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September 16, 2013

FDA bans the use of any drugs made at Ranbaxy’s Mohali facility

The US Food and Drug Administration has announced an import ban on any drugs produced at Ranbaxy's facility in Mohali, India, until further notice due to compliance issues.

By Heidi Vella

Medicines

The US Food and Drug Administration has announced an import ban on any drugs produced at Ranbaxy’s facility in Mohali, India, until further notice due to compliance issues.

The agency said Ranbaxy will remain on the import alert list until it complies with US drug manufacturing requirements, known as current good manufacturing practices (CGMP).

The facility, on FDA orders, will be subject to certain terms of the consent decree of permanent injunction taken out against Ranbaxy in January 2012.

The decree contains provisions to ensure CGMP compliance at certain Ranbaxy facilities, including in Paonta Sahib and Dewas, India, as well as provisions addressing data integrity issues at those two facilities.

CGMP requirements are the primary regulatory safeguard of drug manufacturing in the US.

FDA’s Center for Drug Evaluation and Research Office of Compliance director Howard Sklamberg said: "The FDA is committed to using the full extent of its enforcement authority to ensure that drugs made for the US market meet federally mandated quality standards.

"We want American consumers to be confident that the drugs they are taking are of the highest quality, and the FDA will continue to work to prevent potentially unsafe products from entering the country."

Ranbaxy said in a statement on its website that it would review the details and continue to fully cooperate with the US FDA, taking all necessary action to resolve the concerns.

"We want American consumers to be confident that the drugs they are taking are of the highest quality."

The company added that it ‘remains fully committed to upholding the highest standards that patients, prescribers, regulators and all other stakeholders expect’.

Last year, after inspections in September and December, the FDA discovered significant CGMP violations at Ranbaxy’s Mohali facility, including failure to adequately investigate manufacturing problems and failure to establish adequate procedures to ensure manufacturing quality.

Ranbaxy is banned from manufacturing FDA-regulated drugs at the Mohali facility and the company is required to hire a third-party expert to conduct a thorough inspection of the Mohali facility and certify to the FDA that the facilities, methods, processes, and controls are adequate to ensure continuous compliance with CGMP.

The pharmaceutical company will be permitted to resume manufacturing and distribution of FDA-regulated drugs at the Mohali facility once the FDA is satisfied that Ranbaxy has come into compliance with CGMP, the agency said.


Photo: Ranbaxy said it ‘remains fully committed to upholding the highest standards’. Image: courtesy of Alaa Hamed.

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