Innovative Drug Serialization and Anti-Counterfeiting Solution for Regulatory Compliance in Pharmaceutical Supply Chain

Abstract

ABSTRACT: Title: Innovative Drug Serialization and Anti-Counterfeiting Solution for Regulatory Compliance in Pharmaceutical Supply Chain The present disclosure proposes a system for drug serialization and anti-counterfeiting. This system enhances traceability, security, and regulatory compliance of pharmaceutical products within the supply chain by assigning unique identifiers to each product unit. The drug serialization system (100) comprises a computing device (102) having a processor (104) and a memory (106) for storing one or more instructions executable by the processor (104). In addition, the processor (104) is configured to execute plurality of modules (108) for performing multiple operations. The plurality of modules (108) comprises an assigning module (110), a storage module (112), and a scanning module (114). The proposed system (100) improves inventory and supply chain management, allowing manufacturers, distributors, and pharmacies to monitor and optimize inventory levels using serialization data, thereby minimizing shortages and preventing overstock.

Specification

Description:DESCRIPTION:
Field of the invention:
[0001] The present disclosure generally relates to the technical field of pharmaceutical supply chain management, specifically, relates to a system for drug serialization and anti-counterfeiting. This system enhances traceability, security, and regulatory compliance of pharmaceutical products within the supply chain by assigning unique identifiers to each product unit.
Background of the invention:
[0002] The pharmaceutical industry is grappling with significant challenges due to the spread of counterfeit drugs, stricter regulations on supply chain transparency, and a rising demand for improved drug safety. Counterfeit drugs are a global health crisis, as they often lack active ingredients or contain harmful substances, which can pose severe health risks. According to the World Health Organization (WHO), an estimated 10% of medicines in low- and middle-income countries are counterfeit or substandard, leading to ineffective treatment and potential harm.

[0003] Given these concerns, global governments and regulatory bodies have instituted guidelines requiring pharmaceutical companies to adopt systems that can verify product authenticity and traceability. The pharmaceutical supply chain is inherently complex, involving multiple stakeholders across various regions. Products pass through numerous stages-from manufacturing to wholesaling, distribution, and finally to pharmacies-before reaching the consumer. Each point of transfer presents an opportunity for counterfeiters to introduce fake products, highlighting the need for a unified system that enables tracking, traceability, and verification across the entire supply chain.

[0004] As pharmaceutical production and distribution networks expand, the call for integrated security measures has become even more crucial. Serialization, which assigns unique identifiers to individual drug units, has emerged as a primary solution to enhance traceability and safeguard product authenticity. Unlike traditional batch-based tracking, serialization allows each drug package to be individually tracked throughout its supply chain journey. This one-to-one tracking system offers granular control and visibility, enabling companies to monitor every step in a product's movement and verify its authenticity in real-time.

[0005] Besides helping to deter counterfeiting, serialization allows for more efficient recalls by targeting specific units, which prevents unnecessary costs associated with broad recalls. To further counter the risks of counterfeit drugs, companies are adopting a variety of anti-counterfeiting methods, such as tamper-evident seals, holographic labels, digital watermarks, and even blockchain-based verification systems. These features make drug packaging more secure and deter replication, helping prevent counterfeit drugs from entering the market.

[0006] Advancements in digital solutions, such as QR codes and NFC tags, have also been introduced, allowing stakeholders and consumers alike to verify the legitimacy of a product quickly and easily. Responding to these safety concerns, regulatory bodies worldwide have implemented stringent compliance requirements. In the United States, for example, the Drug Supply Chain Security Act (DSCSA) mandates unique identification codes on all drug products distributed in the country, requiring serialization and track-and-trace capabilities.

[0007] The European Union's Falsified Medicines Directive (FMD) similarly requires serialization and safety measures for all prescription drugs. These regulations emphasize the need for standardized drug safety protocols, encouraging companies to implement globally compliant systems. Technological advancements are now playing a crucial role in improving the security and traceability of pharmaceutical products. Blockchain technology, artificial intelligence (AI), and the Internet of Things (IoT) offer improved data integration, anomaly detection, and environmental monitoring capabilities for pharmaceuticals. Blockchain, with its decentralized and tamper-resistant structure, ensures that unauthorized changes are easily identifiable.

[0008] Meanwhile, AI-driven data analysis can detect irregularities indicative of counterfeiting, and IoT devices can monitor environmental conditions-such as temperature and humidity-to ensure that drugs remain within safe parameters throughout storage and transport. Despite the benefits, implementing serialization and anti-counterfeiting measures presents challenges, including logistical and financial demands. For example, ensuring that serialization systems are compatible with existing manufacturing and data management processes can be complex, especially for smaller manufacturers.

[0009] Furthermore, these systems require ongoing maintenance, robust data handling, and specialized training for staff. However, the long-term advantages-reduced counterfeit risk, increased consumer confidence, and seamless regulatory compliance-are invaluable for maintaining market trust and public health safety. The need for a comprehensive serialization and anti-counterfeiting solution in the pharmaceutical supply chain is now essential.

[0010] As counterfeit drugs continue to threaten patient safety and regulatory requirements grow stricter, pharmaceutical companies are encouraged to adopt solutions that ensure product authenticity, supply chain security, and regulatory compliance. Through advanced technology and adherence to regulatory standards, such a system can protect consumers and reinforce the integrity of the pharmaceutical supply chain, ultimately supporting safer health outcomes globally.
Objectives of the invention:
[0011] The primary objective of the invention is to provide a system for drug serialization and anti-counterfeiting that enhances traceability, security, and regulatory compliance of pharmaceutical products within the supply chain by assigning unique identifiers to each product unit.

[0012] Another objective of the invention is to provide a system for drug serialization and anti-counterfeiting that assigns a unique identifier to each pharmaceutical product unit, allowing it to be tracked individually throughout the supply chain, from manufacturing to end-user.

[0013] The other objective of the invention is to provide a system for drug serialization and anti-counterfeiting that enables real-time traceability of drugs within the pharmaceutical supply chain.

[0014] The other objective of the invention is to provide a system that supports the integration of IoT devices within the supply chain, ensuring that drug storage conditions such as temperature and humidity are continuously monitored and controlled, thus maintaining product integrity.

[0015] Yet another objective of the invention is to provide a system that facilitates rapid recall processes by allowing precise identification and retrieval of affected products through unique serialization, reducing the scope of recalls and enhancing patient safety.

[0016] Further objective of the invention is to provide a system that improves inventory and supply chain management, allowing manufacturers, distributors, and pharmacies to monitor and optimize inventory levels using serialization data, thereby minimizing shortages and preventing overstock.
Summary of the invention:
[0017] The present disclosure proposes an innovative drug serialization and anti-counterfeiting solution for regulatory compliance in the pharmaceutical supply chain. The following presents a simplified summary in order to provide a basic understanding of some aspects of the claimed subject matter. This summary is not an extensive overview. It is not intended to identify key/critical elements or to delineate the scope of the claimed subject matter. Its sole purpose is to present some concepts in a simplified form as a prelude to the more detailed description that is presented later.

[0018] In order to overcome the above deficiencies of the prior art, the present disclosure is to solve the technical problem to provide a system for drug serialization and anti-counterfeiting. This system enhances traceability, security, and regulatory compliance of pharmaceutical products within the supply chain by assigning unique identifiers to each product unit.

[0019] According to an aspect, the invention provides an innovative drug serialization and anti-counterfeiting solution for regulatory compliance in the pharmaceutical supply chain. In one embodiment herein, the drug serialization system comprises a computing device having a processor and a memory for storing one or more instructions executable by the processor. In addition, the processor is configured to execute multiple modules for performing various operations. These modules include an assigning module, a scanning module, and a storage module.

[0020] In one embodiment herein, the assigning module is configured to assign a unique serialized identifier to each pharmaceutical product. The unique serialized identifier is selected from the group consisting of a serial number, barcode, or QR code. The pharmaceutical product includes one or more security features, selected from the group consisting of holographic labels, tamper-evident seals, invisible watermarks, UV inks, and digital watermarks.

[0021] In one embodiment herein, the storage module is configured to store the serialized data in a centralized database accessible to all supply chain entities, which include manufacturers, distributors, and retailers. In one embodiment herein, the scanning module is configured to scan the product at each stage of the supply chain, ensuring regulatory compliance with serialization and anti-counterfeiting regulations.

[0022] The serialized identifier is scanned using a portable verification device, and the scanned data is compared against data stored in the secure database to verify the authenticity of the pharmaceutical product. The serialized data is recorded on a decentralized, tamper-proof ledger to ensure product traceability throughout the supply chain. The computing device includes a smartphone, a laptop, and a computer, and is in communication with an application server via a network.

[0023] According to another aspect, the invention provides a method for operating the drug serialization system. At one step, the assigning module assigns the unique serialized identifier to each pharmaceutical product. At one step, the storage module stores the serialized data in the centralized database accessible to all supply chain entities. At one step, the scanning module scans the product at each stage of the supply chain, ensuring regulatory compliance with serialization and anti-counterfeiting regulations.

[0024] Further, objects and advantages of the present invention will be apparent from a study of the following portion of the specification, the claims, and the attached drawings.
Detailed description of drawings:
[0025] The accompanying drawings, which are incorporated in and constitute a part of the specification, illustrate an embodiment of the invention, and, together with the description, explain the principles of the invention.

[0026] FIG. 1 illustrates a block diagram of a drug serialization system, in accordance to an exemplary embodiment of the invention.

[0027] FIG. 2 illustrates a flowchart of a drug serialization system, in accordance to an exemplary embodiment of the invention.
Detailed invention disclosure:
[0028] Various embodiments of the present invention will be described in reference to the accompanying drawings. Wherever possible, same or similar reference numerals are used in the drawings and the description to refer to the same or like parts or steps.

[0029] The present disclosure has been made with a view towards solving the problem with the prior art described above, and it is an object of the present invention to provide a system for drug serialization and anti-counterfeiting. This system enhances traceability, security, and regulatory compliance of pharmaceutical products within the supply chain by assigning unique identifiers to each product unit.

[0030] According to an exemplary embodiment of the invention, FIG. 1 refers to a block diagram of a drug serialization system 100. In one embodiment herein, the drug serialization system 100 is designed to enhance pharmaceutical supply chain security by incorporating a computing device 102 that facilitates serialization and anti-counterfeiting mechanisms. The computing device 102 comprises a processor 104 and a memory 106, where the memory stores one or more instructions that are executable by the processor 104 to carry out serialization tasks.

[0031] The processor 104 is configured to operate multiple modules 108, each dedicated to a specific function within the serialization and anti-counterfeiting framework. These modules 108 include an assigning module 110, a storage module 112, and a scanning module 114, all of which interact to ensure product traceability and authenticity throughout the supply chain.

[0032] In one embodiment, the assigning module 110 is configured to assign a unique serialized identifier to each pharmaceutical product. This identifier can be selected from a serial number, barcode, or QR code, ensuring that each product unit has a distinct, traceable code. The pharmaceutical product itself is designed to incorporate one or more security features, such as holographic labels, tamper-evident seals, invisible watermarks, UV inks, and digital watermarks. These features add layers of security, making it challenging for counterfeiters to replicate the product accurately, thereby increasing the product's authenticity verification capability.

[0033] The storage module 112 in one embodiment is configured to securely store the serialized data within a centralized database. This database is accessible to various supply chain entities, such as manufacturers, distributors, and retailers, facilitating collaborative monitoring of the product's journey. By having a centralized database, the system ensures that any changes in the product's status are updated in real time, which aids in quick responses to potential issues, such as recalls or instances of tampering.

[0034] The scanning module 114 is configured to scan the pharmaceutical product at each stage of the supply chain, maintaining compliance with serialization and anti-counterfeiting regulations. At each checkpoint, the unique identifier is scanned using a portable verification device, which captures and sends the data to the central database 124 for comparison. This scanned data is checked against existing records in the database, verifying the product's authenticity and detecting any discrepancies that might indicate counterfeiting.

[0035] To further ensure the integrity of the serialized data, the system records all serialized identifiers on a decentralized, tamper-proof ledger, such as a blockchain. This ledger prevents unauthorized modifications and serves as a permanent record of the product's path through the supply chain. The decentralized nature of the ledger adds resilience against data tampering and ensures that every transaction or update within the system is transparent and immutable.

[0036] The computing device 102 supporting this system can include various devices such as a smartphone, laptop, or desktop computer. The computing device 102 connects to an application server 118 via a network 116, which allows for continuous data synchronization and system updates. This networked setup ensures that each entity within the supply chain has up-to-date access to serialization data, facilitating seamless communication and collaboration among stakeholders while promoting a secure, traceable, and compliant supply chain for pharmaceutical products.

[0037] According to another embodiment of the invention, FIG. 2 refers to a flowchart 200 of a drug serialization system 100. At step 202, the assigning module 110 plays a crucial role in the drug serialization process by assigning a unique serialized identifier to each pharmaceutical product. This identifier is typically a distinctive code, such as a serial number, barcode, or QR code, ensuring that each product can be individually tracked and traced across the entire supply chain.

[0038] The assigning module 110 ensures that every pharmaceutical product is given a unique identifier, which is essential for preventing counterfeit products from entering the market. The assigned identifier is linked to key product data, such as manufacturing details, batch numbers, and expiration dates, to facilitate full traceability. This identifier serves as the foundation for tracking the product's journey through the supply chain, ensuring that each unit of the product is identifiable and verifiable at all stages.

[0039] At step 204, once the unique serialized identifier has been assigned, the storage module 112 comes into play. It is responsible for securely storing the serialized data in a centralized database. This database is accessible to all supply chain entities, including manufacturers, distributors, wholesalers, and retailers. By maintaining a centralized database, the system ensures that all stakeholders in the supply chain have access to real-time information about the product, enabling them to verify its authenticity and ensure it complies with regulatory requirements.

[0040] The storage module 112 stores essential data linked to each serialized identifier, such as transaction history, shipment details, and storage conditions, providing a complete and transparent record of the product's lifecycle. This centralized repository ensures that there is no gap in information access, helping to prevent fraudulent activities and maintain regulatory compliance across the supply chain.

[0041] At step 206, the scanning module 114 is employed to scan the pharmaceutical product at each stage of its journey through the supply chain. This scanning process is integral to ensuring regulatory compliance with serialization and anti-counterfeiting regulations. At each checkpoint-whether at manufacturing facilities, distribution centers, or retail locations-the serialized identifier on the product is scanned using a portable verification device. The scanned data is then cross-referenced with the data stored in the centralized database. This process ensures that the product has not been tampered with, counterfeit, or diverted along the way.

[0042] By verifying the product's serialized identifier at multiple stages, the system provides ongoing validation of its authenticity. This step is critical in mitigating the risks associated with counterfeit drugs, ensuring that only genuine, compliant products reach the end consumer, and providing transparency at every point of the supply chain. The scanning process also facilitates real-time updates to the database, enabling stakeholders to track the product's location and status throughout its journey.

[0043] Numerous advantages of the present disclosure may be apparent from the discussion above. In accordance with the present disclosure, an innovative drug serialization and anti-counterfeiting solution for regulatory compliance in the pharmaceutical supply chain. The proposed system 100 for drug serialization and anti-counterfeiting that enhances traceability, security, and regulatory compliance of pharmaceutical products within the supply chain by assigning unique identifiers to each product unit.

[0044] The proposed system 100 for drug serialization and anti-counterfeiting that assigns a unique identifier to each pharmaceutical product unit, allowing it to be tracked individually throughout the supply chain, from manufacturing to end-user. The proposed system 100 for drug serialization and anti-counterfeiting that enables real-time traceability of drugs within the pharmaceutical supply chain. The proposed system 100 supports the integration of IoT devices within the supply chain, ensuring that drug storage conditions such as temperature and humidity are continuously monitored and controlled, thus maintaining product integrity.

[0045] The proposed system 100 facilitates rapid recall processes by allowing precise identification and retrieval of affected products through unique serialization, reducing the scope of recalls and enhancing patient safety. The proposed system 100 improves inventory and supply chain management, allowing manufacturers, distributors, and pharmacies to monitor and optimize inventory levels using serialization data, thereby minimizing shortages and preventing overstock.

[0046] It will readily be apparent that numerous modifications and alterations can be made to the processes described in the foregoing examples without departing from the principles underlying the invention, and all such modifications and alterations are intended to be embraced by this application.
, Claims:CLAIMS:
I / We Claim:
1. A drug serialization system (100), comprising:
a computing device (102) having a processor (104) and a memory (106) for storing one or more instruction executable by the processor (104), wherein the processor (104) is configured to execute plurality of modules (108) for performing multiple operations, wherein the plurality of modules (108) comprises:
an assigning module (110) configured to assign a unique serialized identifier to each pharmaceutical product;
a storage module (112) configured to store the serialized data in a centralized database accessible to all supply chain entities; and
a scanning module (114) configured to scan the product at each stage of the supply chain, ensuring regulatory compliance with serialization and anti-counterfeiting regulations.
2. The drug serialization system (100) as claimed in claim 1, wherein the unique serialized identifier is selected from the group consisting of a serial number, barcode, or QR code.
3. The drug serialization system (100) as claimed in claim 1, wherein the supply chain entities include manufacturers, distributors, and retailers.
4. The drug serialization system (100) as claimed in claim 1, wherein the pharmaceutical product comprises one or more security features, selected from the group consisting of holographic labels, tamper-evident seals, invisible watermarks, UV inks, and digital watermarks.
5. The drug serialization system (100) as claimed in claim 1, wherein the serialized identifier is scanned using a portable verification device, and the scanned data is compared against data stored in the secure database to verify the authenticity of the pharmaceutical product.
6. The drug serialization system (100) as claimed in claim 1, wherein the serialized data is recorded on a decentralized, tamper-proof ledger to ensure product traceability throughout the supply chain.
7. The drug serialization system (100) as claimed in claim 1, wherein the computing device (102) includes a smartphone, a laptop, and a computer.
8. The drug serialization system (100) as claimed in claim 1, wherein the computing device (102) is in communication with an application server (118) via a network (116).
9. A method for operating a drug serialization system (100), comprising:
assigning, by an assigning module (110), assign a unique serialized identifier to each pharmaceutical product;
storing, by a storage module (112), the serialized data in a centralized database accessible to all supply chain entities; and
scanning, by a scanning module (114), the product at each stage of the supply chain, ensuring regulatory compliance with serialization and anti-counterfeiting regulations.

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