Researchers from ETH Zurich have suggested that DNA-based tags mixed into pharmaceutical formulations could be an effective anticounterfeiting method. Their approach used chemical unclonable functions (CUFs) based on pools of short random DNA oligos. Usually, these types of tags would need a complex verification process, but the team was able to develop what they described as a “low-tech workflow that is fast and cost-effective.”
Pharmaceutical counterfeiting is more than just a supply chain problem – it’s a health crisis, particularly in certain regions. According to the World Health Organization, around 10.5 percent of drugs in low- and middle-income countries are counterfeit or substandard. Typically, anticounterfeit efforts use packaging features such as tamper-evident seals, RFID tags, and QR codes, but these become useless if the packaging is removed.
By embedding security directly into the product, CUFs offer a practical, long-lasting alternative to packaging-based anticounterfeit methods. The tags are made up of pools of random DNA sequences, creating a cryptographic signature that gives each batch of medicine a unique identity akin to a DNA. When tested, authentic products produce a specific response that a counterfeit wouldn’t match.
The researchers used acetaminophen to demonstrate their method. CUFs were integrated using silica nanoparticles, which stabilizes the DNA against environmental changes and potential degradation. The team found that their tags were detectable at concentrations below 50 nanograms per gram, making them both safe for patients and robust enough to withstand pharmaceutical storage conditions.
Through accelerated stability testing, the researchers determined that the tags remained stable for years, surpassing the standard shelf life of most pharmaceuticals. This means that CUFs could provide lasting counterfeit protection from production to end use, without compromising the drug’s integrity. CUFs also offer strong resistance to tampering or dilution attempts. Because each DNA sequence is unique, replicating or altering these tags would be both costly and complex for counterfeiters. CUFs are cryptographically secure, producing an unreplicable response that cannot be cloned or predicted, even if the DNA sequence is known.
The researchers conclude, “The method has a high level of security against replication and dilution attacks and enables labeling on the product level, the batch level or even the dose level. The implemented formulation is versatile in its use and is suitable for solid, liquid or gel formulations and polymers. Thus, chemical unclonable functions are a promising tool for the fight against counterfeit products in pharmaceuticals and beyond.”
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