Canada cuts Apotex a break on some banned drugs

Health Canada is having to backtrack on regulatory actions taken last month to ban all products manufactured at three Indian plants operated by Canada's Apotex and India's IPCA Laboratories. More than three dozen drugs and APIs that were originally banned by health regulators in Canada will be allowed into the country because they are medically necessary.

Health Canada has posted a list of the drugs, but according to the Toronto Star, the agency said they will be allowed into the country only after they have been tested by an independent third party. They include products sold by other drugmakers like AstraZeneca ($AZN) and Teva Pharmaceutical Industries ($TEVA) that bought the drugs or ingredients from Apotex or IPCA.

"No company is allowed to sell or distribute products originating from these three plants until Health Canada's strict conditions are fully met, thereby ensuring the health and safety of Canadians," a government spokesman told the newspaper in a statement.

They include products like the beta blocker atenolol from Actavis ($ACT) and Teva and the heart drug losartan from Teva as well as the attention deficit hyperactivity disorder (ADHD) drug methylphenidate from Apotex.

Last month, Health Canada took action after the FDA put an Apotex finished-dose plant in Bangalore, India, under import alert. Health Canada banned the import of 30 finished products and a similar number of APIs that Apotex manufactures at its Bangalore plants. The regulator has also banned almost 20 APIs and 50 products in which they are used from an IPCA Laboratories plant in Ratlam. In both cases, the FDA said there were questions about the companies altering or faking testing data.

- read the Health Canada announcement
- get more from the Toronto Star