CDSCO Pilots AI Across Regulatory Processes to Build Data-Driven Regulatory System: DCGI

Speaking at the event, Dr Raghuvanshi also announced that CDSCO will roll out the first phase of an end-to-end digital drug regulatory platform within the next 18 months as part of efforts to modernise India's pharmaceutical regulatory ecosystem.

The Central Drugs Standard Control Organisation (CDSCO) is piloting Artificial Intelligence (AI) across its regulatory processes to create a faster, more agile, and data-driven regulatory system, Drugs Controller General of India (DCGI) Dr Rajeev Singh Raghuvanshi announced at the inaugural Global Drug Regulatory Conclave (GDRC) 2026, held on July 30 in Delhi.

Speaking at the event, Dr Raghuvanshi also announced that CDSCO will roll out the first phase of an end-to-end digital drug regulatory platform within the next 18 months as part of efforts to modernise India's pharmaceutical regulatory ecosystem.

He said that more than 99 percent of CDSCO's regulatory processes have already been digitised, improving transparency and approval timelines. He further announced that Good Manufacturing Practice (GMP) and Certificate of Pharmaceutical Product (COPP) certificates will soon carry QR code-based digital authentication, enabling overseas regulators to instantly verify their authenticity while reducing verification timelines.

In his virtual address, Union Minister for Health and Family Welfare J.P. Nadda said India is building a future-ready drug regulatory framework to accelerate healthcare innovation while maintaining the highest standards of patient 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 added that digital regulatory platforms, risk-based oversight, strengthened inspection systems, and enhanced surveillance are creating a modern regulatory ecosystem that inspires greater global confidence.

Dr Raghuvanshi also outlined initiatives aimed at strengthening quality and innovation. He said CDSCO has streamlined its export regulatory framework through a fully digitised export No Objection Certificate (NOC) system, introduced globally aligned regulatory reliance mechanisms, and accelerated approval pathways to enable faster patient access to innovative therapies.

He added that around 25–30 percent of clinical trials are currently being considered for waiver for eligible innovative products. He also highlighted MedTech Mitra, which has supported more than 800 startups in navigating regulatory pathways, and said similar facilitation mechanisms are planned for biologics and other emerging technologies.

Organised by Pharmexcil in association with CDSCO, the Global Drug Regulatory Conclave 2026 brought together global drug regulatory authorities, policymakers, researchers, industry leaders, and international organisations to discuss the future of pharmaceutical regulation. Namit Joshi, Chairman, Pharmexcil, said the conclave aims to promote harmonised standards, clearer regulatory pathways, and faster access to quality, affordable medicines while strengthening confidence in Indian pharmaceuticals across global markets.

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