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Canada partially lifts import ban on Indian manufacturing sites

Generics/General | Posted 14/11/2014 0 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 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.

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

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Source: Health Canada