On September 30, 2014, Health Canada took action to ban the import of finished drug products and active pharmaceutical ingredients (“API”) from the following sites located in India: Apotex Pharmachem India Pvt Ltd (APIPL), Apotex Research Private Limited (ARPL) and IPCA Laboratories.
Health Canada has compiled a list of drug products affected by the import ban and has been updating the list as new information is received. The list can be accessed here. The list of products affected by the import ban has been recently updated and reveals that in addition to Apotex Inc. (“Apotex”), various pharmaceutical companies are affected.
With respect to the products appearing on the list, Health Canada has deemed certain drugs to be medically necessary. These drugs are excluded from the import ban so long as testing against the product’s specifications is conducted by an independent third party before use or sale in Canada. The updated list provides the status of testing respecting the medically necessary products.
Apotex takes action against Health Canada
In connection with the import ban, Apotex has commenced two judicial review applications. On October 29, 2014, Apotex brought an application seeking an order, among other things, declaring that the decision of the Minister of Health to issue the import ban is unlawful, quashing the Minister’s decision, and prohibiting the Minister from amending Apotex’s establishment licenses so as to prohibit the importation of drugs from APIPL and/or ARPL.1
A second judicial review application was commenced on November 24, 2014. In this application, Apotex argues that it has met all the lawful requirements for approval of its drug Apo-Rasagiline and seeks an order quashing the decision of the Minister that refused to issue a Notice of Compliance to Apotex for Apo-Rasagiline on the basis that the product was manufactured at ARPL or uses API from APIPL.2