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The company ignored tests showing unknown impurities in some drugs, and inspectors came across samples with bacteria and mould that were “TNTC,” too numerous to count.

The reviewers also noted the washroom for factory workers, situated in a separate building, lacked hot water, soap, air dryers or single-service towels.

Health Canada barred imports from Dr. Reddy’s plant after the U.S. Food and Drug Administration (FDA) inspection.

But that is only the latest fallout from this country’s growing dependence on medicines made in India, as foreign regulators monitoring the booming South Asian industry uncover questionable manufacturing standards, manipulated records and even defective drugs.

“The numbers here are so large – in terms of the facilities and types of drugs being made and ingested – and it’s just a drop in the bucket how many are getting inspected,” says Andrew Beato, a Washington lawyer involved in a major prosecution of an Indian drug company.

“And yet you look at the inspections that have occurred now, and you see dozens of warning letters over the last several years for these facilities in India.”

The worry is not just those “unknown impurities,” but whether the drug will actually work, he notes.

The pharmaceutical industry was once concentrated in Europe and North America, but has spread increasingly into the developing world, where low costs cater to a growing Western pressure.

Most of the blockbuster drugs that fuelled Big-Pharma profits over the last two decades went off patent in the last few years, opening the market to generic copies. To exploit that “patent cliff,” governments and insurers in Canada have pushed for lower and lower prices on the copies, and often mandate that patients’ prescriptions be filled with generics.