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 The launch of National Single Window System (NSWS) portal by the Central Drugs Standard Control Organisation (CDSCO) as a one-stop shop for all approvals is an excellent initiative, and may help the naive new investors, but its success will lie on boarding of various other ministries and regulators, says Association of Indian Medical Devices Industry (AiMeD), the umbrella association of Indian manufacturers of medical devices covering all types of medical devices.
Rajiv Nath, Forum Coordinator, AiMeD, said, "The single window portal is an excellent initiative of DPITT, Invest India & CDSCO as Ease of Doing Business which is intended to act as a one-stop shop of all the approvals required from an investor. However, its success will lie on boarding of the various other ministries and regulators at Central government and state governments and stop need to apply on parallel or independent portals and physical payments of fees and challans."
For instance, if a manufacturer is looking to set up a medical devices factory as a greenfield project in the State of Haryana, currently the entrepreneur needs to apply for over 35 regulatory approvals. Success of the new portal will also lie in ensuring the single portal to list all regulatory approvals with well defined checklists helping to reduce in person communication while giving access points to make payments etc and hopefully to also ensure an e-platform to enable regulators to communicate to each other and to be supervised and held accountable in performance and efficiency, he said.
"We hope it will help in doing away with the arbitrary requirements of asking manufacturers to collect NOC (No Objection Certificates)," he averred. This should be a communication sought from one regulator to another, and should not be a burden for a manufacturer to run from pillar to post.
The success of the portal also lies in the ability of the government creating a governance structure for coordination and time bound approvals by option of 3rd party certification bodies accredited appropriately. "It will help naive new investors but how helpful it will be for existing manufacturers we have still to see”, he added.
It may be noted that the CDSCO announced the launch of the NSWS on January 1, 2024, initially offering three activities for the medical devices industry. 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.
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 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.
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