Health Canada OKs restart of Apotex products from India, but with oversight plan

Health Canada took action  last September to restrict products coming to Canada from Apotex Pharmachem India and Apotex Research Private in India due to unsatisfactory processes and systems in place to assure Canadians of their quality and safety.

In June 2015, Health Canada inspectors conducted a rigorous verification of the corrective measures implemented by parent company Canada’s Apotex. It said Apotex’ actions included the implementation of new computer systems, strengthened operating processes and procedures, as well as training and re-training of staff. Earlier this year, the US Food and Drug Administration also issued warnings relating to  failures at Apotex facilities in India.

Health Canada concluded that the corrective work implemented has progressed to a point where products from these facilities may now be imported on the Canadian market under specified conditions. As such, Health Canada has amended the company’s licence to include the following conditions as the company ramps up production at the two Indian sites and completes outstanding actions: