On-Dose Authentication: Closing the Last Gap in Pharmaceutical Security

While pharmaceutical packaging safeguards, such as barcodes, QR codes, and serialization, are now standard requirements under regulations like the EU Falsified Medicines Directive (FMD) and US Drug Supply Chain Security Act (DSCSA), these measures have proven ineffective in preventing counterfeiting, if used alone.

It is time to consider solutions beyond QR code/serialisation, for reasons:

• There are high-profile cases of counterfeit products being sold in reused authentic packaging in the legitimate supply chain.
• QR codes are easy to replicate and can be misused on counterfeit medicines.

Recent incidents in India highlight this issue.

Authorities must therefore understand that while QR codes and serialisation can aid in supply chain traceability, they are not foolproof solutions. They need to be accompanied by authentication technologies such as digital watermarks, holograms, micro-optics, security ink, and anti-tampering devices, to protect packaging from tampering and counterfeiting.

While technologies are available for protecting outer packaging, the authenticity of the medicine inside the packaging remains a valid concern. This represents the last major vulnerability in the pharmaceutical supply chain. On-dose authentication, which marks the medicine itself rather than its container, offers a compelling solution.