India is building the Digital Drugs Regulatory System (DDRS), a unified platform integrating 21 national databases to harmonise drug, medical device, Ayush, and veterinary product regulation across central and state agencies. Designed by CDSCO, DDRS enables end-to-end traceability, standardised approvals, and real-time coordination. With India supplying 20% of global generics and 60% of vaccines—but facing 3,104 NSQ and 245 spurious samples in 2024–25—DDRS aims to strengthen supply chain visibility and regulatory compliance. Experts hail it as long overdue; others warn of implementation complexity amid manpower gaps and uneven readiness.
According to www.livemint.com, India is developing a unified digital platform—the Digital Drugs Regulatory System (DDRS)—to harmonise drug regulation across central and state authorities, with integration planned across 21 national databases, including tax, identity, and corporate registries.
A Unified Regulatory Infrastructure
The DDRS is being developed by the Central Drugs Standard Control Organisation (CDSCO) and aims to replace fragmented, siloed processes with a single, interoperable digital architecture. It will support end-to-end lifecycle tracking of regulated products—including drugs, medical devices, Ayush, and veterinary products—and enable standardised approvals, real-time coordination between central and state regulators, and integrated certifications.
Government documents reviewed by Mint describe the DDRS as India’s first Digital Public Infrastructure (DPI) for regulatory systems—designed to ensure quality medicines for domestic and global markets. States have been asked to review the proposed framework and submit feedback on implementation challenges, phased onboarding strategies, and capacity-building needs.
Industry and Expert Perspectives
Mixed reactions reflect both urgency and operational caution. Dr Indu Bhushan, founder CEO of the National Health Authority (NHA) and architect of the Ayushman Bharat Digital Mission (ABDM), called DDRS an “excellent” and “long overdue” reform that will bridge Centre-state gaps and improve transparency and accountability.
“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.” — Government document reviewed by Mint
Sudarshan Jain, secretary general of the Indian Pharmaceutical Alliance (IPA), emphasised that digitisation will standardise inspections, testing, and approvals—bringing greater objectivity and helping align Indian regulations with global standards.
Conversely, Uday Bhaskar, hon director general at the All India Drug Control Officers Confederation and former chief of Pharmexcil, cautioned that the DDRS is “overambitious and impractical” given its 196-page mandate, chronic manpower shortages, limited hiring across states, and uneven industry readiness. He advocated phased implementation.
Supply Chain Implications for Global Professionals
For global supply chain professionals, DDRS directly addresses longstanding traceability and compliance pain points in India’s pharmaceutical supply chain. India supplies 20% of the world’s generic medicines and 60% of its vaccines to over 200 countries. Yet persistent quality issues remain: in 2024–25, of 116,323 drug samples tested, 3,104 were declared Not of Standard Quality (NSQ), and 245 were spurious and adulterated.
Rajiv Nath of the Association of Indian Medical Device Industry (AiMeD) cited fragmented portals, inconsistent document uploads, lack of real-time status tracking, and frequent downtime as key barriers for medical device approvals. His recommendations—single-window, paperless workflow; auto-alerts; standardized data fields; and interoperable state-Centre architecture—are now embedded in DDRS design goals.
Nitin Jain of Iberia Pharmaceuticals noted that current processes require navigating multiple authorities with limited visibility into application progress. A unified platform, he said, “can improve visibility, speed up decision-making, and bring much-needed predictability”—though impact hinges entirely on execution reliability and user experience.
Source: www.livemint.com
Compiled from international media by the SCI.AI editorial team.
