Health Canada puts in place new oversight of Apotex Inc. imports from APIPL and ARPL

Starting date:
September 1, 2015
Type of communication:
Information Update
Subcategory:
Drugs
Source of recall:
Health Canada
Identification number:
RA-54854

Issue

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 – Health Canada took action last September to restrict products coming to Canada from Apotex Pharmachem India Pvt. Ltd. (APIPL) and Apotex Research Private Limited (ARPL) in India due to unsatisfactory processes and systems in place to assure Canadians of their quality and safety. 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.

In June 2015, Health Canada inspectors conducted a rigorous verification of the corrective measures implemented by Apotex. Apotex’s actions included the implementation of new computer systems, strengthened operating processes and procedures, as well as training and re-training of staff.

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:

  • Health Canada requires that product originating from APIPL and ARPL be re-tested at an Apotex good manufacturing practices-compliant facility in Canada, before entering the Canadian market, and
  • Health Canada requires Apotex to report any deficient testing results and investigations with products originating from these two Indian sites.

Conditions will remain in effect until Health Canada is satisfied that corrective actions are fully and sustainably implemented at both Indian sites at full production. Health Canada plans to re-inspect both Indian sites in early 2016.

As part of Health Canada’s ongoing activities, Health Canada inspectors will be present in Apotex’s Canadian facility beginning in September to conduct an inspection of the operations and the testing of the products from India.

In addition, Health Canada requires Apotex Inc. to provide regular updates on all corrective actions implemented at APIPL and ARPL. Health Canada will continue to work with its trusted international regulatory partners to review any new information regarding the quality or safety of products originating from APIPL and ARPL.

Health Canada will not hesitate to take immediate action at any time should a risk to the health and safety of Canadians be identified.

Summary reports of the inspection visits are available at: Drug and Health Product Inspections Database.

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