Washington: European regulators said on Thursday they have completed their assessment of manufacturing violations at Ranbaxy Laboratories Ltd`s facility in Toansa, India, and although deficiencies were found, they pose no risk to public health.
The regulators said they were satisfied by corrective measures put in place by the pharmaceutical company and reinstated a good manufacturing practices certificate that was suspended in January.
The move stands in stark contrast to the response of US regulators to the deficiencies found at the plant. The Food and Drug Administration barred Ranbaxy in January from making and selling pharmaceutical ingredients from the Toansa facility in Punjab "to prevent substandard quality products from reaching US consumers."
Ranbaxy is in the process of being acquired by Indian-based Sun Pharmaceutical Industries Ltd for USD 3.2 billion. In March the FDA banned imports from Sun`s plant at Karkhadi.
The US ban on products from the Toansa facility, part of a broader crackdown by the US regulator on substandard generic drugs from India, followed an FDA inspection completed on Jan. 11. Toansa became the fourth Ranbaxy plant whose products were barred from the United States.
Following the FDA`s inspection, European regulators sent a team of inspectors from Germany, Ireland and the United Kingdom, who were joined by inspectors from Switzerland and Australia, the European Medicines Agency (EMA) said in a statement.
"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," the agency said.
"This conclusion was supported by tests of samples of these medicines, all of which met the correct quality specifications."
Still, the EMA said that 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."
A spokesman for Ranbaxy had no immediate comment.
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.
