When Regulatory Framework Ensures Sameness between Branded Generics and Generics: A Review of Evidence and Policy Implications

Dr. Shilpa B. Mendon

Abstract: The distinction between branded generics and plain generics has long been debated in pharmaceutical markets, particularly in India. Globally, generics are marketed under International Non-proprietary Names (INN), but India sustains a dual system: branded generics marketed under trade names, and plain generics marketed under INN. Despite this commercial differentiation, both categories are subject to identical regulatory requirements under DCGI and the Indian Pharmacopoeia (IP). This review provides a descriptive analysis of the scientific and regulatory framework that ensures therapeutic equivalence, including bioequivalence studies, dissolution testing, impurity profiling, stability evaluation, and pharmacovigilance. It also explores biowaivers, excipient considerations, and empirical evidence from India. By contextualizing industry narratives and policy responses, the article highlights how regulatory science dismantles misconceptions about branded superiority. Findings confirm no significant difference in quality between branded and plain generics, reinforcing that the distinction is commercial rather than scientific. Policy implications emphasize recognizing regulatory equivalence to promote rational prescribing, patient confidence, and access to affordable medicines.

Keywords: generic medicines, bioequivalence testing, drug quality standards, regulatory compliance India, affordable healthcare

How to Cite?: Dr. Shilpa B. Mendon, "When Regulatory Framework Ensures Sameness between Branded Generics and Generics: A Review of Evidence and Policy Implications", Volume 15 Issue 4, April 2026, International Journal of Science and Research (IJSR), Pages: 1941-1943, https://www.ijsr.net/getabstract.php?paperid=SR26430101923, DOI: https://dx.dx.doi.org/10.21275/SR26430101923

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