The Central Drugs Standard Control Organisation (CDSCO) has decided to extend the deadline for eligible Software Service Providers (SSPs) to submit their Expression of Interest (EOI) for the development of the unified digital ecosystem Digital Drugs Regulatory System (DDRS). The DDRS is designed to function as a single window, single sign-on, and unified portal for all regulatory activities.
According to media reports, the EOI was initially issued on November 2, with a submission deadline of November 30, 2023. The CDSCO has, however, extended the deadline, and SSPs now have until December 7, 2023, to submit their expressions of interest.
The DDRS aspires to increase trust and confidence in the quality of medications, medical equipment, cosmetics, and other products in both domestic and international markets. It also seeks to increase openness and accountability in quality regulation and ensure effective standard enforcement on the ground.
|- There is no definition of generic drugs: CDSCO|
Furthermore, the system strives to assure adherence to Indian pharmacopoeia and standards. The CDSCO envisions the DDRS as a platform for CDSCO, the Indian Pharmacopoeia Commission (IPC), and the National Institute of Biologicals (NIB) to modernise them using digital technology.
According to a drug regulator statement, the action intends to build DDRS as a single digital ecosystem. "Once operational, all existing portals will be decommissioned, and DDRS will serve as a Single Window, Single Sign On, and Unified Portal for all regulatory activities," the drug regulator explained.
The selection of a Software Services Provider (SSP) is expected to be for eight to 10 years. Based on the successful models of other Digital Public Infrastructures (DPIs) in India, the EoI invitation notice emphasises the creation of the system utilising a platform design approach with an open-source technology stack and open standards.