Building End-to-End Pharmaceutical Traceability in India: A Multi-Stakeholder Assessment of Interoperability, Data Quality and Supply-Chain Integration Readiness

Abstract

India's pharmaceutical supply chain relies on an interoperable digital system, but inefficiencies in regulatory pathways, outdated information systems, inconsistent data quality, and inconsistent stakeholder readiness make end-to-end traceability difficult, and allow room for counterfeit and diverted medicines. The objective of this study is to evaluate the pharmaceutical supply-chain readiness for end-to-end traceability based on the organizational characteristics, regulatory compliance, the adoption of digital-standard, integration of traceability, and the readiness of the supply-chain. The survey was of a quantitative, cross sectional design utilizing a questionnaire with 200 pharmaceutical stakeholders, such as manufacturers, distributors, wholesalers, retail pharmacists and regulatory/compliance officials. Data was analyzed by descriptive statistics, Pearson correlation and regression analysis in MS Excel and SPSS 27. The results showed strong positive moderate association between organizational characteristics and integration of traceability systems (r = 0.373, p < 0.001); there was a weak but significant positive association between regulatory compliance and readiness to integrate traceability systems in the supply chain (r = 0.212, p = 0.003). Reducing counterfeit or diversion incidents had a moderate positive relationship with digital standard adoption (R = 0.456, R² = 0.208), which was statistically significant (F = 51.849, p < 0.001), and had a positive coefficient (B = 0.496). The paper concludes that organizational preparedness, regulatory adherence, and the establishment of uniform digital systems and data management, along with multi-stakeholder cooperation, are essential for pharmaceutical traceability.