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The Department-related Parliamentary Standing Committee on Health and Family Welfare has called for decentralisation of powers to license medical devices to State Licensing Authorities (SLAs) to create a positive regulatory mechanism in the country and encourage states to bring in global companies to set up their manufacturing base in their states.
The Panel, in its 176th report on affordability and accessibility of healthcare facilities in public and private sector, also recommended to the Centre to provide greater autonomy to SLAs for licensing of medical devices as per quality approved by notified laboratories which are approved by the Quality Council of India (QCI).
"The Committee strongly recommends for decentralization of A&B medical devices to State Level Authority (SLA) so that respective State Government can be empowered to create a positive regulatory mechanism and also to increase competition amongst various state governments to attract global companies to set up manufacturing base in their states helping the entire country in turn," said the Panel headed by Member of Parliament Prof. Ram Gopal Yadav.
As both health and industry are state subject, it would be appropriate for the state government to regulate A&B medical devices to notified laboratories, it added.
The Panel, while considering the operations of the CDSCO in the medical devices field, observed that ensuring the availability of high-quality, safe, and effective medical devices across both public and private health institutions is paramount to building public trust and avoiding substandard clinical outcomes.
Under the risk-based classification framework of the Medical Devices Rules (MDR), 2017, the CDSCO has successfully licensed 3,480 manufacturing units for Class A & B devices, 1,100 manufacturing units for Class C & D devices, and approved 12,866 import license applications as of July 1, 2026.
Furthermore, to secure the supply chain, the Committee noted, that CDSCO issued a circular on November 25, 2025, mandating that all procurement agencies, hospitals, and health institutions must require a valid CDSCO or SLA license for the procurement of medical devices.
It opined that structural accountability must be institutionalized through technology without human interface to ensure that uncertified or non-compliant equipment does not penetrate the healthcare delivery network.
"The Committee, therefore, recommends that the ministry of health and family welfare should impress upon the concerned state government to stringently monitor the compliance of the November 25, 2025 Procurement Mandate across all public and private entities to verify that only legally licensed, globally compliant technologies reach patients," said the Panel.
It further recommended that the government should encourage the state governments to fully utilize the powers delegated under the MDR, 2017 to establish and notify additional Medical Device Testing Laboratories (MDTLs), expanding beyond the currently registered 84 MDTLs and 18 Notified Bodies.
"The Committee is of the firm view that expanding this public testing infrastructure and deploying the pool of 258 notified Medical Device Officers (MDOs) will drive robust domestic quality assurance, ultimately making safe medical technologies accessible to all socioeconomic strata," it added.
It also recommends for greater autonomy to SLAs for licensing of medical devices as per quality approved by notified laboratories which are approved by the QCI.
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