America
Canada lifts ban against two India-based pharmas
Toronto, Sep 8
Health Canada has lifted an
11-month-old ban it imposed on import of pharmaceuticals from two
India-based firms after a re-inspection found "satisfactory progress",
media reported on Tuesday.
The re-inspection carried out in June
paved the way for Canadian pharmaceutical giant Apotex to import from
two Bengaluru-based facilities products, under strict conditions,
Toronto Star reported.
The Apotex company had stopped importing
dozens of drugs and pharmaceutical ingredients from the two
Bengaluru-based plants in September last year.
The ban came into
effect after inspectors from the US found that the staff had manipulated
data and were re-testing drug samples until they got favourable
results.
"Health Canada concluded that the corrective work
implemented has progressed to a point where products from these
facilities may now be imported on the Canadian market under specified
conditions," the Canadian drug regulator announced on its website.
According
to Health Canada's new conditions, the staff at Apotex's Canadian labs
would have to retest all the products from the Indian plants before they
can be released into the market.
It has also made it mandatory
that the company should report all "deficient testing results" of
products from the Indian plants for monitoring.
"Health Canada
will not hesitate to take immediate action at any time should a risk to
the health and safety of Canadians be identified," a government
statement said.
The end of the ban comes two weeks before Apotex is scheduled to appear in a federal court against the country's drug regulator.
Headquartered in Ontario, Apotex - Canada's largest drug company - had decried the ban as illegal.
It said it has always backed its Indian-made products which, it maintained, were safe and effective.