Health Canada Formally Retracts Import Ban on Indian Apotex Products

Health Canada has agreed to comply with a Canadian court ruling quashing the agency’s import ban on drugs from a generics manufacturer. In a Nov. 2 statement, Health Canada retracted an information update that prohibited imports from two Apotex manufacturing facilities in India.

The move was ordered by the Federal Court of Canada Oct. 14, which concluded that the regulator had proceeded unfairly. The action formally ends the ban and an Apotex lawsuit filed as a result, although Health Canada had begun to allow imports from the Indian facilities prior to the court’s ruling.

In the agency’s release, Health Canada acknowledged the court’s ruling that it had “acted for an improper purpose” and formally withdrew the information update from September 2014, along with a statement to that effect from Canada’s health minister. These retractions were requested by the court in its order.

Health Canada stated following the court decision that it still harbors reservations about the sites and will require products coming from them be retested at a GMP-compliant Apotex facility in Canada.

A June 2015 inspection by the regulator showed the two sites had made progress, with improvements coming from Apotex’s use of new computer systems, strengthened operating processes and procedures, as well as training and retraining of staff.

Health Canada originally instituted the ban on the Indian sites last September, citing data integrity issues from the plants — API maker Apotex Pharmachem India and finished product maker Apotex Research Private Limited.

Two months later, Apotex filed suit, claiming that Health Canada enforced the ban to blunt criticism against it by leaders in parliament and a national newspaper rather than in response to any legitimate quality manufacturing issues. — Kellen Owings


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