Health Canada bans drug ingredients from 3 factories in India

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.”

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.

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...

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...

This has been excerpted from 1 October 2014 article by the CBC News.