Indian Regulators Suspend Imports from Troubled Ranbaxy Plant

Indian authorities quietly suspended Ranbaxy’s Toansa facility from exporting active pharmaceutical ingredients to Europe late last month, signaling the country’s new, tougher approach to manufacturing quality violations.

The country’s Central Drugs Standard Control Organization without fanfare withdrew the site’s “written confirmation,” which certifies that exported APIs meet manufacturing standards. The European Medicines Agency revealed the decision this week.

Ranbaxy had already voluntarily stopped exports to Europe from its Toansa and Dewas plants in January, but CDSCO’s decision to formally withdraw the quality certification means the company will have to satisfy Indian regulators if it intends to start shipping products from the facility again.

The Toansa facility has been in hot water before. In January, the FDA prohibited the site from making and distributing APIs for U.S. products after an inspection revealed serious good manufacturing practice violations, such as retesting raw materials to produce a passing result.

Earlier this year, the Toansa plant was added to a 2012 FDA consent decree that imposed limitations on Dewas and three other facilities. Ranbaxy informed European officials that an internal investigation found GMP violations at the Dewas plant, but insisted they were not significant enough to impact the quality or safety of products on the European market, the EMA said.

A recent inspection of the Toansa facility by EMA investigators found no new issues, the agency said, and European authorities plan to reinspect the Dewas site in June.

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