CDSCO to Develop Digital Drugs Regulatory System for Effective, Unified Infrastructure

The CDSCO plans to build this DDRS using open-source technology and standards similar to successful Digital Public Infrastructure (DPI) models. It aims for DDRS to be India's DPI for healthcare product regulation.

The Central Drugs Standard Control Organisation (CDSCO) has initiated plans to establish a Digital Drugs Regulatory System (DDRS) to serve as a unified digital ecosystem, simplifying regulatory activities for drugs, medical devices, cosmetics, and more.

The CDSCO aims to improve trust and confidence in the quality of healthcare products in both domestic and global markets. The proposed DDRS will consolidate existing portals, providing a single window, single sign-on, and unified portal for all regulatory activities.

To support this initiative, the CDSCO has issued an invitation for Expression of Interest (EoI) from Software Services Providers (SSPs) to facilitate the digital transformation of CDSCO, IPC, and NIB. The expected duration of this digital transformation project is eight to ten years.

The DDRS is intended to be modular, accommodating various aspects of regulatory oversight, including end-to-end product management, seamless stakeholder integration, real-time information capture and display, supply chain tracking, and monitoring the outcomes of vigilance and enforcement activities.

The system is expected to be built using an open-source technology stack and open standards in alignment with successful Digital Public Infrastructure (DPI) models in India. The CDSCO envisions DDRS as India's DPI for regulatory systems, ensuring the quality of healthcare products in India and around the world.

The proposed DDRS will be designed to include features for monitoring, reporting, inspection, assessment, auditing, and the integration of payment gateways, among others. It will also incorporate user guides, manuals, training videos, interactive charts, and stakeholder communication platforms.

To ensure a robust regulatory system, the DDRS will enable various analytics, both in-house and third-party, to assess the proper functioning of different regulatory aspects, including document verification, license duplication prevention, employee performance measurement, and more.

The CDSCO also expects the SSP to handle data migration from existing systems to the new DDRS platform. Additionally, DDRS is designed to integrate with key government platforms and services, connecting various stakeholders from government agencies, businesses, and support services.

The CDSCO will establish a Project Management Committee comprising senior officers from various departments within the organisation. A named project director will oversee vendor selection for the project, and a nodal officer will provide project oversight.

Over time, the CDSCO has developed various online platforms to facilitate regulatory activities, including Sugam Online, MD Online, Sugam Labs, the Online National Drugs License System for State Authorities, and more. However, these platforms have been developed and operated independently over the years, leading to fragmented user experiences.

Many of these platforms do not provide a single window experience, and their performance during peak demand has been inconsistent. Furthermore, these platforms lack integration with other government identification platforms, such as Aadhar, PAN, DigiLocker, and ONDC, necessitating manual verification.

The CDSCO aims to streamline these regulatory processes, improve efficiency, and provide a unified digital ecosystem for stakeholders. It seeks to leverage technology to ensure the quality, safety, and efficacy of healthcare products in India and enhance transparency and accountability in the regulatory process.

Interested service providers who meet the pre-qualification criteria may submit their Expression of Interest (EoI) with all the required documents by November 30, 2023. The CDSCO intends to modernise its regulatory activities to provide efficient oversight of healthcare products and ensure their quality, safety, and efficacy in the market.

This initiative is expected to revolutionise the regulatory landscape in India, simplify processes for stakeholders, and promote the development of a unified digital ecosystem for regulatory activities, ultimately benefiting the healthcare sector and ensuring the well-being of consumers in India and abroad.