Abstract
BACKGROUND: High out-of-pocket expenditure (OOPE) on medicines continues to be a major driver of health-related financial hardship in India. The Jan Aushadhi Scheme (JAS), launched by the Government of India, seeks to improve affordability and access to essential medicines through generic substitution. However, systematic evidence on its pricing dynamics, affordability, and equity implications remains limited. METHODS: We conducted an observational analysis of 696 branded formulations for Eye and Ear, Nose, and Throat (ENT) conditions, comparing their prices with Jan Aushadhi generics listed in the Pharmaceuticals and Medical Devices Bureau of India (PMBI). Data were drawn from the Current Index of Medical Specialties (CIMS, 2021) and PMBI catalogs. Cost ratios and price variation percentages were calculated, alongside affordability assessment using the WHO/HAI one-day wage benchmark. Correlation and regression models assessed the relationship between brand proliferation and price dispersion. Supplementary analyses included chronic disease medicines (diabetes, hypertension, and insulin), distribution trends of Jan Aushadhi Kendras (2018-2022), and global benchmarking using WHO indicators. RESULTS: Branded formulations exhibited wide cost variation, with correlation analysis showing that greater brand numbers were associated with higher-not lower-price dispersion. While most JAS medicines met the WHO affordability threshold, chronic therapies such as glaucoma drugs remained financially burdensome for low-income households. Supplementary analyses demonstrated that dosage form, packaging, and storage requirements contribute to persistent price gaps. Geographic analysis revealed strong growth in Kendras (3,200 in 2018 to 9,000 in 2022), but significant inequities persisted, with large states such as Uttar Pradesh and Bihar showing low per-capita availability. Global benchmarking highlighted India's paradox: despite being a global leader in generic production, domestic uptake of generics remains far below comparator countries. CONCLUSION: The Jan Aushadhi Scheme has made measurable progress in improving medicine affordability, but inequities in access, persistent price variation, and limited uptake constrain its full potential. Strengthening regulatory oversight, improving geographic distribution, and addressing physician and patient perceptions of generics are essential to maximize policy impact. Future research should apply quasi-experimental methods and integrate patient perception data to better capture the affordability-access-adherence pathway.