Articles

Access to healthcare is a fundamental human right, and it is the government’s responsibility to ensure that its citizens receive reliable medical services backed up by a strong healthcare infrastructure. In recent decades, both the government and healthcare sectors have been seeking an effective solution to the rise of counterfeit pharmaceuticals, which pose a major threat to society. According to the World Health Organization's estimates, approximately 40 percent of medicines developed in low-income countries may be adulterated or denatured. Counterfeit drugs lead to economic loss in the billions worldwide, risks to patient safety, and diversion of funds towards pharmaceutical research and innovation. A decade-long strategy has been introduced by the United States Food and Drug Administration as a response to these concerns, the plan aiming to improve drug traceability throughout the supply chain process. The task of mandating the printing of barcodes and human-readable data on packaging has been designated to the Healthcare Distribution Alliance. Moreover, the FDA is also involved in helping wholesalers and pharmaceutical manufacturers to leverage blockchain technology for secure data transfer and traceability within interoperable digital networks. Preventing counterfeit medicines from making their way into the supply chain remains a major obstacle for governments and regulatory authorities. Likewise, there is an increasing emphasis on implementing stricter guidelines to avert counterfeiters and criminals from infiltrating counterfeit medicines into the market. The healthcare sector requires strong regulatory measures and secure technologies to ensure the shipment of safe, authentic drugs to patients.

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 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.