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
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
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
1. Apotex Inc., Apotex Pharmachem India Pvt Ltd. and
Apotex Research Private Limited v. Minister of Health and Attorney
General of Canada, Court File No. T-2223-14
2. Apotex Inc. v. Minister of Health and Attorney
General of Canada, Court File No. T-2411-14
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