AI and Regulatory Transformation in India’s Pharmaceutical Sector

India’s pharmaceutical industry is entering a transformative era, with single-window clearance systems and AI-powered regulatory platforms set to streamline approvals and enhance transparency, says Dr. BR Jagashetty, former Karnataka State Drugs Controller. AI is shifting regulatory compliance from a reactive to a proactive model, enabling faster, data-driven decision-making across safety, efficacy, and market access.

However, the legal framework is fragmented, spanning the Drugs and Cosmetics Act, Patents Act, IT Act, and DPDP Act, 2023. AI adoption faces challenges including algorithmic bias, data privacy, and the need for Explainable AI and blockchain-based audit trails. Real-world evidence integration and standardized AI validation are crucial for patient safety and global acceptance.

Dr. Jagashetty emphasizes a structured roadmap: CDSCO-led AI guidelines, capacity building for regulatory professionals, and collaboration with international regulators. By combining technology with legal rigor, India can maintain its global pharmaceutical leadership while ensuring safe, effective, and timely medicines for patients worldwide.

02-12-2025