CDSCO to Replace SUGAM Portal With New Open-Architecture Digital Platform

The SUGAM portal, introduced as an e-governance platform, currently facilitates regulatory approvals related to drug, cosmetic, and medical device manufacturing, sale licenses, and import-export clearances.

In a move to modernise India’s drug regulatory infrastructure, the Central Drugs Standard Control Organization (CDSCO) will replace its decade-old SUGAM portal with a new open-architecture digital platform. 

The transition follows final approval from the Department of Expenditure, Government of India.

The SUGAM portal, introduced as an e-governance platform, currently facilitates regulatory approvals related to drug, cosmetic, and medical device manufacturing, sale licenses, and import-export clearances. According to officials, the system has completed its operational lifecycle.

Dr. Rajeev Raghuvanshi, Drug Controller General of India (DCGI), said the new platform will be designed as a fully integrated system covering the entire regulatory value chain. “The SUGAM portal is 10 years old and has lived its life. We are now moving towards a new platform built on open architecture,” he said, adding that CDSCO plans to launch the platform within 18 months from the start of development.

The proposed system will digitally integrate central and state-level approvals, sale license processes, laboratories, pharmacopoeial bodies, and research institutions. Key institutions, including the Indian Pharmacopoeia Commission, National Institute of Biologicals, and Indian Council of Medical Research, are expected to be connected through the unified platform.

“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 said.

He noted that CDSCO has already achieved over 97% digitisation across its regulatory processes. The new platform is expected to strengthen interoperability, transparency, and data-driven decision-making.

The Request for Proposal (RFP) is currently under preparation, and tenders are expected to be floated shortly. CDSCO indicated that the open-architecture framework will allow broader participation from qualified developers, beyond government-affiliated entities, in building the system.

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