Health Canada says it is banning imports of some medications and drug ingredients produced in India due to concerns about quality.The agency took the action against Apotex Pharmachem India, Apotex Research Private Ltd. and IPCA Laboratories.
It says it has “significant concerns” with the manner in which research data is collected and reported, raising serious doubts about quality and safety.
The agency says until it is satisfied that production processes at the three sites meet international standards, it will keep these products off the market.
Health Canada stresses there are “no specific safety issues” with products now on the market from those companies, nor has a recall been requested.
It adds that consumers should not make any change to their medication without first consulting with a healthcare professional.
Health Canada also said certain medically necessary products may be excluded from the ban on the condition they are tested by an independent third party.
The move follows a recent report that the U.S. Food and Drug Administration banned imports from an Apotex factory in Bangalore after discovering problems there.
But the Toronto Star investigation suggested Health Canada’s attempt to ban imports from the facility was ignored by the company and that the now-banned drugs continued to be sold in Canadian pharmacies.