The U.S. Food and Drug Administration (FDA) on Monday issued a temporary ban on drug imports from an Indian pharmaceutical company’s facility in Mohali for regulatory violations.
Regulators placed an injunction on product imports from Ranbaxy Laboratories Ltd.’s facility in Mohali, India, saying the pharmaceutical company would remain on “import alert” until it complies with U.S drug manufacturing practices.
“The FDA is committed to using the full extent of its enforcement authority to ensure that drugs made for the U.S. market meet federally mandated quality standards,” Howard Sklamberg, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, told reporters in a statement. “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.”
The regulator also ordered that the company’s Mohali facility be subject to specific terms of an injunction issued by the FDA in January 2012, which sought to ensure regulatory compliance — including issues pertaining to data integrity — at two other company facilities, located in Paonta Sahib and Dewas, India. The FDA initially put those two facilities on import alert in 2008.
FDA inspectors last September, and again in December, identified “significant” manufacturing violations at Ranbaxy’s Mohali facility, including a failure to investigate manufacturing problems as well as a failure to establish procedures to ensure quality control. Now, the FDA has prohibited Ranbaxy from manufacturing U.S.-regulated drugs at the Mohali facility. The company is also banned from selling those drugs on the international market, in the United States, and elsewhere.
The Indian pharmaceutical company will be permitted to resume manufacturing and distribution of U.S.-regulated drugs at the Mohali facility following a successful inspection from a third-party expert to ensure FDA compliance.
The FDA does not expect the injunction to disrupt the supply of pharmaceutical drugs in the U.S.