Washington, Sep 16: The US Food and Drug Administration Monday issued an import alert against drug products manufactured at Indian drug major Ranbaxy’s facility in Punjab’s Mohalifor non-compliance with US drug manufacturing requirements.
Under the import alert which will stand until the company complies with what are known as current good manufacturing practices (CGMP), US officials may detain at the US border drug products manufactured at the Mohali facility, the US regulator said in a media release.
“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,” said Howard Sklamberg, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research.
The US drug regulator also ordered that the Mohali facility be subject to certain terms of the consent decree of permanent injunction entered against Ranbaxy in January 2012.
The decree contains provisions to ensure CGMP compliance at certain Ranbaxy facilities, including in Paonta Sahib in Himachal Pradesh and Dewas in Madhya Pradesh, 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.
In September and December 2012, FDA inspections identified 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, the FDA release said.
Under the decree, Ranbaxy 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.
Once the agency is satisfied that Ranbaxy has come into compliance with CGMP, Ranbaxy will be permitted to resume manufacturing and distribution of FDA-regulated drugs at the Mohali facility, the FDA said.