Pharmaceutical quality and cost-effectiveness of branded versus generic medicines across 22 drug types and 8 therapeutic categories: a citizen-funded comparative study from regulated retail outlets in Kerala, India.

BACKGROUND

Despite India's status as a global pharmaceutical hub, skepticism regarding the quality of generic medicines persists among healthcare professionals and the public. This study aimed to comprehensively evaluate the pharmaceutical quality and cost-effectiveness of branded versus generic medicines to address these concerns and inform healthcare policy.

METHODS

In a cross-sectional analytical study, 131 samples of 22 essential medicines across 8 therapeutic categories were procured using convenience sampling from 7 diverse source categories of licensed retail outlets in Kerala, India, including government, private generic, and branded outlets. Samples underwent rigorous testing for description, dosage uniformity, dissolution, impurities, and assay content in an accredited laboratory according to Indian Pharmacopoeia 2022 standards. Cost-effectiveness was analysed using unit pricing and price ratios.

RESULTS

All 131 samples (100%) met all pharmacopeial standards, demonstrating pharmaceutical equivalence across all quality parameters, regardless of whether they were generic, brand, or priced differently. Generic medicines were, on average, 48.6% cheaper than branded equivalents. The study revealed substantial price disparities, with the most expensive branded products costing up to 13.9 times as much as the lowest-priced generics. Government-run Jan Aushadhi outlets consistently offered the most affordable options across 81.8% of medicine categories tested in the study.

CONCLUSION

The data confirm that low-cost government generic programs maintain rigorous quality control comparable to that of expensive private brands, highlighting a significant opportunity for cost savings in chronic disease management. Generic medicines tested in this study are pharmaceutically equivalent to their branded counterparts. Shifting to quality-assured generics, particularly through effective government retail schemes, will substantially reduce out-of-pocket healthcare expenditure and improve treatment adherence without compromising therapeutic quality.