20/02/2026
The Indian Council of Medical Research organized a highly impactful session titled “Regulatory Pathway for AI-based Medical Devices: Bridging Training, Validation, and Clinical Evaluation.” The session provided a comprehensive platform for deliberations on strengthening regulatory science, ensuring clinical validity, and promoting responsible adoption of artificial intelligence in healthcare.
The speakers included Dr. Rajiv Bahl, Secretary DHR and Director General, ICMR, who outlined India’s vision for fostering innovation while ensuring robust regulatory oversight for AI-based medical devices; Dr. Alka Sharma, Additional Director General (Extramural), ICMR, who emphasized the critical role of evidence generation, validation frameworks, and ethical implementation of AI in healthcare; and Dr. Aparna Mukherjee, Scientist-F, ICMR, who discussed clinical evaluation pathways and the integration of AI technologies into public health systems.
The panel discussion featured Mr A. Basil, Central Drugs Standard Control Organization (CDSCO), who explained regulatory requirements and approval pathways for AI-based medical devices; Mr Rado Andriantsimiavona, Director, HealthAI - The Global Agency for Responsible AI in Health, who shared global perspectives on training datasets, benchmarking, and real-world validation; Dr. K. Rangarajan, AIIMS (All India Institute of Medical Sciences, New Delhi), who highlighted issues related to clinical usability, trust, and patient safety; Sh. S. Agarwal, Remidio, who discussed industry challenges in regulatory compliance and deployment; and Sh. V. Mithal, Cera & A&A, who addressed quality assurance and audit preparedness for AI solutions. The session was effectively moderated by Dr. Taruna Madan Gupta, ICMR, and Dr. Mona Duggal, Director, ICMR-NIRDHDS.
The session witnessed enthusiastic participation and generated meaningful discussions on regulatory pathways, clinical validation, and the safe, ethical, and scalable deployment of AI-based medical devices in India.
