EU, UK evaluating FDA findings on Ranbaxy's Toansa facility

Days after the US Food and Drug Administration banned import of Ranbaxy products to America from its Toansa plant, health regulators of EU and the UK have said they are evaluating the FDA inspection findings to assess if deviations from GMP have any implication in their markets.

European Medicines Agency (EMA), a body under the European Union, said Ranbaxy Laboratories site in Toansa, Punjab is a supplier of active ingredients for four centrally authorised medicines Enyglid (repaglinide), Repaglinide Krka (repaglinide), Repaglinide Teva (repaglinide) and Nevirapine Teva (nevirapine), besides several non-centrally authorised medicines.

"The EMA and national medicines authorities in the EU have been informed of the recent FDA inspection findings and prohibition of importation or distribution within the US of active pharmaceutical ingredients (APIs) from the Ranbaxy Laboratories' site in Toansa, India, due to deviations from Good Manufacturing Practice (GMP) identified during the inspection in Toansa," EMA told PTI in an email reply.

"European authorities are currently evaluating the FDA inspection findings, which have been shared under confidentiality arrangements. "They are also evaluating information requested from the marketing authorisation holders in the EU and from Ranbaxy itself, in order to assess the impact that these GMP deficiencies may have on medicines on the EU market," EMA said.

As part of this evaluation, the EMA and national medicines authorities will take 'any measures necessary to protect' the health of EU patients should a risk to public health be identified, it further said.

Citing manufacturing norm violations, the FDA had last week prohibited Ranbaxy Laboratories from distributing drugs produced at the Toansa unit in the US, including medicines made by the company's Ohm Laboratories facility in New Jersey.

The Medicines and Healthcare Products Regulatory Agency (MHRA) of UK said they are aware of the results of the FDAs inspection relating to GMP issues at the Toansa plant.MHRA said as of now, they found no evidence that Ranbaxy's medicines in the UK are defective, so people can continue to consumes them as usual.

"We are aware of the results of the FDA's inspection relating to Good Manufacturing Practice (GMP) issues at Ranbaxy's Toansa plant in India," an MHRA spokesperson said."Patient safety is our priority and we are currently working with EU and International regulatory partners to assess whether these findings have any implication for the UK. There is no evidence that medicines in the UK are defective so people should continue to take their medicines accordingly," the spokesperson added. 

Presence of flies in sample storage room, un-calibrated instruments in laboratory and non-adherence to sample analysis procedure were among the eight lapses found in Ranbaxy's Toansa plant that led to US health regulator FDA banning imports of drugs made at the facility.

Expressing disappointment over the FDA ban, Ranbaxy had said it will cooperate with the FDA and "comply with Consent Decree in both letter and spirit."