Parliamentary Panel Urges Faster, Digitized Approvals to Boost Medical Devices Innovation

The Panel further suggested that the CDSCO leverage AI-driven analytics to identify procedural bottlenecks, reduce manual interventions, and improve the predictability of approvals, thereby fostering a globally competitive medical device ecosystem.

The Parliamentary Standing Committee on Health and Family Welfare has recommended a series of regulatory reforms aimed at expediting approvals and encouraging innovation in India’s medical devices sector, citing persistent delays and procedural inefficiencies within the Central Drugs Standard Control Organisation (CDSCO).

In its 170th report on action taken by the government on recommendations made in the 163rd report on Demands for Grants for the Department of Health for 2025–26, the Panel called on the Department of Health to ensure complete digitisation and automation of the medical device licensing process. It also proposed the introduction of a single comprehensive query system and a time-bound conditional approval mechanism to improve predictability and reduce approval timelines.

The Committee acknowledged initiatives taken by the government, including the MD Online portal, creation of a Medical Devices Vertical within CDSCO, establishment of testing laboratories and notified bodies, and the launch of the MedTech Mitra platform to support innovators. However, it noted that industry concerns around delays, inconsistent timelines, and the absence of end-to-end real-time tracking of applications continue to persist.

“The Committee recommends that the Department must ensure complete digitisation 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,” the report, presented to the Rajya Sabha on December 11, stated. It also called for a performance monitoring and accountability framework to track adherence to defined service timelines and penalise undue delays.

The Panel further suggested that the CDSCO leverage AI-driven analytics to identify procedural bottlenecks, reduce manual interventions, and improve the predictability of approvals, thereby fostering a globally competitive medical device ecosystem.

Addressing concerns over delayed and fragmented communication between regulators and industry, the Committee took note of steps such as tooltips on the MD Online portal, updated FAQs, guidance documents, Public Relations Offices, and regular stakeholder meetings. Despite these measures, it observed that applicants—particularly startups and small-scale manufacturers—continue to face multiple, sequential queries that prolong approval timelines.

To address this, the Panel recommended implementing a single comprehensive query system to consolidate all regulatory observations. It also proposed a time-bound conditional approval mechanism, especially for products holding recognised international certifications such as CE or US FDA approvals.

Additionally, the Committee sought the establishment of a dedicated regulatory facilitation cell for startups under the MedTech Mitra framework to provide real-time guidance and query resolution.

In its earlier report, the Panel had flagged delays, inconsistent timelines, and a lack of transparency in CDSCO’s licensing process as key impediments to the growth of the medical devices industry and reiterated the need for a fully digitised, trackable, and time-bound approval system.

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