New Delhi: The Parliamentary Panel on Health and Family Welfare has recommended various significant regulatory changes in the regulation of medical devices, including decentralisation of approval for all medical devices with the State Drug Authorities, self-financing of the drug control authority using the substantial revenues generated from medical device licensing, and an immediate overhaul of the Central drug regulator’s medical devices (MD) online portal to reduce the bottlenecks in approvals.
The Department Related Parliamentary Standing Committee on Health and Family Welfare, in its 172nd report on the Demands for Grants for 2026-27 for the Department of Health and Family Welfare, observed that that present decentralized framework is under which the State Authorities regulate drugs and Class A/B devices, while the Central Drugs Standard Control Organisation (CDSCO) oversee imports and Class C and D devices.
However, it recommended a decentralized framework for imports and Class C/D devices.
“The Committee strongly recommends that CDSCO approval for imports be completely decentralized to the State Authorities. Centralization with the DGCI at the Central level has created major bottlenecks and is the biggest hurdle in India being at the forefront of Medical devices manufacturing,” said the Panel headed by Member of Parliament Prof. Ram Gopal Yadav.
“The Committee recommends for decentralization of approval for all Medical Devices with the State Drug Authorities to reduce pendency. In this current phase when we are competing with China, Vietnam, Malaysia giving CDSCO approvals for even already approved devices/technologies beyond a period of 45 days resulting in India losing its competitive edge,” said the Panel.
It noted with concern that significant administrative bottlenecks hindering the swift clearance of medical devices, particularly the Class C and Class D categories regulated by the CDSCO.
Out of 2,999 manufacturing and import applications processed, approximately 62% were subjected to queries more than twice, and 253 import applications, even those possessing US FDA/CE certifications, have been pending for over 90 days, (most of these import applications are pending at the applicants end for submission of requisite documents as per MDR-2017).
Repetitive query cycles indicate a systemic lack of clarity in the initial submission guidelines and point toward an inefficient, iterative assessment process, it opined.
The Panel recommended that the Department immediately overhaul the ‘MD Online’ portal to include a mandatory, AI assisted pre-submission validation checklist to ensure applications are complete before formal submission.
“The Committee is of the view that CDSCO must adopt a ‘single comprehensive query’ policy, wherein all deficiencies in an application are identified and communicated to the applicant in a single instance, rather than in piece-meal fashion,” it added.
Besides, it recommended establishment of a dedicated facilitation cell within CDSCO to assist domestic manufacturers in navigating the Medical Device Rules (MDR) 2017, thereby reducing the delays currently attributed to pending applicant responses.
The CDSCO has generated substantial revenue of around Rs. 87.18 crore and Rs. 118.69 crore annually over the last three financial years from medical devices licensing. Therefore, the revenue earned from the activity should be used for self-financing of the institution.
A designated percentage of the revenue collected by CDSCO be ring-fenced and directly reinvested into upgrading the digital and technical infrastructure of both the Central and state regulatory bodies, it recommended.
“The Committee is of the view that the Department must utilize these funds to develop a unified, real-time National Regulatory Dashboard that seamlessly integrates CDSCO‘s ‘MD Online’ portal with State-level licensing databases,” it added.
This will ensure that intelligence regarding non-compliant manufacturers, suspended licenses, and spurious drug trails is instantly shared across jurisdictions, leveraging both Central and state expertise to guarantee uniform enforcement of the Drugs and Cosmetics Act nationwide, averred the Panel.
SOURCE : Pharmabiz
