India Regulatory News

The Indian Government proposes a new Draft National Policy for Medical Devices, 2022, to reduce India's reliance on high-end medical device imports. The government intends to adopt public-private partnerships to reduce healthcare costs, increase efficiency, and improve the quality of medical devices manufactured in the country.

Among the key proposals are:

·       The use of tax breaks and refunds to encourage the export of medical devices and related technology projects.

·       Increasing government spending on "high-risk" medical device projects

·       A single-window clearance system to be used for the licencing of medical devices.

·       Pricing environment with no price control on newly developed sector innovation

·       A dedicated fund to be established for encouraging collaborative research among existing industry players, reputable academic institutions, and start-ups.

·       Incorporate a framework for consistent pricing regulation to make high-quality, cost-effective medical devices available to all citizens at reasonable prices.

·       The National Pharmaceutical Pricing Authority (NPPA) will be strengthened with adequate manpower and appropriate expertise to provide effective price regulation while balancing the needs of patients and industries.