The challenge
Both the US Drug Supply Chain Security Act (DSCSA) and the EU Falsified Medicines Directive (FMD) mandate serialisation and electronic tracking across the pharmaceutical supply chain. These frameworks have transformed visibility — yet they have not eliminated counterfeiting.
A serial number confirms identity in theory, but not in practice. Counterfeiters routinely harvest legitimate serials and print them on falsified packaging, which then passes basic database checks. Serialisation provides traceability, but not proof of authenticity.
The Bluemet Solution
Bluemet’s patented demetallised watermark label closes this gap by adding a physical, unclonable layer of security to every pack. Combined with a dynamic QR code (two-factor authentication) and optional RFID chip, it verifies both:
Data integrity — confirming that the serial number is valid and registered within the DSCSA/FMD repository.
Physical authenticity — verifying that the label’s optical or radio signature matches the encrypted reference, proving it hasn’t been tampered with or copied.
If tampering occurs — such as the removal or resealing of a pack — the integrated circuit changes state.
In practice, Manufacturers achieve full DSCSA/FMD compliance with enhanced real-world security.
Wholesalers and pharmacists can verify authenticity with a standard smartphone — no specialist readers required.
Regulators receive tamper event data in real time, improving traceability and enforcement.
Outcome
Bluemet bridges the final gap between regulation and reality.
Serialisation provides compliance.
Authentication provides confidence.
