Health Canada is allowing drugs and drug ingredients from two Bangalore, India-based factories back into Canada, almost a year after banning them.
But generic drugs maker Apotex Inc. will have to test its products again at a Canadian facility before it can sell them here.
- Apotex warned by U.S. to raise quality control standards
- Health Canada bans drug ingredients from 3 factories in India
Health Canada announced last week it will put inspectors in Apotex's Canadian facility beginning in September to conduct an inspection of the operations and the testing of the products from India.
The products from two Apotex plants in India, Apotex Pharmachem India Pvt. Ltd. and Apotex Research Private Ltd., were banned last October after the U.S. Food and Drug Administration alerted Health Canada to substandard procedures in the plants.
Among the problems were reports the companies falsified data from testing of the drugs, repeatedly retesting until they got results compliant with Canadian standards.
Ingredients from the factories are used in the making of generic blood pressure medications, antihistamines, anti-virals and other drugs for Canadian consumption. There is a full list of the drugs affected on the Health Canada website.
Health Canada sent inspection team
The U.S. blocked drug ingredients from the plants six months ahead of Canada.
Health Canada said it sent an inspection team to the plants in June to assess whether the company had corrected its practices.
The inspection team found that "satisfactory progress" had been made in areas such as collecting and analyzing laboratory data and the investigation process for why drugs did not meet standards. Apotex had also pledged to improve employee training.
Canada's regulatory agency has demanded that Apotex retest all its products at a Canadian facility that uses the manufacturing practices standard expected by Health Canada.
It also has demanded the Indian-based plants report on all deficient testing from their facilities.
It plans to return to India to inspect the plants again in 2016.