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Vol. 14 No. 2 (2026): 2026 Volume -14 - Issue 2

Copyright (c) 2026 Gangishetti Manasa, G. Chinna Devi

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This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

The Regulatory Framework for Complex Generics in India

https://doi.org/10.61096/ijamscr.v14.iss2.2026.1077-1092
Gangishetti Manasa
Department of Regulatory Affairs, Palamuru University, Mahbubnagar Bandameedipally, Telangana, 509001, India.
G. Chinna Devi
Department of Regulatory Affairs, Palamuru University, Mahbubnagar Bandameedipally, Telangana, 509001, India.

International Journal of Allied Medical Sciences and Clinical Research, Vol. 14 No. 2 (2026): 2026 Volume -14 - Issue 2

Abstract

The study examines the evolving regulatory framework for complex generics in India, emphasizing the role of the Central Drugs Standard Control Organization (CDSCO) in ensuring quality, safety, and efficacy. Complex generics, such as liposomes, inhalation products, and drug-device combinations, present unique challenges in characterization, bioequivalence, and approval pathways. The research highlights gaps in current guidelines, the need for harmonization with international standards (USFDA, EMA), and the importance of scientific review capacity building. Strengthening regulatory clarity, promoting innovation, and expediting approvals are essential to enhance market access and global competitiveness of Indian manufacturers.

Keywords

Complex generics, CDSCO, regulatory framework, bioequivalence, drug-device combination, approval pathway, India.
Author biographies is not available.
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