Canada allows Apotex Indian plants to regain access to its markets

Canadian Health Minister Rona Ambrose

After the FDA banned a couple of Apotex's plants in India last year, Canadian Health Minister Rona Ambrose had Canadian regulators follow suit. Health Canada has now decided enough improvements have been made by Apotex to let the facilities off the hook, with provisos. The FDA's sanctions, however, remain solidly in place.

Health Canada recently posted a notice that after its inspectors in June did a "rigorous verification of the corrective measures implemented by Apotex," it had concluded the products were safe enough to be returned to the market. It is requiring that all the products coming out of the Indian plants be retested by Apotex in Canada to ensure they meet the country's standards. It also ordered the company to report to Health Canada when the products have failed to hit testing requirements. The agency said it will have inspectors in Apotex's Canadian plant this month to make sure that the company abides by its requirements.

The action, the Toronto Star reports, comes a couple of weeks ahead of a court date in which Apotex is trying to have the ban overturned. The company has publicly said it thinks the health minister was politically motivated in cutting the plants off from the Canadian market and that the action is illegal. The agency has been criticized for being soft on the Canadian-based company.

Health Canada acted last year after the FDA first banned the two Apotex facilities in Bangalore. The FDA laid out its issues in a warning letter earlier this year saying they facilities had been caught manipulating testing data, a practice it said had gone on for years.

In fact, Apotex has been a perpetual problem for the FDA. Two of its Canadian plants were banned from shipping products to the U.S. from 2009 to 2011. Apotex protested that action to a North American Free Trade Agreement (NAFTA) arbitration panel but struck out in its efforts to win some compensation. New warning letters were issued to the plants in 2013, when the FDA again found issues. Those warning letters were closed out by the FDA last year.

- here's the release 
- get more from the Toronto Star

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