“The Committee expresses serious concern that due to rigid process and inordinate delays by CDSCO, a large number of manufacturing units have gone to Vietnam and Malaysia. Rather, several medical devices manufacturers are scared to set up a unit in India due to delaying tactics of the CDSCO,” it said.
The Committee has opined that the department should promote startups in medical devices by streamlining and overhauling the licensing system and preventing the deliberate delays by following a transparent process with minimum room for discretion or human inference. “The Committee believes that these steps would result in India becoming a hub for manufacturing of medical devices and generating over a trillion dollar from the medical devices industry alone,” the report said.
The committee observed that the frequent and delayed queries raised by CDSCO are a major obstacle for applicants, particularly startups and entrepreneurs.
The committee also expressed that the perception of CDSCO as “license raj” highlights a critical need for improved communication and collaboration with the medical device industry.
The report also recommended the establishment of an independent industry advisory board, comprising representatives from manufacturers (including startups), importers, healthcare providers, and experts.
The committee said that it is having concerns that centralisation of authority at any level may result in creating a situation for arbitrary or discretionary decision making. “This may have an adverse impression that India is keen on over regulation to create a business of licensing rather than making it a manufacturing powerhouse for medical devices. The department should ensure a faster documentation process, including reduction of human interface to facilitate the growth of the medical devices industry in the country”.
The committee recommended a significant overhaul of the query process which includes establishing a single query policy, where all necessary queries are consolidated and raised at once, rather than in multiple rounds; implementing a system of conditional approvals within 45 days.
