The Central Drugs Standard Control Organisation (CDSCO) has established an expert committee to address the regulation of artificial intelligence in drug discovery, as announced by Drugs Controller General of India (DCGI) Rajeev Raghuvanshi at the 8th CII Pharma and Lifesciences Summit in New Delhi on Friday. According to reports from Business Standard, the committee includes AI experts and will focus on discussions regarding how to evaluate, approve and regulate AI in drug discovery processes. This development comes as CDSCO advocates for responsible development of AI with clear guardrails, emphasizing the need for regulatory frameworks to support emerging technologies.
DCGI Raghuvanshi emphasized that regulation of AI in healthcare is a subject being discussed by all agencies globally, highlighting the international scope of these regulatory considerations. As reported by Business Standard, this expert committee formation represents CDSCO's proactive approach to addressing the growing integration of AI in pharmaceutical research and development processes. The regulatory body is advocating for responsible development of AI with clear guardrails, ensuring that emerging technologies meet safety and pacing standards.
The announcement follows CDSCO's issuance of a guidance document just one month ago detailing how software-based medical devices, including AI-enabled products, will be regulated under the Medical Devices Rules (MDR), 2017. According to Business Standard, the guidance document stated that any software intended for medical purposes and defined as a medical device under the Drugs and Cosmetics Act, 1940, and MDR, 2017, will be regulated as a medical device. This regulatory framework provides the foundation for evaluating and approving AI-based medical technologies.
Bengaluru-based deeptech startup Theranautilus is set to begin human trials of its nanorobot-based dental technology in November-December, starting with about 30 patients in the first phase. The startup won the Top Innovator category at The Economic Times Startup Awards 2026 for this work and will follow the initial trials with a 300-patient multicentric trial as the company moves toward commercialisation. The human trials will commence after the company secures permission from the Central Drugs Standard Control Organisation (CDSCO), with Theranautilus having already conducted trials in mice for its oral-health application. As cofounder and CEO Peddi Shanmukh Srinivas noted, nanorobotics is still an emerging global field, with research groups across countries working to crack the technology.
DCGI Raghuvanshi announced that CDSCO is aiming to start the Digital Drugs Regulatory System (DDRS) within a month, describing it as a unified, single-window digital platform designed to overhaul India's pharmaceutical and medical device regulation. As reported by Business Standard, 12 companies had bid for developing the system, with technical presentations completed and financial viability checks scheduled for the next seven to ten days. The new DDRS system will streamline complex processes including registration, clinical trial approvals, import-export licensing, and supply-chain traceability across central and state regulators.
