The Central Drugs Standard Control Organization (CDSCO) has announced its endeavor to develop a state-of-the-art Digital Drugs Regulatory System (DDRS). This announcement was issued on 2nd November, 2023 through its notice inviting proposals.
CDSCO is responsible for setting drug standards, approving clinical trials and new drugs, controlling the quality of imported drugs, and enforcing the Drugs and Cosmetics Act, among other critical functions.
India, with its vast and diverse population, faces unique health challenges. Ensuring the availability of safe and effective medicines is not just a commercial necessity but also a vital public health concern. To meet these challenges and build a robust digital regulatory ecosystem, CDSCO is inviting Expression of Interest (EoI) from Software Services Providers.
The aim of this project is to develop the DDRS as a unified digital ecosystem that will replace existing portals. DDRS is envisioned to be a Single Window, Single Sign On, and Unified Portal for all regulatory activities in the field of pharmaceuticals.
CDSCO emphasizes the use of a platform design approach, open-source technology stack, and open standards for the development of DDRS. The organization has outlined specific sections in the EoI document detailing the existing system, scope, pre-qualification criteria, terms and conditions, and suggested response formats.
Interested Software Service Providers that meet the pre-qualification criteria are encouraged to submit their Expression of Interest, along with all necessary documents, by 16:00 hours on Wednesday, November 30, 2023, via email at admn@cdsco.nic.in. The anticipated duration for the development and maintenance of the DDRS is approximately 8 to 10 years.
The development of DDRS represents a significant step towards enhancing regulatory systems in India, ensuring the availability of quality medicines for the country and the world.
