Govt Launches National Single Window System Portal to Streamline Medical Device Approvals

Developed by Tata Consultancy Services (TCS), the NSWS serves as a one-stop platform for obtaining certificates of registration and licences to manufacture or import medical devices for various purposes, such as clinical investigations, tests, evaluations, demonstrations, or training.

In a significant move to streamline the ease of doing business in the healthcare sector, the Government of India has introduced National Single Window System (NSWS), a streamlined online portal for managing medical devices. 

The newly launched system started operations from 1st January, 2024 . Further, the initiative seeks to simplify the process of import, clinical investigations, testing, and other necessary approvals for investors and businesses.

Developed by Tata Consultancy Services (TCS), the NSWS serves as a one-stop platform for obtaining certificates of registration and licences to manufacture or import medical devices for various purposes, such as clinical investigations, tests, evaluations, demonstrations, or training. This user-friendly portal replaces the existing SUGAM and cdsco online portals, which will be disabled by January 15.

Moreover, the objective of the NSWS, as outlined by finance minister Nirmala Sitharaman, is to establish a genuine single-window system that eliminates the need for investors to navigate multiple platforms and authorities. 

This move also aligns with the Investment Clearance Cell (ICC) initiative, allowing investors, entrepreneurs, and businesses to identify, apply, track, and obtain approvals online before commencing operations in India.

India, with a projected medical device demand of $50 billion by 2030, currently produces approximately $7.6 billion worth of medical devices, exporting around $3.4 billion. 

How NSWS Can Address Prevailing Issues?

The NSWS addresses the challenges posed by the draft New Drugs, Medical Devices and Cosmetics Bill, 2023, which has faced opposition from medical device makers, patient interest groups, and hospitals.

In response to concerns related to the lack of clearly defined norms for conducting clinical investigations, Malini Aisola, co-convenor, All India Drug Action Network (AIDAN), emphasised the need for transparency in regulatory processes. Aisola said, "There is a complete lack of transparency in how the regulatory mechanism and expert committees provide recommendations and undertake assessments of the studies."

Rajiv Nath, the forum coordinator of the Association of Indian Medical Device Industry (AiMeD), sees the NSWS as a positive step, acknowledging it as an excellent initiative for ease of doing business. Nath stressed the importance of onboarding various ministries and regulators to ensure the success of the single-window portal.

While recognising the potential benefits for new investors, Nath emphasised the need for the government to create a governance structure for coordination and time-bound approvals. 

He said, "Its success lies in the ability of the government to create a governance structure for coordination and time-bound approvals by the option of third-party certification bodies accredited appropriately."

The NSWS is poised to play a crucial role in streamlining regulatory processes, contributing to the growth of the medical device industry in India.