ABSTRACT

The CDSCO, under the aegis of the DCGI, is responsible for formulating and implementing regulatory guidelines that govern clinical trial administration and the marketing authorization of new medications, medical devices, and biologics. These regulations are designed to safeguard the Trial participants' rights and well-being participants, ensure the trial validity results, and maintain public trust in the research process. Compliance with CDSCO and DCGI regulations is essential for sponsors, investigators, ethics committees, and all stakeholders involved in clinical research. This review article aims to provide a comprehensive overview of the protocol compliance requirements outlined by CDSCO and DCGI for conducting India clinical trials and information about Report any severe adverse events that occur during the clinical trial, formulae for determining the amount of compensation in the event of clinical trial injury, Regulatory pathway for product registration and SEC review process. By delving into the key regulatory aspects, procedural guidelines, and recent updates, this review intends to serve as a valuable resource for researchers, sponsors, regulatory authorities, and other professionals engaged in clinical research activities. Keywords: - Clinical Trial, CDSCO and DCGI, Safety, Efficacy and Wellbeing of subject, SEC Review process, ADR, Product registration pathway
Publication date: 01/04/2025

https://ijbpas.com/pdf/2025/April/MS_IJBPAS_2025_8959.pdf

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https://doi.org/10.31032/IJBPAS/2025/14.4.8959