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 The Central Drugs Standard Control Organisation (CDSCO) will roll out the first phase of an end-to-end digital drug regulatory platform within the next 18 months, marking a major step in the government's efforts to modernise India's drug regulatory framework through digitalisation, artificial intelligence (AI), and globally aligned regulatory practices, informed Drugs Controller General of India (DCGI) Dr. Rajeev Singh Raghuvanshi at the Global Drug Regulatory Conclave (GDRC) 2026 held recently in New Delhi.
Dr. Raghuvanshi further said that the integrated platform will connect the entire pharmaceutical regulatory value chain, from research and clinical development to manufacturing, approvals, distribution, and post-market surveillance, bringing central and state regulators, manufacturers, and other stakeholders onto a common digital ecosystem.
Dr. Raghuvanshi outlined CDSCO's roadmap for regulatory transformation, centred on digitalisation, innovation, quality assurance, and global regulatory convergence. He said the upcoming common digital platform is designed to create a seamless regulatory ecosystem that improves coordination, transparency, and efficiency across the pharmaceutical sector.
According to Dr. Raghuvanshi, more than 99 per cent of CDSCO's regulatory processes have already been digitised, leading to greater transparency and faster approval timelines. Building on this progress, CDSCO has started piloting the use of artificial intelligence across various regulatory processes to establish a faster, more agile, and data-driven regulatory system.
He also informed that Good Manufacturing Practice (GMP) and Certificate of Pharmaceutical Product (COPP) certificates will soon carry QR code-based digital authentication. The initiative will enable overseas regulators to instantly verify the authenticity of certificates while reducing verification timelines and strengthening confidence in India's regulatory systems.
Highlighting measures to improve regulatory efficiency and promote innovation, Dr. Raghuvanshi said CDSCO has streamlined its export regulatory framework through a fully digitised export No Objection Certificate (NOC) system. He added that the organisation has introduced globally aligned regulatory reliance mechanisms and accelerated approval pathways to facilitate quicker patient access to innovative therapies.
He further informed that nearly 25 to 30 per cent of clinical trials are currently being considered for waiver for eligible innovative products under the evolving regulatory framework. Referring to support for emerging technologies, he said the MedTech Mitra initiative has already assisted more than 800 startups in navigating regulatory pathways, while similar facilitation mechanisms are being planned for biologics and other advanced technologies.
In his virtual address at GDRC -2026, Union minister for health and family welfare Jagat Prakash Nadda said India is building a future-ready drug regulatory framework that supports healthcare innovation while maintaining standards of patient safety, quality, and efficacy. Nadda said India's pharmaceutical industry is progressing from being a global supplier of affordable generic medicines to becoming a centre for pharmaceutical innovation.
He said that as healthcare advances towards biologics, biosimilars, gene therapies, precision medicine, AI-assisted drug development, and digital therapeutics, India's regulatory framework must evolve simultaneously to facilitate innovation without compromising safety, quality, and efficacy.
Highlighting ongoing regulatory reforms, Nadda said CDSCO is undergoing a comprehensive transformation driven by transparency, scientific rigour, efficiency, accountability, and digital governance. He noted that digital regulatory platforms, risk-based oversight, strengthened inspection systems, and enhanced surveillance are helping create a modern regulatory ecosystem that strengthens global confidence in India's pharmaceutical sector.
The health minister also called for stronger international regulatory collaboration through greater information sharing, partnerships in regulatory science, collaborative inspections, and convergence of scientific standards to improve global access to safe, effective, and affordable medicines.
Mohit Yadav, joint secretary, Department of Commerce (DoC), Export Promotion (Pharma), said, "For pharmaceuticals, regulation is the true border. Faster, transparent, and predictable pathways can improve patient access without lowering standards. India must build on the trust it has earned through quality manufacturing by deepening regulatory cooperation, reliance, and responsible use of digital and AI-enabled tools."
Namit Joshi, chairman, the Pharmaceuticals Export Promotion Council of India (Pharmexcil) said, “India has established itself as a major supplier of medicines globally and should now strengthen its role as a regulatory partner. He said the GDRC -2026 would provide a platform for regulators and industry to work towards harmonised standards, clearer regulatory pathways, consistent compliance, and improved global confidence in Indian pharmaceutical products.”
The GDRC 2026, organised by the CDSCO in association with Pharmexcil, brought together global drug regulatory authorities, policymakers, researchers, industry leaders, and international organisations to deliberate on the future of pharmaceutical regulation. The discussions focused on strengthening regulatory cooperation, advancing digital transformation, promoting regulatory science, encouraging innovation, and building resilient global healthcare supply chains to improve timely access to safe, effective, and affordable medicines.
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