Europeans, U.S. differ
over safety of Ranbaxy facility
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[June 06, 2014]
By Toni Clarke
(Reuters) - European
regulators said on Thursday they have completed their
assessment of drug manufacturing violations at Ranbaxy
Laboratories Ltd's facility in Toansa, India, and
although deficiencies were found, they pose no risk to
The regulators said they were satisfied by corrective measures put
in place by the company after U.S. regulators found deviations in
The assessment stands in stark contrast to the response of U.S.
regulators to the deficiencies found at the plant. The Food and Drug
Administration barred Ranbaxy from making and selling pharmaceutical
ingredients from the Toansa facility "to prevent substandard quality
products from reaching U.S. consumers."
Ranbaxy is in the process of being acquired by Indian-based Sun
Pharmaceutical Industries Ltd for $3.2 billion. In March the FDA
banned imports from Sun's plant at Karkhadi.
G.N. Singh, the Drugs Controller General of India, did not respond
to a call for comment made after business hours, but some experts
said they expect India to use the split between Europe and the
United States to validate their claims that the U.S. is being too
harsh on Indian drug companies.
"In that sense I see this as being very negative," said Roger Bate,
economist at the American Enterprise Institute. "It would have been
far more useful if Europe and the U.S. had walked the same line."
The U.S. ban on products from the Toansa facility is part of a
broader crackdown by the U.S. regulator on substandard generic drugs
from India. Toansa became the fourth Ranbaxy plant whose products
were barred from the United States.
Following FDA's Toansa 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.
"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
"This conclusion was supported by tests of samples of these
medicines, all of which met the correct quality specifications."
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Still, the EMA said European 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 it will not lift its ban on Ranbaxy until it is
satisfied the products meet quality standards.
"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 inspections were similar, the FDA said, the two regulatory
authorities applied their own, differing, regulatory and legal
standards to address the violations.
(Reporting by Toni Clarke in Washington; additional reporting by
Sumeet Chatterjee in Mumbai; Editing by Bill Trott and Diane Craft)
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