(Updates with analyst comment, detail)
By Toni Clarke
June 5 (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 public health.
The regulators said they were satisfied by corrective
measures put in place by the company after U.S. regulators found
deviations in January.
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 said.
"This conclusion was supported by tests of samples of these
medicines, all of which met the correct quality specifications."
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