Global Pharmaceutical Track And Trace Systems: A Comprehensive Analysis Of Regulatory Frameworks, Implementation Challenges, And Technological Solutions

Abstract

Counterfeit drugs have become a major issue for health care systems worldwide. The lives of patients are at stake, and confidence in medical supply chains is being further lost. The World Health Organization maintains a documentation that one out of ten medical products that are sold in the underdeveloped nations do not meet the standards of quality, or they include counterfeit substances. Antimalarial drugs show especially troubling results, with more than half failing quality tests in some areas. Governments have responded by creating track and trace rules that require unique serial numbers on medicine packages. Europe runs a centralized verification system through the European Medicines Verification Organization. America takes a different path with a decentralized model under the Drug Supply Chain Security Act. Underdeveloped nations try to balance health needs against limited budgets and technology gaps. Drug makers face serious hurdles: outdated technology, conflicting rules between countries, broken supply chain communication, and employees resisting change. Centralized management offers some answers by bringing data together and making procedures uniform. New technologies introduce new weapons: blockchain leaves permanent records of transactions, artificial intelligence detects unusual behaviors, spectroscopy devices confirm the presence of the chemical substance, and sensors on the Internet monitor the conditions in the storage facility. It takes various levels of protection, effective computer security, and highly trained personnel to win this fight.