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The US Food and Drug Administration (FDA) has extended the ongoing consent decree with Ranbaxy, for its Paonta Sahib and Dewas units, to its third and newly commissioned manufacturing facility in Mohali, which attracted an import alert from the regulator on Friday.
“... the Mohali facility be subject to certain terms of the consent decree of permanent injunction entered against Ranbaxy in January 2012,” the American regulator said in a statement issued on September 16.
The consent decree means that Ranbaxy would be barred from supplying any products from its Mohali facility to the US until it takes all corrective action to the satisfaction of the US FDA, which would re-inspect the facility before giving it a go-ahead. Experts suggest that the process is expected to take no less that two-three years. Meanwhile, the company might not be able to file new applications from the ailing facility as well.
According to the US FDA, Ranbaxy, owned by Japan’s Daiichi Sankyo, is now also required to hire a third-party consultant to conduct a thorough inspection of the facility and certify to the regulator that the facilities, methods, processes, and controls are adequate to ensure continuous compliance with good manufacturing norms.
Ranbaxy, however, had maintained on Monday that it has so far not received any communication from the US FDA related to the Mohali import alert.
The decree, signed by Ranbaxy in 2012, contains provisions to ensure current good manufacturing compliance at certain Ranbaxy facilities, including in Paonta Sahib and Dewas, as well as provisions addressing data integrity issues at those two facilities. Ranbaxy’s Paonta Sahib and Dewas facilities have been on FDA import alert since 2008.
While usually consent decrees are signed between the company and regulator, in this particular incident, the FDA has exercised its authority, under a provision in the consent decree, to extend the existing decree to the Mohali facility, after an inspection determined violations.
“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,” said Howard Sklamberg, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research.
US FDA officials came for inspection of the Mohali facility duing September and December 2012, and identified significant violations of manufacturing norms, including failure to adequately investigate manufacturing problems and the failure to establish adequate procedures to ensure manufacturing quality.
Following the import alert, Ranbaxy scrip on BSE tanked over 30 percent to Rs 318.85 a share on Monday. The US drug regulator also said that it does not anticipate that the action (on Ranbaxy) might cause any supply disruption in the United States.
“We want American consumers to be confident that the drugs they are taking are of the highest quality, and the FDA would continue to work to prevent potentially unsafe products from entering the country,” said Sklamberg.
