National Medical Devices Policy, 2023

May 1, 2023

India’s dependence on imported medical devices has been a growing concern in recent years, with the majority of medical devices sold in India being imported from foreign countries. The high import dependence has been a significant barrier to the development of the indigenous medical devices industry in India. The National Medical Devices Policy, 2023 seeks to address this issue.

Current Status of Medical Device Market in India

According to industry estimates, 80-85% of medical devices currently sold in India are imported, mainly from the United States, Germany, Japan, China, and Israel. Indian manufacturers have primarily focused on producing low-cost and low-tech products such as consumables and disposables, leaving high-end devices to foreign companies. India’s current market share in the medical device category is just 1.5% of the global space, which is significantly lower than the country’s potential.

Future Goals of the Indian Government for the Medical Device Industry

The Indian government aims to reduce the dependence on imported medical devices to nearly 30% in the next couple of years. It has set a goal of achieving a 10-12% global market share for India’s medical device industry in the next 25 years. To achieve these goals, the government has launched several initiatives, including changes to the Medical Devices Rules in 2020, promoting domestic manufacturing of high-end medical devices, and the National Medical Devices Policy.

Initiatives to Promote Domestic Manufacturing of Medical Devices

In 2020, the Indian government announced changes to the Medical Devices Rules to strengthen the regulatory framework and improve patient safety. The changes were triggered by the revelation of faulty hip implants marketed by Johnson & Johnson. Under the Production-Linked Incentive (PLI) scheme, the government has approved 26 projects to promote domestic manufacturing of high-end medical devices such as Linear Accelerator, MRI Scan, CT-Scan, Mammogram, C-Arm, MRI Coils, high-end X-ray tubes, etc. The government’s immediate short-term goal is to make the medical devices sector a $50 billion industry by 2030.

National Medical Devices Policy

The National Medical Devices Policy aims to create a conducive ecosystem for the medical devices industry in India. The policy promotes research and development, availability of skilled manpower, and learning from the best global practices of manufacturing. It establishes Centres of Excellence in academic and research institutions and promotes innovation hubs to encourage research and development. The policy supports dedicated multidisciplinary courses in existing institutions to ensure the availability of skilled manpower. Furthermore, the policy initiates studies and projects to learn the best global practices of manufacturing and adopt globally successful models in India.

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