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Comment by pkaye | Hacker News Reader

Are these problems only limited to the US? Do Canada or the EU have similar issues? Do they not import chemicals from similar suppliers or do they screen the better?

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It's an issue in Canada[1] and the EU[2].

[1]https://www.bcpharmacists.org/news/update-august-18-2018-dru...

[2]https://www.ema.europa.eu/en/medicines/human/referrals/angio...

What about India? Are Indian generics affected as well?

Very likely too, including other issues previously found I'd expect anything to happen there.

It's an issue everywhere. Almost all generics are manufactured in India and China. And most with Chinese precursors.

Yeah but the article and some others are making it seem like something unique to the FDA. It seems to be a global issue and they all need to improve their quality control and testing processes.

To be honest, QC and testing has never really been the FDA's job. They perform a one time assessment for safety and effectiveness to prevent the sale of snake oil equivalents. They also have the power to inspect manufacturers periodically (maybe 1 in 100 manufacturers per year). Otherwise testing, QC, and release is self-regulated by the manufacturers.

Pretty much worldwide, since there's usually only a few manufacturers of the Active Pharma Ingredients supplying the whole market.

Scale matters.

In this case, the manufacturer came up with a new technique for manufacturing the API. They failed to account for these very small molecule impurity side-products in their model/testing.

They probably filtered out a lot of it in their purification process and still met USP standards, but 99% or 99.9% pure still leaves a risk for potent side products.

Sometimes these side-products are tested for, but you have to know what to look for. A tiny blip may not be elucidated.

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