What this paper covers
Counterfeit medicine is the one authentication problem where failure is measured in lives rather than margin. Estimates put the global counterfeit drug trade around $200 billion, concentrated in high-value therapies and in markets with fragmented distribution. Falsified products enter through diversion, repackaging, and grey-market re-importation far more often than through crude wholesale forgery.
This paper explains why serialization, while necessary, is not sufficient. A serial number is data printed on a carton; it can be copied onto another carton, and it says nothing about whether the carton in a patient's hand has been opened. Regulatory frameworks verify the number, not the physical unit, which leaves refill and repackaging attacks intact.
It then details the provenance architecture: a tamper-evident seal per pack, an append-only chain of custody across manufacturer, wholesaler, and pharmacy, and first-opening detection that flags any pack that was opened before dispensing. A competitive analysis of the available approaches and a full ROI framework close the paper.