New Delhi: A sweeping overhaul is in the works to streamline the process of approval of drugs and medical devices in India, wherein the focus is to converge various online channels into a single platform for industry players.
For years, the Central Drugs Standard Control Organisation (CDSCO), the country’s top drug regulatory body, has been attempting to move all licensing and approvals online. However, several pharma and medical devices manufacturers have reported technical issues on various online channels, leaving their approval applications in limbo.
Now, CDSCO is preparing for a complete digital overhaul as it invited bids 13 April for the selection of a software service provider to build the Digital Drugs Regulatory System (DDRS), an online platform for the regulation of drugs and medical devices.
The platform, according to the proposal, is meant to replace the current fragmented licensing and approval process with a single, fully digital regulatory system. The system will cover all product categories, including drugs, biologicals, medical devices, cosmetics, veterinary products, and emerging therapies, regulated by central and state licensing authorities.
CDSCO’s proposal describes DDRS as India’s Digital Public Infrastructure (DPI) for regulatory systems—comparable to how Aadhaar and Unified Payments Interface (UPI) transformed identity verification and payments.
Source : Theprint
