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The Parliamentary Panel on Health and Family Welfare has recommended to the Department of Health to ensure complete digitisation and automation of licensing process, and implement a single comprehensive query system and a time-bound conditional approval mechanism in the Central Drugs Standard Control Organisation (CDSCO) to expedite approvals and encourage innovation in the medical devices sector.
The Panel, in its 170th report on action taken by the government on its recommendations and observations in the 163rd report on Demands for Grants for the Department of Health for the year 2025-26, took note of various initiatives such as implementation of MD online portal, creation of a Medical Devices Vertical, establishment of testing laboratories and notified bodies and launch of MedTech Mitra platform to support innovators.
While these measures are commendable steps towards improving regulatory efficiency and transparency, the Committee observes that persistent industry concerns remain regarding delays, inconsistent timelines, and lack of end-to-end real-time tracking of licensing applications, it observed.
"The Committee, therefore, recommends that the Department must ensure the complete digitization and automation of the licensing process through a unified and integrated digital platform linking central and state licensing authorities, with mandatory public disclosure of application status, query logs, and processing timelines," said the Panel headed by Member of Parliament Prof. Ram Gopal Yadav in the report presented to the Rajya Sabha on December 11.
"The Committee further urges that a robust performance monitoring and accountability framework be instituted to track adherence to defined service timelines and penalize undue delays," it added.
Additionally, the Panel expressed its desire that CDSCO leverage AI-driven analytics to identify procedural bottlenecks, reduce manual interventions, and improve predictability in approvals so as to foster a globally competitive and innovation friendly medical device ecosystem in India.
With regards to the delayed query process and communication between the industry and the CDSCO, observed in its previous report, the Panel noted the steps taken by the Department and CDSCO to enhance transparency and reduce procedural ambiguities, including the introduction of tooltips on the MD Online portal, publication of updated FAQs and guidance documents, establishment of Public Relations Offices (PROs), and regular stakeholder consultations and open meetings by the Drugs Controller General of India.
However, the Committee observed that despite these initiatives, applicants—particularly startups and small-scale manufacturers—continue to face multiple and sequential queries, causing delays and uncertainty in approval timelines.
"The Committee, therefore, recommends the Department for implementing a single comprehensive query system to ensure that all observations are raised in one go, thereby minimizing repetitive communication and expediting approvals," said the report.
The Panel further recommended the adoption of a time-bound conditional approval mechanism, especially for products possessing recognized international certifications such as CE or US FDA, to promote ease of doing business and encourage innovation.
It also sought the CDSCO to establish a dedicated regulatory facilitation cell for startups within the MedTech Mitra framework to provide real-time query assistance and guidance, ensuring that India’s regulatory environment becomes more predictable, responsive, and innovation-friendly.
In its previous report, the Panel raised concerns that the CDSCO's current licensing process is plagued by delays, inconsistent timelines, and a lack of transparency, hindering the growth of the medical device industry. It recommended implementation of a fully digitized, time-bound, and trackable licensing system, in the report.
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