Monday, October 6, 2014
Statement by the Honourable Rona Ambrose on the import ban of drug products from three plants in IndiaSeptember 30, 2014 - Ottawa - Health Canada Copy
Statement by the Honourable Rona Ambrose on the import ban of drug products from three plants in IndiaSeptember 30, 2014 - Ottawa - Health Canada
Protecting the health and safety of Canadians is our government's highest priority. Our expectation is that Health Canada uses the appropriate powers and tools at its disposal to help ensure that the drugs Canadians need meet the highest safety and quality standards.
To that end, Health Canada has taken decisive action today to stop the import into Canada of all drug products from three plants in India. They are:
Apotex Pharmachem India Pvt Ltd
Apotex Research Private Limited
The Department has ordered an import ban after it received new information yesterday from the United States Food and Drug Administration (US FDA). This latest information puts into question Health Canada's trust in the reliability of data that all three plants are required by law to provide to demonstrate the safety and quality of their products.
I would like to reassure Canadians that Health Canada actions are guided by science and evidence every step of the way.
The ban is a precautionary step. Health Canada has received no evidence that the products pose an immediate risk. Like the FDA, Health Canada does not feel that a recall of any products made at these plants is required at this time.
But when trust between a regulator and a company is broken, strong actions are required. The import ban will remain in place until such time as the Department is satisfied that the data integrity problems have been resolved.
Health Canada is in ongoing communication with provinces and territories to determine what impact a ban might have on the supply of medically necessary drugs. Should it be determined that there are no alternatives on the Canadian market to certain products from these plants they will be exempted from the import ban, but only after they have undergone testing by an independent quality assurance laboratory.
Our government will not tolerate a failure by drug companies to meet their obligations to abide by Canada's high safety and quality standards. New powers proposed in Vanessa's Law (Bill C-17) will provide the tools to better respond to drug safety issues including powers to order mandatory recalls of unsafe drugs so that Health Canada does not have to negotiate with companies when safety issues are identified, tough new fines for companies who put Canadians at risk, and the authorities required to publish even more data from drug reviews and clinical trials.
We will continue to take actions as needed to protect Canadians, and provide information in an open and transparent way.
- 30 -