By Gary Pond | December 10, 2020

With the World Health Organisation reporting that over half of all drugs purchased from online pharmacies are suspected counterfeit, and the number of illegal online pharmacies increasing dramatically since the start of the COVID-19 pandemic, there is a growing recognition that serialisation alone will not solve the problem of falsified medicines.

The Royal Pharmaceutical Society is also warning that the UK could see “an influx of counterfeit medicines” after the Falsified Medicines Directive ceases to apply at the end of the Brexit transition period on January 1, 2021.

In addition to the use of security tags on packaging, there is now a move towards ‘on dose authentication’, which is achieved by incorporating microtags into the core ingredients or coatings of pharmaceutical and nutraceutical products. These covert microtags can be detected using either field or lab-based equipment to mitigate counterfeiting and product diversion, assist quality control, returns monitoring and product recall. A further innovation is leading to the introduction of associated phone apps, enabling simplified field-based authentication by patients and caregivers.

Through on-dose authentication, microtags that are customised with unique information for product verification and traceability are embedded into each pill. For example, theTruTag platform uses microscopic silica particles, each of which bears a unique spectral signature, while Applied DNA Sciences uses unique molecular tags that can be detected at parts per billion or trillion. These covert taggants can be incorporated directly into the tablet coatings or inks used on tablets, capsules, vials and even the excipients used in the dosage form. Crucially this requires no additional manufacturing equipment or processes. The materials have ‘generally recognised as safe’ (GRAS) status and are resilient for the entire product lifetime, providing an individual ‘barcode’ that cannot be broken.