The US Food and Drug Administration (FDA) Thursday notified Ranbaxy Laboratories Ltd that its facility in Toansa had been added to the 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 (Himachal Pradesh) and Dewas (Madhya Pradesh).
In September 2013, the FDA added Ranbaxy’s Mohali (Punjab) facility to the CGMP provisions of the decree.
Under the decree, the FDA has also prohibited Ranbaxy from distributing in the US drugs manufactured using active pharmaceutical ingredients or API from Toansa, including drugs made by Ranbaxy’s Ohm Laboratories facility in New Jersey.
“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 Centre 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’s inspection of the Toansa facility, which concluded on Jan 11, identified significant CGMP violations, the FDA said.
“These included Toansa staff retesting raw materials, intermediate drug products, and finished API after those items failed analytical testing and specifications, in order to produce acceptable findings, and subsequently not reporting or investigating these failures,” it said.
Ranbaxy is also 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, the FDA said.
Ranbaxy has been a major supplier of drugs, especially generics, to the US. With the new FDA action, most Ranbaxy products are now banned here.