Parl panel on health: Cos scared to set up units due to CDSCO approach

Parliamentary Standing Committee on Health and Family Welfare, in its latest report, has expressed concerns over the functioning of India's drug regulatory authority-Central Drugs Standard Control Organisation (CDSCO)-saying that the current licensing process is plagued by delays, inconsistent timelines, and a lack of transparency, hindering the growth of the medical device industry.

«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.

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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