PHARMA-CHAIN: A BLOCKCHAIN-ENABLED, IOT-POWERED SUPPLY-CHAIN TRACEABILITY FRAMEWORK ON HYPERLEDGER FABRIC FOR COMBATING COUNTERFEIT AND SUBSTANDARD MEDICINES

Abstract

Background: Substandard and falsified (SF) medicines are a persistent global health emergency that is disproportionately concentrated in low- and middle-income countries (LMICs). The World Health Organization estimates that approximately one in ten medical products in LMICs fails quality testing, and pooled meta-analytic evidence places the prevalence at 13.6%, with antimalarials and antibiotics most heavily affected. Conventional pharmaceutical supply chains rely on fragmented, centrally held, paper-based or siloed digital records that are easy to forge, difficult to audit, and slow to mobilise during recalls, creating fertile conditions for counterfeit penetration.

Objectives: This study designs, models and evaluates Pharma-Chain, a permissioned blockchain and Internet-of-Things (IoT) traceability platform built on Hyperledger Fabric — that delivers immutable, end-to-end provenance of every drug batch from manufacturer to patient, enables instantaneous QR-based authenticity verification, and provides the Drug Regulatory Authority of Pakistan (DRAP) with real-time oversight, recall and quarantine capabilities.

Methods: We adopted a design science methodology. System requirements were captured through a Unified Modelling Language (UML) use-case model spanning five actors and six functional packages; interaction logic was specified through a sequence diagram tracing a transaction from the React front end through a Node.js gateway to Fabric chaincode, the Raft ordering service, and a CouchDB-backed world state; and the full business process was formalised as a swim-lane activity diagram. Four chaincodes (manufacturing, transfer, retail, and recall) were implemented and benchmarked for throughput, latency, and authentication accuracy under increasing transaction loads.

Results:  The prototype sustained a committed throughput of up to 471 transactions per second (TPS) before saturation, maintained sub-second confirmation latency below 500 TPS, and executed read-only verification queries in under 0.20 s. Across four field verification scenarios, the system correctly authenticated genuine batches in 98.7% of cases, flagged 100% of counterfeit/unknown QR codes, and recalled batches. Relative to a conventional baseline, modelled supply-chain capability improved by a factor of two to three across traceability, tamper-resistance, recall speed and counterfeit detection.

Conclusions:  A permissioned, IoT-integrated blockchain is a technically viable and operationally compelling instrument for securing the pharmaceutical supply chain in resource-constrained settings. Pharma-Chain aligns with international serialization regimes (DSCSA, EU FMD) while remaining tailored to Pakistan's governance realities, offering a deployable blueprint for a national drug-authentication infrastructure.