Description
Counterfeit drugs cost the pharma industry nearly $40 billion a year. Explore how Track & Trace serialization secures the supply chain, and the six-step roadmap procurement can follow to lead the transition.
Key Takeaways
- Today's pharmaceutical tracking relies on manual inputs with no central database and no single entity responsible, thus creating gaps that let counterfeits into a supply chain losing billions each year.
- Every country sets its own serialization laws and standards, such as the U.S. and EU differ on codes, technologies and packaging levels; so, country playbooks matter more than one global strategy.
- A six-step roadmap — dedicated team, country playbooks, supply chain SWOT, pilots and a flexible, scalable solution — lets procurement lead serialization and shape emerging standards.
Executive Summary
Counterfeit drugs cost the pharmaceutical industry nearly $40 billion a year, by WHO estimates. The structure of the supply chain is what makes it possible.
Drugs change hands repeatedly — manufacturer, wholesaler, pharmacy, patient — and often flow back through returns and recalls. Every hand-off, chargeback and price change creates openings for counterfeits, diversion and theft: in one case, $2.7 million in prescription drugs was diverted for resale; in another, a stolen shipment of expired seizure medication re-entered the legitimate supply chain. Unique codes, holograms and manual chain-of-custody records have all been tried, without success.
Track & Trace (T&T) replaces this with mass serialization: a unique identifying code on every product, fixing a tracking process built on manual inputs, no central database and no single entity responsible. Beyond blocking counterfeits, T&T improves profitability through efficient recall management, reverse logistics, chargeback resolution and better planning.
But adoption is demanding. Annual running costs can reach $180–$300 million for a major pharmaceutical company. Regulations are fragmented (with the U.S. and EU alone differing on codes, technologies and packaging levels) and packaging, IT, distribution and change management all take the strain.
This paper gives procurement a six-step roadmap to lead the transition: a dedicated T&T team, country-specific playbooks, supply chain readiness assessment, a gap-based roadmap, pilots, and a flexible, scalable solution.
With deadlines varying by country, procurement that moves early shapes the standards everyone else will follow.
Read the paper now.
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Frequently Asked Questions
Traditional tracking relies on manual inputs, with no central database and no single entity responsible for tracking a product — leaving it vulnerable to counterfeits. Unique codes, holograms and manual chain-of-custody records have all failed. T&T instead serializes every item with a unique code, enabling end-to-end traceability.
Each country has separate laws and standards: the U.S. requires serial identifiers at all packaging levels via 2D data matrix and linear barcodes, while the EU requires product codes at primary packaging only, allowing RFID. This fragmentation restricts tagging adoption, complicates cross-site coordination and makes country-specific playbooks essential.