Ranbaxy Laboratories has suffered major setback as US FDA has prohibited it from manufacturing and distributing active pharmaceutical ingredients from its facility in Tonasa. The Toansa facility is now subject to certain terms of a consent decree of permanent injection entered against Ranbaxy in January 2012. Ranbaxy scrip lost heavily by Rs.75 or over 18 per cent in the morning session today and was moving around Rs.341. It opened at Rs.375.45 as against its previous day close of Rs.417.15 and touched to its lowest at Rs.335 on BSE.
Arun Sawhney, CEO and managing director, said, “This development is clearly unacceptable and an appropriate management action will be taken upon completion of the internal investigation.”
The Toansa facility is now subject to certain terms of a consent decree of permanent injunction entered against Ranbaxy in January 2012. The decree contains, among other things, provisions to ensure compliance with current good manufacturing practice (CGMP) requirements at Ranbaxy facilities in Paonta Sahib and Dewas, India, as well as provisions to address data integrity issues at those facilities. In September 2013, the FDA added Ranbaxy’s Mohali facility to the CGMP provisions of the decree.
In early January 2014, Ranbaxy received the form 483 from US FDA with certain observations as a result of the recent inspection at its API plant at Toansa, Punjab, India. The company voluntarily and proactively suspended shipments of API from this facility to the US market when it received the inspection findings. Ranbaxy is disappointed with the recent FDA action and would like to apologize to all its stakeholders for the inconvenience caused by the suspension of shipment.
“We are taking swift action to prevent substandard quality products from reaching US consumers,” said Carol Bennett, acting director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “The 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.”
The FDA exercised its authority under a provision in the consent decree which permits the agency to extend the decree’s terms to any Ranbaxy-owned or operated facility if an FDA inspection finds the facility in violation of the Federal Food, Drug, and Cosmetic Act or FDA regulations, including CGMP requirements. CGMP requirements serve as the primary regulatory safeguard over drug manufacturing and must be followed by companies to ensure manufacturing quality. The FDA also acted under a separate provision in the decree which permits the agency to order additional corrective actions that FDA determines are necessary to achieve compliance with the law or the decree.
Ranbaxy is required to hire a third-party expert to thoroughly inspect the Toansa facility and certify to the FDA that the facility and its methods and controls are adequate to ensure continuous compliance with CGMP. Ranbaxy will not be permitted to resume manufacturing and distributing API for FDA-regulated drugs from the Toansa facility until the agency is satisfied that Ranbaxy has addressed its manufacturing quality issues at that facility.