India’s NDCTR 2019: A New Era for Drug Development and Clinical Research

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NDCTR 2019 reformed drug approval processes, enhancing safety and ethical oversight in clinical trials.
Structured timelines and ethical safeguards from NDCTR improved efficiency, notably seen in COVID-19 related drug approvals.
Assessment of NDCTR through real-world success stories illustrates its influence on pharmaceutical R&D and regulatory practices.
While NDCTR has streamlined processes, critiques of its reliance on foreign data and ethics committee variability remain significant.

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Review highlights NDCTR 2019's impact on clinical trials and drug development in India, indicating regulatory advancements.

Bansal et al. (2025) studied this question.

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