The cost of medical devices has been a concern for many patients in India, with some being unable to access them due to their high price. 

Ramesh Kumar, a retired school teacher, was suffering from chronic joint pain for the past few years. He was advised by his doctor to undergo knee replacement surgery, which required the use of a medical device - a knee implant. However, Mr. Gupta was unable to afford the high price of the implant, which was beyond his budget. He had to continue living with the pain and discomfort, which affected his quality of life.

 

Kumar’s case is not unique. Many patients in India face similar challenges in accessing affordable and quality medical devices, which are essential for the treatment and management of diseases and medical conditions. This has led to an increase in the import of medical devices in the past few years. While this has helped to address the growing demand for medical devices, it has also led to concerns about the quality and safety of these devices.

The Impact of the National Medical Device Policy 2023

The National Medical Device Policy 2023 has the potential to transform the healthcare industry in India by promoting the availability of safe, effective, and affordable medical devices while also fostering innovation and entrepreneurship in the sector. The policy has several key components that will help drive the growth of the medical device industry in India and improve the accessibility and affordability of implants.

Under the policy, medical devices will be classified based on their risk profile and intended use, and manufacturers will be required to obtain approval from the regulatory authority before they can sell their products in the Indian market. This will help ensure that medical devices are safe and effective and that they meet the needs of patients in India.

Promoting the Accessibility and Affordability of medical devices is one of the key objectives of the National Medical Device Policy 2023. The policy recognizes that the high cost of medical devices is a significant barrier to their availability to patients in India. To address this issue, the policy calls for the establishment of a national procurement system that will enable the government to purchase medical devices at affordable prices and distribute them to healthcare facilities across the country. Besides, it also seeks to promote the development of low-cost medical devices that meet the needs of the Indian population. This will be achieved by providing funding and support for startups and SMEs in the sector, establishing centers of excellence for medical device research and development, and promoting collaboration between academia, industry, and government.

Post-marketing surveillance is another important component to ensure the continued safety and effectiveness of medical devices after they have been approved for use. This will enable the government to monitor the safety and performance of medical devices and take appropriate regulatory action if necessary.

Furthermore, it attempts to harmonize the regulatory requirements for medical devices across different regulatory bodies, including the Central Drugs Standard Control Organization (CDSCO), the Medical Devices Rules (MDR), and the Indian Council of Medical Research (ICMR). This will help ensure that medical devices are safe, effective, and of high quality.

Road ahead

The National Medical Device Policy 2023 has the potential to transform the healthcare industry in India by promoting the availability of safe, effective, and affordable medical devices while also fostering innovation and entrepreneurship in the sector. 

Besides, it also aims to address the challenges facing the sector, including regulatory fragmentation, inadequate infrastructure, and insufficient funding. However, collaboration between respective stakeholders including the industry and government is critical for the success of the policy.