Canada lifts ban against two India-based pharmas
TORONTO: 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.
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.
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