Articles

Pharmaceutical drug traceability is a regulatory compliance adopted by most nations in the world. A comprehensive analysis was carried out to explain the benefits of adopting enterprise system for pharmaceutical drug traceability. Counterfeit drugs are medicines that are fake and have been produced using incorrect potency, or incorrect ingredients used to manufacture these drugs. Solving the drug counterfeiting problems by identifying the most effective and innovative technologies for protecting people's health is of essence these days for the world. Drug serialization is essential concept for drug traceability in the pharmaceutical supply chain. Blockchain is the latest stringent technology that makes drug distribution more secure in the supply chain. The blockchain-based drug traceability is a distributed shared data platform that shares information that is irreversible, reliable, responsible, and transparent in the PSC. Blockchain uses two powerful module, Hyperledger Fabric and Besu to satisfy important criteria for medication traceability, such as privacy, trust, transparency, security, authorization and authentication, and scalability. Researchers in Health informatics can use blockchain designs as a useful road map to develop and implement end-to-end pharmaceutical drug traceability in the supply chain to prevent drug counterfeiting. Industrial IoT is also a key component for the pharmaceutical industry. IoT systems in pharmaceutical drug traceability can be beneficial as they are based on automation and computational methodologies.

The Blockchain technology uses different type of database that transact data in blocks and then chained each data blocks. When data fills one block, it is chained the same data onto previous block therefore, all the data blocks are stored in chronological order. The blockchain technology can help to ensure that data in supply chain is reliable, accurate and can be shared with all stakeholders without any manipulation. It makes supply chain more transparent and end-to-end digital visibility of data source. Blockchain is stringent technology which fill the gap between stakeholders by providing transparent unmanipulated and truthful data in supply chain. There are many initiatives has been taken by multiple regulatory bodies with partnering with supply chain stakeholders including pharmaceutical manufacturer, distributors and dispensers. In USA, Food and Drug Administration’s regulatory body Drug Supply Chain Security Act (DSCSA) initi-ated pilot program in 2019 with the partnership of leading pharmaceuticals distributors to au-thenticating saleable returns to distributor from supply chain partners. DSCSA used MediLedger blockchain interoperable technology for process evaluation and it robustness for mitigating risk of drug counterfeiting possibilities in supply chain. The DSCSA found that pilot project was suc-cessful and results were astonishing. Later it was declared that blockchain technology can also be used for meeting DSCSA’s 2023 Act for unit level traceability.

The healthcare access is fundamental rights for every human being. It is Governments responsibility to provide good healthcare services and infrastructure to its citizen. Since last few decades, Government and healthcare industries are struggling to minimize the adverse events impacting people health due to fake medicine. The world health organization also predicted that 4 out of 10 medicines in developing and poor countries are either fake or potentially adulterated. Counterfeit drugs cost billions of dollars deficit to world economy and reduce research and development (R&D) funds allocation from organizations. Stopping counterfeit medicine into supply chain is main challenge for Government and regulatory authorities. The Government and regulatory authorities are now making stringent guidelines to prohibit criminals and counterfeiters to supply fake medicine in markets. Healthcare industry need stringent regulations and secure technologies provide sage and authentic drugs to patients. The FDA has published the 10 years roadmap to implement the drug traceability in United States. The Healthcare Distribution Alliance (HDA) has also mandated to print several barcodes and human readable data in product packaging hierarchy. The FDA is participating in pilot project with leading pharmaceutical drug manufacturer and wholesales to use blockchain technology in interoperable digital network for securing digital traceability data transfer between authorized trading partners.