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The Central Drugs Standard Control Organisation (CDSCO) has decided to provide more time for the eligible Software Service Providers (SSPs) to submit their Expression of Interest (EoI) for developing the unified digital ecosystem Digital Drugs Regulatory System (DDRS) as a single window, single sign on and unified portal for all regulatory activities.
The EoI was issued earlier with the start date of issuance of EoI document as November 2, fixing the last date of submission as November 30, 2023. With the extension, the last date of EoI submission is fixed as December 7, 2023.
The proposed DDRS is aimed at building trust and confidence in the quality of drugs, medical devices, cosmetics, etc., in the domestic and global market, transparency and accountability in the regulation of the quality, effective enforcement of quality, safety and efficacy at the field level, and ensuring compliance to Indian pharmacopoeia & standards, according to the CDSCO. It is expected to carry out the digital transformation of CDSCO, Indian Pharmacopoeia Commission (IPC) and National Institute of Biologicals (NIB).
"The aim is to develop DDRS as a unified digital ecosystem. Once operational, all existing portals will be discontinued, and DDRS will serve as a Single Window, Single Sign On, and Unified Portal for all regulatory activities," said the drug regulator.
The selection of Software Services Provider (SSP) is for an expected period of eight to 10 years.
The system needs to be developed using a platform design approach with an open-source technology stack, and open standards built on the models of other successful DPIs (Digital Public Infrastructure) in India, said the EoI invitation notice.
"This platform is envisioned to serve as a new approach to the regulatory system in the form of India’s DPI for regulatory systems, thereby ensuring quality medicines for India and the world," it added.
The proposed DDRS should be modular and take care of various aspects such as creation of a unified portal for end-to-end management of all categories of products regulated by CLA and State Licensing Authorities; design and develop a modular, flexible, and unified system that enables integration of different stakeholders seamlessly; develop dynamic online registries for capturing and displaying real-time information in a sortable, searchable and filterable manner; systems to track and trace the entire value chain to gather information on all licensed products, better inventory management and monitoring the corrective or punitive outcomes of vigilance and enforcement.
It should also take care of designing, development, implementation and maintenance including user interfaces for the web, mobile and other platforms for ten years. This should include features such as monitoring and reporting; inspection, assessment and auditing; integration of payment gateway and others; apart from user guides, manuals, training videos, interactive charts, communication platform for interface between State Licensing Authorities, Central Licensing Authority, Labs, manufacturers and others.
It also stipulates that the system should be designed in a way that enables various analytics (in-house and third-party) to be performed and to assess the proper functioning of different aspects of the regulatory system, such as algorithms for basic checks and balances for verification of documents such as duplication in batch number or name, algorithms to scan the database to avoid duplicate licenses, algorithms to measure employee performance and others, algorithms to detect whether states are undertaking specific sampling, targeted cases, etc, and algorithms for identifying companies that are manufacturing drugs at risk, drug quality surveillance, etc., among others.
"DDRS shall aim at bringing all stakeholders, viz Central government regulators and agencies, state government regulators and agencies, businesses (manufacturers, importers, exporters, distributors, retailers, etc.) and integrate with key Central government platforms like Aadhaar, PAN, DigiLocker, GST, DGFT, Customs, etc., state government platforms and other support & services agencies like private laboratories, audit agencies, consultants etc., together," it added.
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