API-first, DPI-driven DDRS platform aims to modernize drug and medical device regulation in India
In a significant step toward modernising India’s regulatory architecture, the Central Drugs Standard Control Organisation(CDSCO) has invited bids on the Government e-Marketplace (GeM) for the selection of a software service provider to build the Digital Drugs Regulatory System (DDRS), a next-generation digital platform for drug and medical device regulation.
The platform will be designed as an API-first, Digital Public Infrastructure (DPI)-driven system, covering the design, development, implementation, operations, and maintenance of the new regulatory stack.
The initiative is expected to transform how regulatory workflows are managed across approvals, submissions, compliance tracking, and medical device oversight, while enabling greater interoperability with industry stakeholders and government digital ecosystems.
The bid, listed under GeM Bid No. GEM/2026/B/738439, has a submission deadline of 28 May, 2026.
The move aligns with the government’s broader push to digitise healthcare governance and strengthen regulatory agility through scalable public digital infrastructure—an increasingly critical need as India sharpens its focus on innovation-led pharmaceuticals, medtech, and faster market access pathways.
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