EU lifts ban on Ranbaxy’s Toansa-made drugs

European regulators on Thursday lifted the EU ban on drugs manufactured at Ranbaxy Laboratories' Toansa plant, saying that although deficiencies in manufacturing practices were found, they do not pose a risk to public health.

Export to EU from the company's other plant at Dewas in Madhya Pradesh, however, remains suspended.

The regulators said they were satisfied by corrective measures put in place atthe Toansa plant and reinstated a good manufacturing practices certificate that was suspended in January.

In a statement, the European Medicines Agency (EMA) said European regulatory authorities have finalised their assessment of reported non-compliance with Good Manufacturing Practice (GMP) at the Toansa plant.

"There were a number of GMP deficiencies at the concerned site, assessment of all available information has reassured European regulators that there has been no risk to public health from these deficiencies," it said.

As a consequence, the EU authorities will reinstate the GMP certificate which was suspended in January 2014. The certificate will be re-entered into EudraGMDP, the EU database that contains GMP certificates, EMA added.

It further said, "Patients should continue to take their medicines as prescribed by their healthcare professional."

Ranbaxy had voluntarily suspended exports from the Toansa plant to the EU in January 2014 after US Food and Drug Administration (FDA) had banned the company from exporting drugs produced at the plant to be sold in the US (See: US FDA raises concerns over a fourth Ranbaxy facility).

The assessment of the Toansa facility by EMA followed an inspection by the FDA, which revealed areas of non-compliance with GMP at the site.

"The European medicines regulatory network responded quickly to the FDA's findings, and sent a team of inspectors from Germany, Ireland and the UK, who were joined by inspectors from Switzerland and Australia to undertake an unannounced international inspection of the site," EMA said.

On the status of remedial measures taken up by the company, it said, "The GMP inspection concluded that appropriate corrective and preventive measures have been put in place by the manufacturer."

The inspection team concluded that there was no evidence that any medicines on the EU market that have an active pharmaceutical ingredient manufactured in Toansa were of unacceptable quality or presented a risk to the health of patients taking them, it said.

The regulator added, "European regulatory authorities have identified the need to keep the Toansa site under close supervision and this will be done in collaboration with India and other regulatory authorities around the globe".

The Toansa site had been supplying APIs (active pharmaceutical ingredients) for four centrally authorised medicines - Enyglid (repaglinide), Repaglinide Krka (repaglinide), Repaglinide Teva (repaglinide), and Nevirapine Teva (nevirapine) ? and several non-centrally authorised medicines.

Two GMP certificates have been issued by EU authorities - one covering APIs that are used in medicines authorised in the EU, and a second certificate covering an intermediate of a finished medicine authorised in the EU.

The Suspension of export to EU from the company's other plant at Dewas in Madhya Pradesh, however, remains. 

The EU regulatory stand on the Toansa plant is in contrast to the response of the FDA, whose ban on Toansa-made drugs remains in place.

Ranbaxy is in the process of being acquired by Sun Pharmaceutical Industries for $3.2 billion (Sun Pharma, Ranbaxy to merge in Rs24,000 all-stock deal).

In March the FDA banned imports from Sun's plant at Karkhadi (US FDA warns Sun Pharma over manufacturing practices at Karkhadi plant).

The FDA said that it will not lift its ban on Ranbaxy until it is satisfied that the products meet quality standards and are safe and effective.

"EMA and FDA inspected the Toansa facility using similar quality standards and underlying principles of current good manufacturing practices," the FDA said in a statement. "Both regulators identified significant manufacturing and other violations that needed to be addressed, and both placed restrictions on the Toansa facility."

While the inspections were similar, the FDA said, the two regulatory authorities applied their own, differing, regulatory and legal standards to address the violations.