An entirely new criminal enterprise has emerged – counterfeit ingredients.  While counterfeit API (active pharmaceutical ingredient) isn’t a new issue, there is a new and frightening manifestation.  In the past, counterfeit API was purchased by criminals making counterfeit drugs.  Today a new, significantly more dangerous and difficult to fight enterprise is underway – the sale of counterfeit (“tainted”) ingredients to legitimate pharmaceutical manufacturers.  The most high profile example of this is the deadly case of Heparin.It is impossible to believe that the case of Heparin was an unfortunate mistake – a quality lapse, a one-time and unique circumstance. The facts speak otherwise.  This was a case of fraud.  Criminal fraud.  So let’s call it by its proper name — counterfeiting.

Counterfeit medicines, according to the WHO are “deliberately and fraudulently mislabeled with respect to identity or source. Counterfeiting occurs both with branded and generic products and counterfeit medicines may include products with the correct ingredients but fake packaging, with the wrong ingredients, without active ingredients or with insufficient active ingredients.”

It’s time to rethink and broaden that definition to include the potential for fake ingredients (“tainted” is both too polite and too inaccurate a term) that insidiously find their way into legitimate pharmaceutical manufacturing.

And, unfortunately, it means that CMPI must recalculate its global estimates for counterfeit medicines and their profits upwards.

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