healthmedicinet

Six months after the U.S. Food and Drug Administration sounded a warning on generic drug maker Apotex’s quality standards, Health Canada has moved to ban the import of all drugs and drug ingredients from three factories in India, two of them associated with Apotex.

Minister Rona Ambrose announced Tuesday that it received new information from the FDA yesterday that “puts into question Health Canada’s trust in the reliability of data that all three plants are required by law to provide to demonstrate the safety and quality of their products.”

• Apotex warned by U.S. to raise quality control standards 
• Health Canada: List of drugs and drug ingredients affected

Health Canada is not calling for a recall of drugs from these plants, but said that trust between the regulator and the company is broken. Her action follows a series of reports from the Toronto Star exposing the ineffectiveness of Health Canada inspectors in dealing with pharmaceutical companies in Canada.

The ban covers drugs and drug ingredients from Apotex Pharmachem India Pvt Ltd,  Apotex Research Private Ltd. and IPCA Laboratories, another India-based drug company that supplies Canadian pharmaceutical makers.

Earlier this year, the FDA probed problems with drugs and ingredients from two Apotex facilities and found that Apotex staff had manipulated data and retested samples until they got favourable results, then destroyed records. The U.S. regulator barred all imports from the affected factories.

Apotex refuses to remove drugs

Health Canada asked Apotex to voluntarily remove a drug made at one of the affected factories, but had to back down when the company refused.

“Whenever there is a dangerous product identified, Health Canada inspectors act immediately. In the case of a drug produced by Apotex, Health Canada inspectors asked the company to remove it from the shelf and it refused,” Ambrose said in the House of Commons.

Ingredients from the factories are used in the making of generic blood pressure medications, antihistamines and other drugs for Canadian consumption.

In a statement released today, Ambrose said the ban on imports would remain in place until Health Canada is satisfied that the factories meet quality standards.

“Health Canada is in ongoing communication with provinces and territories to determine what impact a ban might have on the supply of medically necessary drugs. Should it be determined that there are no alternatives on the Canadian market to certain products from these plants they will be exempted from the import ban, but only after they have undergone testing by an independent quality assurance laboratory,” Health Canada said.