India's Drug Regulator Not Using AI for Approvals, Government States

India's drug regulator, the Central Drugs Standard Control Organisation (CDSCO), is not currently using artificial intelligence (AI) for the approval of medicines. The government informed Parliament that the organization continues to rely on scientific and technical reviews for its regulatory decisions. The Subject Expert Committee (SEC) examines clinical trial approvals, a process the government deems sufficient for ensuring the safety, efficacy, and accountability of medicines.

Concurrently, India is establishing a regulatory framework specifically for AI-enabled medical device software. Recent guidance from CDSCO outlines detailed requirements for developers, including disclosures on AI model functionality, training datasets, and strategies for mitigating risks such as bias, lack of explainability, and model drift.

While the government supports AI research in drug discovery through schemes like PRIP and educational initiatives at NIPERs, the core drug approval process remains human-driven. The new guidance for medical device software, however, introduces specific regulatory obligations for AI-powered products, addressing their unique challenges before and after market entry.