In a significant move to modernise India’s drug regulatory framework, the Central Drugs Standard Control Organization (CDSCO) will replace its decade-old SUGAM portal with a new open-architecture digital platform, following final approval from the Department of Expenditure, Government of India.
SUGAM is an online e-Governance portal introduced by the Government of India to build an in-depth regulatory framework for the registration processes of the CDSCO. The platform is utilized for obtaining necessary clearances for the import and export of pharmaceutical products. SUGAM also handles the issuance and renewal of licenses for the manufacture and sale of drugs, cosmetics, and medical devices.
Talking about the development, Dr. Rajeev Raghuvanshi, Drug Controller General of India (DCGI), said the existing SUGAM portal has completed its lifecycle and it is time for a more integrated and future-ready system.
“The SUGAM portal is 10 years old and has lived its life. We are now moving towards a new platform built on open architecture. The CDSCO plans to launch the new platform within 18 months from the start of development. With final approval secured and preparatory processes underway, the initiative signals a decisive step towards building a fully integrated, transparent, and digitally empowered regulatory ecosystem in India,” Dr. Raghuvanshi said.
The new portal aims to integrate the entire regulatory value chain under one digital umbrella. According to Dr. Raghuvanshi, the vision is to ensure that every stakeholder involved in drug regulation, from central approvals to state-level clearances, can operate seamlessly on a single platform.
The proposed system will bring together State drug approvals, CDSCO approvals, sale licence processes, laboratories, Pharmacopoeial bodies and research and testing institutions.
Key institutions such as the Indian Pharmacopoeia Commission (IPC), National Institute of Biologicals (NIB), and Indian Council of Medical Research (ICMR) will be digitally integrated into the platform, ensuring that every contributor to the regulatory ecosystem, whether playing a major or minor role, can participate efficiently.
“The aim is to bring every aspect of the regulatory value chain in the country under one platform. All stakeholders who carry responsibility, small or big, should be able to be part of the system. At the click of a button, one should be able to access every relevant piece of information,” Dr. Raghuvanshi emphasised.
Highlighting CDSCO’s digital progress, Dr. Raghuvanshi noted that the regulatory system has already achieved more than 97% digitisation. “We have digitised the complete CDSCO and regulatory system to more than 97%. This new platform will be a big push from the digitisation point of view,” he said.
The transition to the new portal is not just an upgrade but a transformation aimed at improving interoperability, transparency, efficiency, and data-driven decision-making. Unlike earlier systems, the new portal will be based on open architecture, encouraging broader participation in its development.
Dr. Raghuvanshi informed that the Request for Proposal (RFP) is currently under preparation, and tenders will soon be floated. “We expect that not only government affiliated developers, but any capable organisation can come forward and help us develop this platform. This approach is expected to foster innovation and attract top-tier technological expertise,” he stated.
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