Technology · India Bureau
India's drug regulator forms panel to govern AI use in pharmaceutical development
The Central Drugs Standards Control Organisation has established an expert committee to create a regulatory framework for artificial intelligence applications in drug discovery. The panel will address evaluation, approval, and oversight standards for AI-assisted pharmaceutical development.
LSN India ·

India's apex drug regulator has constituted a specialised committee to establish guidelines governing the use of artificial intelligence in drug discovery and development. The move aims to create a coherent regulatory framework as pharmaceutical companies increasingly adopt AI technologies in their research pipelines.
Drugs Controller General of India Rajeev Raghuvanshi announced the formation of the expert panel, which comprises AI specialists alongside regulatory professionals. The committee's mandate includes defining how AI-assisted drug discovery processes should be evaluated, the approval mechanisms for such innovations, and the regulatory oversight required throughout the development lifecycle.
The initiative reflects India's recognition of AI's growing role in accelerating pharmaceutical research while maintaining safety and efficacy standards. As global pharmaceutical companies integrate machine learning and computational methods into their discovery workflows, Indian regulators seek to establish clear benchmarks that align with international best practices while addressing domestic requirements.
The committee's framework is expected to facilitate faster approval timelines for AI-enabled drug candidates while ensuring robust quality control measures. The panel will work to balance innovation incentives with stringent regulatory oversight, positioning India competitively in the global pharmaceutical innovation landscape.