New Delhi: The Medical Technology Association of India (MTaI) has responded to the recent report by the Department-related Parliamentary Standing Committee on Health and Family Welfare, emphasising the need for a more balanced assessment of the Central Drugs Standard Control Organisation (CDSCO).
While acknowledging the committee’s constructive recommendations, MTaI highlighted that the panel had accurately identified several areas for improvement. These include the need for ongoing training of CDSCO officials, implementing a fully digitised, time-bound, and trackable licensing system, minimising frequent and delayed queries, encouraging lateral entry from industry experts, and establishing an industry advisory board to streamline regulatory operations.
MTaI believes these measures will significantly enhance CDSCO’s efficiency and responsiveness, ultimately benefiting the medical device industry.
However, the association stressed that some aspects require a broader perspective. It pointed out that the centralization of complex regulatory decisions within CDSCO is often necessary due to the concentration of specialized expertise within the agency. It also noted that some companies choosing Vietnam and Malaysia as manufacturing destinations do so for various reasons beyond CDSCO’s regulatory processes, including local policies, tax structures, and economic incentives.
The association, acknowledging the committee’s earlier observation regarding CDSCO’s understaffing, added that this challenge has become even more pronounced since all classes of medical devices were brought under a mandatory licensing regime.
MTaI further welcomed the committee’s recommendation to establish a dedicated support team to assist applicants with regulatory queries. Such a system, similar to a chaperone service, would be particularly helpful for startups and new entrants by simplifying the licensing process and ensuring smoother communication with regulatory authorities.
MTaI concluded by emphasizing that CDSCO must continue to uphold industry quality and ethical standards while fostering sectoral growth. By addressing key challenges and adopting the committee’s recommendations, CDSCO can further streamline its operations, drive innovation, and strengthen India’s position in the global medtech landscape.
The Parliamentary Standing Committee on Health and Family Welfare, in its latest report, has raised concerns about the functioning of India’s drug regulatory authority, the CDSCO. The committee noted that the existing licensing process is marked by delays, inconsistent timelines, and a lack of transparency, which has been hindering the growth of the medical device industry.
