India Unveils Single-Window Portal for Medical Device Management
Wednesday, 03 January 2024, 14:02 IST
The National Single Window System (NSWS) has been introduced by the Centre to streamline the import, clinical investigations, and testing processes for medical devices. According to Rajeev Raghuvanshi, drugs controller general of India, the NSWS serves as a genuine single-window system, acting as a comprehensive platform for all necessary approvals, thereby promoting ease of doing business. Developed by Tata Consultancy Services (TCS), the NSWS portal is separate from existing SUGAM and cdscomdonline portals. It facilitates the submission of applications for certificates of registration and licenses for manufacturing or importing medical devices, covering various purposes such as clinical investigations, tests, evaluations, demonstrations, and training.
The Finance Minister, Nirmala Sitharaman, announced the establishment of an investment clearance cell (ICC) during her Budget speech on February 1, 2020. The ICC, now realized as the NSWS, allows investors to discover, submit applications, monitor progress, and secure essential approvals prior to commencing business operations in India. This eliminates the requirement for investors to navigate multiple IT platforms and engage with various authorities, as stated in the notice by the Central Drugs Standard Control Organisation (CDSCO).
The anticipated demand for medical devices in India is estimated to reach $50 billion by 2030. Currently, the country manufactures around $7.6 billion worth of medical devices, with approximately $3.4 billion being exported. However, the upcoming presentation of the draft New Drugs, Medical Devices, and Cosmetics Bill, 2023 in Parliament has faced resistance from medical device manufacturers, patient advocacy groups, and hospitals. They are pushing for a dedicated Bill for medical devices, separate from pharmaceuticals.
In a statement dated December 12 from medical device manufacturers’ lobby groups, patient advocacy groups, hospital industry bodies, and others, Malini Aisola, co-convenor of the All India Drug Action Network (AIDAN), noted, "There are no clearly defined norms for conducting clinical investigations, particularly for high-risk devices that go into the body of a patient or have higher potential to cause harm, leading to some very poor study designs and insufficient or dubious data. There is complete lack of transparency in how the regulatory mechanism and expert committees provide recommendations and undertake assessments of the studies, and the data which is the basis for granting approval".
She further said, "Under the current law, medical devices are granted virtually automatic approval in India if they have received licensure/certification for use in a number of developed country jurisdictions". The NSWS is thus a step in the right direction, felt Rajiv Nath, forum coordinator of the Association of Indian Medical Device Industry (AiMeD) and chairman and managing director of Hindustan Syringes and Medical Devices (HMD), one of the top three disposable syringe makers in the world.
"The single window portal is an excellent initiative intended to act as a one-stop shop for all the approvals required by an investor. However, its success will lie in onboarding various other ministries and regulators at central government and state government (levels) and stopping the need for applying on parallel or independent portals and physical payments of fees and challans", he said. Nath felt that the Centre needs not only to ensure a single portal to list all regulatory approvals and give access points to make payments but also an e-platform to enable regulators to communicate with each other and to be supervised and held accountable.
The Finance Minister, Nirmala Sitharaman, announced the establishment of an investment clearance cell (ICC) during her Budget speech on February 1, 2020. The ICC, now realized as the NSWS, allows investors to discover, submit applications, monitor progress, and secure essential approvals prior to commencing business operations in India. This eliminates the requirement for investors to navigate multiple IT platforms and engage with various authorities, as stated in the notice by the Central Drugs Standard Control Organisation (CDSCO).
The anticipated demand for medical devices in India is estimated to reach $50 billion by 2030. Currently, the country manufactures around $7.6 billion worth of medical devices, with approximately $3.4 billion being exported. However, the upcoming presentation of the draft New Drugs, Medical Devices, and Cosmetics Bill, 2023 in Parliament has faced resistance from medical device manufacturers, patient advocacy groups, and hospitals. They are pushing for a dedicated Bill for medical devices, separate from pharmaceuticals.
In a statement dated December 12 from medical device manufacturers’ lobby groups, patient advocacy groups, hospital industry bodies, and others, Malini Aisola, co-convenor of the All India Drug Action Network (AIDAN), noted, "There are no clearly defined norms for conducting clinical investigations, particularly for high-risk devices that go into the body of a patient or have higher potential to cause harm, leading to some very poor study designs and insufficient or dubious data. There is complete lack of transparency in how the regulatory mechanism and expert committees provide recommendations and undertake assessments of the studies, and the data which is the basis for granting approval".
She further said, "Under the current law, medical devices are granted virtually automatic approval in India if they have received licensure/certification for use in a number of developed country jurisdictions". The NSWS is thus a step in the right direction, felt Rajiv Nath, forum coordinator of the Association of Indian Medical Device Industry (AiMeD) and chairman and managing director of Hindustan Syringes and Medical Devices (HMD), one of the top three disposable syringe makers in the world.
"The single window portal is an excellent initiative intended to act as a one-stop shop for all the approvals required by an investor. However, its success will lie in onboarding various other ministries and regulators at central government and state government (levels) and stopping the need for applying on parallel or independent portals and physical payments of fees and challans", he said. Nath felt that the Centre needs not only to ensure a single portal to list all regulatory approvals and give access points to make payments but also an e-platform to enable regulators to communicate with each other and to be supervised and held accountable.
