India CDSCO

CDSCO-IndiaAI Health Innovation Acceleration Hackathon

IndiaAI (under MeitY) and CDSCO have launched the Health Innovation Acceleration Hackathon to develop AI and ML solutions for automating regulatory review of drugs, medical devices, and clinical trials. The competition seeks AI tools for data anonymisation (PII/PHI detection), document summarisation, completeness assessment, and comparison/reporting, to be integrated with CDSCO's SUGAM and MD Online portals. Prize pool is ₹85 lakh; application deadline is 30 April 2026.

Draft Guidelines on Similar Biologics - Regulatory Requirements for Marketing Authorization in India, 2025

CDSCO has published draft guidelines for Similar Biologics (biosimilars) regulatory requirements for marketing authorization in India, replacing existing guidelines to align with recent international standards. The document covers quality considerations, manufacturing process, analytical assessment, preclinical and clinical data requirements, pharmacovigilance, and post-market obligations across 15 sections and 5 annexures. Stakeholders have 30 days from publication to submit comments to biological@cdsco.nic.in.