India launches a single-window portal for medical devices management

The Drugs Controller General of India said that the National Single Window System (NSWS) has been established as a 'genuine single-window system which acts as a one-stop shop for all approvals'

In a move to streamline the import, clinical investigations, and testing of medical devices, the Centre has launched the National Single Window System (NSWS). 

In a notice dated January 1, Rajeev Raghuvanshi, drugs controller general of India, said the NSWS has been established as a “genuine single-window system, which acts as a one-stop shop for all the approvals required by the investor and facilitates ease of doing business”. Business Standard has a copy of the document.

The NSWS portal, distinct from the existing SUGAM and cdscomdonline portals, has been developed by Tata Consultancy Services (TCS). It facilitates applications for the certificate of registration and licences to manufacture or import medical devices for various purposes, including clinical investigations, tests, evaluations, demonstrations, and training. The existing portals will be disabled by January 15, the notice stated.

 

Finance Minister Nirmala Sitharaman had previously announced the creation of an investment clearance cell (ICC) during her Budget speech on February 1, 2020. The proposed ICC, now developed as the NSWS, enables investors to identify, apply, track, and obtain the necessary approvals before starting any business operations in India, eliminating the need for investors to visit multiple IT platforms and authorities, the Central Drugs Standard Control Organisation (CDSCO) notice read.

India’s demand for medical devices is projected to reach $50 billion by 2030. Currently, the country produces approximately $7.6 billion worth of medical devices, exporting roughly $3.4 billion. The annual demand for medical devices in India is estimated at around $12 billion, with imports accounting for close to $7.6 billion, or over 60 per cent, of the domestic requirement.

However, the draft New Drugs, Medical Devices and Cosmetics Bill, 2023, expected to be tabled in Parliament soon, has triggered opposition from medical device makers, patient interest groups, and hospitals. They are advocating for a separate Bill for medical devices, distinct from drugs.

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 the way 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… which is intended to act as a one-stop shop for all the approvals required by an investor. However, its success will lie in the on-boarding of 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 an e-platform to enable regulators to communicate with each other and to be supervised and held accountable.

“We hope it will help in doing away with the arbitrary requirements of asking manufacturers to collect NoCs (no objection certificates); this should be a communication sought by one regulator from another but not a burden on a manufacturer to run from pillar to post. Its success lies in the ability of the government to create a governance structure for coordination and time-bound approvals with the option of appropriately accredited 3rd party certification bodies,” he added.