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INSIDER INSIGHT
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Emerging Options for Worldwide Authentication and Counterfeit Detection
Gary E. Ritchie, MS InfraTrac
Abstract
The development and commercialization of high-quality hand- held spectrometers has enabled the use of a new set of tools for rapid, remote, and real-time anti-counterfeiting measures—blurring the previous distinction between covert and forensic protections by making spectral identification a reality in the field. Emerging regulatory requirements for serialization have not eliminated the need for authentication. It is now possible to screen products and packaging instantly, on-site, without any wet chemistry or chemists. Better authentication methods make it possible to test more efficiently, and target security resources to catching and deterring counterfeiters, ultimately protecting patients. In this article, we provide several examples of near-infrared spectroscopy (NIRS) techniques developed and commercialized for authentication and counterfeit detection for commercial pharmaceutical packaging.
Introduction
Submitted: 11/13/2014 Accepted for Publication: 11/25/2014
Ritchie G.E. Emerging options for worldwide authentication and counterfeit detection. Am Pharm Rev. 2015;18(1):50-53.
Brand protection is a strategic imperative for every pharmaceutical manufacturer, packager, and distributor. Maintaining supply chain integrity and keeping patients safe presents perhaps the greatest challenge to companies in the drug marketplace, including branded, generic, and over-the-counter products. Expensive products, including the newer biologics, present a major lure to counterfeiters and diverters, given the extraordinary illicit profit opportunities from even a handful of successfully marketed fakes. But the problem extends across price ranges: the target is one of opportunity, and high- volume/lower cost products are also vulnerable.
Brand protection
measures are essential, and there is a growing consensus that stand- alone instant authentication is a key element of a comprehensive anti-counterfeiting strategy.
50 | | January/February 2015
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