A recent parliamentary panel report on health and family welfare has shed light on the regulatory procedures governing medical devices, calling for a revamp to enhance transparency and facilitate the growth of the sector.
The report highlighted issues with the Central Drugs Standard Control Organisation’s (CDSCO) licensing process, including delays, inconsistent timelines, and lack of transparency, which it said were hindering the growth of the medical device industry. It also raised concerns about the centralization of authority leading to arbitrary decision-making and called for an overhaul of the licensing system to introduce a more transparent and streamlined process.
Industry insiders, while acknowledging the challenges identified in the report, also emphasized the need to address the staffing issues faced by the regulator. They suggested implementing a fully digitized, time-bound, and trackable licensing system to create a more predictable regulatory environment. Additionally, they recommended recognizing third-party certifications from reputable institutions under the CDSCO’s oversight to expedite the approval process.
Anil Jauhri, a former CEO of the National Accreditation Board for Certification bodies, advocated for a risk-based oversight approach that would leverage industry certifications to expedite regulatory decisions. He emphasized the importance of balancing industry input with the need to protect public health.
The Medical Technology Association of India welcomed the report’s recommendations for enhancing collaboration between industry and the regulator, improving training for CDSCO officials, and implementing a more efficient licensing system. The association noted the staffing challenges faced by the regulator and suggested measures to address them.
Overall, the report aims to foster a transparent and collaborative regulatory environment that aligns regulations with the evolving needs of the medical device sector. Industry stakeholders are optimistic about the potential for a more dynamic and responsive regulatory approach, as long as patient welfare remains a priority in decision-making processes.
