Driving business value from pharmaceutical serialisation

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The production and trade of counterfeit medical products is an illegal global industry operated by multinational crime syndicates. The International Medical Products Anti-Counterfeiting Taskforce (IMPACT) estimates that the incidence of counterfeit drugs is less than 1% in developed countries. However, in regions of Latin America, Africa and Asia more than 30% of the medicines on sale can be counterfeit.


According to the US Food and Drug Administration (FDA), a counterfeit medicine is fake medicine. It may be contaminated or contain the wrong or no active ingredient. They could have the right active ingredient but at the wrong dose. Counterfeit medicines are illegal and may put people’s health and lives at risk being a major obstacle to improving global health.


This article provides background on counterfeit medicines and presents serialisation as a key anti-counterfeit measure adopted by different governments, before exploring the key challenges of a serialisation program to become compliant, and how to leverage the necessary investment to achieve additional business goals.


Regulatory mandates typically require serialisation and verification or product tracking at a saleable unit level. Being non-compliant is not an option as it generally implies a total loss-of-sales. Can serialisation help companies achieve more than just regulatory compliance?


The global is moving towards a serialised world. Increasing threats to patient safety from counterfeited and diverted pharmaceuticals are driving the regulatory activity. In over 40 countries, regulatory mandates to secure the supply chain are already in place or in development.