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CDSCO launches National Single Window System portal aiming at developing it as one-stop-shop for all approvals
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Gireesh Babu, New Delhi
January 03 , 2024
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In a step to improve the ease of doing business to the industry stakeholders, the Central Drugs Standard Control Organisation (CDSCO) has launched the National Single Window System (NSWS) portal initially offering three activities for the medical devices industry.
NSWS is established by the central government with the objective to build a Single Window System which acts as a one-stop shop for all the approvals required by the investor and facilitates ease of doing business. The scope of NSWS includes all the approvals/licenses/clearances as acceptable.
The CDSCO has said that the portal for the drug regulator has been developed by Invest India through IT major Tata Consultancy Service (TCS) and this will be an independent portal from the existing SUGAM portal or the cdscomdonline portal, which is for the medical devices industry.
Initially, three activities under the Medical Devices Rules, 2017 have been developed and will be made ‘Live’ on the single window portal with effect from January 1, 2024, it added.
These activities are the application for Certificate of Registration of a notified body under Form MD-01; application for license to manufacture medical device for purpose of clinical investigations, test, evaluation, examination, demonstration or training, under Form MD-12; and application for licence to import medical devices for the purpose of clinical investigations or test or evaluation or demonstration or training, under Form MD-16.
“In view of the above, it is requested that all concerned stakeholders henceforth should submit application related to the above said three activities through NSWS portal only and the existing cdscomdonline portal for the said activities will be disabled with effect from January 15, 2024,” said Dr Rajeev Singh Raghuvanshi, Drugs Controller General (India).
The CDSCO has also released a user guide for the users as a ready reference to navigate through the NSWS portal, he said. It has also provided a contact number for the users to clarify their doubts.
The drug regulatory organisation has in November, 2023, 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.
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