Paving The Road To Compliance: Serialization Standardization Through Open-SCS

By Volker Ditscher, Business Manager and Martin Kuhn, Vice President

At $200 billion annually, fake pharmaceutical drugs make up the largest, global counterfeit market. While less than one percent of counterfeit drugs are sold in industrialized nations, such as the United States, 10 to 30 percent of medicines sold in developing countries are counterfeit¹. In some countries, this number is as high as 70 percent. The federal mandate, Drug Supply Chain Security Act (DSCSA), enacted in November 2015, attempts to combat this problem by outlining a timeline of serialization mandates that stretch all the way to 2024. It is expected that the majority of the global drug supply will fall under some type of serialization requirement by 2018.

As companies around the world implement the necessary changes to become compliant, it will add an increased level of cost, risk, and especially complexity to today’s operations.