Ottawa halts import of drugs from Indian firms
The federal government has halted the import of several drugs and drug ingredients from two Indian factories, as concern grows about Canadian health products sourced in the burgeoning south Asian pharmaceutical industry.
Health Canada said another government had passed on worries about “data integrity” at the plants, and Canadian importers — mostly generic pharmaceutical companies — agreed to quarantine the products indefinitely.
The 16 affected medicines range from blood-pressure pills to chemotherapy drugs, anti-psychotics and opioid painkillers.
One expert on pharmaceutical regulation is questioning, however, why Health Canada has blocked import of the medicines — but not the sale of those that had arrived on shelves earlier from the factories.
“How can the product be too dangerous to import, but safe enough to go down a Canadian’s throat?” asked Amir Attaran, Canada research chair in law and population health at the University of Ottawa. “This makes no sense.… What about the doses already sitting in [Canadian] warehouses, what about the doses already sitting on pharmacy shelves?”
He said the integrity problems could range from relatively innocuous data-entry shortcomings to clearly fraudulent behaviour — such as fudging results on crucial drug-stability tests.
Meanwhile, Canada’s increasing use of Indianmade medications, coupled with India’s antiquated regulatory system, points to the need for more drastic action, such as barring all imports if the country fails to modernize its rules, argued Prof. Attaran.
Health Canada said it has identified “no immediate risk” to Canadians’ health from the products, urging patients not to change their medication without consulting their doctors.
A spokesman said the data-integrity issues ranged on the spectrum of poor record keeping to intentional falsification, calling into question the reliability of lab data the facilities provided to regulators. Health Canada says it has engaged provinces and territories to share pertinent information.
A report from India’s dna newspaper said inspectors from the U.S. Food and Drug Administration had earlier found problems at the plants — Dr. Reddy’s Laboratories in Srikakulam and IPCA Laboratories in Pithampur.
Health Canada quietly posted a notice about the voluntary quarantine of products from the factories two days before Christmas.
It related to both pharmaceutical ingredients used in drugs made in Canada, and finished medicines. The importers were 11 generic pharmaceutical companies, including giants Teva Canada and Sandoz Canada.
Officials for neither Dr. Reddy’s nor IPCA could be reached for comment. India’s dna newspaper quoted a Dr. Reddy’s spokesman as saying the flagged products “pose no risk to the health and safety of the Canadian people,” and that the company is working to resolve the issue.
An IPCA factory and two owned by Canada’s Apotex in India were subject to a similar ban announced in September. The government later allowed the drugs through, however, as long as they passed independent tests. Meanwhile, Apotex sued federal officials, saying the “arbitrary, discriminatory” action was based on politics, not patient safety.
The medicines consumed by Canadians once originated almost entirely from this country, the U.S. and Western Europe but “greater and greater numbers” are coming from developing nations with lessstringent regulatory systems, noted a report last October by the Senate’s social affairs and science committee.
India is now the secondbiggest exporter to Canada, accounting for almost one in 20 finished prescription products, according to the Senate report. It and similar countries likely supply a much larger percentage of the medicinal ingredients used by manufacturers here, said Prof. Attaran.
The Senate committee took Health Canada to task for not overseeing drug suppliers in the developing world more vigorously, voicing “particular concern” about the case of Ranbaxy Laboratories, another Indian company. Health Canada has placed no restrictions on the 160 drugs marketed here by Ranbaxy, even though American authorities have prosecuted the firm for falsifying its records, and banned many of its products, the report said.
Countries like Canada need to borrow a page from aviation to solve one of the key problems: the fact India’s own, ineffective drug-regulation law dates from the 1940s, when it was still a British colony, said Prof. Attaran.
If a foreign transporta- tion agency is not up to the standards of a jurisdiction such as Canada or the U.S., for instance, airlines from that country will be barred or restricted, he said. Similarly, industrialized nations should insist that India modernize its regulations within, say, five years, or have its firms’ access to those markets cut off, he said.
“Unless they change that law, put in place something modern and enforce that something modern, I don’t think they should be exporting a single pill — zero,” said Prof. Attaran.