Copyright (c) 2026 Gangu Kavya, V. Prabhakar Reddy
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Regulatory Challenges in Introducing New Drug Delivery Systems in The Indian Pharmaceutical Market
Corresponding Author(s) : Gangu Kavya
International Journal of Allied Medical Sciences and Clinical Research,
Vol. 14 No. 2 (2026): 2026 Volume -14 - Issue 2
Abstract
The introduction of new drug delivery systems (NDDS)—including nanoparticles, liposomes, transdermal patches, inhalable formulations, and sustained/controlled-release technologies—has revolutionized modern pharmacotherapy by improving drug bioavailability, patient compliance, and therapeutic outcomes. However, in the Indian pharmaceutical market, the regulatory environment governing NDDS remains complex and continuously evolving. Despite India’s growth as a global manufacturing and research hub, the regulatory framework still faces significant challenges in evaluation, standardization, and approval of novel delivery technologies.
The current Indian system, primarily governed by the Drugs and Cosmetics Act, 1940, and Schedule Y, provides limited explicit guidance specific to NDDS products. The Central Drugs Standard Control Organization (CDSCO) evaluates such products on a case-by-case basis, often requiring additional non-clinical, stability, and bioequivalence data. This lack of standardized criteria results in regulatory uncertainty, prolonged review timelines, and duplication of studies, posing hurdles for innovators and generic developers alike. Moreover, limited infrastructure for characterization, inadequate reviewer training, and absence of harmonized guidelines further impede timely product approvals.
Recent initiatives such as the New Drugs and Clinical Trials Rules (NDCTR), 2019, the SUGAM online submission portal, and alignment efforts with International Council for Harmonisation (ICH) standards are positive steps toward regulatory modernization. However, effective implementation requires clearer categorization of NDDS products, standardized evaluation metrics, and strengthened collaboration between academia, industry, and regulatory authorities.
This study highlights the regulatory gaps, procedural bottlenecks, and scientific challenges affecting NDDS approval in India and emphasizes the need for a dedicated regulatory framework for advanced drug delivery technologies. Strengthening this framework will ensure that India not only keeps pace with global innovation but also enhances drug safety, efficacy, and accessibility for its growing patient population.