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Health Canada puts measures in place for medically necessary products affected by import restriction from 3 facilities in India

Starting date:
October 17, 2014
Type of communication:
Information Update
Subcategory:
Medical Device
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public
Identification number:
RA-41851

March 14, 2016: Health Canada issued a new decision which imposed no terms and conditions on Apotex’s Establishment Licences for products fabricated at Apotex Pharmachem India Pvt. Ltd. (APIPL) and Apotex Research Private Limited (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.

OTTAWA – Further to a September 30, 2014 communication restricting imports of health products from three sites in India, Health Canada is today providing an update on measures it is taking so that Canadians can have access to affected medically necessary products. 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.

An initial list of medically necessary products affected by the import restriction from Apotex Pharmachem India Pvt Ltd (APIPL), Apotex Research Private Limited (ARPL), and IPCA Laboratories was identified and published by Health Canada on October 10. This list was informed by input from the provinces and territories based on information available at the time.

Health Canada remains in regular contact with its provincial and territorial counterparts to monitor the impact of the import restrictions. The list of medically necessary products may change over time as new information becomes available.

The licences of companies that import products from these three facilities have all been amended with terms and conditions to require independent third party testing against the approved Canadian specifications prior to release of any medically necessary products to the Canadian market.

Independent testing will provide confidence that these products meet Canadian quality standards, and will allow consumers to have continued access to medically necessary products that are safe and of good quality. Products from these three sites that are not on the medically necessary list will not be imported or released on to the Canadian market until Health Canada is satisfied that the data integrity issues at the plants have been addressed.

Although the new licence conditions are effective today, companies (see below) have already begun taking appropriate steps to comply with the terms and conditions and are working to put in place, or have already arranged, the required testing.

  • Actavis/Cobalt
  • AstraZeneca Canada
  • International Pharmaceutical Generics (IPG)
  • Intervet
  • Jubilant Draximage Inc.
  • Mint Pharmaceuticals
  • Mylan Pharmaceuticals
  • Pharmascience
  • PRO DOC Ltee
  • Ranbaxy Canada
  • Sandoz Canada
  • Sanis Health Inc.
  • Sivem Pharmaceuticals
  • Teva Canada Ltd

Health Canada has revised the lists of products affected by the import restriction so that consumers can more easily see which products are currently considered medically necessary and those that are being released on to the Canadian market further to the testing required by Health Canada in the terms and conditions.

The list is based on the most recent information received by Health Canada as of October 16, 2014, from importers, companies as well as provinces and territories. It includes information attested to by companies to Health Canada as part of the licensing process. The list will continue to be updated as new information becomes available.

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