India forms expert panel to set rules for AI-driven drug discovery

During the CII Pharma and Lifesciences Summit, the Drugs Controller General of India, Rajeev Raghuvanshi, revealed that the CDSCO has assembled an expert committee comprising artificial-intelligence experts to address regulatory questions surrounding AI in drug discovery. The panel’s remit covers the evaluation, approval and oversight of AI-enabled pharmaceutical research, though specific timelines or terms of reference were not disclosed.

This initiative comes a month after the CDSCO released guidance classifying software, including AI products, as medical devices under the Medical Devices Rules, 2017. Raghuvanshi also mentioned the upcoming launch of the Digital Drugs Regulatory System, a single-window platform intended to streamline approvals, licensing and supply-chain tracking. He noted that twelve firms had bid to develop the system, with financial assessments due within the next week. Additionally, the regulator is close to approving India’s third CAR-T therapy and an indigenous gene therapy entering phase-1 trials.