Health Canada has banned the import of all drugs and drug ingredients made by two Apotex factories in Bangalore, India, with Health Minister Rona Ambrose saying Tuesday night that the trust between the regulator and the Toronto-based drug company has been “broken.”
The regulator said Tuesday night that it has “significant concerns” and “serious doubts” about the company’s drug safety and quality data. The import ban will remain in place until Apotex’s “data integrity problems” are resolved.
No recall has been issued. Health Canada said “no specific” safety issues have been identified with drugs already in drugstores. “Consumers should not make any change to their medication without first consulting with a health-care professional,” according to the Health Canada release.
“Our government will not tolerate a failure by drug companies to meet their obligations to abide by Canada’s high safety and quality standards,” the health minister said in a brief statement issued after the supper hour Tuesday.
Reached Tuesday night, an Apotex spokesperson had no comment.
The move comes in the wake of a Toronto Star investigation that has revealed Health Canada had so little sway over drug companies that a previous request by the regulator to ban imports from an Apotex facility was ignored by the company. Ambrose recently had to explain this to Parliament, while critics lambasted her department as “feeble, inadequate and incompetent.”
The Star investigation has also shown that the U.S. regulator, the Food and Drug Administration, has a stricter enforcement regime. When the FDA probed issues at an Apotex factory in Bangalore, it successfully banned import of drug products to the United States after finding that Apotex staff had manipulated data, retested samples until they got favourable results, and destroyed records.
Ambrose, under fire from MPs citing the Star stories during question period, responded last week by announcing a quarantine of all products from the Apotex finished drug factory. Health Canada said information from the FDA led to this decision to review the quality and safety of the drugs. This showed that the regulator is now paying attention to the results of FDA probes.
But neither Ambrose nor the regulator named the drugs under review. This brought more criticism from opposition politicians and drug safety experts who said, in the Star and on Parliament Hill, that the regulator must become more transparent.
Then, on Tuesday night, Health Canada — citing new information from the FDA that led to this escalation in enforcement against Apotex — released the list and announced the import ban.
The ban affects more than 30 drugs from one Apotex plant in Bangalore, including a generic form of Viagra, the antibiotic azithromycin, and other drugs made to treat hypertension, dementia, high blood pressure, asthma, convulsions and Lou Gehrig’s disease.
The ban also extends to roughly 30 drug ingredients made at the second Apotex site in Bangalore.
Ambrose said new information from the FDA was received Monday and “puts into question Health Canada’s trust in the reliability of data” that the plants “are required by law to provide to demonstrate the safety and quality of their products.”
The minister said the “precautionary” action is designed to protect the health and safety of Canadians.
In addition, Health Canada took action against an India-based company, IPCA Laboratories. A Health Canada document suggests that more than 15 of the company’s drug ingredients, which are imported and used by several drug manufacturers, have also been banned. Additional details were unavailable Tuesday night.
Ambrose said in her statement that her department, which has been criticized as secretive and ineffective, “will continue to take actions as needed to protect Canadians, and provide information in an open and transparent way.”
Health Canada said that certain drugs considered “medically necessary” may be excluded from the ban provided they are tested by an independent third party before being released for sale.