Once again Health Canada’s role as a consumer protection agency is being called into question over concerns that contaminated drugs may be on store shelves.

The agency faced accusations last fall that it was not standing up for consumer safety after the U.S. Food and Drug Administration deemed drug ingredients from Toronto-based Apotex’s facilities in Bangalore, India, unsafe and banned them.

Instead of initially identifying and banning the drugs itself, Health Canada simply asked Apotex to stop importing them. It did not remove the drugs from market, nor did it alert the public as the FDA did in the U.S., by posting its inspection findings online. Further, when the drug company simply ignored its request, Health Canada did nothing.

It took a campaign by Star reporters Jesse McLean and David Bruser, as well as criticism in Parliament, for Health Minister Rona Ambrose to finally ban the import of more than 30 drugs and 30 drug ingredients from two of Apotex’s Bangalore plants.

Now Apotex is in the spotlight again — and once again Health Canada seems to be dragging its feet.

This time it’s the company’s plant in Brantford that has drawn the attention of the FDA. The plant is accused of terminating an internal review that found equipment was inadequately cleaned. It then used that equipment to manufacture other drug products, despite the contamination, and released them “based on a less stringent” quality control requirement, FDA inspectors found.

It’s not clear whether the contamination was from other drugs or from bacteria. It could be either, according to an industry expert.

That is disturbing.

The company makes drugs that fill one of every five prescriptions in Canada. And it is unclear which drugs might — or might not — be contaminated. In an FDA inspection report obtained by the Star, the specific products that were manufactured under the suspect conditions are redacted.

Nor was the company forthcoming about the problem. An Apotex spokesman said the company has responded to the FDA about its inspection findings and “cannot make any further comments.”

More to the point, Health Canada’s voice is nowhere on this issue, despite the FDA’s actions. It says its report on its own July inspection is still being finalized.

That’s not good enough. It’s January and drugs that could possibly be contaminated are on the market.

Health Canada must move a lot more quickly to ensure consumer safety. And it clearly needs to take a much more rigorous look into Apotex’s manufacturing practices. The company has a long history of safety issues at its plants.

There have been 20 FDA inspections of Apotex facilities in Canada and India since 2008, 17 of them resulting in findings termed “objectionable” or noted as “repeated deficiencies.” In one case the company failed to uphold its “legal obligation,” the FDA said.

And it’s not the first time there have been problems noted with Apotex’s Toronto facilities. In 2009 the FDA found that Apotex distributed antihistamine and diabetes tablets made with contaminated ingredients. That finding forced a recall of more than 600 batches of drugs made at Apotex’s Toronto-area facilities from the Canadian and U.S. markets.

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In the end, consumers are dependent on Health Canada — not the FDA — to ensure that drugs on the Canadian market are safe and effective. Health Canada should immediately identify the drugs in question and issue its report on Apotex’s Brantford plant. And it needs to have a good hard look at all of Apotex’s manufacturing practices.

Consumer safety is at stake.

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