Products affected by action to stop imports from ARPL, APIPL and IPCA facilities in India

Health Canada took action on September 30, 2014 to stop the import of health products from the following sites in India:

• Apotex Pharmachem India Pvt Ltd (APIPL)
• Apotex Research Private Limited (ARPL)
• IPCA Laboratories

The action applied to finished products from ARPL, as well as active pharmaceutical ingredients (APIs) and products made with APIs from APIPL and IPCA.

On August 31, 2015, Health Canada amended the terms and conditions on Apotex’s Establishment Licences for APIPL and ARPL as a result of an onsite inspection of corrective actions at these sites in June 2015.

Judgments of the Federal Court set aside import restrictions on APIPL and ARPL products, ordered a retraction of statements and declared amended terms and conditions on Apotex's Establishment Licence unlawful.

On March 14, 2016, Health Canada issued a new decision which imposed no terms and conditions on Apotex’s Establishment Licences for products fabricated at APIPL and ARPL. As such, products fabricated at these two sites are not subject to any import restrictions. This decision was based on all available information, including new information provided by Apotex.  Products imported from these two sites have been removed from the table below.

These lists are based on the most recent information received by Health Canada as of April 19, 2016, from various importers and companies including Apotex, and include attested information submitted to Health Canada as part of the licensing process. The lists will continue to be updated as new information becomes available.

Medically Necessary Products

The following products have been identified as medically necessary by Health Canada and the list has been informed by input from the provinces and territories. This list is based on the most recent information received by Health Canada as of April 19, 2016. The list will continue to be updated as new information becomes available.