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The Central Drugs Standard Control Organisation (CDSCO) has initiated efforts to set up a Digital Drugs Regulatory System (DDRS) as a unified digital ecosystem as a single window, single sign on and unified portal for all regulatory activities.
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.
"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.
It has floated an invitation for Expression of Interest (EoI) for selection of Software Services Provider (SSP) for digital transformation of CDSCO, IPC and NIB 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, it said.
"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.
Interested service providers who meet the pre-qualification criteria may furnish their EoI with all the necessary documents on or before 4 pm on November 30, 2023.
The proposed DDRS should be modular and should 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.
The SSP should also take care of data migration required to transition from the existing systems to the new system, among other aspects.
"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.
CDSCO shall set up a Project Management Committee comprising senior officers of CDSCO from various departments with a named project director who will put in place various vendors in place for the project. The CDSCO will nominate a nodal officer who will oversee the project.
Over a period of time, the drug regulator has developed a website serving as a gateway of information and access to online platforms, Sugam Online as online licensing portal from January, 2016, MD online for licensing of medical devices and in-vitro diagnostic devices, Sugam Labs as a laboratory information management system, Online National Drugs License System for State Authorities as a single window platform for online processes, among others.
Besides, Indian Pharmacopoeia Commission is operating its e-commerce website for disseminating updates related to activities carried out by the Commission, sales and distribution of IP reference standards and various publications and National Institute of Biologicals (NIB), Noida has its website and Hemo Vigil and Donor Vigil web-based applications under the Haemovigilance Programme of India.
However, these websites are mostly developed and implemented in silos over the years and they do not permit a single window experience to the applicants and officers of the Central and State Governments as they are hosted and operated from individual domain names with minimal integration with each other.
The performance of these platforms has been found to be slow and inconsistent during peak load demands by the users and these platforms have not been integrated with other Government of India identification platforms like Aadhar, PAN, DigiLocker, ONDC, etc., leading to manual verification.
"The in-built checks and balances within the platform for licenses and permits are not found to be parameterised enough, leading to manual verification of electronic data submitted by the applicants at various stages in duplicating efforts many times among officers," said the CDSCO.
The usage of these platforms by the State government agencies for issuance of permits or licenses is not uniformly operational across the country, with most of the state government agencies operating their platforms. The integration with these state government agencies for data aggregation is also not fully in place, so generating national-level data on licenses, permits, etc., is a time-consuming exercise with substantial manual efforts, it added.
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