Dodgy drugs left on Canadian shelves
Canada’s biggest pharmacies are selling allergy pills made with ingredients from a drug facility in India that hid unfavourable test results showing excessive levels of impurities in its products, a Star investigation has found.
Recently, the Star purchased packs of over-the-counter desloratadine tablets from Toronto-based Shoppers Drug Mart, Rexall, Walmart and Costco stores.
One month before, on Dec. 23, Health Canada had announced these antihistamines — made by Pharmascience — were under quarantine after serious problems were unearthed during an inspection of the company’s drug facility in India. Inspectors found unsanitary con- ditions at the facility, including high growth of bacteria and mould.
Even though government inspectors discovered significant misconduct dating back to 2012, the December quarantine technically affects only new products made in the past month and a half — not ones already sitting on store shelves.
“How can a medicine be too dangerous to import but safe enough to consume? This makes no sense,” said Amir Attaran, a law professor and health policy expert at the University of Ottawa.
By not ordering a recall, he said, “Health Canada is knowingly leaving adulterated medicines on the pharmacy shelves.” Health Canada said it has restricted imports from the Indian plant as a “temporary precautionary measure,” and, so far, a recall is unwarranted. “At this time, no specific safety issues have been identified with these products currently on the market,” a government spokesman said in an email.
“How can a medicine be too dangerous to import but safe enough to consume? This makes no sense.” AMIR ATTARAN HEALTH POLICY EXPERT, UNIVERSITY OF OTTAWA
“If at any time health or safety issues are detected, the department takes immediate action, including a recall, if necessary.”
Spokespeople for Shoppers, Rexall, Walmart and Costco emphasized that no recall has been made and the regulator has deemed the drugs safe to stay on their shelves.
“We will continue to monitor this situation closely,” Rexall said in a statement. “If a patient has any concerns or questions about any medications they are taking, we would encourage them to speak with their Rexall pharmacist.”
In all the packages the Star purchased in January and early February, the drugs were labelled under the store’s own brand, with the name of the tablets’ Canadian manufacturer — Pharmascience — in small print. No store had any disclaimer stating products from the company are now under quarantine.
Pharmascience, which voluntarily agreed to the government’s quarantine, said it retests all of the ingredients it imports and is confident the allergy tablets are safe.
“Safety is our priority. The desloratadine products that have been released on the Canadian market have passed strict quality control tests and have also been deemed safe by Health Canada,” company spokeswoman Maria Angelini said.
The company said it has secured a new supplier of the chemical ingredients used to make the allergy medication.
The problems at the India facility, Dr. Reddy’s Laboratories in Srikakulam District, were troubling and numerous, according to an inspection report obtained by the Star.
During a November inspection, agents from the U.S. Food and Drug Administration (FDA) found Dr. Reddy staff repeatedly retested raw materials found to have unacceptable levels of impurities and did not document or report the undesirable results. These problems date back to January 2012.
The name of the specific products that failed purity tests are redacted by the FDA from the inspection re- port, making it impossible to tell which specific drugs are affected.
The inspectors’ review of one company hard drive “uncovered evidence that analytical raw data had been collected throughout the month of November 2014 and had been deleted,” according to FDA inspectors.
“The identity of the product(s) analyzed could not be determined.”
The first day of the inspection, agents found more data and test results sitting in the trash room, tucked in bags listed as waste material.
The U.S. agents also raised concerns about the water used to manufacture the drug ingredients. A probe of the microbiology lab found “significant growth of both bacteria and mould, and appeared to be TNTC (too numerous to count).” The company’s data used for detecting worrisome trends did not mention the problem, inspectors found.
Meanwhile, the facility failed “to have adequate toilet and clean washing facilities supplied with hot water, soap or detergent,” inspectors found.
A spokesman for Dr. Reddy’s said the company agreed to a quarantine and no drug ingredients are currently being exported to Canada.
Nick Cappuccino said the firm has conducted its own internal review and has “no reason to question the safety of the products involved.
“We are now working collaboratively with (Health Canada) to address their concerns with the goal of lifting the voluntary quarantine as quickly as possible,” Cappuccino said.
The University of Ottawa’s Attaran, however, said the inspectors’ findings should be treated more seriously. “The cheapest greasy spoon in Toronto would be shut down if it had these conditions, but the pharmaceutical company sending stuff to Canada is allowed?” he said.
He questions why the government is allowing products originating from the facility to remain on pharmacy shelves, considering Canada’s Food and Drugs Act prohibits the sale of any drug manufactured under unsanitary conditions.
“The law is very clear on this,” he said. “We have evidence here that the product was manufactured under unsanitary conditions, and they’re selling it. What more does Health Canada want?”
The government said its decisions about regulatory actions are made on a case-by-case basis and can be “deployed in a graduated and proportional fashion, and tailored to the specifics of individual circumstances.”
Since a Star investigation in September revealed drug products banned from the U.S. market have been allowed by Health Canada into Canadian pharmacies, the government has banned or quarantined imports from at least nine Indian drug manufacturing facilities.
The facilities make more than 100 drugs and drug ingredients imported into Canada.