By: IPP Bureau
Last updated : July 31, 2026 7:43 am
New platform aims to accelerate approvals, strengthen transparency and enhance global confidence in India's pharmaceutical regulatory system
India is set to launch the first phase of an end-to-end digital drug regulatory platform within the next 18 months, marking a major step towards modernising the country's pharmaceutical regulatory ecosystem, Drugs Controller General of India (DCGI) Dr. Rajeev Singh Raghuvanshi announced at the inaugural Global Drug Regulatory Conclave (GDRC) 2026.
The platform, being developed by the Central Drugs Standard Control Organisation (CDSCO), will integrate the entire pharmaceutical regulatory value chain—from research and clinical development to manufacturing, approvals, distribution, and post-market surveillance—into a single digital ecosystem connecting central and state regulators, manufacturers, and other stakeholders.
Addressing the conclave virtually, Union Health and Family Welfare Minister, J.P. Nadda said India is building a future-ready regulatory framework that supports healthcare innovation while maintaining the highest standards of patient safety, quality, and efficacy.
He noted that India's pharmaceutical industry is evolving from a global supplier of affordable generic medicines into a global innovation hub for biologics, biosimilars, gene therapies, precision medicine, AI-assisted drug development, and digital therapeutics.
Nadda highlighted that CDSCO is undergoing a comprehensive transformation driven by transparency, scientific rigour, efficiency, accountability, and digital governance. He said digital regulatory platforms, risk-based oversight, stronger inspection systems, and enhanced surveillance are helping create a modern regulatory ecosystem that inspires greater global confidence. He also called for deeper international collaboration through information sharing, regulatory science partnerships, collaborative inspections, and harmonisation of scientific standards.
Dr. Raghuvanshi said over 99% of CDSCO's regulatory processes have already been digitised, significantly improving transparency and reducing approval timelines. Building on this progress, CDSCO is piloting Artificial Intelligence across regulatory processes to develop a faster, more agile, and data-driven regulatory system.
He also announced that Good Manufacturing Practice (GMP) and Certificate of Pharmaceutical Product (COPP) certificates will soon feature QR-code-based digital authentication, enabling overseas regulators to instantly verify their authenticity.
He further highlighted that CDSCO has introduced a fully digitised export No Objection Certificate (NOC) system, adopted globally aligned regulatory reliance mechanisms, and accelerated approval pathways for innovative therapies. Around 25–30% of clinical trials are currently being considered for waiver for eligible innovative products.
He added that MedTech Mitra has already supported more than 800 startups in navigating regulatory pathways, with similar facilitation mechanisms planned for biologics and other emerging technologies.
Speaking at the event, Mohit Yadav, Joint Secretary, Department of Commerce, said faster, transparent, and predictable regulatory pathways can improve patient access without compromising standards, while India should strengthen regulatory cooperation and responsible adoption of digital and AI-enabled tools.
Pharmexcil Chairman Namit Joshi said India has earned global trust as the "pharmacy of the world" and the next step is to become a stronger regulatory partner through harmonised standards, clearer regulatory pathways, and consistent compliance.
Organised by CDSCO in association with Pharmexcil, the Global Drug Regulatory Conclave 2026 brought together regulators, policymakers, researchers, industry leaders, and international organisations to discuss digital transformation, regulatory science, innovation, and global collaboration for ensuring timely access to safe, effective, and affordable medicines.