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1
Kasi, Sudheer Kumar. "Pharmaceutical Drug Serialization in the Supply Chain." International Journal for Research in Applied Science and Engineering Technology 11, no. 8 (2023): 99–103. http://dx.doi.org/10.22214/ijraset.2023.55130.
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Abstract: Pharmaceutical medication serialization is often a regulatory requirement established by large nations to combat pharmaceutical drug counterfeiting. Since the 19th century, drug fraud has been a serious issue for the healthcare sector. The regulator y and healthcare organizations struggle from time to time to reduce the danger of negative outcomes brought on by fake medications. According to estimates from the World Health Organization (WHO), four out of every ten pharmaceuticals sold in underdeveloped or disadvantaged nations may be tainted. Ultimately, because of stolen, diverted, and counterfeit pharmaceuticals, drug makers lose billions of dollars annually. The regulatory authorities are currently developing severe regulations to prevent criminals from supplying and diverting fake or stolen medicine in the supply chain. To offer patients with safe and authentic medications, the healthcare business needs strict rules and secure traceability technologies. In essence, pharmaceutical drug serialization offers benefits by enhancing the supply chain's drug security by lowering adverse occurrences and investigations. Additionally, tracking and tracing technology is used in pharmaceutical drug serialization to take advantage of the advantages of tracking individual drug packages in the supply chain.
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Rajora, Naveen. "Dynamics of Pharmaceutical Drugs Serialization." Trends Journal of Sciences Research 1, no. 1 (2022): 43–49. http://dx.doi.org/10.31586/ujpp.2022.396.
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Naveen Sharma. "Pharmaceutical sector: Packaging requirement in serialization." International Journal of Science and Research Archive 11, no. 2 (2024): 1719–25. http://dx.doi.org/10.30574/ijsra.2024.11.2.0632.
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Access to healthcare is a fundamental right for every individual, and it is the responsibility of governments to ensure the provision of quality healthcare services and infrastructure to their citizens. Over the past few decades, both governments and the healthcare industry have been grappling with the challenge of minimizing the adverse effects on public health caused by counterfeit medicines. According to the World Health Organization, approximately four out of ten medicines in developing and impoverished countries are either fake or potentially adulterated, leading to significant economic losses and reducing funds allocated for research and development (R&D) by organizations. Preventing counterfeit medicines from entering the supply chain poses a significant challenge for governments and regulatory authorities. Consequently, there is a concerted effort to establish stringent guidelines aimed at thwarting criminals and counterfeiters from infiltrating markets with fake medications. The healthcare industry recognizes the necessity for strict regulations and secure technologies to ensure the provision of safe and authentic drugs to patients. In the United States, the FDA has outlined a ten-year roadmap to implement drug traceability measures. Additionally, the Healthcare Distribution Alliance (HDA) has mandated the inclusion of multiple barcodes and human-readable data in product packaging hierarchy. Furthermore, the FDA is actively engaged in a pilot project with leading pharmaceutical manufacturers and wholesalers to explore the utilization of blockchain technology within an interoperable digital network for securing the transfer of digital traceability data among authorized trading partners.
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Gaurav Kumar. "Securing pharmaceutical supply chain using digital drug serialization." World Journal of Advanced Engineering Technology and Sciences 10, no. 1 (2023): 015–20. http://dx.doi.org/10.30574/wjaets.2023.10.1.0244.
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The supply chain process is a very critical process in the pharmaceutical industry, and through digital drug serialization, we can mitigate the risk of counterfeit drug supply and counter the risk of consumers consuming fake drugs. To deliver medicines free of counterfeiting, the pharmaceutical supply chain's integrity must be preserved. In this article, we have focused on how we may employ digital drug serialization in the pharmaceutical supply chain without harming the public's health. Even though pharmaceutical corporations are working hard to combat medication fraud, it is still a persistent and complicated problem in the drug supply chain that costs the pharmaceutical business money and negatively affects patient health. To solve this issue, pharmaceutical companies are implementing a significant digital transformation in the pharmaceutical supply chain by integrating digital traceability and track-and-trace technologies from the initial raw material supplier to the patient.
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Maeka, Lita, Osly Usman, and Anandha Budiantoro. "THE INFLUENCE OF TECHNOLOGICAL, ORGANIZATIONAL, AND ENVIRONMENTAL FACTORS ON COMPANY PERFORMANCE IN SERIALIZATION SYSTEM IMPLEMENTATION IN PT BIO FARMA (PERSERO)." Journal of Management and Leadership 7, no. 1 (2024): 1–16. http://dx.doi.org/10.47970/jml.v7i1.458.
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A serialization system is a technological solution that enables product tracking and traceability by providing a unique identity for each product unit. This system can prevent the circulation of counterfeit products in the supply chain of pharmaceutical products. Companies must deploy this serialization system technology to comply with applicable requirements and maintain competitiveness. This study aims to determine the effect of TOE framework on the implementation of the serialization system on company performance using a survey/questionnaire method at PT Bio Farma (Persero). Statistical testing uses Structured Equation Modeling (SEM) to measure the relationship between variables. The test result identified that technological, organizational, and environmental contexts have a positive and significant impact on the serialization system's implementation at Bio Farma. The results also revealed that the implementation of the serialization system has had a positive and significant impact on company performance. This research can have good implications for companies and top management in providing appropriate and compatible technology support so that the adoption of implementation serialization technology can improve company performance.
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Madalsa Kumar. "Global drug serialization in pharma sector: Complete review." World Journal of Advanced Research and Reviews 20, no. 1 (2023): 1022–27. http://dx.doi.org/10.30574/wjarr.2023.20.1.2206.
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The primary aim of this paper is to acquire an understanding of drug serialization within the pharmaceutical sector and explore its various dimensions. Presently, pharmaceutical counterfeiting poses a significant challenge in the industry. Various countries have established regulatory measures to combat counterfeit drugs, with drug serialization being one such regulatory compliance mechanism to address this issue. Over an extended period, counterfeit drugs have severely impacted the healthcare industry. Regulatory bodies across different nations are actively deliberating ways to alleviate the problem of counterfeit drugs and their adverse effects on consumers who unknowingly ingest fraudulent medications. Research indicates that in underdeveloped countries, as many as 4 out of 10 drugs are fake or have been adulterated through illicit means, contributing to a substantial problem. This situation has dire consequences for the healthcare industry, resulting in substantial financial losses due to the infiltration of counterfeit drugs into the supply chain. Additionally, consumers are put at risk when they unwittingly consume fake medicines, instead of the life-saving drugs they require. Regulatory authorities are responding by enacting new regulations to tackle this issue and prevent counterfeit or adulterated drugs from entering the supply chain. To ensure the safe and genuine delivery of drugs to patients, the pharmaceutical industry must implement robust traceability measures and adhere to stringent regulations. The tracking and tracing process of pharmaceutical drug serialization ensures the ability to trace individual drug packaging throughout the entire supply chain, encompassing manufacturers, distributors, wholesalers, pharmacies, and end consumers. Importantly, these serialization measures enhance the security of drugs within the supply chain without compromising drug quality, effectively reducing the infiltration of counterfeit drugs into the distribution network.
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Madalsa, Kumar. "Global drug serialization in pharma sector: Complete review." World Journal of Advanced Research and Reviews 20, no. 1 (2023): 1022–27. https://doi.org/10.5281/zenodo.12512514.
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The primary aim of this paper is to acquire an understanding of drug serialization within the pharmaceutical sector and explore its various dimensions. Presently, pharmaceutical counterfeiting poses a significant challenge in the industry. Various countries have established regulatory measures to combat counterfeit drugs, with drug serialization being one such regulatory compliance mechanism to address this issue. Over an extended period, counterfeit drugs have severely impacted the healthcare industry. Regulatory bodies across different nations are actively deliberating ways to alleviate the problem of counterfeit drugs and their adverse effects on consumers who unknowingly ingest fraudulent medications. Research indicates that in underdeveloped countries, as many as 4 out of 10 drugs are fake or have been adulterated through illicit means, contributing to a substantial problem. This situation has dire consequences for the healthcare industry, resulting in substantial financial losses due to the infiltration of counterfeit drugs into the supply chain. Additionally, consumers are put at risk when they unwittingly consume fake medicines, instead of the life-saving drugs they require. Regulatory authorities are responding by enacting new regulations to tackle this issue and prevent counterfeit or adulterated drugs from entering the supply chain. To ensure the safe and genuine delivery of drugs to patients, the pharmaceutical industry must implement robust traceability measures and adhere to stringent regulations. The tracking and tracing process of pharmaceutical drug serialization ensures the ability to trace individual drug packaging throughout the entire supply chain, encompassing manufacturers, distributors, wholesalers, pharmacies, and end consumers. Importantly, these serialization measures enhance the security of drugs within the supply chain without compromising drug quality, effectively reducing the infiltration of counterfeit drugs into the distribution network.
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Hariprasad Mandava. "Improving the Integrity of Pharmaceutical Serialization with Enterprise Technologies." International Journal of Scientific Research in Computer Science, Engineering and Information Technology 10, no. 3 (2024): 514–20. http://dx.doi.org/10.32628/cseit2410338.
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Medical devices and pharmaceutical drugs undergo packaging procedures to ensure their stability and integrity remain intact throughout post-production shipping and storage, prior to their clinical utilization. Throughout delivery and storage, the packaging may interact either directly or indirectly with the drug product or medical device, potentially leading to chemical reactions between the two. The role of packaging is paramount in ensuring success, safeguarding the product, and facilitating its sale. Similar to other items found in supermarkets, prescription pharmaceuticals necessitate packaging that addresses various needs, including security, promptness, safety, product identity, quality assurance, patient well-being, and product excellence. Packaging represents both a scientific and artistic endeavour, involving the consideration of numerous factors, beginning with the fundamental design and technology utilized to package the product securely, while also ensuring its protection, presentation, and compliance with manufacturing standards during transportation, storage, and consumption. To uphold the physiochemical, biological, and chemical stability of drugs, packaging professionals design containers capable of withstanding the pressures encountered during supply and shipping processes. Enhancements in the field of prescription drug development have long emphasized the importance of packaging expertise. This serialization process is crucial for bolstering drug security within the supply chain while maintaining drug quality, thereby minimizing the risk of counterfeit drugs infiltrating the distribution network.
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RAKESH NALAM. "Essentials of pharmaceutical packaging to prevent drug counterfeiting." International Journal of Science and Research Archive 9, no. 2 (2023): 599–605. http://dx.doi.org/10.30574/ijsra.2023.9.2.0610.
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The purpose of this paper is to explain the process for pharmaceutical drug packaging with serialization regulatory requirements. Generally, pharmaceutical packaging deals with the labeling and packing of products including injectables, tablets, pills, and other forms of medication. It is essential to maintain the quality and safety of the product from the manufacturing site to the customer. When it comes to labeling, it provides identification for the product, such as dosage, strength, and name, and in packing, it secures the product from physical damage, contamination, and degradation. During the packing of products, there will be a set of standards to be maintained, such as GxP standards. The FDA has released some guidelines to be followed with the packaging of pharmaceutical products. Serialization is an additional mandatory requirement for the prescribed products to secure drugs from falsification and counterfeiting throughout the supply chain.
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Sarkar, Shambhu. "Serialized Barcode Printing Solution for Drug Traceability: An Architectural Design and Approach." Journal of Applied Life Sciences International 26, no. 5 (2023): 58–65. http://dx.doi.org/10.9734/jalsi/2023/v26i5619.
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Medicine serialization seems to be a key to both counterfeiting and the complex supply chain of the pharmaceutical industry, including recalls and returns. Though there are countries that use serialization as a legal necessity, it is still a developing topic within the industry. Serialization is not just for anti-counterfeit technology but also to use supply chain and stock management more proficiently. The design of the Barcode is a fundamental requirement as per Healthcare Distribution Alliance (HDA) guidelines for serialized products. Encoding Barcodes on pharmaceutical drugs with critical product attributes is necessary for tracking and validating product sources. Since the serialization guidelines are regulated, small-scale pharmaceutical companies are struggling to comply with regulations due to heavy investments. Printing Serialized labels with barcodes required specialized third-party systems and software. The cost of third-party systems that integrate with ERP and Serialized systems for exchanging data is very expensive. On the other hand, the operational and sustainability costs of these systems will be an additional year-to-year cost for the company.
 Aim: This Study investigated the feasibility of designing a barcode printing solution for drug traceability.
 Material and Method: A case study has been carried out at a USA-based generic pharmaceutical company to print serialized labels using their enterprise Resource planning (ERP) integrated with the packaging line.
 Result: This dynamic solution for serialized label printing saves the company a significant number of resources and money, as they do not need to buy any specialized third-party system to print the label or send back the product to the packaging line.
 Conclusion: In this paper, we implement and validate a dynamic solution to print 2D data matrix and 1D Linear barcodes successfully within an ERP system by eliminating the need for a specialized third-party printing system.
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Goldhammer, Alan, and Scott M. Lassman. "Pharmaceutical Supply Chain Security: A View From the Pharmaceutical Research and Manufacturers of America." Journal of Pharmacy Practice 19, no. 4 (2006): 239–43. http://dx.doi.org/10.1177/0897190006293514.
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The introduction of counterfeit drugs into the supply chain poses risks to patients. Supply chain security is of paramount concern to the pharmaceutical industry, and companies employ a variety of technologies that can be used to authenticate packaged pharmaceuticals. Serialization of individual package units coupled with the use of machine-readable codes should permit the electronic tracking and tracing of these units throughout the supply chain. Progress on establishing identification and information technology standards is moving forward, but many complexities must be resolved, such that full implementation is still some years away. Several states are implementing pedigree requirements. To prevent the proliferation of differing state requirements, the Food and Drug Administration should take a leadership role in establishing clear federal guidelines and implement the pedigree requirements under the Prescription Drug Marketing Act.
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Madalsa Kumar. "Pharmaceutical serialization dynamics to restrain illicit trade and counterfeiting of drugs." World Journal of Advanced Research and Reviews 22, no. 2 (2024): 913–18. http://dx.doi.org/10.30574/wjarr.2024.22.2.1461.
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Every individual has a fundamental entitlement to healthcare access. It falls upon governments to guarantee the delivery of high-quality healthcare services and infrastructure to their populace.. Over the past few decades, both governments and healthcare industries have been grappling with the challenge of minimizing the adverse effects on public health caused by counterfeit medicines. The World Health Organization has estimated that 40 % medicines in developing and impoverished countries are either counterfeit or potentially adulterated. The global economy suffers billions of dollars in losses due to counterfeit drugs, which also divert funds away from research and development (R&D) initiatives. In the United States, the Food and Drug Administration (FDA) has devised a 10-year roadmap to implement drug traceability measures. The Healthcare Distribution Alliance (HDA) has been tasked with mandating the printing of multiple barcodes and human-readable data on product packaging. Additionally, the FDA is actively involved in pilot projects with leading pharmaceutical manufacturers and wholesalers to leverage blockchain technology within interoperable digital networks for secure data transfer and traceability among authorized trading partners. Preventing counterfeit medicines from infiltrating the supply chain remains a significant challenge for governments and regulatory authorities. Consequently, there is a growing emphasis on implementing stringent guidelines to deter criminals and counterfeiters from distributing fake medicines in the market. The healthcare industry requires robust regulations and secure technologies to ensure the delivery of safe and authentic drugs to patients.
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Dhoke, Shrikant. "Innovations and Challenges in Pharmaceutical Supply Chain, Serialization and Regulatory Landscape." Universal Journal of Pharmacy and Pharmacology 4, no. 1 (2025): 7–12. https://doi.org/10.31586/ujpp.2025.6002.
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Madalsa, Kumar. "Pharmaceutical serialization dynamics to restrain illicit trade and counterfeiting of drugs." World Journal of Advanced Research and Reviews 22, no. 2 (2024): 913–18. https://doi.org/10.5281/zenodo.14607377.
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Every individual has a fundamental entitlement to healthcare access. It falls upon governments to guarantee the delivery of high-quality healthcare services and infrastructure to their populace.. Over the past few decades, both governments and healthcare industries have been grappling with the challenge of minimizing the adverse effects on public health caused by counterfeit medicines. The World Health Organization has estimated that 40 % medicines in developing and impoverished countries are either counterfeit or potentially adulterated. The global economy suffers billions of dollars in losses due to counterfeit drugs, which also divert funds away from research and development (R&D) initiatives. In the United States, the Food and Drug Administration (FDA) has devised a 10-year roadmap to implement drug traceability measures. The Healthcare Distribution Alliance (HDA) has been tasked with mandating the printing of multiple barcodes and human-readable data on product packaging. Additionally, the FDA is actively involved in pilot projects with leading pharmaceutical manufacturers and wholesalers to leverage blockchain technology within interoperable digital networks for secure data transfer and traceability among authorized trading partners. Preventing counterfeit medicines from infiltrating the supply chain remains a significant challenge for governments and regulatory authorities. Consequently, there is a growing emphasis on implementing stringent guidelines to deter criminals and counterfeiters from distributing fake medicines in the market. The healthcare industry requires robust regulations and secure technologies to ensure the delivery of safe and authentic drugs to patients.
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Chiacchio, Ferdinando, Diego D’Urso, Ludovica Maria Oliveri, Alessia Spitaleri, Concetto Spampinato, and Daniela Giordano. "A Non-Fungible Token Solution for the Track and Trace of Pharmaceutical Supply Chain." Applied Sciences 12, no. 8 (2022): 4019. http://dx.doi.org/10.3390/app12084019.
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Industry 4.0 is leading society into a new era characterized by smart communications between consumers and enterprises. While entertainment and fashion brands aim to consolidate their identities, increasing consumers’ participation in new, engaging, and immersive experiences, other industry sectors such as food and drugs are called to adhere to stricter regulations to increase the quality assurance of their processes. The pharmaceutical industry is inherently one of the most regulated sectors because the safety, integrity, and conservation along the distribution network are the main pillars for guaranteeing the efficacy of drugs for the general public. Favoured by Industry 4.0 incentives, pharmaceutical serialization has become a must in the last few years and is now in place worldwide. In this paper, a decentralized solution based on non-fungible tokens (NFTs), which can improve the track and trace capability of the standard serialization process, is presented. Non-fungible tokens are minted in the blockchain and inherit all the advantages provided by this technology. As blockchain technology is becoming more and more popular, adoption of track and trace will increase tremendously. Focusing on the pharmaceutical industry’s use of track and trace, this paper presents the concepts and architectural elements necessary to support the non-fungible token solution, culminating in the presentation of a use case with a prototypical application.
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Komissarov, A. V., O. A. Lobovikova, I. V. Shul'gina, et al. "Labeling of Immunobiological Drugs, Produced by the Russian Research An-ti-Plague Institution "Microbe" of the Rospotrebnadzor (Review)." Drug development & registration 10, no. 3 (2021): 115–30. http://dx.doi.org/10.33380/2305-2066-2021-10-3-115-130.
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Introduction. This publication describes the design and implementation sequence of technological procedures for labeling immunobiological medicinal products produced by the FGHI RusRAPI "Microbe" of the Rospotrebnadzor. In light of meeting the requirements of the Federal Act "On the Circulation of Pharmaceutical Products", the materials of this study are undoubtedly relevant.Text. The paper presents a step-by-step sequence of introducing technological procedures for labeling and interaction with the system for monitoring the movement of pharmaceutical products (MMPP) into the production process of medicines. At the preparatory stage, the following main issues were addressed: verification of the identity of information about medicinal products in the State Register of Medicines and in the automatic identification system "UNISCAN/GS1 RUS"; determination of the method and possibility of applying the identification means onto the secondary packaging; amendments to the pharma-copoeial monographs of the enterprise for each type of drug. Stage 2 [development of requirements for the system of labeling, serialization, verification and aggregation (LSVAS)] included the following activities: development of a functional model of the labeling process in the FGHI RusRAPI "Microbe" and determination of the responsible for the implementation of this scheme units; determination of the method of secondary packaging (manual or automatic), as well as the required degree of aggregation and the required automation of the process, based on the analysis of the functional model and the technological process of labeling; analysis of the experience of introducing drug labeling systems; analysis of the existing IT-structure of the FGHI RusRAPI "Microbe"; monitoring of the market of hardware and software manufacturers; development of technical requirements for the created system of marking, serialization, verification and aggregation. Stage 3 (implementation of the labeling, serialization, verification and aggregation system at the production sites) included the following activities: equipment supply and commissioning; equipment qualification (IQ/OQ); training of the personnel; amendments to regulatory documents. In the materials devoted to the implementation of the final stage, the issues of validation of technological procedures for drug labeling and interaction with the system of labeling, serialization, verification and aggregation are considered.Conclusion. The works performed made it possible to produce medicines in accordance with the requirements of the Federal Act "On the Circulation of Pharmaceutical Products" and the Decree of the Government of the Russian Federation dated December 14, 2018 № 1556 "On Approval of the Regulation on the System for Monitoring the Movement of Drugs for Medical Use". The material presented may be of interest to manufacturers who produce medicines in small amounts.
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Patel, Dhavalkumar, Dev Kumar Singh, Birajuben Patel, and Chetan Borkhataria. "Impact and overview of track and trace system and serialization in pharmaceutical industry." Indian Journal of Pharmacy and Pharmacology 8, no. 1 (2021): 47–51. http://dx.doi.org/10.18231/j.ijpp.2021.008.
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Nishi, Patel* Hitesh Dani Dr. Maitreyi Zaveri Zuki Patel. "Advancing Pharmaceutical Supply Chain: Rules & Regulations, Strategies for Overcoming Challenges." International Journal of Pharmaceutical Sciences 3, no. 3 (2025): 01–25. https://doi.org/10.5281/zenodo.15117523.
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The pharmaceutical supply chain plays a critical role in ensuring the safe and efficient distribution of medications. However, challenges such as demand variability, logistical complexities, regulatory compliance, and counterfeit drugs threaten its stability. This study explores regulatory frameworks, distribution channels, emerging challenges, and the transformative role of technology in enhancing supply chain resilience. Regulations like DSCSA, EU FMD, GDP, and WHO guidelines safeguard product integrity through strict documentation, serialization, and tracking. Despite these measures, disruptions from supply shortages, pandemics, geopolitical tensions, and cold chain vulnerabilities persist. To address these issues, pharmaceutical firms adopt multisourcing strategies, flexible logistics, and digital monitoring. Distribution networks range from direct manufacturer-to-pharmacy models to complex multi-tier systems, including e-commerce and direct-to-patient delivery, which improve access but introduce regulatory challenges.
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Sarkar, Shambhu. "Why Pharmaceutical Drug Traceability in the US Needs a Centralized Cloud-Based Platform." Current Journal of Applied Science and Technology 42, no. 21 (2023): 1–11. http://dx.doi.org/10.9734/cjast/2023/v42i214153.
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Pharmaceutical serialization is a regulatory compliance that assures a unique identifier assigned to every unit of prescribed medicine. This unique identifier is used for product tracking and authentication in the supply chain. Initially, in 2018, the Drug Supply Chain Security Act (DSCSA) implemented pharmaceutical drug serialization regulations to mitigate the risk of counterfeit medicine entering the US market. Under this regulation, the pharmaceutical drug manufacturer is required to print a 2D data matrix barcode encoded with unique identification on each drug unit. Basically, printing a unique identification code on each prescribed drug for authenticity and traceability is not sufficient to eliminate the risk of drug counterfeiting. Subsequently, criminals and drug counterfeiters can still supply illicit or stolen drugs into the supply chain through an illegal source or online trade by imitating the same information in multiple units. After this regulation's enforcement, we observed that the US market lacks a mechanism to authenticate individual drug units with a centralized, secure repository before dispensing them to patients. Since the COVID-19 pandemic, drug counterfeiters and criminals have produced large quantities of contaminated drugs, which they then distribute through their illicit networks and underground social media platforms. Furthermore, COVID-19 supply chain disruptions, non-business resilience, and the fear of ransomware have all contributed to a rise in the mass fabrication of counterfeit medications. Ultimately, the United States needs a centralized cloud-based database hub where all authorized trading partners should be connected for medicine authentication. In this process, the manufacturer must update the product's unique identifier in the centrally connected hub database before supplying drugs to the market. Further, the dispenser, pharmacy, or hospital should authenticate the unique identifier of the product using the same database before dispensing it to patients. Finally, this process will ensure that patients are getting authenticated medicine and will mitigate the risk of dispensing counterfeit or illegal drugs.
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Muskan, Kumari Yogesh Tamang Khushi Sahu Parshant Pokhriyal*. "From Blood Sugar to Body Weight: The Expanding Therapeutic Potential of GLP-1 Agonists." International Journal of Pharmaceutical Sciences 3, no. 4 (2025): 141–51. https://doi.org/10.5281/zenodo.15120025.
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The pharmaceutical supply chain plays a critical role in ensuring the safe and efficient distribution of medications. However, challenges such as demand variability, logistical complexities, regulatory compliance, and counterfeit drugs threaten its stability. This study explores regulatory frameworks, distribution channels, emerging challenges, and the transformative role of technology in enhancing supply chain resilience. Regulations like DSCSA, EU FMD, GDP, and WHO guidelines safeguard product integrity through strict documentation, serialization, and tracking. Despite these measures, disruptions from supply shortages, pandemics, geopolitical tensions, and cold chain vulnerabilities persist. To address these issues, pharmaceutical firms adopt multisourcing strategies, flexible logistics, and digital monitoring. Distribution networks range from direct manufacturer-to-pharmacy models to complex multi-tier systems, including e-commerce and direct-to-patient delivery, which improve access but introduce regulatory challenges.
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Ogbuagu, Oluchukwu Obinna, Akachukwu Obianuju Mbata, Obe Destiny Balogun, Olajumoke Oladapo, Opeyemi Olaoluawa Ojo, and Muridzo Muonde. "Quality assurance in pharmaceutical manufacturing: bridging the gap between regulations, supply chain, and innovations." International Journal of Multidisciplinary Research and Growth Evaluation 4, no. 1 (2023): 823–31. https://doi.org/10.54660/.ijmrge.2023.4.1-823-831.
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Quality assurance (QA) in pharmaceutical manufacturing is essential for ensuring drug safety, efficacy, and consistency. As global pharmaceutical markets expand and regulations become increasingly complex, there is a pressing need for a holistic approach to integrate regulations, supply chain resilience, and technological innovations to maintain high-quality standards. This paper explores the critical role of regulatory frameworks, such as the FDA, EMA, and GMP guidelines, in ensuring compliance across diverse markets, while addressing the challenges associated with evolving laws and documentation requirements. It delves into the vulnerabilities within the pharmaceutical supply chain, including risks related to raw material sourcing, counterfeit drugs, and cold chain logistics, and highlights strategies such as traceability, serialization, and real-time monitoring to mitigate these risks. The paper also examines how AI, automation, blockchain, and continuous manufacturing revolutionize the quality assurance landscape by improving process control, transparency, and predictive capabilities. Ultimately, this paper recommends harmonizing regulatory frameworks with emerging technologies, ensuring compliance through AI-driven systems, and fostering the next generation of automation in pharmaceutical manufacturing to ensure product integrity and safety in a rapidly evolving global market.
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Adeyeye, Mojisola, John Kayode, Adekunle Adeniran, Folashade Osho, and Walter Udokwelu. "Enabling Pharmaceutical Traceability in The Nigerian Supply Chain using GS1 Global Standards: Lean Traceability Including In-Country Serialization of COVID-19 Vaccines." Journal of Regulatory Science 11, no. 1 (2023): 1–14. http://dx.doi.org/10.21423/jrs.regsci.111252.
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Traceability of the pharmaceutical products across a supply chain creates an environment that provides visibility of the product status from plant to patient. The supply chain is the trade journey products make to consumers or retail stores (e.g. pharmacy store, patented drug store, medical store etc.,) via a network of producers, manufacturers, distributors, transporters and vendors taking that product from creation to delivery. Some of the key benefits of introducing traceability in the Nigerian pharmaceutical sector besides securing the supply chain includes an increment in the quality of data to support pharmacovigilance, decrease in the presence of substandard and falsified (SF) medications and ultimately ensuring patient safety. The drug distribution system in Nigeria is largely undefined and there have been in-country efforts to sanitize it. One such effort has produced a national policy document referred to as the Nigeria Pharmaceutical Traceability Strategy which stipulates the plan to achieve supply chain visibility, prevent infiltration of the SFs and strengthen existing regulatory and legal frameworks in Nigeria using GS1 global standards. The National Agency for Food and Drug Administration and Control (NAFDAC) and other drug regulatory agencies in Africa jointly signed a Call to Action during the 2nd GS1 African Healthcare Conference held in Lagos, Nigeria on September 16-20, 2019 to demonstrate commitment to pursue pharmaceutical traceability by adopting global supply chain standards. This article focuses on how NAFDAC in collaboration with GS1 Nigeria, National Primary Health Care Development Agency (NPHCDA) and other partners have implemented traceability as a public sector pilot for the COVID-19 vaccines received in Nigeria from March 2021 to December 2021. This included the serialization of COVID-19 vaccines that were received without serial numbers that uniquely identify the secondary packing of the COVID-19 vaccines. The lessons learned from the pilot would be used to support development and dissemination of tracebility regulation, publish guidelines for traceability implementation, and engage stakeholders meaningfully as Nigeria implements full track and trace of pharmaceutical products.
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Sarkar, Shambhu. "Blockchain for Combating Pharmaceutical Drug Counterfeiting and Cold Chain Distribution." Asian Journal of Research in Computer Science 16, no. 3 (2023): 156–66. http://dx.doi.org/10.9734/ajrcos/2023/v16i3353.
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In recent years, pharmaceutical drug traceability systems have been developed as critical tools for improving the digital supply chain's transparency and visibility. Blockchain-based drug traceability proposes a promising solution to create a distributed shared data platform for an irreversible, trustworthy, reliable, and transparent system. This article provides a thorough analysis and summary of the current state of drug traceability distribution research on the blockchain platform by using Hyperledger febric and Hyperledger Besu methodologies. Blockchain based platform, Hyperledger Fabric and Besu meets essential needs for drug traceability such as privacy, dependability, transparency, security, authorization, authentication, and scalability. The Hyperledger Fabric blockchain platform executes drug transactions proficiently and securely in the supply chains within a distributed network of stakeholders. This fabric-enabled private, permissioned distributed network comprising various pharmaceutical stakeholder groups aids in the efficient and secure execution of medication in supply chain transactions. This study also examines the impact of blockchain technology in the healthcare system while exhibiting how some features of this disruptive technology have the potential to transform existing cold chain and drug traceability processes. Blockchain technology embraces significant benefits in the processes of pharmaceutical drug serialization, protecting IoT devices, and ensuring temper-proof transaction sharing. Blockchain is also a potential solution to make use of IoT-enabled vehicles and warehouses for cold chain transportation by using smart sensors to capture critical temperature data. Blockchain-enabled IoT sensors in the cold chain ensure the secure transportation of drugs to pharmaceutical stakeholders in the supply chain network.
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Sarkar, Shambhu. "Challenges for Implementing Pharmaceuticals Drugs Traceability in Developing Countries." International Journal of Research Publications 103, no. 1 (2022): 760–66. https://doi.org/10.47119/IJRP1001031620223477.
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The purpose of this paper is to focus on the challenges for the implementing digital traceability of pharmaceuticals drugs in developing countries. The digital traceability of pharmaceutical drugs has been proving a very impactful process to minimize the risk of counterfeit and illicit drugs in the market. Developed countries like Unites States of America in 2018, and Europe in 2019, made unique identifier with 2D barcode mandatory in each drugs packet. Unique identifier on each packets provide provision of digital traceability since drug manufacturers encode them and keep the data in their repository Any stakeholders in supply chain can easily verify the authenticity of product by asking manufacturer to compare product values with their database. Implementing digital traceability of pharmaceutical drugs in developing countries will be challenging due lack of technical infrastructure, weak regulations, geopolitical instability, poverty, low literacy, and government willingness. Developing countries are facing economic depression and unable to allocate funds on research and development which can improve overall healthcare system. Recently COVID- 19 also played a major role for collapsing their entire healthcare infrastructure. Developing countries impacted by global supply chain restrictions and unavailability of resources which created inflation and unemployment.
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Girish, Babu Botta. "Pharmaceutical medicine traceability: An overview of global compliance." World Journal of Biology Pharmacy and Health Sciences 15, no. 2 (2023): 245–52. https://doi.org/10.5281/zenodo.10685862.
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Every human being has a fundamental right to access to healthcare. It is the duty of the government to provide its citizens with high-quality infrastructure and healthcare services. Government agencies and the healthcare sector have been working to reduce the negative effects that bogus drugs have on people's health for the past few decades. According to the World Health Organization, 4 out of 10 medicines in emerging and underdeveloped nations are either fraudulent or may be contaminated. The international economy suffers from counterfeit drug costs in the billions of dollars, and organizations are forced to spend less on research and development (R&D). The biggest difficulty facing the government and regulatory agencies is preventing the entry of fake medications into the supply chain. The government and regulatory bodies are currently creating strict regulations to forbid criminals and medicine counterfeiters from selling phony drugs in markets. To offer patients with safe and effective medications, the healthcare business needs strict laws and secure systems. The FDA has released a 10-year implementation roadmap for drug traceability in the US. The Healthcare Distribution Alliance (HDA) has additionally specified that the product packaging hierarchy print multiple barcodes and human readable data. The FDA is taking part in a pilot initiative with major prescription medicine producers and wholesalers to deploy blockchain technology in an open-source, interoperable digital network for ensuring the transfer of digital traceability data between licensed business partners.
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Valcheva, Krasimira. "THE IMPACT OF THE EUROPEAN DIRECTIVE AGAINST FALSIFIED MEDICINES ON THE PHARMACEUTICAL WHOLESALERS IN BULGARIA." Journal of IMAB - Annual Proceeding (Scientific Papers) 27, no. 1 (2021): 3598–603. http://dx.doi.org/10.5272/jimab.2021271.3598.
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In the last few decades, the problem with falsified medicine became a global threat that accounts for millions of human lives and billions of financial loses for the national health authorities and pharmaceutical industry. Different measures were developed to fight their uncontrolled spread but had only limited success. The resolution that united the pharmaceutical supply chain actors worldwide is the introduction of track-and-trace systems, based on product serialization and verification. The European Union also adopted this solution, and its official operation began in 2019. Each Member State has specifics that have to be accounted for in the national transposition process and should influence the system design and functionalities. In Bulgaria, the responsible authorities seriously delayed to adopt an adequate legal and regulatory framework to support its smooth operation. This created many problems for some of the key supply chain participants – the wholesalers. Since the European system is not a full track-and-trace solution, their role in the verification process is limited and left to the national authorities to decide how to regulate it. At present, more than one year after the launch of the system, the national bylaws that should regulate their activities with reference to the European policy are still not enforced. The wholesalers are left to align their operations in a regulatory vacuum that may compromise the effectiveness of the policy and lead to sanctions for noncompliance.
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Perumalsamy, Shanthi, and Venkatesh Kaliyamurthy. "Blockchain Non-Fungible Token for Effective Drug Traceability System with Optimal Deep Learning on Pharmaceutical Supply Chain Management." Engineering, Technology & Applied Science Research 15, no. 1 (2025): 19261–66. https://doi.org/10.48084/etasr.9110.
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In recent times, the number of fake drugs has increased dramatically, which has resulted in millions of victims severely affected by poisoning and treatment failures, resulting in a need for Drug Supply Chain (DSC) traceability. The DSC is generally reluctant to share traceability data and includes several parties having heterogeneous interests. Moreover, existing provenance and traceability systems for DSCs need more trust, data sharing transparency, and separated data storage. By realizing decentralized, trustless systems, a decentralized Blockchain (BC)-based solution is proposed to tackle these constraints. BC is an immutable, decentralized, shared network that allows management directly through a peer-to-peer (P2P) network without the necessity of a central authority to check transactions. This study proposes a new Blockchain Non-Fungible Token-based Drug Traceability with Enhanced Pharmaceutical Supply Chain Management (BNFTDT-EPSCM) model. The proposed BNFTDT-EPSCM model presents transparent and more secure reporting of changes in the operating condition of transported pharmaceutical products to prevent drug recalls. The Ethereum BC enables transactions and computational services using the cryptocurrency Ether (ETH). Simultaneously, an enhanced Byzantine fault-tolerant consensus (RB-BFT) leverages a reputation system to address reliability issues of primary nodes and reduce communication complexity inherent in the Practical Byzantine algorithm (PBFT). The BNFTDT-EPSCM model presents a decentralized solution using Non-Fungible Tokens (NFTs) to improve the traceability and tracking capabilities of the standard serialization process. In addition, the BNFTDT-EPSCM model employs a Deep Belief Network (DBN) approach to perform the inbound logistics task prediction process. Finally, the Tasmanian Devil Optimization (TDO) method is utilized to enhance the hyperparameter tuning of the DBN approach. A detailed set of simulations was executed to examine the effectiveness of the BNFTDT-EPSCM approach, demonstrating a higher throughput at the highest user count of 6000 and achieving 551.22 TPS, significantly outperforming existing models.
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Greenberg, Mary Anne. "Serialization: Benefits Beyond Regulatory Compliance." Therapeutic Innovation & Regulatory Science 48, no. 6 (2014): NP22—NP27. http://dx.doi.org/10.1177/2168479014553034.
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Gaurav Kumar. "The Future of Enterprise resource planning (ERP): Harnessing Artificial Intelligence." International Journal of Scientific Research in Computer Science, Engineering and Information Technology 10, no. 4 (2024): 94–99. http://dx.doi.org/10.32628/cseit24104112.
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A large pharmaceuticals corporation utilizing a complex IT infrastructure such as SAP ERP typically faces a substantial volume GMP and Serialization data annually, numbering in the hundreds of thousands. These inquiries, whether initiated over the phone or online via platforms like integration, seek assistance with various issues. Enterprise resource planning (ERP) software streamlines business processes by integrating technology, services, and human resources across interconnected applications. This research proposes implementing an intelligent system to streamline volume of the data and analyzation for the SAP ERP. This system aims to automate responses to user queries, reducing the time required for issue investigation and resolution, and enhancing user responsiveness. Employing machine learning algorithms, the system efficiently interprets and classifies text across multiple categories, facilitating accurate question comprehension. Additionally, it utilizes a specialized framework to retrieve relevant evidence, ensuring the delivery of optimal responses. Furthermore, its conversational AI capabilities enable the creation of chatbots, fostering collaborative problem-solving among user groups in real-time.
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Sarkar, Shambhu. "Supply Chain Security Act 2023 : Interoperable Data Exchange for Drug Traceability." International Journal of Scientific Research in Computer Science, Engineering and Information Technology 8, no. 3 (2022): 471–77. https://doi.org/10.32628/CSEIT228390.
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The purpose of this paper is to focus on the requirements of the 2023 DSCSA Act. recommended by HDA. Drug Supply Chain Security Act (DSCSA) has outlined the guidelines to develop and enhance drug supply chain security act by 2023. This includes product tracing requirements that went into effect in 2015 for manufacturers, re-packagers, wholesale distributors and dispensers (primarily pharmacies). As we are approaching to 2023, It will be final phase of 10 yearlong implementation of Drug Supply Chain Security Act (DSCSA) since compliance enacted in 2013. Verification router services (Saleable Return) is another compliance which was scheduled to enforce on 2020 but it is now push back to 2023 due to Covid-19 impact. Under 2023 DSCSA Act, manufacturers need to provide product tracing information in secure and interoperable manner electronically to distributors and wholesaler in supply chain. Wholesaler must transfer product tracing information to dispensers and pharmacy and verify saleable returns receive from supply chain stakeholders. Dispenser/Pharmacy should be able to receive Electronic Product Code Information Services (EPCIS) and product tracing information electronically and to be able to reconcile physical product unique identifier with electronic records. Finally, everyone in supply chain must be connected electronically through interoperable network which will allow regulatory bodies to track and trace the information’s. DSCSA 2023 Act is very impactful regulation which also requires supply chain partners to exchange traceability information’s such as Transaction History (TH), Transaction Information (TI), and Transaction Statement (TS) electronically. Electronic product Code Information Services (EPCIS) version 1.2 will have all provisions of TH, TI, TS, and adaptation of EPCIS version 1.2 will fulfill the requirement for all stakeholders in supply chain.
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Researcher. "FROM ORIGIN TO END: BLOCKCHAIN FOR SEAMLESS PRODUCT AUTHENTICATION AND OWNERSHIP VERIFICATION." International Journal of Advanced Research in Engineering and Technology (IJARET) 15, no. 6 (2024): 46–57. https://doi.org/10.5281/zenodo.14323328.
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Counterfeiting poses a significant threat to global supply chains, undermining consumer trust, compromising public safety, and eroding brand value. Traditional methods such as serial number serialization and holograms, while tamper-resistant, require more robust, scalable solutions. This paper presents "Proof Point," a blockchain-based anti-counterfeiting system that leverages the Ethereum blockchain to ensure product authenticity and ownership tracking. By creating a decentralized, tamper-proof ledger, Proof Point enables real-time verification of product authenticity through QR codes linked to unique blockchain records. Smart contracts automate key processes such as product registration and ownership transfers, minimizing manual intervention and reducing fraud risks. To enhance performance, a local database stores metadata for fast and efficient access without dependency on external services. The decentralized architecture ensures secure tracking from manufacturers to end consumers, offering scalable applications across industries such as pharmaceuticals, electronics, and luxury goods. Although high transaction costs remain a challenge on Ethereum, future iterations aim to integrate cost-effective scaling solutions. Proof Point provides a transparent, reliable, and efficient mechanism for mitigating counterfeiting risks, fostering trust in supply chains, and supporting long-term resilience.
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NALAM, RAKESH. "Systematic review of pharmaceutical drugs serialization." International Journal of Research Publications 120, no. 1 (2023). http://dx.doi.org/10.47119/ijrp1001201320234507.
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Shambhu Sarkar. "Pharmaceutical Serialization : A Challenge for Small Manufacturers." International Journal of Scientific Research in Computer Science, Engineering and Information Technology, July 5, 2022, 174–81. http://dx.doi.org/10.32628/cseit228428.
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The purpose of this paper is to focus on the Challenges faced by Small Manufacturers due to the Serialization compliance. Pharmaceutical serialization is the process of assigning unique serial number to each saleable product pack. Each product pack contains information about product source, Global Trade Identification Number (GTIN), Batch number, Expiry date and unique serial number. Pharmaceutical serialization is not new compliance, and it was initially introduced by Turkey in 2010, and other market such as the China and South Korea. Since many years China made compulsory for all supply chain partners to record drug distribution information of individuals drugs units in a traceability system. As we are approaching to 2023, It will be final phase of 10 yearlong implementation of Drug Supply Chain Security Act (DSCSA) since compliance enacted in 2013. Verification router services (Saleable Return) is another compliance which was scheduled to enforce on 2020 but it is now push back to 2023 due to Covid-19 impact. Under 2023 DSCSA Act, manufacturers need to provide product tracing information in secure and interoperable manner electronically to distributors and wholesaler in supply chain. Wholesaler must transfer product tracing information to dispensers and pharmacy and verify saleable returns receive from supply chain stakeholders. Dispenser/Pharmacy should be able to receive Electronic Product Code Information Services (EPCIS) and product tracing information electronically and to be able to reconcile physical product unique identifier with electronic records. Finally, everyone in supply chain must be connected electronically through interoperable network which will allow regulatory bodies to track and trace the information’s. The importance of drug traceability has been increasingly emphasized and mandated by several countries across the world. The Drug Supply Chain Security Act (DSCSA) has been working on a pilot project with big pharmaceutical companies, wholesalers and distributors to design and test interoperable network to trace pharmaceutical prescribed drug electronically at package level. This will help supply chain stakeholders to verify the authenticity of drug in United States.
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Dattatreya Galande, Amol. "Current Status and Challenges of Serialization in Pharma Industry." Open Access Journal of Pharmaceutical Research 5, no. 3 (2021). http://dx.doi.org/10.23880/oajpr-16000247.
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Access to safe and quality medicines to all is long stated goal of healthcare agencies across the globe. Pharmaceutical industry has reached the new milestones with respect to quality of the manufactured medicines due to combined efforts of all - industries, regulators, international agencies etc. However merely manufacturing of quality medicines does not necessarily guarantee its access to those in need. In fact, more organized efforts are required to control the counterfeit medicine trade which is finding easy access to the countries in the world, especially middle or low income countries having weak legal framework of drug regulations. Pharmaceutical serialization is proving to be critical tool to help control the illegal trade across the globe. Though serialization and subsequent aggregation is getting good pace in recent time, the implementation of the system is having some challenges. Adaptation of the serialization, its current status and the difficulties involved for industry is discussed in the current review.
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Chowdhary, Vikram, and Marek Vinš. "STRENGTHENING PHARMACEUTICAL SUPPLY CHAIN SECURITY IN EUROPE: SERIALIZATION AND EMERGING TECHNOLOGIES." Perner's Contacts 18, no. 2 (2023). http://dx.doi.org/10.46585/pc.2023.2.2493.
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The pharmaceutical industry's profitability has attracted attention, but it faces challenges from counterfeiters exploiting vulnerabilities worsened by globalization and complex supply chains. In 2019, European authorities introduced regulation EU 2016/161 to enhance drug supply chain security and traceability. By conducting a systematic literature review, this study assesses the effectiveness of the European Drug Serialization system, examining its implementation and the potential benefits of integrating digital technologies like RFID and Blockchain. The aim is to investigate and identify measures contributing to the strengthening of pharmaceutical supply chains against counterfeiting. The research suggests that while serialization is crucial, it may not provide foolproof security, emphasizing the need for additional digital technology integration.
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"Advances of AI-driven Drug Design and Discovery in Pharmaceuticals - Review." Journal of Angiotherapy 8, no. 1 (2024). http://dx.doi.org/10.25163/angiotherapy.819488.
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The field of drug design and discovery is undergoing a transformative shift, leveraging Artificial Intelligence (AI) and Machine Learning (ML) techniques to expedite and optimize the drug development process. Traditional methods are often costly and time-consuming, involving extensive testing and sequential stages. However, contemporary drug development integrates AI, particularly in drug identification and preclinical studies, resulting in significant resource and time savings. AI is utilized for bioactivity and physicochemical forecasting, de novo molecule design, synthesis prediction, and drug-target profile representation. This review introduces the AI-based Drug Design and Discovery System (AI-D3S), a comprehensive approach utilizing serialization, de-serialization, Particle Swarm Optimization (PSO), and Support Vector Machine (SVM). The system demonstrates superior accuracy, precision, sensitivity, and specificity compared to conventional methods, showcasing an average improvement of 8.7%. Our review study evaluates the system on two chemical databases, MAO and Biodegradation, and illustrates its efficacy in predicting drug-annotation combinations. The potential of AI in pharmaceuticals extends from drug design to personalized therapies, decision-making, and efficient resource allocation in marketing. The research envisions AI as an indispensable tool in the pharmaceutical sector, driving innovation, reducing costs, and ensuring the production of higher-quality products. The AI-D3S model presented in this study sets the stage for future advancements in drug design and discovery, offering a promising avenue for the integration of AI in revolutionizing the pharmaceutical industry.
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Singhal, Rohit. "Serialization And Aggregation Solution Overview to Combat Counterfeit Drugs in The Pharmaceutical Industry." Progress in Medical Sciences, October 31, 2024, 1–5. http://dx.doi.org/10.47363/pms/2024(8)e117.
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Counterfeit medications can be a real threat to patient safety. It is estimated the counterfeit drugs have increased year over year to provide approximately $200 billion in revenue annually to illegal operators and have caused approximately 1,000,000 deaths each year. In one incident, international authorities seized 25,000,000 counterfeit medicines in just one week. Almost every pharmaceutical manufacturer and its associated supply chain partners have been affected by counterfeited and diverted medicines. In response to these global incidents, the government agencies have implemented serialization and track and trace requirements to protect patients.
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Kim, Joshua J., Yuhyun Ji, Denny L. Guo, Young L. Kim, and Jung Woo Leem. "Bioinkjet Printing and Protein Tagging of Camouflaged Biosafe Quick Response Codes for Medicine Authentication." Advanced Materials Technologies, December 15, 2023. http://dx.doi.org/10.1002/admt.202301438.
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AbstractOnline pharmacies and social media platforms are responsible for the growing presence of counterfeit medicines, and the verification and authentication of dosage levels are imperative for protecting individual medicines. However, the existing anticounterfeit methods for medicines and exterior box‐level protection are often limited, and they focus on pharmaceutical supply chains instead of empowering patients. Here, bioprinting and taggant construction of camouflaged biosafe quick response (QR) codes are introduced for on‐dose (or in‐dose) medicine security, integrated with the dosage form. Machine‐readable color QR codes contain concealed invisible patterns with biologically safe near‐infrared absorption properties, which help enhance the security of conventional QR codes. The reported bioinkjet printing and protein taggant construction guarantee printability, imperceptibility, stability, biocompatibility, digestibility, and tamper resistance to be an inherent part of each unit of medicine in solid dosage formats. Camouflaged biosafe QR code taggants can offer various medicine security applications including anticounterfeit measures, authentication features, track‐and‐trace, and serialization at the dosage level. This approach is expected to empower patients to play an active role in fighting illicit medicines and pharmaceutical products.
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Bapatla, Anand Kumar, Saraju P. Mohanty, and Elias Kougianos. "PharmaChain 3.0: Efficient Tracking and Tracing of Drugs in Pharmaceutical Supply Chain Using Blockchain Integrated Product Serialization Mechanism." SN Computer Science 5, no. 1 (2024). http://dx.doi.org/10.1007/s42979-023-02510-9.
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Ashkar, Ghada L., Kalpan s. Patel, Josenor De Jesus, et al. "Evaluation of Decentralized Verifiable Credentials to Authenticate Authorized Trading Partners and Verify Drug Provenance." Blockchain in Healthcare Today, March 11, 2021. http://dx.doi.org/10.30953/bhty.v4.168.
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Summary: In 2013, the Drug Supply Chain Security Act (DSCSA) was signed into law to address the growing threat of counterfeit drugs and to ensure prescription drugs remain safe and effective for patients. As part of this law, US pharmaceutical supply chain stakeholders are required to confirm the authorized status of trading partners for transactions and information disclosures, even when there is no prior business relationship. While larger Authorized Trading Partners (ATPs) have connectivity solutions in place, newer and smaller ATPs have not traditionally participated, including tens of thousands of dispensers. To unlock the full potential of the interoperable system mandated by the DSCSA, the authors tested eXtended ATP (XATP), a blockchain-backed framework for ATP authentication and enhanced verification in a real-world pharmacy with genuine drug packages. The objective of this research study was to prove that electronic authentication and enhanced verification can be achieved between ATPs using a mobile-based solution. Moreover, we tested accurate reading of drug and associated electronic med guides, flagging of expired and recalled drugs, and correct generation of documentation to support saleable returns. Methods: This study involved two dispensers and three participating manufacturers. Dispensers were onboarded to a mobile application and used supporting documentation to authenticate their identities, and then scanned 2D drug barcodes to submit drug verification requests to manufacturers (including 11 additional, randomly selected manufacturers). Genuine and synthetic drug package barcodes were used to test workflows against genuine and synthetic manufacturer serialization data records. Manufacturers authenticated the identity of requesting dispensers with verifiable credentials and responded to verification requests. Results: Enhanced drug verification was achieved, with 100% of requests successfully delivered to participating manufacturers and 88% of requests being delivered to other manufacturers (based on the pharmacist selection of random packages from the pharmacy). Drug verification matching against synthetic serialization data records resulted in 86% accuracy, with the 14% error rate attributed to human factors. All barcodes were successfully scanned and provided package-accurate data, and 97% of randomly selected packages successfully generated drug package inserts. All synthetic recalls and expired drugs were successfully flagged. Four of the manufacturers contacted were among the top 15 pharmaceutical manufacturers globally; all four responded. Conclusions: The XATP framework provides a secure, reliable, and seamless remote method to conduct enhanced verification as required by law. Interoperability between manufacturers and dispensers with no prior business relationship can be achieved on ‘day zero’ using mobile devices that enable digital authentication and rapid barcode scanning. As users retain control of their own private keys, the framework also mitigates the single-point-of-attack risks associated with centrally managed systems.