India's drug regulator establishes AI expert committee

India's Central Drugs Standard Control Organisation (CDSCO) has established an expert committee to focus on artificial intelligence (AI) in healthcare regulation. Drugs Controller General of India Rajeev Singh Raghuvanshi confirmed the committee's formation on September 18. However, no official order, member list, terms of reference, or timeline for this committee has been published by the CDSCO.

Raghuvanshi stated at the 8th CII Pharma and Lifesciences Summit in New Delhi that AI regulation in healthcare is a global discussion point. He indicated the committee includes AI experts and will cover the evaluation, approval, and regulation of AI in drug discovery. MediaNama could not independently verify his full remarks due to the lack of a publicly available session recording.

As of September 21, CDSCO's website contained no public notice of the committee. A parliamentary response in August from Union Minister JP Nadda stated that the CDSCO had not adopted AI for regulatory approvals, with decisions still based on established scientific and technical reviews. This response did not mention an AI committee.

The committee is expected to address AI in drug discovery, medical devices, and diagnostics. India's Ministry of Health and Family Welfare has launched a Strategy for Artificial Intelligence in Healthcare (SAHI) and a testing platform (BODH). Industry stakeholders are calling for clear principles on responsible AI and regulatory sandboxes for AI-driven innovations.