Published on: March 16, 2022

NATIONAL POLICY FOR MEDICAL DEVICES, 2022

NATIONAL POLICY FOR MEDICAL DEVICES, 2022

NEWS

The government of India is proposing National Policy for Medical Devices, 2022 to reduce India’s dependence on import of high-end medical devices

THE POLICY

WHAT IS PROPOSED?

  • Incentivizing the export of medical devices and related technology projects through tax rebates and refunds
  • Increasing government spending in “high-risk” projects in the medical devices sector
  • Single-window clearance system for licensing medical devices
  • Public-private partnerships to reduce the cost of healthcare, drive efficiency
  • Aid quality improvements in medical devices manufactured in the country
  • Enabling a pricing environment with no price control on newly developed innovation in the sector
  • NPPA (National Pharmaceutical Pricing Authority) shall be strengthened with adequate manpower of suitable expertise to provide effective price regulation balancing patient and industry needs and incorporating innovation and life cycle costs as factors in pricing regulation of medical devices

WHAT IS THE NEED?

  • Nearly 80 per cent of the medical devices currently sold in the country are imported, particularly high-end devices
  • Government aims to
    • Reduce India’s import dependence from 80 per cent to nearly 30 per cent in the next 10 years
    • Become one of the top five global manufacturing hubs for medical devices by 2047
  • India’s medical devices sector has so far been regulated as per provisions under the Drugs and Cosmetics Act of 1940, and a specific policy on medical devices has been a long standing demand from the industry. There is a lack of regulatory teeth when it came to medical devices.
  • Also aims to increase India’s per capita spend on medical devices