Health Canada allows drug ingredients into the country from hundreds of pharmaceutical facilities that have not been inspected by a regulator, an ongoing Star investigation has found.

Instead, nearly 300 foreign drug facilities have been inspected only by themselves or hired consultants.

Drug ingredients made overseas are then imported and used to make medications sold in Canada. Poorly made drug ingredients have been linked to side effects and deaths, Health Canada has said.

The regulatory blind spot means a swath of the pharmaceutical industry is in charge of policing the quality of its own products.

“It’s a huge conflict of interest when a company chooses its own inspector to test whether a product is safe and a factory is clean,” said Amir Attaran, a University of Ottawa law professor who researches drug regulations.

“The companies are playing to profit and win and Health Canada is letting them hire their own referees for the game.”

Health Canada said it has been assessing the compliance of these ingredient-making facilities and will soon issue a “stakeholder communication” to the drug industry, but did not offer specifics.

There are roughly 2,000 facilities around the world exporting to Canada active pharmaceutical ingredients, which are used by manufacturers here to make everything from antibiotics to popular heart medications.

Health Canada inspects only about 10 foreign drug facilities a year. So, Canada relies heavily on other health regulators to visit hundreds of other plants in person.

Not every foreign plant has been inspected by a regulator, nor does it need to be under Health Canada’s developing regulations.

As of early June, only 286 foreign facilities have been subjected to what Health Canada calls “corporate (internal) or consultant (third party) audits.”

Using these audits, Canadian drug companies attest that the products they are importing were made at a foreign facility that was up to code. Health Canada takes their “attestation” as proof the foreign plant is compliant with the law.

“Should any concerns be identified in the information provided, Health Canada will take immediate action to protect the health and safety of Canadians,” a government spokesman said in an emailed statement.

Canadian companies importing the drug ingredients must be prepared to provide Health Canada with evidence the foreign plants are compliant within 48 hours if requested by the regulator.

But Attaran said it’s reckless for the regulator to take a drug company’s word that its facilities are up to standards.

“It’s self-inspection, and self-inspection is simply not in today’s world regarded as a reliable regulatory model for very obvious reasons,” he said.

In 2013, then-Health Minister Leona Aglukkaq announced she was bolstering Canada’s drug regulatory system, extending the government’s oversight to include active pharmaceutical ingredients.

“Poorly manufactured and contaminated active ingredients have been associated with negative health outcomes, including death, in a number of incidents over the past decades,” said a Health Canada document on the changes to the regulations.

But pushback from the pharmaceutical industry concerned about an “increased regulatory burden” led to this “attestation” program, with the regulator indicating further measures would be in place by the middle of 2015, Health Canada said at the time.

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“The goal of these changes is to phase out sole reliance on company attestations and rely on independently validated evidence,” a Health Canada spokesman said.

Health Canada would not provide specifics on how its regulation of these ingredient-making plants will change.

The government said any drugs sold in Canada are rigorously tested and meet high safety and quality standards.

“This testing takes place at various points in the manufacturing process and includes tests designed specifically to assess safety and quality,” a Health Canada spokesman said.

Numerous Canadian pharmaceutical companies import drug ingredients from foreign facilities that have not been inspected by a regulator.

Apotex, the country’s largest drug maker, imports drug ingredients from as many as 31 plants that have undergone only these internal or consultant audits, according to Health Canada.

This is at the same time the company is in court battling a Health Canada ban on drug products made at two of the firm’s own plants in Bangalore, India. These two facilities have been inspected by several drug regulators, including the U.S. FDA. Canada’s import ban is based on the findings of the FDA, who say the Indian facilities’ staff had, among other things, retested samples until they got favourable results.

Apotex said it defies logic that Health Canada can claim to distrust the company in relation to its Indian-made products while permitting it to use imported active ingredients made at other facilities that have not been inspected by a regulator.

“How could it possibly make sense to suggest that Apotex could not be trusted to test products from (its own Indian facilities) . . . but that Apotex could be trusted to test and release goods from plants that had never been inspected by any of Health Canada, the U.K., Australia, or U.S. FDA?” the company said in a statement to the Star.

The company has said the ban on its products is politically motivated, the unfair consequence of a government embarrassed by the Star’s ongoing investigation into drug safety.

Apotex said Health Canada’s previous inspections found its India facilities compliant, and that its drugs, which are “fully tested” in the company’s Canadian labs, are safe and effective.

“It is thus all the more remarkable that Health Canada would ban these plants, that Health Canada itself had inspected and approved, simply because of pressure from the Star to do so, while continuing to allow imports from many plants that had never even been inspected,” the company said.

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