The Parliamentary Standing Committee on Health and Family Welfare has urged the Department of Health to ensure complete digitisation and automation of the medical device licensing process at the Central Drugs Standard Control Organisation (CDSCO). The Committee has recommended the introduction of a unified digital platform, a single comprehensive query system, and a time-bound conditional approval mechanism to speed up approvals and promote innovation in the medical devices sector.

In its 170th report on action taken by the government on recommendations made in its earlier 163rd report on Demands for Grants for the Department of Health for 2025–26, the Committee acknowledged several initiatives undertaken by the government. These include the rollout of the MD Online portal, creation of a dedicated Medical Devices Vertical, establishment of testing laboratories and notified bodies, and the launch of the MedTech Mitra platform to support innovators.

While recognising these efforts as positive steps towards improving regulatory efficiency and transparency, the Committee noted that industry concerns persist around delays, inconsistent timelines, and the absence of end-to-end, real-time tracking of licensing applications.

The Committee, chaired by Member of Parliament Prof Ram Gopal Yadav, recommended that the Department implement a fully integrated digital platform linking central and state licensing authorities. It called for mandatory public disclosure of application status, query histories, and processing timelines to enhance transparency and accountability. The report was presented in the Rajya Sabha on December 11.

The Committee also stressed the need for a robust performance monitoring and accountability framework to ensure adherence to defined service timelines and to penalise undue delays in the approval process.

In addition, the Panel suggested that CDSCO adopt artificial intelligence-driven analytics to identify procedural bottlenecks, reduce manual interventions, and improve predictability in regulatory decision-making. Such measures, it said, would help foster a globally competitive and innovation-friendly medical devices ecosystem in India.

Addressing concerns over delays in query resolution and communication between industry and regulators, the Committee acknowledged steps taken by CDSCO, including the introduction of tooltips on the MD Online portal, publication of updated FAQs and guidance documents, establishment of Public Relations Offices, and regular stakeholder consultations led by the Drugs Controller General of India.

However, it observed that applicants—particularly startups and small manufacturers—continue to face multiple, sequential queries, leading to prolonged approval timelines and uncertainty. To address this, the Committee recommended implementing a single comprehensive query system to ensure all regulatory observations are raised at once.

The Panel further proposed the adoption of time-bound conditional approvals for products that already hold recognised international certifications, such as CE marking or US FDA approvals, to improve ease of doing business and encourage innovation.

It also called for the creation of a dedicated regulatory facilitation cell for startups within the MedTech Mitra framework to provide real-time assistance and guidance, making India’s regulatory environment more predictable, responsive, and supportive of innovation.