Parliamentary panel puts CDSCO’s approach to MedTech industry under scanner, MTaI calls for reforms

New Delhi: 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 highlighted that delays, inconsistent timelines, and a lack of transparency in the licensing process have compelled numerous medical devices manufacturers to relocate operations to countries like Vietnam and Malaysia.

The report emphasized that the current licensing procedures are particularly burdensome for startups and entrepreneurs, hindering innovation and growth within the sector. To address these challenges, the committee recommended implementing a fully digitized and trackable licensing system with clearly defined timelines for each stage. Such a system would promote transparency, reduce discretionary decision-making, and foster a more efficient regulatory environment.

Additionally, the panel proposed the establishment of an independent industry advisory board comprising representatives from manufacturers, importers, healthcare providers, and experts. This board would provide regular feedback to CDSCO on regulatory challenges, participate in the development of new guidelines, and serve as a platform for resolving disputes, thereby ensuring that the regulatory framework aligns with industry needs and global standards.

The committee also expressed concern that the centralization of authority within CDSCO has created an over-regulated environment, discouraging domestic manufacturing. They advocated for a more transparent approval system and incentives for medical device startups to encourage innovation and make India a hub for medical device manufacturing.

These recommendations aim to overhaul the existing regulatory framework, making it more conducive to the growth and competitiveness of India’s medical device industry on a global scale.

MTaI calls for improvement in CDSCO’s functioning

In its reaction, the Medical Technology Association of India (MTaI) has sought a more nuanced perspective when evaluating the functioning of CDSCO. Rather than blaming the regulator for each and every challenge, it called for overall drastic measures to stem out the discontent about the medical devices industry.

MTaI agreed with Parliamentary Standing Committee’s assessment over opportunities for improvement—such as ongoing training of CDSCO officials, the implementation of a fully digitized, time-bound, and trackable licensing system, minimizing frequent and delayed queries, lateral entry from the industry and the establishment of an industry advisory board to streamline operations.

Specifically pointing out the need for course correction on a few aspects, MTaI highlighted how the centralization of intricate matters within CDSCO is largely due to the concentration of expertise at the organization.

However, the leading association exempted the role of CDSCO on the issue of certain companies choosing neighboring countries over India. “The preference of some companies for Vietnam and Malaysia as manufacturing destinations stems from a variety of factors beyond just CDSCO’s regulatory processes, such as policies, tax regimes, etc.”

Highlighting the understaffing in CDSCO, MTaI has called for adequate staffing of the regulator since all classes of devices have recently come under a mandatory licensing regime.

“The committee’s proposal to create a dedicated support team to assist applicants with queries—akin to a chaperone service—would be particularly beneficial, especially for startups, and should be taken up. In its role as a regulator, CDSCO should continue to champion industry quality and ethical standards thus contributing to the sector’s enduring growth and global positioning,” mentioned the statement.