Parliamentary Panel Calls For Faster, Transparent Approvals To Boost Medical Device Innovation

India’s medical devices sector could see faster approvals and a more innovation-friendly regulatory environment if key recommendations made by a Parliamentary Panel are implemented.

The Panel in its recent report tabled in Rajya Sabha on December 11 has urged the Department of Health under the Union Health Ministry to fully digitise and automate the licensing process, streamline communication with manufacturers, and introduce time-bound approval mechanisms to cut delays that continue to trouble the industry.

Chaired by Member of Parliament (MP) Prof. Ram Gopal Yadav, noted that despite several reforms, the Central Drugs Standard Control Organisation (CDSCO) still faces challenges that slow down approvals and create uncertainty for companies, particularly startups and small manufacturers.

The Committee also took note of initiatives already launched by the government, including the MD Online portal, the creation of a dedicated Medical Devices Vertical within CDSCO, the establishment of testing laboratories and notified bodies, and the MedTech Mitra platform designed to support innovators. While these steps mark progress towards better regulation, the Panel observed that industry concerns around delays, inconsistent timelines and limited real-time tracking of applications remain unresolved.

To address these issues, the Panel recommended complete digitisation and automation of the licensing process through a unified digital platform that links both central and state licensing authorities. It called for mandatory public disclosure of application status, queries raised by regulators, and processing timelines so that applicants have full visibility of where their submissions stand.

The Committee also urged the introduction of a strong performance monitoring and accountability framework within CDSCO. Such a system, it said, would help ensure adherence to defined service timelines and enable action against undue delays. According to the Panel, accountability is essential to build trust and predictability in the regulatory process.

Recognising the growing role of technology in governance, the Panel suggested that CDSCO should leverage artificial intelligence-driven analytics to identify procedural bottlenecks, reduce manual intervention, and improve consistency in decision-making. This, it noted, could help India build a globally competitive and innovation-friendly medical device ecosystem.

A recurring concern highlighted in both the current and previous reports related to the way regulatory queries are handled. While the Department and CDSCO have taken steps to improve communication—such as adding tooltips on the MD Online portal, publishing updated FAQs and guidance documents, setting up Public Relations Offices, and holding regular stakeholder consultations—many applicants continue to face multiple, sequential queries, said the Panel in its reports.

These repeated back-and-forth exchanges often delay approvals and create uncertainty, especially for smaller companies with limited resources. To address this, the Panel recommended implementing a single comprehensive query system, under which all observations are raised at once. This, it said, would reduce repetitive communication and significantly speed up the approval process.

The Committee also proposed a time-bound conditional approval mechanism for medical devices that already have recognised international certifications, such as CE marking or approval from the US Food and Drug Administration. Such a measure, it said, would promote ease of doing business while ensuring patient safety.

Additionally, the Panel suggested setting up a dedicated regulatory facilitation cell for startups under the MedTech Mitra framework. This cell would provide real-time guidance and help innovators navigate regulatory requirements more smoothly.

In its earlier report, the Panel had warned that delays, inconsistent timelines and lack of transparency were holding back the growth of India’s medical device industry.