A significant number of medical device manufacturers have shifted their operations to Vietnam and Malaysia due to prolonged delays, unpredictable timelines, and a lack of transparency in India’s licensing process, according to the Parliamentary Standing Committee on Health and Family Welfare.
The committee’s report, recently tabled in the Rajya Sabha, highlighted concerns over the Central Drugs Standard Control Organisation (CDSCO), stating that many manufacturers hesitate to establish units in India due to bureaucratic hurdles and slow approvals.
Rajiv Nath, forum coordinator of the Association of Indian Medical Device Industry (AIMED), mentioned that the industry has raised these concerns with the Union Health Secretary. He emphasized the need for process streamlining, training sessions for state regulators and manufacturers, and regular meetings of the Medical Devices Technical Advisory Group (MDTAG), which was formed in 2020 but has yet to convene.
To address these issues, the panel has suggested implementing a digital, trackable licensing system with clearly defined timelines for each stage. The system should include automatic notifications for applicants and a publicly accessible database for real-time monitoring. This would help identify inefficiencies, enhance transparency, minimize arbitrary decision-making, and create a more efficient and predictable regulatory framework.
The committee, led by Samajwadi Party MP Ram Gopal Yadav, urged the CDSCO to modernize its approach and move away from the outdated “licence raj” mentality. It recommended setting up an independent industry advisory board with representatives from manufacturers (including startups), importers, healthcare professionals, and regulatory experts.
This advisory board would provide regular feedback on regulatory challenges, help shape policies and guidelines, and act as a forum for dispute resolution.
The report also criticized the CDSCO’s habit of raising repeated queries, which often cause significant delays, particularly for startups. To address this, the committee proposed a streamlined query resolution process where all concerns are raised in a single round rather than multiple stages. Additionally, it recommended introducing conditional approvals within 45 days for products with international certifications, based on self-declarations and submitted documents.
To tackle issues related to staffing and expertise, the panel suggested speeding up the recruitment of qualified drug inspectors and other key personnel in the medical-device sector. It also encouraged considering lateral hiring of industry professionals into regulatory roles.
Other recommendations include fostering startup growth, preventing unnecessary delays, and holding regular consultations with stakeholders through open forums, workshops, and online platforms.
