Safeguarding Brands and Patients: Layered Anti-Counterfeiting Measures in Packaging Design

David Gonzalez, Technical Account Manager, MM Packaging. 

Packaging security is a serious concern for the healthcare market. As the 10th most counterfeited product in the world, fake pharmaceuticals are recognised by authorities as a substantial threat to public health.

The prevalence of counterfeit pharmaceuticals in the market varies by region, on average ranging between 1-30%. This trade’s exact value is by nature difficult to quantify but is estimated at US $65 billion-$200 billion per year. These fakes do not just endanger consumers; any health incident caused by counterfeit medicines can damage customer trust in the supplier and undermine their credibility in the public eye.

With pharmaceutical packaging serving as the primary safeguard for medicines and other treatments, technologies that can combat counterfeiting are of the utmost importance. To protect their brands and customers, packaging manufacturers have a duty to integrate the latest anticounterfeiting features into their designs, adopting a layered approach that provides multiple points of security.

Working in Tandem

Effective pharmaceutical packaging needs to be both secure and accessible to consumers. As experts in secondary packaging for the pharmaceutical sector, MM Packaging has a wealth of experience in creating new technical solutions to prevent counterfeiting or tampering, without sacrificing ease of use.

MM Packaging broadly classifies anti-counterfeiting measures into two groups: ‘non-visible’ forensic and covert features; and ‘visible’ overt and brand enhancement features. While hidden features (e.g., reactive and non-visible inks, encrypted information, and hidden images) require specialist equipment to detect, overt measures allow customers to prove authentication at the point of purchase. This latter category can encompass everything from holograms to pearlescent and thermochromic inks – all of which are designed to be visually distinctive and difficult to replicate.

None of these features in isolation can provide a ‘silver bullet’ in terms of protecting products from fraud. Building truly secure pharmaceutical packaging means layering different features to create a unique solution bespoke to each customer’s needs.

Serialisation

Serialisation technology has made it easier than ever to track products across the pharmaceutical supply chain. The process is one of the easiest anti-counterfeiting tools to implement, and since the introduction of the European Falsified Medicines Directive (EU FMD) in 2019, it is now required practice in many parts of the world.

Under regulations like this, companies are required to authenticate pharmaceutical folding cartons in a unified manner by including Data Matrix codes and their inscription in national databases. Serialisation provides information on everything from product origin to expiration dates and conditions of use, with unique serial numbers meaning the data is simple to trace, store, monitor, and optimise.

This measure facilitates monitoring products as they move through the supply chain, providing enhanced visibility and a clear chain of custody that makes it far harder for counterfeits to move through undetected. It also has the added benefit of allowing batches to be quickly traced should a product recall be required.

For the most part, serialisation is conducted using inkjet printing, thermal transfer, or laser etching. However, next-generation coding technology, such as MM Packaging’s Clear Code, has been developed offering a wide array of benefits. By using CO2, fibre, or UV lasers combined with colour-change technology, manufacturers can produce high-contrast imaging on robust coatings that delivers quality images tailored for optical character recognition systems.

The advantages of using such methods include enhanced rub resistance, high contrast and clarity of the image code, higher line speed, and reduced waste due to vision system errors during coding. This process can also be specially formulated for specific customer applications and is fully compatible with other printing methods like thermal transfer or hot stamping, providing versatility in packaging design.

In many cases, serialisation can be carried out during the packaging design stage. This can lead to significant time savings for manufacturers and optimises the packaging process later on.

Tracking and Tamper-Proofing

Like many sectors, pharmaceutical supply chains can struggle with poor transparency and product oversight. Control of traceability is critically important for identifying irregularities in this network, and as a result, advanced tracking systems such as radio frequency identification (RFID) seals are an exciting innovation for the industry.

RFID seals can be integrated into pharmaceutical packaging, letting companies track the products’ journey throughout the supply chain from warehouse to pharmacy. These solutions make it simple to trace products back to the manufacturer and reject any that cannot be reliably sourced back as counterfeits.

Blockchain technology provides even greater oversight, with the additional benefit of making products difficult to tamper with. This means it is perfect to combine with other tamper-evident solutions, such as carton dust flap locks, glued thumb tabs, and re-close tear tops, to render pharmaceuticals unalterable, enabling pharmaceutical companies and consumers alike to easily monitor if the contents have been manipulated.

With the EU FMD also requiring businesses to employ tamper evident labels and closures in secondary pharmaceutical containers, technologies like these can work together to provide effective compliance and security.

Micro-optics

Micro-optics are another anti-counterfeiting tool that has seen significant advances in recent years. These small lenses, ranging from a few micrometres to millimetres in size, focus on even smaller customised icons beneath them to provide high-quality authentication.

Through a strategic partnership with Crane Currency (‘Crane’), MM Packaging has successfully implemented world-leading micro-optics into pharmaceutical packaging. This collaboration has led to an integrated, secure solution that is having a real-world impact on patients’ safety.

As a pioneer in overt security features, Crane provides micro-optics that are used on some of the world's most valuable banknotes, including the US $100 bill. Its specialist PROFOUND technology offers three-dimensional depth and movement for easy authentication and is unique in the market in that it can be integrated with customers’ designs, enabling them to select everything from the colours to the icons used.

The production methods that go into Crane’s micro-optics are a closely guarded secret, requiring secure proprietary tooling and software that only Crane can access, with effects unmatched elsewhere in the world. This technology also uses unique raw materials and production equipment, meaning it is easy to authenticate but difficult to replicate.

Working in conjunction with MM Packaging’s expertise in secondary packaging, and a strong multi-layered portfolio of overt and covert security technologies, PROFOUND micro-optic solutions provide the capstone of a thorough approach to pharmaceutical packaging security.

The growth of counterfeiting will continue to challenge the pharmaceutical sector for years to come. It is a problem without a single easy solution; instead, addressing this will require a multi-layered approach, incorporating multiple security technologies to protect both consumers and pharmaceutical company reputations. The result of such work will be packaging that is beyond the scope of counterfeiting, putting replication out of reach.