India's CDSCO Forms Expert Panel to Regulate AI in Drug Discovery, DCGI Says
核心洞察
The Central Drugs Standard Control Organisation (搜索) has created an expert committee to advise on how AI in drug discovery should be evaluated, approved and regulated.
DCGI Rajeev Raghuvanshi said the panel includes AI experts, but no timeline or terms of reference have been disclosed.
The move follows a CDSCO guidance document on regulating software-based medical devices, including AI-enabled products, under the Medical Devices Rules, 2017.
The Central Drugs Standard Control Organisation (搜索) (CDSCO) has constituted an expert committee to deliberate on regulatory pathways for reviewing and approving products developed using or enabled by artificial intelligence, Drugs Controller General of India Rajeev Raghuvanshi said at the 8th CII Pharma and Lifesciences Summit in New Delhi.
"Regulation of AI in healthcare is a subject that is being discussed by all agencies globally," Raghuvanshi said. He added that the committee includes AI experts and that its discussions cover how to evaluate, approve and regulate AI in drug discovery. No timeline or terms of reference for the expert committee were disclosed.
A Different Regulatory Problem
Raghuvanshi has repeatedly highlighted a structural challenge in governing AI. Drugs are approved for specific indications and can subsequently be regulated across their lifecycle, whereas AI can learn and evolve continuously, which he said requires a more dynamic regulatory approach. "The kind of transformation AI is driving is mind-boggling and we cannot stay away from this and must be part of this revolution," he said.
The panel's formation comes a month after CDSCO issued a guidance document detailing how software-based medical devices, including AI-enabled products, will be regulated under the Medical Devices Rules (MDR), 2017. That document states that any software, whether alone or in combination, intended by the manufacturer for medical purposes and defined as a medical device under the Drugs and Cosmetics Act, 1940, and MDR, 2017, is regulated as a medical device. CDSCO said the role of software in healthcare is becoming increasingly critical.
Digital Drugs Regulatory System Nears Launch
Raghuvanshi said the apex regulator aims to start the Digital Drugs Regulatory System (DDRS) within a month. The unified, single-window digital platform is intended to overhaul India's pharmaceutical and medical device regulation. Twelve companies bid to develop the system, technical presentations are complete, and financial viability will be checked within the next seven to ten days, he said.
The system is designed to streamline processes from registration and clinical trial approvals to import-export licensing and supply-chain traceability, bringing central and state regulators, laboratories and allied agencies onto a unified, real-time digital architecture. Raghuvanshi said the industry will see substantial AI interventions, simplified processes and data analytics supporting the regulator's internal processes, which he said will increase the ease of doing business.
Advanced Therapies in the Pipeline
Raghuvanshi said CDSCO is looking at approving new-age therapies to increase their availability in India. India's third CAR-T therapy is in the final stages of approval, and an indigenous gene therapy will soon begin Phase 1 trials, he said.
In pharmaceuticals, AI is increasingly deployed to advance research and drive operational efficiencies across functions including manufacturing and distribution. Among the early movers is US-based drug discovery company Insilico Medicine (搜索), which launched a Phase 3 study earlier this year for its AI-generated molecule rentosertib (搜索) in idiopathic pulmonary fibrosis (搜索).
Regulators elsewhere are moving in parallel. In January 2025, the US Food and Drug Administration (搜索) became the first regulatory agency to issue detailed guidance on "Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products."