CDSCO to Launch First Phase of End-to-End Digital Drug Regulatory Platform Within 18 Months: DCGI

According to Dr. Raghuvanshi, the integrated platform will connect the 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.

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, Drugs Controller General of India (DCGI) Dr. Rajeev Singh Raghuvanshi announced at the Global Drug Regulatory Conclave (GDRC) 2026 held recently in New Delhi.

According to Dr. Raghuvanshi, the integrated platform will connect the 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.

He said the platform is part of CDSCO’s roadmap for regulatory transformation, which is centred on digitalisation, innovation, quality assurance, and global regulatory convergence. The common digital platform is intended to create a seamless regulatory ecosystem that improves coordination, transparency, and efficiency across the pharmaceutical sector.

Dr. Raghuvanshi said that more than 99% of CDSCO’s regulatory processes have already been digitised, resulting in greater transparency and faster approval timelines. Building on this, the organisation has started piloting the use of artificial intelligence (AI) across various regulatory processes to establish 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 carry QR code-based digital authentication. The measure is expected to enable overseas regulators to verify certificate authenticity instantly while reducing verification timelines.

Highlighting additional regulatory reforms, Dr. Raghuvanshi said CDSCO has implemented a fully digitised export No Objection Certificate (NOC) system and introduced globally aligned regulatory reliance mechanisms and accelerated approval pathways to facilitate quicker patient access to innovative therapies.

He further said that nearly 25% to 30% of clinical trials are currently being considered for waiver for eligible innovative products under the evolving regulatory framework. He added that the MedTech Mitra initiative has supported more than 800 startups in navigating regulatory pathways, while similar facilitation mechanisms are being planned for biologics and other advanced technologies.

In a 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. He said the regulatory framework must evolve alongside advances in biologics, biosimilars, gene therapies, precision medicine, AI-assisted drug development, and digital therapeutics.

The GDRC 2026, organised by CDSCO in association with the Pharmaceuticals Export Promotion Council of India (Pharmexcil), brought together global drug regulatory authorities, policymakers, researchers, industry leaders, and international organisations to discuss regulatory cooperation, digital transformation, regulatory science, innovation, and resilient global healthcare supply chains.

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