Health Canada bans shipment of products from Ipca Laboratories

Health Canada has asked Ipca Laboratories, an Indian pharma major, to voluntarily stop shipment of products to Canada on account of a review of recent GMP inspection report by US FDA which identified falsification and manipulation of data issues. The federal department has also asked Canadian companies that import products containing the active ingredients from IPCA facilities to temporarily quarantine the products.

Health Canada estimates that this will affect approximately 21 active pharmaceutical ingredients (APIs). There has been no indication that the issues identified during the FDA inspection pose a risk to health. Therefore, Health Canada is not requesting a recall of products already on the market.
Health Canada has requested that the voluntary quarantine continue until it is satisfied that adequate measures are in place to confirm the quality of the products from IPCA facilities. Health Canada continues to work with other international regulatory partners, Canadian importers and IPCA to gather more information about the products involved.