IndiaAI–CDSCO AI push to speed up MedTech approvals

IndiaAI, the government’s flagship AI initiative under MeitY, is collaborating with the Central Drugs Standard Control Organisation (CDSCO) to deploy artificial intelligence and machine learning tools that streamline India’s regulatory processes for drugs, medical devices, and clinical trials, including MedTech and software as a medical device (SaMD) products. The collaboration is being operationalised through the CDSCO–IndiaAI Health Innovation Acceleration Hackathon, which invites startups, industry, and academia to build AI solutions using real-world regulatory problem statements and CDSCO workflows as reference.

The partnership focuses on automating document-heavy, rules-based tasks within CDSCO’s SUGAM and MD Online systems, such as triage and routing of applications, automated validation against regulatory checklists, and natural language processing-based extraction and summarisation of data from dossiers, trial documents, and supporting studies. Another explicit objective is robust data anonymisation, where AI tools will identify and mask personally identifiable and health information to align with India’s evolving data protection and health data governance frameworks.

For MedTech developers, including SaMD and AI-based devices, the initiative is expected to reduce bottlenecks and improve predictability in approvals by enhancing the speed and consistency of internal regulatory reviews. It also complements CDSCO’s ongoing work on a clearer framework for medical device software and SaMD, which is gradually bringing Indian regulation closer to international, IMDRF-aligned practices. Together, these moves signal a regulatory environment that is more receptive to digital and AI-native medical technologies, provided companies can supply structured, well-documented, and anonymised clinical evidence tailored to the new AI-augmented review processes.
MB Bureau