Canada lifts ban against two drug facilities in India

Vikrant

Gold Member
Apr 20, 2013
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The U.S.
Good for Canada.

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Health Canada has lifted its ban against two Apotex facilities in India, allowing the pharmaceutical giant to import its products under strict conditions.

Dozens of drugs and pharmaceutical ingredients from the two Bangalore plants had been barred from entering Canada since September 2014, after U.S. inspectors found staff had manipulated data and were retesting drug samples until they got favourable results.

Canada’s drug regulator reinspected the two plants in June and determined “satisfactory progress” had been made to address its concerns about the company’s data integrity.

“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 regulator said in an announcement quietly posted to its website on Sept. 1.

Apotex, which has decried the costly ban as illegal, has always said its Indian-made products are safe and effective.

Under Health Canada’s new conditions, staff at Apotex’s Canadian labs must retest all of the products from the two Indian plants before they can be released to market: a safeguard the company has said it already employed before the ban.

The company must also report all “deficient testing results” for products originating from the Indian plants so that Health Canada can monitor the firm’s internal investigations into the suspect drugs.

“Health Canada will not hesitate to take immediate action at any time should a risk to the health and safety of Canadians be identified,” the government said in its statement.

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Canada lifts ban against two drug facilities in India | Toronto Star
 

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