India plans single drug platform for Centre, states

India is planning a sweeping overhaul of its drug regulatory system by unifying central and state licensing, approvals, and compliance into a single digital platform, according to two government officials and documents reviewed by Mint.

- Priyanka Sharma [e-mail]

At the centre of the plan is a proposed, interoperable Digital Drugs Regulatory System (DDRS) being developed by the Central Drugs Standard Control Organisation (CDSCO).

The regulator is preparing to invite proposals from information technology (IT) services firms to build and run the platform, the documents show.

The DDRS is designed to streamline complex processes from registration and clinical trial approvals to import-export licensing and supply chain traceability-by bringing central and state regulators, laboratories, and allied agencies onto a unified, real-time digital architecture.

States have been asked to review the proposed framework and provide feedback, the first person cited above said, requesting anonymity. “Additionally, the Centre has sought viewson implementation challenges, phased onboarding strategies, and specific capacity-building or change management support required for effective adoption,” this person said.