Health Canada issues import ban from three Indian drug plants

Regulator Health Canada has taken action to stop the imports from three Indian manufacturing sites. Drugs and active pharmaceutical ingredients from Apotex Pharmachem India Private Limited, Apotex Research Private Limited and IPCA Laboratories are now subject to an import ban.

Health Canada’s initial list of products affected by the ban will be updated when new information becomes available, while certain medically necessary products may be excluded from the action if they are tested by an independent third party before being released for use or sale.

The ban has been prompted by information received from the US Food and Drug Administration relating to the reliability of data that all three plants are required to provide by law, in order to demonstrate the safety and quality of their products. Until Health Canada can be satisfied that the production processes meet internationally-recognized good manufacturing practices, it is keeping the products made at the sites off the Canadian market. No specific safety issues have been identified at present in products currently on the market, and no recalls have been issued.