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Health Canada has banned the import of all drugs and drug ingredients made by two Apotex factories in Bangalore, India, with Health Minister Rona Ambrose saying Tuesday night that the trust between the regulator and the Toronto-based drug company has been “broken.”
Certain medically necessary products may be excluded from the action on the condition they are tested by an independent third party before being released for use or sale. Independent testing against specifications will provide confidence that these products meet Canadian quality standards, and will allow consumers to have continued access to medically necessary and safe products.
When data integrity issues were first identified at each of these sites by the US Food and Drug Administration (US FDA), Health Canada took action to protect the health and safety of Canadians. There is currently a voluntary quarantine on products from ARPL and IPCA. Products from APIPL have been undergoing additional testing, as required by Health Canada before being allowed on the Canadian market.
Health Canada continues to gather information about the situation at these three sites from trusted regulatory partners, including the FDA. Based on recent information, the Department has significant concerns with the manner in which data are collected and reported, raising serious doubts about the quality and safety of finished products and APIs produced at these sites. Until Health Canada can be satisfied that the production processes used at these three sites meet internationally recognised good manufacturing practices (GMP), it is taking this additional precautionary step to keep these products off the Canadian market.
Consumers should be aware that no specific safety issues have been identified with products currently on the market from the list. To date, neither the FDA nor Health Canada has requested a recall of these products. Health Canada has stopped imports as a temporary precautionary measure until it is satisfied of the processes followed at these sites. Consumers should not make any change to their medication without first consulting with a healthcare professional.
Health Canada continues to work with the provinces and territories to monitor the supply situation and, if necessary, develop mitigation strategies. The Department will keep Canadians informed on further developments related to both the supply situation and the import of the products.
Agencies/Canadajournal
