How does H010 support pharmaceutical authentication and compliance?

Counterfeit medicines are one of the most dangerous forms of product fraud. The WHO estimates that 1 in 10 medical products in low and middle-income countries is substandard or falsified. Even in regulated markets, counterfeit pharmaceuticals enter the supply chain through parallel imports, online pharmacies, and marketplace sellers.

The regulatory landscape

Pharmaceutical serialisation requirements are tightening worldwide. The EU Falsified Medicines Directive (FMD) mandates unique identifiers and tamper-evident features on prescription medicines. The US Drug Supply Chain Security Act (DSCSA) requires unit-level traceability. Similar frameworks exist across Asia and the Middle East.

These regulations set a baseline. But compliance alone does not protect patients. A serialised code on a standard label can be copied. A tamper-evident seal tells a patient the box has not been opened, but not whether the contents are genuine.

How H010 fits into pharmaceutical authentication

H010 labels add layers of security that go beyond regulatory minimums:

Tamper evidence that works

H010 holographic labels are destroyed on removal. They cannot be lifted from a genuine pack and applied to a counterfeit. This closes the most common attack: repackaging substandard product in genuine-looking boxes.

Unit-level verification

Each label carries a unique identifier validated against a secure database. This works alongside existing serialisation systems. When a pharmacist, distributor, or patient scans the label, the system confirms the specific unit is genuine and has not been flagged.

Patient-facing verification

Patients can scan the label with any smartphone. No app required. This is particularly valuable for medicines dispensed outside traditional pharmacy channels, such as direct-to-patient delivery, clinical trials, or markets where patients buy medicines from informal sellers.

Real-time analytics

The H010 dashboard shows where and when products are being scanned. Unusual patterns, such as the same code appearing in multiple countries, or scan volumes exceeding production, are early indicators of diversion or counterfeiting.

Example: a specialty pharma company managing diversion risk

A specialty pharma company distributes a high-value biologic across 12 European markets. Each unit carries an H010 holographic label with a unique QR code alongside the existing FMD serialisation. When a unit is scanned in a market where it was not distributed, the company's brand protection team is alerted. They can trace the diversion route using scan location data and take action before the problem grows.

Patients receiving the product at home scan the label for peace of mind. They see confirmation of authenticity, the batch number, expiry date, and a link to the prescribing information.

Complementing existing systems

H010 does not replace existing serialisation or track-and-trace infrastructure. It adds a physical security layer and a patient-facing verification channel that most serialisation systems lack.

See how H010 works with pharmaceutical products. Explore features.