Advancement of serialisation and labelling at PHARMAP 2025


Recent research shows that the pharmaceutical industry is intensifying efforts to combat counterfeit drugs, which account for up to 30% of medicines sold globally. In a major step toward securing pharmaceutical supply chains, regulatory bodies worldwide are tightening serialisation and labelling requirements. Latest updates to the EU Falsified Medicines Directive (FMD) and the US Drug Supply Chain Security Act (DSCSA) highlight the industry’s ongoing push to enhance product authenticity and patient safety. These regulations require unique identifiers on pharmaceutical packaging, enabling end-to-end traceability across the supply chain.

While such measures are essential for preventing fraud and ensuring compliance, they also introduce operational complexities. Companies must integrate new technologies, manage increased production costs and ensure compatibility with existing packaging lines, all while keeping pace with evolving regulatory demands. With counterfeit pharmaceuticals still a major global threat, causing annual losses estimated at $200 billion worldwide, how can the industry overcome these challenges and leverage innovation to strengthen supply chain security?

To safeguard products and maintain consumer trust, pharmaceutical companies and packaging suppliers are adopting cutting-edge technologies. For example, blockchain is being leveraged to create immutable records of a product’s journey, enhancing transparency and reducing the risk of tampering. AI-powered digital authentication solutions are also gaining traction, enabling real-time genuine product verification.

Boehringer Ingelheim, for instance, has collaborated with SAP to develop a blockchain-based application designed to track, trace and authenticate prescription medicines in the U.S. market. This initiative aims to enhance the security and integrity of their pharmaceutical supply chain.

Similarly, Vertical Integration (VI) has been adopted by Novartis to collect, store, contextualise and visualise data from equipment to users, enhancing data-driven decision-making in their manufacturing processes. This approach reflects the company’s commitment to the ethical and responsible use of AI systems.

However, the integration of these technologies often requires significant adjustments to packaging design and production processes. Companies must balance the need for advanced security features with the practicalities of high-speed manufacturing and cost efficiency. This has led to a growing demand for specialised equipment and expertise in serialisation and labelling.



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