 "EU lifts drug export ban from Ranbaxy's Toansa plant, says no risk to public health")
New Delhi: European health regulator today lifted suspension imposed on export of drugs produced at Ranbaxy’s Toansa plant to the EU stating medicines produced at the site posed no risk to public health despite having a number of manufacturing deficiencies.
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 (USFDA) had banned the company from exporting drugs produced at the plant to be sold in the US.
The assessment of the Toansa facility by EMA followed an inspection by the USFDA, 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 afinished medicine authorised in the EU.
Suspension of export to EU from the company’s other plant at Dewas in Madhya Pradesh, however, remains.
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