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 (see page 6).
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 (see page 5), 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.
What is on-dose authentication?
On-dose authentication involves applying traceable markers directly to tablets, capsules, or coatings. These markers serve as covert or overt identifiers, enabling verification of the dosage level throughout the supply chain. By marking the medicine, these tools establish a secure and persistent link between the product and its origin, further strengthening the outer packaging.
Current on-dose technologies include:
- TruTag Technologies offers approved, spectrally encoded excipients (inactive substances) for product or dose-level authentication that can be verified with cell phones.
- SECURtracers by Micro-Tracers utilise ethyl cellulose-based particles visible under UV light and detectable with simple field tools.
- Molecular/DNA taggants (eg. Applied DNA).
- Edible inks or UV-fluorescent coatings.
- Luminescent or magnetic particles that can be read with handheld tools.
These technologies can be incorporated into oral dosage forms without affecting quality, strength, or bioavailability, thereby eliminating the need for new clinical trials and lowering the barrier to their adoption.
New bill in US
While no major pharmaceutical regulation currently mandates on-dose authentication, a new bill was introduced in the US in February 2025 calling for physical-chemical identifiers to be included in or on each dose of a product that is a controlled substance.
The legislation also updates the definition of ‘product identifier’ to encompass both traditional packaging codes and on-dose identifiers, thereby broadening the tools available for drug verification.
The bill is currently under review by the House Committee on Energy and
Commerce, and passing it would be important in advancing the use of physical-chemical identifiers in the US.
Barriers to adoption
Despite proven technology and regulatory support, uptake has been cautious. Key concerns include manufacturing compatibility; safety and stability of new materials; cost implications, particularly for generic drugs; and regulatory re-approvals for modified products.
Nevertheless, for high-value products such as oncology drugs and controlled substances, the added protection may justify the cost, especially in high-risk markets.
Beyond pharmaceuticals
On-dose-style authentication is expanding into other sectors. Micro-Tracers has just completed animal feeding trials, is starting clinical trials, and is focusing on developing countries, especially Nigeria, Colombia, and India.
While Applied DNA Sciences exited this space in 2023, several companies – including Authentix, SICPA, TraceTag, DOW, and Tracerco – continue to develop their DNA-based solutions. Most of these are active in fuel security, where integration into existing infrastructure is technically more straightforward than in pharmaceuticals. Their ongoing success highlights the resilience and adaptability of forensic marking, even if adopting it on a pharmaceutical scale remains challenging.
Another field where DNA tagging is advancing is textiles. For textile traceability, markers are embedded into raw cotton to verify sources, support ethical sourcing, and combat counterfeiting. Researchers are also exploring DNA-based systems for food authentication to address refilling
and adulteration.
These developments demonstrate how on-dose authentication has become increasingly relevant across various industries.
Bridging the phygital worlds
The true strength of on-dose authentication is its ability to combine physical and digital verification, ultimately improving product integrity and consumer safety. This opens new possibilities for patient engagement, safety monitoring, and anti-diversion controls – far beyond the capabilities of packaging alone.
Digitising medicines through on-dose authentication also offers a means of engaging patients and improving adherence.
On-dose authentication offers a timely, effective way to close the final gap in pharmaceutical product security. The technology is ready, regulatory support exists, and the risks of inaction are too high to ignore.
Securing the dose – not just the box – must be the next step.