The Central Drugs Standard Control Organisation (CDSCO) will launch the first phase of its end-to-end Digital Drug Regulatory System (DDRS) within the next 18 months, marking a major step towards modernising India’s pharmaceutical regulatory ecosystem. Announcing the initiative at the Global Drug Regulatory Conclave (GDRC) 2026, Dr. Rajeev Singh Raghuvanshi, Drugs Controller General of India (DCGI), said the new platform will create a single-window, digital-first regulatory framework to improve transparency, efficiency and ease of doing business for the pharmaceutical and medical device sectors.

What the CDSCO Digital Drug Regulatory System Will Replace and Include

The upcoming Digital Drug Regulatory System (DDRS) will replace the existing SUGAM portal with a modern, open-architecture platform that digitises the entire regulatory lifecycle — from application submission and clinical trial approvals to manufacturing licences, inspections, Certificates of Pharmaceutical Product (CoPP), import-export permissions and post-market surveillance. The platform is designed to minimise manual intervention, enable real-time application tracking and improve coordination between the Centre and State drug regulatory authorities.  Explore our Pharma Regulatory Updates hub

Building on 99% Digitisation: How AI Will Power the New Platform

Speaking at the conclave, the DCGI noted that over 99% of CDSCO’s regulatory processes have already been digitised, significantly improving approval timelines and transparency. Building on this progress, the regulator is now integrating Artificial Intelligence (AI) into multiple regulatory functions, including risk-based inspections, application screening, document evaluation, inspection report generation, reviewer allocation and pharmacovigilance. These AI-enabled capabilities are expected to accelerate regulatory decision-making while maintaining high standards of quality, safety and compliance. Read more on AI in Healthcare

Strengthening Interoperability with IPC, ICMR and Public Health Agencies

The DDRS will also strengthen India’s pharmaceutical regulatory framework by introducing enhanced interoperability with organisations such as the Indian Pharmacopoeia Commission (IPC), Indian Council of Medical Research (ICMR) and other public health agencies. According to officials, the integrated platform will support data-driven regulatory decisions, improve traceability and facilitate faster approvals for medicines and medical devices while ensuring greater accountability across the regulatory ecosystem. The initiative aligns with the Government of India’s broader vision of digital governance and globally harmonised pharmaceutical regulation.

Industry Response to the CDSCO Digital Drug Regulatory System

Industry experts have welcomed the announcement, stating that the end-to-end digital platform will significantly improve regulatory efficiency, reduce compliance timelines and enhance investor confidence in India’s pharmaceutical sector. By combining digital technologies, AI-enabled regulatory tools and a unified single-window interface, CDSCO is expected to strengthen India’s position as a globally trusted pharmaceutical manufacturing hub while supporting innovation, faster market access and improved public health outcomes.

Frequently Asked Questions

What is replacing the SUGAM portal?

The CDSCO Digital Drug Regulatory System (DDRS) will replace the existing SUGAM portal with a modern, open-architecture, single-window platform covering the entire pharmaceutical regulatory lifecycle.

When will the CDSCO Digital Drug Regulatory System launch?

The first phase of the DDRS is expected to launch within 18 months, as announced at the Global Drug Regulatory Conclave (GDRC) 2026.

How will AI be used in the new CDSCO platform?

AI will be integrated into functions such as risk-based inspections, application screening, document evaluation, inspection report generation, reviewer allocation and pharmacovigilance to accelerate regulatory decision-making.

Which organisations will the DDRS be interoperable with?

The DDRS will have enhanced interoperability with the Indian Pharmacopoeia Commission (IPC), the Indian Council of Medical Research (ICMR), and other public health agencies.