Canada partially lifts import ban on Indian manufacturing sites

Genéricos/General | Posted 14/11/2014 post-comment0 Post your comment

In an attempt to avert drug shortages, Canada’s federal department responsible for health, Health Canada, has partially lifted an import ban on products from three Indian manufacturing facilities that were banned from importing generics into the country due to quality violations.

Health Canada V13I20

Health Canada announced on 30 September 2014 that it had taken action to stop the import of medicines from the following manufacturing sites in India due to data integrity problems at the sites [1]:

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

However, in an announcement by Health Canada on 22 October 2014, the agency published a list of 42 products that have been identified as medically necessary. The agency is issuing new licenses to companies that sell the products in Canada, provided that they are independently tested.

‘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’, Health Canada stated.

The agency believes that ‘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.’

The licences, which became effective on 17 October 2014, have been issued to Actavis/Cobalt, AstraZeneca Canada, International Pharmaceutical Generics (IPG), Intervet, Jubilant Draximage, Mint Pharmaceuticals, Mylan Pharmaceuticals, Pharmascience, PRO DOC Ltée, Ranbaxy Canada, Sandoz Canada, Sanis Health, Sivem Pharmaceuticals, and Teva Canada.

Related article
Implications of Canadian-European Trade Agreement for generics

Reference
1.   GaBI Online - Generics and Biosimilars Initiative. Canada bans imports from three API facilities in India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Nov 14]. Available from: www.gabionline.net/Generics/General/Canada-bans-imports-from-three-API-facilities-in-India

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2014 Pro PharmaCommunications International. All Rights Reserved.

Source: Health Canada

comment icon Comments (0)
Post your comment
Related content
Empresas farmacéuticas en Argentina
150 AA010692
Genéricos/General Posted 08/07/2022
Most viewed articles
Sobre GaBI
INICIO/Sobre GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
INICIO/Directrices Posted 08/10/2010