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.
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 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 views on implementation challenges, phased onboarding strategies, and specific capacity-building or change management support required for effective adoption,” this person said.
“This platform is envisioned to serve as a new approach to the regulatory system in the form of India’s DPI (digital public infrastructure) for regulatory systems, thereby ensuring quality medicines for India and the world,” said the document reviewed by Mint.
The DDRS will integrate with 21 national databases—including tax, identity, and corporate registries—as well as platforms across key ministries and state governments.
The system will enable end-to-end lifecycle tracking of regulated products, standardised approvals, real-time coordination between central and state regulators, and certifications for drugs, medical devices, Ayush and veterinary products, according to the government document.
Queries sent on Tuesday to spokespersons of the Union health and family welfare ministry, the Drugs Controller General of India (DCGI), CDSCO, Sun Pharma, Mankind, Cipla and Zydus Life Sciences remained unanswered till press time.
Queries sent on Thursday to GSTN, CBIC, UIDAI and the finance ministry were not answered immediately.
Mixed reactions
While some experts hailed DDRS as a timely reform, others were sceptical.
Dr Indu Bhushan, founder CEO of the National Health Authority (NHA) and a key architect of the Ayushman Bharat Digital Mission (ABDM), called DDRS an “excellent” and “long overdue” reform that will bridge Centre-state gaps, and make the system more transparent and accountable.
Sudarshan Jain, secretary general of the Indian Pharmaceutical Alliance (IPA), said digitisation will standardise regulatory processes—from inspections and testing to approvals—bringing greater objectivity and transparency, and help Indian regulations align with global standards.
However, Uday Bhaskar, hon director general at All India Drug Control Officers Confederation and former chief of Pharmaceuticals Export Promotion Council of India (Pharmexcil), said the DDRS is overambitious and impractical in the current environment, given the scale of database integration under a complex 196-page mandate, alongside chronic manpower shortages, limited hiring across states, and uneven industry readiness.
He added that such a transformation would be difficult to implement and should be pursued in phases, though if executed well, it could make the system more transparent and consumer-friendly.
Managing persistent issues
The move assumes significance considering that India—which supplies 20% of the world's generic medicines and 60% of its vaccines to over 200 countries—has been plagued by challenges such as spurious drugs and the lack of uniform enforcement of quality standards across different states.
In 2024-25, of 116,323 drug samples tested, 3,104 samples were declared Not of Standard Quality (NSQ), and 245 samples were found to be spurious and adulterated.
DDRS can enable end-to-end traceability, real-time monitoring, and uniform regulatory standards across India, to counter the quality issues, according to Dr Aashish Chaudhry, managing director of Aakash Healthcare.
“For patients, this means safer medicines, reduced risk of counterfeit drugs, and quicker regulatory action in case of adverse events,” he said.
Medical devices, too, face several pain points including fragmented portals, inconsistent document uploads, lack of real-time status tracking, limited integration with state systems, and frequent downtime delaying approvals, said Rajiv Nath, forum coordinator at, Association of Indian Medical Device Industry (AiMeD).
“We recommend a single-window, paperless workflow with auto-alerts, standardized data fields, and interoperable state-Centre architecture,” Nath said. “Industry stands ready to collaborate on user-testing and mapping MedTech-specific approval pathways to ensure DDRS is efficient, transparent, and globally aligned.”
Nitin Jain, founder and managing director of Iberia Pharmaceuticals, said the current system involves navigating multiple authorities, with limited visibility on application progress, slowing decision-making.
“A unified platform that brings applications, approvals, and communication into one place can improve visibility, speed up decision-making, and bring much-needed predictability,” he said, but added that its impact will depend on execution.
“If the system is intuitive and reliable, it can significantly ease operations—but if it is complex or unevenly implemented, it risks adding to existing challenges,” Jain said.