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Stream/Area:
-
Subject:
-
Paper ID:
IJSREM64481
Volume:
10 |
6 |
Jun 2026
Pages:
1-10
Publication Frequency:
Monthly (12 issues per year)
License:International Journal of Scientific Research in Engineering and Management follows the Creative Commons Attribution 4.0 (CC BY 4.0) License, allowing free use and distribution with proper attribution.

Department of Computer Science
RV College of Engineering
Department of Computer Science
RV College of Engineering

Department of Computer Science
RV College of Engineering
Department of Computer Science
RV College of Engineering
Department of Computer Science
RV College of Engineering
Department of Computer Science
RV College of Engineering
The threat of counterfeit medicines to world health and public health in general is a constant and growing chal-lenge, compromising patient safety and the trust of legitimate pharmaceutical products. supply chains. The current traceability systems, which are mainly based on centralised databases and systems, Paper-based record keeping is susceptible to falsification of records, insider manipulation of records, and other issues, There was a clear lack of transparency with stakeholders and a very basic lack of cross-stakeholder transparency. In this paper, a framework based on blockchain technology for end-to-end pharmaceutical supply-chain is proposed. Distributed ledger technology security that combines consortium distributed ledger technology and IoT enabled physical. smart contracts with cryptographically enforced enforce the conditions, and monitor for tampering activities. The provenances from manufacturer to patient. The framework is based on an architecture using a consortium permissioned approach with Practical Byzantine (PBFT) governance. Deterministic transaction finality is provided by Fault Tolerance (PBFT) consensus, which is bounded.Fault Tolerance (PBFT) consensus is bounded deterministic transaction finality. latency, and role-based access control for the regulatory requirements of pharmaceutical organizations. distribution. One of the on-chain/off-chain storage models with IPFS content-addressed storage Solve the conflict between scalability in data size and auditable blockchain use. A detailed security analysis covers the major attack vectors such as Sybil attacks, countersfeit injection, IoT spoofing, and smart contract vulnerabilities, and identifies Cryptographic and architectural countermeasures that correspond to the threats. The evaluation against representative previous architectures shows that The proposed framework delivers better throughput, lower latency, and access-control. preserves multi-party trust, with assurances that come with public-blockchain solutions. A set of properties that are missing in private blockchain deployments. The framework provides a replicable, standards-based structure for safe pharmaceutical supply chain. regulatory regimes such as traceability for modern-day needs the U.S. Drug Supply Chain Security Act and the EU Falsified Medicines Directive.
KEYWORDS
The current study aims to propose a secure, blockchain-integrated model for the pharmaceutical supply chain aimed at combating the ever-prevailing problem of the proliferation of counterfeit medicines. The framework provides end-to-end tamper-proof traceability for all tiers of the supply chain and inter-node distance, as well as the physical monitoring gaps, which the existing serialisation schemes are unable to monitor. The comparative analysis of blockchain architecture types provides evidence that consortium permissioned blockchain architectures provide better throughput, data confidentiality, compliance and multi-party trust than both public and private blockchain architectures. The performance features that are suited for large national-scale pharmaceutical serialisation workloads have been selected for PBFT consensus and are the basis for the selection.PBFT consensus has been chosen for its performance features: deterministic finality, BFT fault tolerance, and Hyperledger Fabric compatibility. The smart-contract architecture provides programmatic and immutable enforcement of supply-chain business rules: au-tomatic sequence of custody transfers, expiry management, automated policy alerting, etc., without the need for trusted intermediaries and without the delay of manual verification among existing deployments. The hybrid IPFS-based stor-age model further expands the use of the model’s practical scalability to high-frequency IoT telemetry volumes without compromising the cryptographic integrity guarantees that are a core part of the anti-counterfeiting value proposition of blockchain. The formal security analysis shows that the proposed sys-tem is resistant against the main attack techniques that pose threats to pharmaceutical blockchain systems, which include mitigative measures such as cryptographic hardware security, role-based access control, multi-signature governance, and selectively disclosure via zero-knowledge-proofs. The pro-posed framework represents a step towards implementing a standards-based, interoperable and economically viable trace-ability framework that directly contributes to the goals of UN SDG 3 (Good Health and Well-being) and is part of the larger agenda of transparent, accountable healthcare supply-chain governance. Going forward, further research is planned to explore scalable BFT consensus mechanisms such as HotStuff for wide-ranging deployments and the use of cutting-edge zero-knowledge proofs (zk-SNARKs and zk-STARKs) to ensure privacy-preserving regulatory audits. In addition, we are work-ing to bring the lightest possible verification logic at the IoT edge to perform real-time screening and investigate NFTs for drug identities to prevent batch splitting. This framework can eventually be interconnected with larger, decentralized healthcare systems that include clinical trials and patient data management by empirical pilot deployments and working with standardisation bodies (GS1, ISO, IEEE).
[1] World Health Organization, Substandard and Falsified Medical Products, WHO, Geneva, Switzerland, Fact Sheet, 2023. [Online]. Available: https://www.who.int/news-room/fact-sheets/detail/ substandard-and-falsified-medical-products [2] INTERPOL, “Operation Pangea XIII: Global results,” INTERPOL, Lyon, France, Technical Report, 2020. [Online]. Available: https://www. interpol.int/News-and-Events/News/2020/ [3] U.S. Food and Drug Administration, “Drug Supply Chain Security Act (DSCSA),” FDA, Silver Spring, MD, 2023. [Online]. Available: https: //www.fda.gov/drugs/drug-supply-chain-security-act-dscsa [4] European Medicines Agency, “Falsified medicines: Overview and regulatory framework,” EMA, Amsterdam, The Netherlands, 2023. [Online]. Available: https://www.ema.europa.eu/en/human-regulatory/ overview/public-health-threats/falsified-medicines [5] European Commission, “Commission Delegated Regulation (EU) 2016/161 supplementing Directive 2001/83/EC on safety features ap-pearing on the packaging of medicinal products for human use,” Official Journal of the European Union, L 32, pp. 1–27, Feb. 2019. [On-line]. Available: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri= CELEX:32016R0161 [6] S. Nakamoto, “Bitcoin: A peer-to-peer electronic cash system,” Bit-coin.org, Oct. 2008. [Online]. Available: https://bitcoin.org/bitcoin.pdf [7] V. Buterin, “A next-generation smart contract and decentralised appli-cation platform,” Ethereum White Paper, Ethereum Foundation, 2014. [Online]. Available: https://ethereum.org/en/whitepaper/ [8] G. Wood, “Ethereum: A secure decentralised generalised transaction ledger,” Ethereum Yellow Paper, Ethereum Foundation, Apr. 2014, rev. 2022. [Online]. Available: https://ethereum.github.io/yellowpaper/paper. pdf [9] E. Androulaki et al., “Hyperledger Fabric: A distributed operating system for permissioned blockchains,” in Proc. ACM EuroSys, Porto, Portugal, Apr. 2018, Art. no. 30, doi: 10.1145/3190508.3190538.
Publication Date
6/3/2026
Peer Review Type
Double-Blind Peer Review
Review Rounds: 2
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