Economic and Health Consequences of Unregulated Pharmaceutical Distribution in Assam: Examining Religious Patterns and the Path to Regulatory Reform

Abstract

Background: Unregulated over-the-counter (OTC) medication sales, particularly antibiotics and non-steroidal anti-inflammatory drugs (NSAIDs), represent a significant public health challenge in Assam, India. This study examines the relationship between unregulated pharmaceutical distribution, development of chronic diseases, associated financial burdens, demographic patterns in distribution networks, and pathways to regulatory reform. Methods: We employed a multi-phase mixed-methods approach across 7 districts in Assam (January 2023-March 2024). Our innovative methodology integrated market surveillance (n=94), pharmaceutical tracing investigations (n=127), healthcare provider surveys (n=312), patient interviews (n=543), and in-depth case studies of 18 distribution networks. We employed social network analysis to map distribution pathways and developed sophisticated economic models to estimate financial impacts at household, healthcare system, and macroeconomic levels. This novel integration of pharmaceutical tracing, patient outcomes, and religious demographic analysis provides unprecedented insights into the organized nature of unregulated distribution networks. Results: Unregulated medication sales demonstrated significant correlation with chronic disease prevalence (r=0.74, p<0.001) and catastrophic health expenditure incidence (OR 3.8, 95% CI: 2.9-4.7). Laboratory analysis of unregulated pharmaceuticals revealed 41.7% failed quality standards, with significant variation across medication categories (antibiotics: 53.2%, NSAIDs: 39.4%, corticosteroids: 68.7%). Distribution network analysis identified organized supply chains with 72.3% linked to specific religious affiliations. These operations resulted in estimated annual healthcare system costs of ₹1,297 crores (US$171 million)—equivalent to 11.3% of Assam\u27s total health budget—and pushed 11.4% of affected households below the poverty line. Conclusions: Our findings document systematic circumvention of pharmaceutical regulations with specific religious demographic patterns, resulting in significant public health and economic consequences. We propose a three-phase implementation strategy beginning with a 6-month stakeholder engagement process, followed by 12-month regulatory infrastructure development, and culminating in coordinated cross-sector enforcement with technology-enabled monitoring. Urgent comprehensive regulatory reform focusing on pharmacovigilance, cross-sector enforcement, and accountability mechanisms is essential to address this "pharmacy terrorism" and protect public health