The Medical Technology Association of India (MTaI) has urged a nuanced evaluation of the Central Drugs Standard Control Organisation (CDSCO) in response to the recent Parliamentary Standing Committee report on health and family welfare. While supporting key regulatory reforms, MTaI emphasized that CDSCO’s centralization is essential due to its specialized expertise in medical device regulation.
The association welcomed several proposed measures, including:
- A digitized, time-bound, and trackable licensing system to enhance transparency and efficiency.
- Improved training for CDSCO officials to streamline regulatory operations.
- Reduction of frequent and delayed regulatory queries, which often create bottlenecks for applicants.
- Encouragement of lateral industry expertise within CDSCO to improve decision-making.
- Establishment of an industry advisory board to ensure smoother collaboration between regulators and stakeholders.
MTaI believes these reforms will significantly improve CDSCO’s efficiency and responsiveness, benefiting the medical device sector.
However, the association also highlighted the need for a broader perspective on certain issues raised in the report. It pointed out that while some companies have moved manufacturing operations to Vietnam and Malaysia, their decisions are influenced by multiple factors beyond CDSCO’s regulatory framework, such as local policies, tax structures, and economic incentives.
MTaI further noted that staff shortages within CDSCO have become more critical since all classes of medical devices were brought under a mandatory licensing regime. It welcomed the committee’s recommendation to establish a dedicated support team to assist applicants, particularly startups and new entrants, in navigating regulatory requirements more smoothly.
The association underscored CDSCO’s role in upholding industry quality and ethical standards while fostering innovation and sectoral growth. By addressing key challenges and adopting the committee’s recommendations, CDSCO can streamline its regulatory framework, support India’s medical technology industry, and strengthen the country’s position in the global medtech landscape.
The Parliamentary Standing Committee report had raised concerns over delays, inconsistent timelines, and a lack of transparency in the licensing process, stating that these issues have hindered the growth of India’s medical device industry.
