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The delays and lack of transparency, among other issues in the current licensing process of the Central Drugs Standard Control Organisation (CDSCO) for the medical devices industry is resulting in units opting countries like Vietnam and Malaysia for their manufacturing operations, says a Parliamentary Panel.
It has also raised concerns that centralisation of authority may result in creating a situation for arbitrary or discretionary decision making and recommended establishment of an independent Industry Advisory Board, comprising representatives from the industry.
The Department-related Parliamentary Standing Committee on Health and Family Welfare, in its 163rd report on the Demands for Grants 2025-26 of the Department of Health and Family Welfare, also recommended various measures to be taken by the Department to overcome the situation.
Upon examination of the submissions made by the Department, the Panel expressed its concerns that the CDSCO's 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," said the panel headed by Member of Rajya Sabha Prof. Ram Gopal Yadav, in its latest report.
It recommended implementation of a fully digitised, time-bound, and trackable licensing system which include clearly defined timelines for each stage of the licensing process, with automatic notifications to applicants; a standardised, publicly accessible database detailing all applications, queries, and approvals, allowing for real time tracking; and utilization of AI and automated systems to pre-screen applications for completeness, reducing the need for repeated queries and human intervention, especially for globally certified, non-invasive products.
It should also include a system that records all queries and the reason for the query along with the date of the query and the date of the reply.
This will help easy tracking of the process, identification of bottlenecks, promote transparency and reduce discretionary decision-making making an efficient and predictable regulatory environment.
Observing that the frequent and delayed queries raised by CDSCO are a major obstacle for applicants, especially startups, it recommended a significant overhaul of the query process, which include establishing a "single query" policy, where all necessary queries are consolidated and raised at once; implementing a system of conditional approvals within 45 days, based on self-declaration and submission of necessary documentation, especially for products with existing international certifications (e.g., CE, US FDA); and providing detailed, standardized guidelines and Frequently Asked Questions to minimize ambiguity and reduce the need for queries.
It also recommended creation of a dedicated support team to assist applicants with the query process and provide timely clarifications.
Taking the challenges faced by CDSCO related to capacity and expertise, which contributes to the delays and inconsistencies in the licensing process, it opined that acceleration of recruitment of qualified personnel, particularly Drugs Inspectors and other key positions in the Medical Device Vertical; and exploring the lateral entry of professionals from the medical device industry to bring in specialized expertise and a more industry-friendly perspective.
It also urged the department to implement a system of regular, mandatory training programs for CDSCO officials to enhance their understanding of the latest technologies, regulatory best practices, and their role as facilitators of industry growth; and implement a system of rotating officials to prevent the development of vested interests and ensure a fresh perspective.
"The Committee would like to express that the perception of CDSCO as a 'license raj' highlights a critical need for improved communication and collaboration with the medical device industry. The Committee, therefore, recommends the establishment of an independent Industry Advisory Board, comprising representatives from manufacturers (including startups), importers, healthcare providers, and experts," it said.
This board would provide regular feedback to CDSCO on regulatory challenges and potential improvements; participate in the development of new guidelines and policies; and serve as a platform for resolving disputes and addressing industry concerns.
Furthermore, CDSCO should implement a system of regular stakeholder consultations, including open forums, workshops, and online platforms, to gather feedback and address concerns proactively. This will foster a more transparent and collaborative regulatory environment, build trust between CDSCO and the industry, and ensure that regulations are aligned with the needs of a rapidly evolving sector, moving CDSCO from a perceived roadblock to a true facilitator, added the Panel.
Commenting on the centralisation of regulatory powers for medical devices, the Committee said that it is having the concerns that centralization of authority at any level may result in creating a situation for arbitrary/discretionary decision making.
This may have an adverse impression that India is keen on over regulation since the last two years to create a business of licensing rather than making it a manufacturing powerhouse for medical devices.
"The Department should ensure faster documentation processes including reduction of human interface to facilitate the growth of the medical devices industry in the country," it added.
The Department should promote start-ups 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, said the Panel.
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