The reliable delivery of temperature-sensitive pharmaceuticals depends on an unbroken cold chain governed by Good Distribution Practice (GDP). As biologics, vaccines, plasma-derived products, and advanced therapy medicinal products expand their share of the global medicines market, the clinical and economic consequences of thermal excursions have intensified. This paper reviews recent advances in cold chain integrity and GDP across the regulatory and scientific foundations of temperature control, the engineering of thermal protection and monitoring, the digital transformation of distribution networks, and the systemic dimensions of equipment reliability, sustainability, economics, and equitable access. It examines how passive and active thermal protection systems have improved through vacuum insulation and engineered phase change materials, how real-time monitoring built on connected sensing has displaced retrospective data capture, and how predictive analytics, distributed ledgers, and digital twins are reshaping visibility and traceability. Focused attention is given to the ultra-cold and cryogenic chains that support messenger ribonucleic acid vaccines and cell and gene therapies, where chain of identity and chain of custody requirements compound the demands of thermal control. The paper also considers quality risk management and validation, the reliability of refrigeration assets and the role of predictive maintenance, sustainability pressures such as refrigerant phase-down and single-use packaging waste, the economics of failure and of investment in monitoring, the persistent last-mile gaps in low- and middle-income settings, and the lessons drawn from the pandemic deployment of temperature-sensitive vaccines. The central finding is that cold chain assurance is shifting from a document-centric, compliance-driven discipline toward a data-driven, predictive, and risk-based model. Integrating continuous monitoring with analytics and product specific stability budgets offers the clearest path to reducing wastage while preserving patient safety, although interoperability, validation, cybersecurity, and equitable access remain unresolved challenges.
Counterfeit and substandard medicines remain a major global public health threat, with the World Health Organization estimating that up to 10% of medicines in low- and middle-income countries are falsified or substandard, exceeding 20% for some therapeutic classes in sub-Saharan Africa. Blockchain technology, with its decentralised, immutable, and transparent digital ledger architecture, has been proposed as a promising solution for strengthening pharmaceutical supply chain traceability, yet little is known about the readiness of community pharmacies in Nigeria to adopt it. This study assessed the knowledge, current practices, and implementation readiness of blockchain-based traceability for counterfeit medicine prevention among community pharmacists in Bayelsa State, Nigeria, and examined the barriers and enablers influencing adoption. A descriptive cross-sectional survey design was employed, using a structured, validated questionnaire administered electronically through the Association of Community Pharmacists of Nigeria (ACPN), Bayelsa State Chapter. A total of 119 valid responses were obtained, exceeding the minimum sample size derived from Yamane's and Cochran's formulae, representing a 79.3% response rate. Data were analysed using descriptive and inferential statistics, including Chi-square tests. Findings revealed that although 71.4% of respondents had heard of blockchain technology, mean knowledge scores across core blockchain concepts were uniformly low (1.26-1.72 on a 5-point scale), reflecting a substantial awareness-comprehension gap. Authentication practices were overwhelmingly manual, with 77.3% relying on visual inspection of NAFDAC numbers and only 9.2% using digital scanning; 68.9% of pharmacists had encountered suspected counterfeit medicines in the past year. Implementation readiness was below average (Mean = 2.70/5.0), driven by strong training willingness (Mean = 3.74) but deficient infrastructure (Mean = 1.80). Resistance to change and high cost were the leading barriers, while user-friendly applications and mandatory regulation were the strongest enablers. The study concludes that community pharmacies in Bayelsa State are not yet structurally ready for blockchain-based traceability, although a receptive attitudinal environment and strong professional motivation exist to support a phased transition. It is recommended that NAFDAC and the Pharmacists Council of Nigeria develop a phased regulatory framework and integrate blockchain literacy into continuing professional development, that government prioritise infrastructure investment, and that technology developers design mobile-first, user-friendly, offline-capable systems, to enable a coordinated transition toward blockchain-enabled pharmaceutical traceability in Nigeria.
Counterfeit medicines, fragmented record management, limited end-to-end visibility, and dependence on centralized databases create security and traceability challenges in pharmaceutical supply chains. This article presents Pharma-Chain, a blockchain-enabled pharmaceutical supply chain management system developed to record medicine registration, stakeholder interactions, ownership transfer, and authenticity verification on an Ethereum blockchain. The system integrates a React.js frontend with Web3.js, MetaMask wallet authentication, Solidity smart contracts, Truffle deployment tools, and Ganache for local blockchain development and validation. Manufacturers register medicine batches with product and lifecycle information; distributors and retailers verify blockchain records before accepting and transferring ownership; and customers retrieve medicine details and transaction history before purchase. The implementation was tested module by module and as an integrated application in a local Ethereum environment. Testing confirmed successful authentication and role-based access, medicine registration, ownership transfer, transaction validation, blockchain record retrieval, and medicine verification. Each successful supply-chain operation generated a blockchain transaction record, providing an immutable ownership history and improving transparency and auditability. The project demonstrates a practical decentralized approach for secure pharmaceutical tracking while identifying QR-code verification, IoT monitoring, AI-assisted analytics, mobile access, and deployment on public or enterprise blockchain networks as future extensions.
Open access
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Blockchain Technology Applications and Security
Pharmaceutical Quality and Counterfeiting
Physical Unclonable Functions (PUFs) and Hardware Security
Deepak Gupta, Temur Eshchanov, Jabbarov Umarbek, Berdiyev Anvar Abduraxmanovich · 6 authors
The global halal industry faces critical challenges in ensuring product authenticity, supply chain transparency, and consumer trust. This chapter examines the transformative role of artificial intelligence (AI) technologies in revolutionizing halal product verification and market analysis. Through comprehensive analysis of machine learning, computer vision, blockchain integration, and advanced analytical techniques, we explore how AI-driven solutions address authentication challenges, detect adulteration, and enhance traceability across halal supply chains. The chapter synthesizes current research on deep learning applications for food fraud detection, spectroscopic analysis coupled with chemometrics, DNA barcoding for species identification, and distributed ledger technologies for certification management. We present frameworks for implementing AI-powered verification systems, discuss technological barriers and opportunities, and propose strategic recommendations for stakeholders.
Ankit Sitaula, Ashraf Uddin, John Ayoade, Nam H. Chu · 5 authors
Counterfeit and unsafe medicines pose significant risks to patient safety and undermine trust in healthcare systems. This paper presents ACTMeds, a blockchain-supported pharmaceutical traceability and recall platform that considers pharmaceutical supply chain requirements and public health operational needs relevant to the Australian Capital Territory (ACT). The system integrates Ethereum smart contracts, developed using Ganache, with a React-based web application providing regulator, operator, pharmacy, and auditor interfaces, alongside a public verification portal leveraging QR and GS1 barcodes. In addition, role-based access control is enforced across the medicine lifecycle, including manufacture, custody transfer, dispensing, and recall, with immutable on-chain events generated to support auditability and accountability. To balance transparency with confidentiality, the platform prototypes a zero-knowledge (ZK) recall mechanism in which regulators can cryptographically prove that recall conditions meet predefined policy requirements without disclosing sensitive incident details. Threat modeling was conducted using the STRIDE framework, and security evaluation combined static application security testing (Solhint and ESLint) and dynamic testing. The paper further discusses deployment options, cost considerations, ZK recall performance analysis, ethical implications, and future enhancements. Security testing validated the platform’s resilience, with no high-severity vulnerabilities identified and medium-severity issues related to HTTP security headers addressed. The results indicate that a regulator-led, privacy-preserving, tamper-evident ledger can improve medicine authenticity verification and recall responsiveness while maintaining compliance and data protection obligations.
Dr. K. Pushpa Latha, Meghana Reddy, Dr. B. Rajalingam, Malleswari Akurati · 6 authors
The pharmaceutical supply chain is a network of various stakeholders such as manufacturers, distributors, logistics providers, pharmacies, and regulatory authorities. It is essential to ensure transparency, security, and trust among them to prevent counterfeit drugs, data manipulation, and financial fraud. Drug supply chains using traditional trade finance processes are heavily dependent on paper, based documentation and centralized systems. These practices often cause delays, result in high transaction costs, and reduce traceability. This article introduces a Trade Finance Framework Powered by Blockchain for enhancing security in the drug supply chain transactions. The framework utilizes blockchain technology to offer decentralized, tamper, proof record keeping and real, time transaction verification. Smart contracts facilitate the automation of trade finance procedures such as letter of credit validation, payment release, and compliance verification, thus cutting down on processing time and human intervention. A distributed ledger keeps a record of each transaction, which is accessible to all and cannot be altered, all while hiding the sensitive data through encrypting mechanisms. The system put forward bolsters the mutual trust of the different parties involved, increases the ability to trace pharmaceutical products, decreases the risks of fraud, and makes regulatory compliance easier. The framework, by combining blockchain with trade finance, enables secure, effective, and transparent drug supply chain management, thus leading to higher patient safety and better financial accountability.
G. Prabakaran, Dharani Priya M, Jumana Fathima S, Keerthini R · 5 authors
The pharmaceutical supply chain is complex and often faces challenges such as lack of transparency, counterfeit medicines, and inefficient tracking. This project proposes a blockchain-based pharmaceutical supply chain management system using smart contracts to ensure secure and transparent operations. Each medicine batch is recorded on the blockchain with a unique ID, allowing all transactions from manufacturer to pharmacy to be tracked in a tamper- proof manner. The system also enables patients to verify the authenticity of medicines and detect counterfeit products. Additionally, a drug recall feature allows manufacturers to mark defective batches, preventing further distribution. By using blockchain technology, the proposed system improves traceability, enhances security, and ensures trust among all participants in the supply chain
Switzerland’s healthcare system is complex, involving a regulated interplay among the federal, cantonal, and local governments. Swiss federalism classically gives power to the cantons, except in areas where the Constitution confers powers to the Confederation. In healthcare, the powers conferred to the Confederation are essentially of a legislative nature, and relate to the regulation of financing, quality and safety of medicines, certain areas of public health, as well as research and development [1]. Outpatient care is mainly provided by the private sector and is essentially based on a liberal system. Most healthcare professionals, including pharmacists, work independently in private care structures. This dynamic interplay between the public and private sectors, along with split responsibilities, significantly influences the system, resulting in a decentralized and fragmented healthcare framework [2]. This fragmentation extends to medicine reimbursement policies, which are regulated under the Federal Law on Compulsory Health Care (LAMal in French). Outpatient services are covered by the compulsory health insurance mandated for all residents of Switzerland, obtained from private health insurance providers [3]. The reimbursement and prices of prescribed medicines are strictly regulated by the Federal Office of Public Health (FOPH), which evaluates whether the medicinal product meets the criteria of effectiveness, appropriateness, and cost-effectiveness before including it on the “List of Pharmaceutical Specialties” (LS). Medicines are either reimbursed if included in the LS or not, with no partial reimbursement. Furthermore, reimbursement may be limited to specific conditions, e.g. based on the clinical situation or the patient’s characteristics. In principle, reimbursement is restricted to indications and conditions of use approved by Swissmedic, the Swiss agency for therapeutic products.
P. Chinnasamy, N. Hemanth Reddy, K. Manjusri, P. Kusuma Priya · 5 authors
Medi Chain is a system that is established to introduce a higher degree of trust and transparency into the process of medicine supply. In the current times, counterfeit and bootleg drugs are a point of serious concern, particularly in cases where the physician prescribes them. Medicine batches are tracked and recorded by Medi Chain via blockchain since the stage of manufacture to the point of sale. The data stored is unchangeable and unbreachable as all the data is stored on the Sepolia Ethereum network in the form of smart contracts. Through QR- based checks, the platform enables users of the site to scan a code and instantly access essential information, including the source of the medication, who touched it, and the presence of a valid prescription pivotal to that prescription. This has made the system easy to use as the blockchain logic is written in Solidity and Web3.js, and the user interface is written in React.js and Tailwind CSS. Firebase is used to deal with secure log in, document uploading, and storage of prescription files. The system includes some basic yet significant precautions to ensure that the process of medicine handling happens safely in all stages. Each medicine flow remains exposed and safe and cannot be abused or misused. MetaMask logins, quick scans on QR, allow its users to quickly verify authenticity, making sure that prescriptions are adhered to.
The rise of counterfeit medicines poses serious health risks to the public and threatens the credibility of pharmaceutical companies. Blockchain technology is gaining attention for its potential to enhance the security and transparency of the pharmaceutical supply chain. This study compares the performance of two blockchain platforms, Ethereum and Nexus, in detecting and preventing counterfeit drugs. A virtual observation system was used to examine how Ethereum and Nexus addressed major challenges in counterfeit drug prevention. Two specialists with expertise in both blockchain technology and healthcare evaluated the platforms using two assessment tools: The Global Quality Scale (GQS) to measure overall effectiveness and the modified DISCERN scale to assess credibility of the information. Nexus outperformed Ethereum in both effectiveness and credibility. Evaluator 1 reported median GQS scores of 4.5 for Nexus and 3.8 for Ethereum, while Evaluator 2 reported scores of 4.2 and 3.8, respectively. These findings indicate that Nexus demonstrated higher efficiency in detecting fake drugs and ensuring supply chain integrity. Blockchain technology shows promise in strengthening pharmaceutical supply chain security. Between the two platforms studied, Nexus was found to be more effective than Ethereum in preventing counterfeit drugs. These results provide valuable insights for pharmaceutical stakeholders and policymakers seeking to implement blockchain-based solutions for drug tracking and security.
This project develops a blockchain-based web application aimed at verifying pharmaceutical products, a critical step in combating counterfeit drugs. By leveraging Ethereum's Sepolia test network and the power of smart contracts, the system facilitates secure, transparent processes for registering, verifying, and tracking pharmaceutical items. The application combines a PHP-based backend with a JavaScript-powered frontend, seamlessly integrating tools like MetaMask for user authentication and Web3.js to enable blockchain communication. The study underscores the significant advantages blockchain offers over traditional verification methods, particularly in terms of data integrity, transparency, and security. As a result, it meets the CIA triad model's requirements for confidentiality and integrity in information security. The novel features of the project include the use of optimism roll-ups for scalability, two-factor authentication (2FA), and data encryption to address critical challenges often overlooked in similar proposals for blockchainbased authentication systems. The results of the project demonstrate a tangible improvement in supply chain transparency and fraud prevention within the pharmaceutical industry. This work lays a strong foundation for further exploration of decentralised applications, not only in pharmaceutical validation but also across other essential sectors.
The modern pharmaceutical supply chain needs robust transparent systems to protect drugs authenticity across all distribution stages because of rising counterfeit medicine threats. This paper develops an Internet of Things (IoT) blockchain framework which implements smart contracts for complete pharmaceutical product traceability together with drugs verification. The proposed solution architecture measures its performance through scalability, latency and throughput metrics. we developed a custom smart contract through optimized state control logic and low gas costs and efficient batch processing functions. The architecture ensures high-throughput operation because it keeps transaction processing times short for large transaction volumes. The system evaluation shows latency results between$\mathbf{1 8 0} \boldsymbol{-} \mathbf{2 5 0}$milliseconds with throughput results between 50–60 transactions per second and batch processing capabilities between 1,000 and 10,000 transactions which demonstrates its scalability and responsiveness. The framework offers an effective solution against counterfeit drugs using secure blockchain execution of IoT device data while preserving supply chain integrity and transparency and maintaining operational efficiency.
Rakan B Aldosari, Farah Kalmey, Abdullah T Alanazi, Ashraf A’aqoulah
Background: Blockchain is a cutting-edge innovation being applied to offer innovative solutions in various fields, including healthcare. The healthcare industry uses blockchain networks to store and distribute patient data across hospitals, physicians, diagnostic labs, and pharmaceutical firms. Blockchain applications are essential in the healthcare industry for identifying crucial fallacies that might be fatal. The effectiveness, security, and transparency in exchanging medical data may thus be improved in the healthcare industry. This technology may also aid medical institutions in procuring information and analysing patient data. Aim: To examine the published papers that discussed the ability of utilization and probable challenges of blockchain technology in KSA's healthcare supply chain management. Methods: Until February 10, 2023, the prime databases: Pub Med, Science Direct, Scopus, Google Scholar, Web of science, Embase and The Cochrane Library were searched. Published studies (except case reports), commentaries, editorials, reviews, and meta-analysis reporting on the use of blockchain technology in healthcare supply chain management were included and a Preferred Reporting Items of systematic Reviews and Meta-analyses (PRISMA) flow diagram was used to present the process. To assess risk of bias and the quality of the included studies, the Joanna Briggs Institute's (JBI) critical evaluation tools were implemented. Results: A total of 22 studies were included and most of them used blockchain in technology for ensuring transparency, security, and storage of electronic health or medical records. Patients benefited from seamless electronic health records provided by a multi-level blockchain eHealth system. It was observed that blockchain technology effectively addresses clinical trial misconduct, and its potential in this area is to boost data productivity for the healthcare sector. The distinctive data storage pattern of blockchain offers a high-security standard that potentially reduces concerns about data tampering. It provides flexibility, accountability, connection, and data access authentication. Blockchain helps the healthcare sector avoid certain risks and offers decentralized data protection. In our study, we observed that the most preferred network for integrating the healthcare authority, manufacturer, wholesaler, retailer, and service was Ethereum (ETH). Conclusion: Healthcare policymakers should implement blockchain in Healthcare Supply Chain Management. Moreover, they need to be aware that the primary issues with blockchain technology in the healthcare industry are the lack of practical applications, the high rate of failed initiatives, and the requirement for collaboration between diverse stakeholders. However, there is a lack of studies on how to evaluate the acceptability and assist healthcare organisations in using blockchain.
Venkateswarlu Boddu, Malaya Dutta Borah, Naresh Babu M
This paper proposes a blockchain-based framework to monitor drugs and trigger alerts to safeguard stakeholders when drugs are reported to be faulty. The proposed system uses a decentralised approach, enhancing the overall transparency and security. The framework identifies counterfeit drugs and reports the issue across various stakeholders in the pharmaceutical supply chain, including regulatory departments, hospitals, and manufacturers. The alerts regarding contaminated or counterfeit drugs are ensured due to the integration of blockchain and distributed ledger. Furthermore, the recorded data are secure, traceable, and immutable. The results demonstrate that the framework successfully registers the departments and sends the alert across the departments associated with the blockchain. Also, the results confirm the feasibility of using blockchain to create a transparent and robust counterfeit drug alert network, providing a reliable solution for pharmaceutical safety management.
Pharmaceutical Quality and Counterfeiting
Blockchain Technology Applications and Security
Physical Unclonable Functions (PUFs) and Hardware Security
Substandard medicines in Nepal represent an under-documented yet critical threat to universal health coverage (UHC) and patient safety, disproportionately impacting marginalized communities. This opinion piece seeks to illuminate the prevalence, drivers, and far-reaching consequences of compromised pharmaceuticals, drawing on both local and global evidence. This paper offers pragmatic strategies to strengthen regulatory capacity and accountability by spotlighting ethical imperatives and systemic gaps. Bridging best practices from international frameworks with Nepal's unique context, I aim to catalyze policy discourse, cultivate public awareness, and spur multi-sectoral collaboration. Ultimately, the goal is to foster equitable and high-quality healthcare for all, reinforcing the moral imperative of safeguarding the integrity of Nepal's medicine supply.Substandard medicines are a pressing, under-recognized public health crisis in Nepal. Despite expanded healthcare access, compromised pharmaceuticals undermine patient well-being and public trust (1,2). The World Health Organization (WHO) estimates that at least one in ten medicines in low-and middle-income countries (LMICs) is substandard or falsified (3). In Africa, reports indicate up to 18.7% of sampled pharmaceuticals are compromised (4). This global issue is significantly influenced by two of the world's major suppliers of medicine, both domestically and internationally: India and China (5). According to estimates from India's Health Ministry, 5% of the nation's medicines are counterfeit and 0.3% are spurious, with one study suggesting that 75% of counterfeit medicines supplied globally originate in India (6). While recent, precise prevalence data for counterfeit drugs from China is not readily available, its role as a global manufacturing powerhouse is undisputed; for example, the country produces approximately 120 billion aspirin tablets annually for the North American market alone (7). A 2024 literature review highlights the historical scale of the issue, noting that 31% of the world's falsified and counterfeit medications are produced in China and Hong Kong (8). This geopolitical context is critically important for Nepal. The country's porous borders with these major pharmaceutical producers (9), combined with its own under-regulated supply chains, significantly heighten its susceptibility to the circulation of substandard drugs (10).A Nepal Health Research Council (NHRC) study found that 15.16% of 244 tested medicine batches failed pharmacopeial standards (11). Alarmingly, 62.16% of these were government-supplied. Compromised products included essential antibiotics, analgesics, and iron supplements, with failures in dissolution, assay, fill volume, and sterility. A 2010-2020 review of drug recall notices in Nepal revealed a surge in recalled products, most frequently antimicrobials (2). These findings indicate an ethical breach: public health facilities primarily serve the underprivileged, disproportionately imposing the burden of substandard medicines on them-a direct affront to the principle of justice (12). Patients, often unaware of compromised drug quality due to identical appearance, are denied meaningful informed consent. This erodes trust in the healthcare system and fuels antimicrobial resistance, a global health security threat with severe implications (3).Limited regulatory capacity exacerbates these dangers. In the Nepalese context, chronic under-resourcing of the Department of Drug Administration (DDA) and the National Medicines Laboratory hampers rapid testing and enforcement (13,14). Testing delays can extend for months, allowing compromised medications to circulate (15). While decentralizing drug procurement to local governments was intended to improve responsiveness, this policy has inadvertently weakened quality control due to a lack of local testing facilities and specialized personnel (14).Nepal's crisis of substandard medicines undermines human rights and core ethical principles.Tolerating this compromise of patient safety is incompatible with universal health coverage (UHC) (16). In Nepal, where a significant portion of the population relies on public health facilities for essential medicines, the prevalence of substandard drugs, especially in public health facilities (17), directly undermines the core tenets of UHC. Specifically, it violates the principle of access to quality healthcare: even if services are nominally affordable or free, receiving ineffective or harmful medication means that true, effective healthcare is not being delivered. Furthermore, the consequences of substandard medicines -prolonged illness, treatment failure, or adverse drug reactions -often lead to increased financial hardship for patients who may require further treatment, hospitalization, or experience loss of income due to illness. This directly contradicts the UHC goal of protecting people from financial risks associated with healthcare (18). This creates a two-tiered system, where those with resources can seek higher-quality care in the private sector, while the most vulnerable are left exposed to potentially dangerous treatments. Addressing this inequity and ensuring the integrity of the medicine supply is not just a matter of policy but a fundamental requirement for social justice. Success requires sustained political commitment, collaboration across sectors, and a steadfast focus on the public interest. Nepal must act decisively to eliminate substandard medicines and ensure equitable, high-quality healthcare for every citizen. This is not merely a matter of improving healthcare statistics; it is about upholding the fundamental dignity and rights of every citizen of Nepal.To address this crisis comprehensively, I argue that Nepal must move beyond isolated interventions and adopt a multi-pronged, systemic approach grounded in international best practices and adapted to the local context. The solution to the challenge of substandard medicines is complex, requiring a foundational shift from reactive detection to proactive prevention and quality assurance throughout the entire supply chain.First, the cornerstone of any effective strategy must be the robust implementation of a national quality assurance framework based on established WHO principles (19). This involves the mandatory adoption and enforcement of Good Manufacturing Practices (GMP) for domestic producers, ensuring that quality is built into products from the outset (20).Critically, this must be complemented by the nationwide implementation of Good Storage Practices (GSP) and Good Distribution Practices (GDP), which are presently lacking in Nepal (2). As detailed in WHO guidelines, this requires establishing a comprehensive Quality Management System that governs every stage of the supply chain, from procurement to delivery. This includes temperature-controlled storage and transport, proper documentation to ensure traceability, and rigorous training for all personnel involved (21,22). The goal is to create a secure, transparent, and controlled environment where opportunities for degradation or the introduction of falsified products are minimized.Second, this preventative framework must be supported by strengthening practices at the point of care through the enforcement of Good Pharmacy Practices (GPP). While pharmacistled detection of visibly substandard medicines is challenging and should not be the primary line of defense, pharmacists are integral to maintaining quality assurance (23). The US Agency for International Development (USAID) funded Medicines, Technologies, and Pharmaceutical Services (MTaPS) program has already highlighted the significant impact of GPP implementation on product quality and patient safety in Nepal (24). The urgency of this is underscored by recent local evidence from the Supervision, Performance Assessment, and Recognition Strategy (SPARS) pilot. The baseline assessment from the SPARS pilot, conducted in 2022 across 284 health facilities, revealed alarmingly poor medicines management practices, with an overall median score of only 34% across key performance indicators. Particularly low scores in domains such as storage management and stock management highlight critical, systemic gaps that a robust GPP framework is precisely designed to address (25). Therefore, a renewed focus on GPP-including proper storage, inventory management using the First-Expired-First-Out (FEFO) principle, and patient counselling (26,27)-is not merely a recommendation but an evidence-based necessity to safeguard medicine quality at the final stage of the supply chain.Third, a fundamental overhaul of the national regulatory body is imperative. While establishing a new, fully autonomous commission with civil society oversight represents an ideal long-term goal, a more pragmatic and immediate strategy is to empower the existing Department of Drug Administration (DDA). Given Nepal's resource constraints, strengthening the current regulatory infrastructure is a more feasible first step. Following successful models from other nations, such as the autonomous South African Health Products Regulatory Authority (SAHPRA) (28), granting the DDA greater operational and financial autonomy would be transformative. An empowered DDA could then engage in the kind of international collaboration essential for modern pharmacovigilance, such as the recent Memorandum of Understanding between SAHPRA and Australia's Therapeutic Goods Administration (TGA) to share regulatory information and expertise (29). Recent progress within Nepal indicates a readiness for such advancement; for instance, with support from USAID MTaPS, the DDA has begun modernizing its document management system by installing secure, access-controlled repositories to increase efficiency and security (30).While these foundational improvements are commendable, they must be viewed as the first steps in a much longer journey. Full regulatory maturity requires sustained investment to build upon these gains. This must include a significant increase in the number of trained inspectors and a shift towards a risk-based inspection model that prioritizes systematic laboratory testing of products from importers and wholesalers before they enter the market, thereby ensuring quality at the source rather than attempting to recall products that have already been dispensed.Finally, these systemic and regulatory reforms should be amplified by leveraging modern technology and strengthening post-market surveillance. A vital component underpinning all these reforms is compliance with Good Practice (GxP) principles. GxP is an acronym for a collection of quality guidelines and regulations designed to ensure that products within heavily regulated industries, such as pharmaceuticals, are consistently safe, effective, and fit for their intended use (31). This framework is not a single standard but an ecosystem of practices-including GMP, GSP, and GPP-that collectively safeguard product integrity.While technology is not a panacea, rigorous track-and-trace systems-using technologies like blockchain or simple 2D barcoding-offer a powerful tool for enforcing GxP compliance and achieving end-to-end visibility. This enables regulators to verify authenticity and rapidly identify diversions in the supply chain (32,33). Such systems, proven to be cost-effective in settings like Bangladesh (34), would support the broader GxP framework (31) and provide crucial data for the empowered DDA. Within this enhanced surveillance system, pharmacists, supported by legally protected reporting mechanisms, become vital nodes for reporting suspected adverse events or quality issues, thereby creating a feedback loop that strengthens the entire regulatory ecosystem (35).The integrity of a nation's medicine supply is a direct reflection of its commitment to health equity and social justice. For Nepal, the continued presence of substandard medicines in the supply chain represents a fundamental contradiction to its goal of achieving universal health coverage. The systemic reforms proposed-implementing a robust GxP framework, empowering an autonomous regulator, and leveraging technology for surveillance-are not merely technical exercises; they are essential acts of building trust with the nation's most vulnerable citizens and affirming their right to safe, effective healthcare. Moving forward, the challenge is not one of awareness, but of political will and sustained action. Ensuring the quality of every pill and vial is not just a matter of public health policy-it is a fundamental test of Nepal's promise of equitable healthcare for all.
The manufacturing and distribution of counterfeit tablets, especially in developing countries, is an urgent and increasingly critical global problem. Falsified medicinal products may contain incorrect ingredients and doses. One of the reasons for drug counterfeiting is the imperfect supply chain system in the pharmaceutical industry. Medicinal products are moved between manufacturers, suppliers, wholesalers, retailers, and pharmaceutical firms before meeting consumers. This study proposes PharmChain, a scenario-oriented drug traceability and regulation blockchain framework that reconstructs the entire service infrastructure by splitting the service provider into three separate service components and ensuring the authenticity and privacy of traceability details. PharmChain can track medication development via patient supply in the pharmaceutical industry. An Ethereum-based blockchain stores the transactions, and only trusted parties can access the data through the chain. We create and test our smart contract code in the Remix environment. We present detailed cost and security analyses incurred by supply chain stakeholders. We also use cost analysis to assess the performance of the proposed solution and demonstrate its affordability. • Introduce PharmChain, a data-driven scenario-based drug traceability and regulation blockchain framework. • Ensure authenticity and privacy of traceability data, enhancing security. • Validate smart contract code rigorously in the Remix environment. • Show the feasibility and affordability of PharmChain through detailed analytics. • Alleviate counterfeit tablet distribution, which poses a pressing and escalating global challenge.
Yedu Krishna, Pavan Kumar Reddy Narala, Harsh Hooda, D. S. Dayana
Pharmaceutical supply chains are beset with many problems such as the presence of counterfeit medicines, traceability problems, and lack of transparency of transactions. Centralized traditional systems are not conducive to real-time tracing or secure proof of dispensation of drugs. In order to overcome these challenges, we suggest a blockchain-based Drug Inventory and Supply Chain Tracking System, authenticating drugs, making transactions secure, and supply chain transparent. Our system uses the Ethereum blockchain, smart contracts, and Proof-of-Stake (PoS) validation to enable stakeholder registration, validation of transactions, and tracing of drugs in an automated way. Through extensive testing and evaluation, our system has proven to enhance security, enhance efficiency, and eliminate fraud, showing the way blockchain technology can re-engineer pharmaceutical supply chain management. Validators also stake ETH to participate in the validation process, promoting trustworthiness, with attempts at fraud resulting in ETH burning instantly. Through extensive testing and evaluation, we demonstrate our system better than the conventional supply chain practices by securing it better, making it more efficient, and effectively preventing fraud, further showing the revolutionary potential of blockchain enhances supply chain management by providing transparency, preventing counterfeit drugs, and bringing efficiency into action.
Blockchain technology has drawn a lot of interest in the healthcare industry in recent years. Efficient data management is crucial for pharmacies. Blockchain technology is a novel technology that has the potential to make many pharmaceutical processes safer and more transparent. In 2013, the US Congress created the Drug Supply Chain Security Act (DSCSA) to prevent the distribution of stolen, contaminated, or counterfeit drugs. Blockchain technology serves as an answer to this problem as it enables the tracking and tracing the product from manufacturer to patient through an electronic, immutable, digitized tracking record of all steps from inventory to consumer in the drug supply chain. To ensure the safety of a peer-to-peer network of transactions, blockchain technology employs cryptographic methods to create a distributed ledger that is not centralized. Incorporating it into a product ensures its safety and marketability. Blockchain technology offers solutions to enhance the validity, reliability, and efficiency of medication manufacturing by facilitating easy compliance with legislation. Additionally, it offers an opportunity to address a major problem: the proliferation of counterfeit drugs that enter the system and ultimately reach consumers. The pharmaceutical industry's deficient supply chain management results in counterfeit and fake drug entering the supply chain and negatively affecting patients' health, leading to serious complications or even death. Supply chain management may benefit from blockchain technology's transparency and immutability at every step of the process, which increases confidence, security, traceability, and transparency. Blockchain technology, designed to manage electronic data, holds promise for enhancing clarity. Every user of a computer network has access to the same immutable record of transactions known as a blockchain. Patent innovations have significant implications for pharmaceutical patent protection, supply chain transparency, and counterfeit prevention.
Maintaining drug authenticity and quality across the pharmaceutical supply chain is a major challenge. Counterfeit medicines and prescription errors threaten patient safety and public health. To address this, we propose a blockchain-based framework using Ethereum, smart contracts, and QR codes. The system ensures secure monitoring from manufacturing to end-user delivery. Each drug is linked to a unique QR code enabling real-time tracking and ownership transfer. Pharmacies use QR verification to reduce human errors during medicine dispensing. Blockchain ensures transparency, data integrity, and resistance to tampering or hacking. Stakeholders benefit from improved trust and verifiable supply chain transactions. The framework enhances traceability and helps eliminate counterfeit medicines. Ultimately, it promotes a safer, more transparent, and trustworthy pharmaceutical ecosystem.