CDSCO-IndiaAI Health Innovation Acceleration Hackathon

IndiaAI, under the Ministry of Electronics and IT (MeitY), is collaborating with the Central Drugs Standard Control Organisation (CDSCO) to launch the Health Innovation Acceleration Hackathon. This initiative aims to streamline the regulatory review process for new drugs, medical devices, and clinical trials by leveraging Artificial Intelligence (AI) and Machine Learning (ML).

Challenge Objective

CDSCO currently performs manual, document-intensive process for reviewing an enormous volume of submissions for new drugs, clinical trials and medical devices products. This bottleneck significantly delays the timely introduction of medical innovations. To address these challenges, the IndiaAI-CDSCO Hackathon aims to leverage AI and ML to streamline the regulatory review and Serious Adverse Event (SAE) assessment processes, enabling faster and more consistent approvals. Furthermore, to ensure the responsible use of data, the hackathon focuses on developing an AI-powered anonymisation tool capable of processing both structured and unstructured data.

Problem Statement: AI-Driven Regulatory Workflow Automation and Data Anonymisation

The expected outcome is a comprehensive end-to-end AI solution integrated with the SUGAM and MD Online portals, incorporating the below features:

• Data Anonymisation: Detect and classify PII/PHI in structured and unstructured data using NLP, ensuring compliance with the DPDP Act 2023, NDHM, and ICMR guidelines.
• Document Summarisation: Convert high-volume regulatory documents (like SUGAM portal applications and SAE narratives) into precise, standardised text.
• Completeness Assessment & Classification: Verify forms for missing fields, classify cases by severity (death, disability, etc.), and detect duplicates.
• Comparison & Reporting: Highlight specific changes between document versions and generate formal reports from unstructured inspection observations.

Who Can Apply?

Indian Company: Indian company registered under the Companies Act, 2013. An Indian company must have 51% or more shareholding by Indian citizens or persons of Indian origin.

Start-up: Start-up as defined in the latest notification by the Department for Promotion of Industry and Internal Trade (DPIIT), accessible at Startup India.

Applicants must provide proof of a proprietary solution submitting verifiable documentation (e.g., technical specifications, necessary certifications, IP and patents). Additionally, entities must demonstrate development and deployment experience of relevant solutions with previous engagements in the private and public sector.

Hackathon Stages

• Stage 1 (Virtual): Virtual hackathon where teams develop and submit their solutions.
• Stage 2 (On-Premises): Up to the top 10 teams will be shortlisted for a 5-day on-premises development round at the CDSCO office in New Delhi.