toansa facility and certify to the USFDA that the facility and its methods and controls are adequate to ensure continuous compliance with current good manufacturing practices.
“We are taking swift action to prevent substandard quality products from reaching US Consumers. FDA is committed to ensuring that the drugs American consumers receive – no matter where they are produced – meet quality standards and are safe and effective,” said Carol Bennett, acting director at the Office of Compliance at the USFDA’s Center for Drug Evaluation and Research.
Drug Controller General of India Dr G N Singh said the Toansa facility will be inspected to see if Indian regulatory standards are being met and then a call taken on whether products made there need to be recalled.
“For the earlier three facilities too we had undertaken a systematic audit and our inspectors had sent samples from these plants for testing in government laboratories. The same protocol will be observed for Toansa and if the products are found to be substandard we will recall them. We will not compromise with the safety of Indian patients,” Singh told The Indian Express.
All test reports of the samples from Paonta Sahib, Dewas and Batamandi, he said, have been satisfactory and the expert panel had made some observations to strengthen quality control. “We have communicated those to Ranbaxy,” he added, refusing to elaborate on the exact nature of the recommendations.