Health Canada conducted only 15% of site inspections as it leaned on foreign regulators for oversight
Eighty-five percent of inspections for drug manufacturing sites that supply Canada were conducted by international regulators — not Health Canada — as confirmed by data obtained by CTV News.
The majority of these inspections were carried out by the United States, which accounts for 70 percent of Canada’s inspection reliance.
But the US Food and Drug Administration (FDA) is facing a backlog and has yet to return to pre-pandemic inspection levels.
According to the US Government Accountability Office, which has flagged drug supply chain oversight as “high risk” since 2009, the FDA continues to face challenges.
A 2024 report said the agency “has had long-standing concerns about FDA’s ability to oversee the increasingly global drug supply chain.”
Duke University health economist David Ridley said, “Many of these establishments are not being inspected by Canadian or US officials.”
He warned that this could result in “low quality products, products that don’t work as well, aren’t as stable, and in a very worst-case scenario…are toxic.”
Canada imported 30.8 percent of its pharmaceuticals from the US in 2024, 33.5 percent from European countries, 3.2 percent from India, and 2.9 percent from China, according to Statistics Canada.
The Canadian drug supply currently depends on 927 domestic sites and 5,024 foreign ones.
Health Canada conducted 312 onsite inspections within Canada and 47 abroad last fiscal year. It relied on trusted partners, including the FDA, for an additional 2,086 foreign site reviews.
However, Health Canada stated it has no inspection backlog.
“That’s the strength of the reliance model,” said Kim Godard, director general at Health Canada. “Everyone kind of pitches in, we’re not in the same situation in terms of creating huge backlogs.”
Still, Ridley noted that the US has struggled to staff overseas offices in India and China — key regions for active pharmaceutical ingredient production.
“The FDA is so big and the United States is so big. We have the scale. It does make sense to partner with us. But that’s conditional on being able to count on us to make those foreign trips,” he said.
Matthew Herder, professor of law and medicine at Dalhousie University, said the lack of physical inspections by the FDA could create room for lax practices. “I worry that people will start to cut corners,” he said.
Historical examples show the risks. A 2007 recall of a blood thinner contaminated during production in China was linked to more than 100 deaths in the US.
In 2023, eye drops made in India were pulled from the market after drug-resistant bacteria caused three deaths and eight cases of blindness in the US, according to the New York Times.
Canada has also recalled drugs in recent years due to microbial and latex contamination.
In 2018, nitrosamine impurities — considered probable human carcinogens — led to a valsartan recall that affected 200,000 Canadian patients in a single month, according to University of Toronto associate professor Mina Tadrous.
He said it caused disruptions throughout the healthcare system, “for patients, doctors and pharmacists.”
CTV News reported that ineffective medications, while harder to detect than toxic ones, can still have serious consequences.
“If the product is low quality, the most likely outcome is it’s just not going to be as effective,” said Ridley. “And that’s going to be really hard for people to notice.”
The result could be prolonged illness, failed treatment, drug resistance, and weakened trust in care.
Pharmacists count on a strong regulatory system to ensure medications are safe and high-quality, said Tyler Gogo, senior communications manager at the Canadian Pharmacists Association.
He noted that when the system fails, it can cause real problems in delivering care.
They make up about 20 percent of pharmaceutical sales by value and 75 percent of prescriptions in Canada, based on the IQVIA Pharmafocus 2027 report.
Ridley said generic manufacturers are “in this race to the bottom with their competitors,” as buyers seek the lowest-cost products.
Tadrous added that hospitals often examine drug origins, but procurement systems don’t always consider manufacturing methods or location.
In 2023, Health Canada recalled three generic drugs — Accel-Ondansetron ODT, Mint-Betahistine, and PMS-Pirfenidone — following the discovery of serious data integrity issues at Synapse Labs in India.
The European Medicines Agency had flagged “irregularities in study data.”
The makers of Accel-Ondansetron ODT and Mint-Betahistine submitted new bioequivalence data, and Health Canada later approved the resumption of sales, determining the drugs to be safe and equivalent to brand-name versions.
Despite industry pressures, Health Canada said it has not identified “significant ongoing compliance concerns specific to generic drug manufacturers.”
Godard said the regulator is actively adapting to industry changes.
“We’re following the context, we’re following the trends, we’re following the technologies, we’re following what’s happening in the pharmaceutical industry,” she said, adding that the goal is to ensure they can meet the demands of tomorrow.
