Ethical Entities and Regulatory Compliance in Biomedical and Clinical Research in India: Bridging Gaps in Awareness and Practice across Biological Samples

Export BACKGROUND: Biomedical and clinical research in India ranges from human, animal, microbial, and plant studies, as well as cadaveric research and is subject to various regulatory and ethical parameters, which include Indian Council of Medical Research regulations, Committee for Evaluation of Control and Supervision of Experiments on Animals regulations, Department of Biotechnology biosafety regulations, National Biodiversity Authority regulation, and New Drugs and Clinical Trials Rules. Though various regulations exist and are in place, certain loopholes in awareness and application continue to hamper effective ethical regulation, specifically in academic and training institutions. OBJECTIVES: This systematic review was conducted to bring together all evidence that currently exists on the topic of oversight mechanisms for ethics and regulatory compliance in biomedical research and clinical research in the Indian setting, to determine where there may be a knowledge gap. METHODS: A systematic literature review was undertaken following the guidelines of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020. Literature search was conducted using the biomedical and scientific databases of PubMed, Scopus, and Web of Science for peer-reviewed literature, audits, analyses of policies, and other regulatory literature related to ethical oversight of biomedical research activities conducted or supported by Indians. Screens were applied to eligible literature, and narrative synthesis was undertaken. RESULTS: Recurring deficiencies were identified in the functioning of Institutional Ethics Committees, Institutional Animal Ethics Committees, and Institutional Biosafety Committees, particularly in smaller institutions. Key challenges included inadequate ethics training, fragmented oversight, overlapping regulatory jurisdictions, inconsistent monitoring, and limited digital traceability. Recent regulatory reforms (2023–2025) and emerging digital governance initiatives show promise in improving transparency and accountability, though implementation remains uneven. CONCLUSIONS: While India possesses a robust ethical and regulatory framework, strengthening institutional implementation is essential. Integrating structured ethics education, capacity building, harmonized regulatory pathways, and interoperable digital governance systems is critical to enhancing research integrity and ensuring ethically robust, globally credible biomedical research.