The Medical Technology Association of India (MTaI) has urged a balanced evaluation of the Central Drugs Standard Control Organisation (CDSCO) following a recent report by the Parliamentary Standing Committee.
MTaI acknowledged the committee’s recommendations, including digitizing licensing, enhancing training, streamlining regulatory operations, and establishing an industry advisory board. They believe these reforms will improve CDSCO’s efficiency, benefiting the medical device industry.
However, MTaI emphasized the necessity of CDSCO’s centralized decision-making due to its specialized expertise. They also pointed out that factors beyond CDSCO’s processes, such as local policies and tax structures, influence decisions by companies to manufacture in places like Vietnam and Malaysia.
The association further welcomed the committee’s suggestion for a support team to assist applicants with regulatory queries. Such a system would be particularly helpful for startups. MTaI concluded by stating that CDSCO should maintain quality and ethical standards while driving the growth of the medtech sector.
The Parliamentary Standing Committee on Health and Family Welfare’s report raised concerns about India’s drug regulatory authority, highlighting delays, inconsistent timelines, and a lack of transparency in the licensing process, which is hindering the growth of the medical device industry.
