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Heather Clarke-Hite, director at Crane Authentication, says that verification for medicines is helped when measures are integrated into the supply chain from the outset.
In June, the Medicines and Healthcare products Regulatory Agency (MHRA) approved the UK’s first GLP-1 receptor agonist tablet for weight loss and management, marking a significant development for patients.
Demand is expected to be high as the tablets are rolled out, with roughly 2.5 million adults already using weight-loss injections in the UK. But that demand is also raising concerns around counterfeiting. A huge number (97%) of pharmacies are worried that its introduction could lead to an increase in fake or unlicensed weight-loss pills being sold via unauthorised channels.
There is good reason for that concern. Counterfeit Ozempic injectables have already demonstrated criminals’ willingness to exploit demand for weight-loss treatments, and tablets could make that opportunity easier to scale. Unlike injectable pens, which involve complex delivery mechanisms, cold-chain requirements, and greater manufacturing precision, tablets are typically easier to manufacture, package, and distribute through conventional retail and delivery channels.
As oral treatments become more widely available, particularly if they are cheaper and easier to access than injectables, criminal networks have a clear incentive to follow demand and take advantage of both online and physical distribution channels.
The cost of counterfeits
Counterfeit medicines can pose an immediate risk for patient safety. A fake tablet offers no reliable assurance about what is inside it. It might contain the wrong dose, the wrong compound altogether, or harmful contaminants never intended for human consumption. The consequences can range from ineffective treatment to serious, long term health effects.
There is also a wider societal impact. Organised crime groups that profit from fake products, including weight-loss pills, are often linked to other illicit activity such as money laundering and drug trafficking, meaning the harm extends beyond the individual who unknowingly consumes a counterfeit pill. Reducing the opportunity for counterfeit medicines to enter circulation therefore protects both patients and legitimate supply chains from criminal activity.
Counterfeiting a medicine does not necessarily mean recreating an entire legitimate manufacturing process. Criminal networks have several routes available to them. Falsified pharmaceuticals can be produced in unregulated laboratories using imported raw materials mixed with other substances, before being packaged and labelled to resemble the real product. Others may be genuine medicines stolen or diverted from legitimate distribution channels and then resold illegally.
Packaging and documentation are part of the deception. Counterfeiters use fake labels, certifications, invoices, and customs declarations to disguise where products have come from, while falsified prescriptions can be used to obtain genuine medicines for illicit resale. In some cases, substandard or falsified medicines are simply relabelled under the name of a legitimate pharmaceutical brand.
They then need routes to market. Online marketplaces and social media are already significant channels for counterfeit pharmaceuticals, alongside websites designed to appear legitimate. Physical distribution can be equally difficult to detect, with tablets moved internationally and delivered through couriers and postal services. Counterfeiters can also break larger consignments into smaller parcels to make customs detection more difficult.
For oral weight-loss treatments, that combination is significant. A product that can be packaged and transported as tablets potentially fits readily into many of the distribution methods criminal networks already use for illicit pharmaceuticals. As demand increases, the challenge is therefore not just identifying where obviously fake medicines are being sold, but preventing falsified, diverted, or illegally distributed products from appearing credible enough to reach patients.
Protecting authenticity from production to patient
Because counterfeiters imitate genuine products with such sophistication, one of the difficulties is that appearance alone is becoming a less reliable guide to authenticity. That places an unrealistic burden on consumers and pharmacists. Instead, pharmaceutical companies need ways for genuine products to demonstrate authenticity throughout the supply chain.
Physical security features can form part of that approach by introducing elements that are more difficult to reproduce than conventional printing alone. For example, technologies such as micro-optics can create distinctive, visual 3D labels that are exceptionally difficult to replicate.
It is equally important that any unique authentication feature on a product can’t be removed. Criminals may attempt to harvest a genuine security label from legitimate packaging and apply it to a counterfeit product. However, tamper-evident, heat-shrinking technology means a label can visibly contract and distort when exposed to the heat from an attempted harvest, rendering it useless when removed.
Traceability measures add another layer of trust by helping manufacturers and pharmaceutical brands understand where a product has been and how it is travelling through the supply chain.
If brands are able to apply secure unique identifiers to each legitimate product, they can capture movements and events throughout the chain. A verifiable product history and centralised data can enable tracking from the production sites through every stage of distribution, stopping counterfeits from entering established legal distribution channels and flagging any incidents of diversion before the medication reaches a consumer.
The growth of oral weight-loss treatments can significantly improve access for patients, but it also changes the counterfeit risk facing pharmaceutical brands and supply chains. Protection shouldn’t just happen after individual fake products appear. Combining physical authentication with product-level traceability can make genuine medicines easier to verify and give brands greater visibility over where products are moving and where risks are emerging.
The key is to integrate measures into the supply chain from the outset. By doing so, organisations can help reduce opportunities for counterfeiters, protect legitimate distribution channels, and, most importantly, help ensure patients receive the treatments they expect.
