APOTEX SUES HEALTH MINISTER AMBROSE A SECOND TIME OVER BANNED DRUGS

Dec 01, 2014

By Jane Brown

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The battle between Health Canada and drug giant Apotex continues.

The federal health agency has refused to license a potent Parkinson’s medication from Apotex because it’s made at one of the drug companie’s beleaguered factories in India.

In response, Apotex has sued Health Minister Rona Ambrose, asking a federal court to order the government to approve the firm’s generic version of the drug.

It’s the second time in a month that Toronto based Apotex has sued the health minister, in a battle that’s been escalating since the Toronto Star published an investigation revealing serious problems at the company’s plants in Bangalore, India.

A published report in September revealed that the U.S. had banned drug products from one of its plants after its inspectors found Apotex staff manipulated data, destroyed records and retested samples until they got favourable results. At the same time, Health Canada allowed the drugs to be imported.  Then on September 30th, Ambrose announced the government was barring imports of drugs and drug ingredients from Apotex’s two Bangalore facilities.

Apotex alleges it was blindsided first by the ban, and then again on November 17th when the regulator told Apotex it would not issue approval to market the Parkinson’s drug in Canada.

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