Government officials may have a built-in impediment to understanding the intricacies of drug counterfeiting. And that impediment is challenging the drug industry in attempts to describe the magnitude of the problem and the urgency of addressing it.
"It's complicated to explain to legislators and politicians because nobody would imagine that in an industry like pharmaceuticals, you'd have gangsters," says Guy Villax, board member of the European Fine Chemicals Group, in in-Pharma Technologist. Villax's main foe is with falsified APIs, rather than the more highly visible and legislator-friendly topic of the email promotions from illegal online pharmacies.
APIs need to be part of the anti-counterfeiting and substandard-drug lexicon to help those outside the industry better grasp the reality. Mandatory inspections of overseas API plants and country-of-origin labeling also are required. Those are among topics addressed by Europe's Falsified Medicines Directive proposal. A parliamentary vote is due in December, but has already been postponed twice.