Pharmaceutical Track-and-Trace Readiness in India: Assessing Digital Infrastructure, Data Governance and Serialization Capability across Supply-Chain Stakeholders

Abstract

Indian pharmaceutical supply chain is plagued with issues like counterfeit drugs, inadequate information systems and technological disparities among stakeholders in the supply chain. The present study measured the readiness of pharmaceutical track and trace system in India by looking into five factors namely; Supply-Chain Transparency, Product Authentication, Regulatory Compliance, Digital Infrastructure Readiness, Data Governance Readiness, and Serialization Capability and Technology Adoption Capability. The design used was quantitative research with primary data collected using a structured questionnaire from 200 stakeholders of the pharmaceutical supply chain. Data were analyzed using Pearson correlation and multiple regression analysis, both in the SPSS software. The correlation results showed that there were significant positive correlation among the variables Supply-Chain Transparency and Product Authentication and Regulatory Compliance. The results of the regression analysis revealed that Digital Infrastructure Readiness and Data Governance Readiness were significant predictors of Track and Trace Readiness, accounting for 51.9% of the variance in Track and Trace Readiness. The second regression model showed that Serialization Capability and Technology Adoption Capability also significantly affected Track-and-Trace Readiness, accounting for 17.8% of the variance. The results underlined the need to improve the technological infrastructure, data governance, and the ability to implement serialization capabilities and technology to enhance pharmaceutical traceability. The study offers viable implications for participating pharmaceutical companies and regulators in India to enhance end-to-end visibility, validation and regulatory adherence.