US FDA differs with EU on Ranbaxy plant safety

The American regulator says Ranbaxy needs to comply before seeking to restart supplies

The US drug regulator’s stand on Ranbaxy’s Toansa factory differs from that of the European Medicines Agency (EMA), which recently reinstated supplies from the facility that is under scanner for violating manufacturing norms. The American regulator has emphasized the company will have to comply with safety and efficacy norms and put adequate corrective measures in place for the US Food and Drug Administration (US FDA) to consider giving it a go ahead.

“Ranbaxy must comply with the consent decree’s provisions before the FDA can make a determination of whether to allow Toansa to resume supplying products for the US market,” the US FDA said.

Earlier this year, drug inspectors from both the US FDA as well as European Union (EU) had inspected the active pharmaceutical (API) manufacturing facility of Ranbaxy and found significant deviations from the good manufacturing practices prescribed by the regulators. Following that, US FDA was the first to take action against the company in January itself as it stopped supplies of any product manufactured in Toansa to the American market. 

However, now EMA says their latest assessment shows  the deficiencies in Ranbaxy’s Toansa factory pose no risk to public health. The assessment stands in stark contrast to the response of US regulators to the deficiencies found at the plant, even as both the regulators maintain they are collaborating and sharing information related to Ranbaxy’s Toansa factory to ensure safe medicines in the market.

“The EMA and FDA inspected the Toansa facility using similar quality standards and underlying principles of current good manufacturing practices. Both regulators identified significant manufacturing and other violations that needed to be addressed, and both placed restrictions on the Toansa facility, consistent with each agency’s legal authorities,” US FDA said.