Nov 20, 2014

By Jane Brown

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Toronto drug giant Apotex has started legal action against Health Canada.  The lawsuit alleges the regulator’s recent ban on it’s drugs made in India was illegal and politically motivated.  Apotex says Health Minister Rona Ambrose acted with “malice” toward the company and caved under political pressure after a series of published reports exposed widespread problems in the company’s Bangalore facilities.  The company is asking a federal court to end the Health Canada ban blocking many of its Indian made products from reaching Canadian consumers. Ambrose told the Toronto Star last night that she stands by her decision to ban Apotex products.  She said “Canadians expect Health Canada to take the action needed to help protect them from drug safety risks.”

Prior to Health Canada’s ban, a newspaper investigation revealed the regulator was so lax that it allowed the import of Apotex drugs and pharmaceutical ingredients that are banned from the United States because the adulterated medications are potentially unsafe.  The Star articles revealed that inspectors from the U.S. Food and Drug Administration had found that staff at Apotex plants in Bangalore manipulated data, destroyed records and retested samples until they got favourable results.

It’s not the first time Apotex has complained about what it calls unfair and costly regulatory sanctions.  In 2012, Apotex complained before an international trade tribunal that a U.S. ban on its imports unfairly punished the Canadian firm and decimated its U.S. sales.  In August, the tribunal unanimously rejected Apotex’s claim and ordered it to pay $1.2 million in legal fees to the U.S. government to cover the cost of the litigation.

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