CLINICAL TRIAL REGULATION IN INDIA: CHALLENGES AND FUTURE PROSPECTS
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Clinical trials are fundamental to the development of safe, effective, and high-quality pharmaceutical products, vaccines, medical devices, and therapeutic interventions. India has emerged as a significant destination for clinical research due to its large patient population, diverse disease burden, skilled healthcare professionals, and cost-effective research infrastructure. However, concerns regarding ethical conduct, participant safety, informed consent, and regulatory oversight have historically challenged the growth of clinical research in the country. Over the past two decades, India has undertaken substantial regulatory reforms aimed at strengthening participant protection, improving transparency, enhancing data quality, and aligning national regulations with international standards.
This review critically examines the evolution of clinical trial regulation in India, with particular emphasis on the New Drugs and Clinical Trials Rules (NDCTR), 2019 and subsequent reforms implemented between 2020 and 2026. The paper discusses the regulatory framework governing clinical trials, the role of Ethics Committees, participant protection mechanisms, clinical trial approval and registration systems, and recent regulatory advancements. Furthermore, major challenges affecting the Indian clinical research ecosystem, including regulatory complexity, infrastructure limitations, workforce shortages, participant recruitment difficulties, and public trust concerns, are analyzed.
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Megha, & Arya, A. (2026). Clinical Trial Regulation in India: Challenges and Future Prospects. International Journal of Science, Strategic Management and Technology, 02(6). https://doi.org/10.55041/ijsmt.v2i6.114
Megha, , and Anisha Arya. "Clinical Trial Regulation in India: Challenges and Future Prospects." International Journal of Science, Strategic Management and Technology, vol. 02, no. 6, 2026, pp. . doi:https://doi.org/10.55041/ijsmt.v2i6.114.
Megha, , and Anisha Arya. "Clinical Trial Regulation in India: Challenges and Future Prospects." International Journal of Science, Strategic Management and Technology 02, no. 6 (2026). https://doi.org/https://doi.org/10.55041/ijsmt.v2i6.114.
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