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Fields & Applications Pharma & Biopharma, COVID-19

Copycat Chemistry: Uncovering Counterfeit Drugs

The US Food and Drug Administration (FDA) defines counterfeit medicine as a fake medicine that is contaminated, contains the wrong or no active ingredient, or contains the right active ingredient at the wrong dose (1). These “knock-offs” have caused significant harm to public health, and though many steps have been taken to deter fraudsters, fake pharmaceuticals remain a serious issue in both developing countries and the Western world. In fact, the Pharmaceutical Security Institute reported 5,081 crime incidents in 2019 – an all-time high – and the COVID-19 pandemic has only exacerbated the problem (2). Earlier this year, Interpol’s annual Operation Pangea reported an increase of around 18 percent in seizures of unauthorized antiviral medication, and more than 100 percent increase in seizures of unauthorized chloroquine (3) – a direct response to the coronavirus outbreak.

It is clear that counterfeiters will stop at nothing to make a profit, so what can be done to combat fraudulent pharmaceuticals? There are a number of measures in place around the world to detect counterfeits, including track and trace packaging, blockchain technology, and monitoring of online pharmacies. But with the global market for counterfeit medicines continuing to expand, it will become increasingly difficult to keep our supply chains safe. Here, we discuss the growing need for sophisticated chemical analysis of the drugs themselves, and our approach to telling the real products from the fakes.  

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About the Authors

Ravi Kalyanaraman

Director, Global Quality Analytical Science and Technology group with Global Product Development and Supply, Bristol Myers Squibb Company, US


Scott Huffman

Associate Director, Global Quality Analytical Science and Technology group with Global Product Development and Supply, Bristol Myers Squibb Company, US

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