IGMPI India

Toronto Generic Drug giant Apotex had sued Health Minister Rona Ambrose over ordering of import ban on apotex products which according to Apotex has been done in lue of political pressure arising due to articles in the Star. Apotex had alleged that Health Minister Rona Ambrose acted with enmity towards the company as she came under political pressure due to series of articles published by star directing towards the problems at the Bangalore facilities of the company.

The company is asking the federal court to put down the ban which is blocking many of its Indian made products to reach the Canadian consumer's.

The company filed a lawsuit in Toronto on Oct 29th saying that the implementation of import was politically motivated to deflect public and parliamentary criticism of the minister as a result of Toronto Star Articles. The earlier star investigations revealed that Health Canada allowed the import of Apotex drugs and pharmaceutical ingredients which were banned in the from the United States because the adultered medications were potentially unsafe. It was found by US FDA that data was manipulated, records were destroyed and samples were retested until they got favorable results in the Bangalore based Apotex Plant. All these led to the criticism of Canada's Drug Regulator being "feeble, inadequate and incompetent" and hence ban was announced which affected more than 60 drugs and drug ingredients — including a generic form of Viagra and popular treatments for hypertension, dementia and high blood pressure.

In the lawsuit company had claimed that the FDA's foreign plant inspection procedure is "discriminatory" and a "breach" of fair trade agreements. As per the lawsuit in the month of September Health Canada inspectors gave one of the Bangalore plants a compliant rating. Then, on Sept. 30, the company alleges, Health Canada suddenly banned products from Apotex's India plants without giving the firm detailed reasons or an opportunity to address the regulator's concerns although the company said it kept Health Canada informed on a "voluntary basis" of the FDA concerns, which the firm says had nothing to do with product quality. In its lawsuit, Apotex has demanded reversals, retractions and reimbursements. It wants the court, among other things, to order Ambrose to retract her online statements justifying the import ban as well as release all Apotex products "unlawfully seized" by the government.

As per the new FDA records revealed by the Star Apotex recently recalled more than 60,000 bottles of blood pressure tablets — a medication called "candesartan cilexetil" — because of impurities. The tablets were made at one of Apotex's Bangalore factories. On asking the Apotex spokesperson did not answer several questions about the lawsuit and recall saying that as per the company policy the proprietary commercial information cannot be discussed and no comments can be made regarding the ongoing litigation.

Earlier this year Health Canada twice asked the Apotex to stop sale and cease imports” from the Bangalore facility owing to results of US inspections showing suspect drug ingredients were made by Apotex in India, but that time the company refused.

This is not the first time Apotex had complained about what according to it is unfair and costly regulatory sanctions. Similar complaint was made by Apotex in the year 2012 before an international trade tribunal that a U.S. ban on its imports unfairly punished the Canadian firm and slowed down its U.S. sales. In August, the tribunal 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.