US import alert on Ranbaxy; Mohali unit part of consent decree
New Delhi: Ranbaxy's Mohali facility, which has been placed under import alert by USFDA on Monday, would also be a part of the existing settlement the drug major signed with American authorities for agreeing to remedy deviations from the current good manufacturing practice requirements.
"The firm will remain on the import alert until the company complies with U.S. Drug manufacturing requirements, known as current good manufacturing practices (CGMP)," USFDA said in a statement.
The health regulator added that as per the import alert the officials may detain at the US border drug products manufactured at Ranbaxy's Mohali facility.
"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," Director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research Howard Sklamberg said.
The USFDA also ordered that the company's Mohali facility be subject to certain terms of the consent decree of permanent injunction entered against Ranbaxy in January 2012.
On the extension of the consent decree to the Mohali plant, the US health regulator said it "exercised its authority under a provision in the consent decree permitting it to order that terms of the decree be extended to a Ranbaxy-owned or operated facility if an inspection determines that the facility is in violation of Federal Food, Drug, and Cosmetic Act or FDA regulations, including CGMP."
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, it added.
Under the decree, Ranbaxy is prohibited from manufacturing FDA-regulated drugs at the Mohali facility and introducing drugs into interstate commerce, including into the United States, until the firm’s methods, facilities, and controls used to manufacture drugs at the facility are established, operated, and administered in compliance with CGMP, it said.
According to USFDA, 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," it added.
The Department of Justice, on behalf of FDA, earlier had filed a consent decree of permanent injunction against Ranbaxy in the US District Court of Maryland.
Ranbaxy also agreed to pay a criminal fine and forfeiture totaling USD 150 million and to settle civil claims under the False Claims Act and related State laws for USD 350 million.
The consent decree will address outstanding current good manufacturing practice (CGMP) and data integrity issues at Ranbaxy’s Paonta Sahib, Batamandi and Dewas, India facilities as well as CGMP issues at Ranbaxy Inc.'s wholly owned subsidiary Ohm Laboratories facility located in Gloversville.