All you need to know about newly approved National Medical Device Policy
The National Medical Device Policy of India is a proposal that aims to promote local manufacturing, innovation, and regulatory oversight in the medical device sector. India has been a major exporter of generic medicines, but the country’s medical device industry has been relatively nascent. With the new policy, the government seeks to create a more conducive environment for the development of medical devices in India.
The medical devices sector in India is an essential and integral constituent of the Indian healthcare sector. The Indian medical devices sector’s contribution has become even more prominent as India supported the domestic and global battle against COVID-19 pandemic through the large scale production of medical devices & diagnostic kits, such as Ventilators, Rapid Antigen Test kits, Real-Rime Reverse Transcription Polymerase Chain Reaction (RT-PCR) kits, Infrared (IR) Thermometers, Personal Protective Equipment(PPE) Kits & N-95 masks.
The medical devices sector in India is a sunrise sector which is growing at a fast pace. The market size of the medical devices sector in India is estimated to be $11 billion (approximately, ₹ 90,000 Cr) in 2020 and its share in the global medical device market is estimated to be 1.5%. The Indian medical devices sector is on a growth track and has an enormous potential to become self-reliant and to contribute towards the goal of universal health care. The Government of India has already initiated implementation of PLI Scheme for medical devices and support for setting up of 4 Medical devices Parks in the States of Himachal Pradesh, Madhya Pradesh, Tamil Nadu and Uttar Pradesh. Under the PLI scheme for Medical Devices, till now, a total of 26 projects have been approved, with a committed investment of Rs.1206 Cr and out of this, so far, an investment of Rs.714 Cr has been achieved. Under the PLI scheme, total of 14 projects producing 37 products have been commissioned and domestic manufacturing of high-end medical devices has started which include Linear Accelerator, MRI Scan, CT-Scan, Mammogram, C-Arm, MRI Coils, high end X-ray tubes, etc. Remaining 12 products will be commissioned in near future. Five projects out of total 26 projects have been approved recently, under Category B, for domestic manufacturing of 87 products / product components.
Building upon these measures, a holistic policy framework to accelerate this growth and fulfil the potential of the sector is the need of the hour. While various Departments of the Government have undertaken programmatic interventions to encourage the sector, the current policy aims to put in place a comprehensive set of focus areas for growth of the sector in a coordinated manner. Secondly, in view of the diversity and multi-disciplinary nature of the sector, the regulations, skilling trade promotion of medical device industry are spread over several departments in the Government both at the Centre and State levels. There is a need to bring together the range of interventions in a coherent manner that would facilitate focused and efficient support and facilitation for the sector by the respective agencies.
The National Medical Devices Policy, 2023 is expected to facilitate an orderly growth of the medical device sector to meet the public health objectives of access, affordability, quality and innovation. This sector is expected to realize its full potential, with the strategies viz, building an enabling ecosystem for manufacturing along with a focus on innovation, creating a robust and streamlined regulatory framework, providing support in training and capacity building programs and promoting higher education to foster talent and skilled resources in line with the industry requirements. Encouraging domestic investments and production of medical devices complements the Government’s ‘Atmanirbhar Bharat’ and ‘Make in India’ programs.
The draft of the National Medical Device Policy was released in 2020, and it has received feedback from various stakeholders, including medical device manufacturers, healthcare professionals, and industry associations. Here are some key provisions of the policy proposal:
Promoting Local Manufacturing
One of the primary aims of the policy is to encourage local manufacturing of medical devices. To achieve this goal, the policy proposes various financial incentives to manufacturers, including tax breaks and subsidies for infrastructure development. The government hopes that these incentives will attract both domestic and foreign investments in the sector.
Indigenous Technology and Innovation
The policy emphasizes the need for developing indigenous technology and innovation in the medical device sector. It acknowledges that India has a vast pool of scientific talent that can contribute to the development of new and innovative medical devices. The policy proposes to create a supportive ecosystem for startups and small and medium-sized enterprises (SMEs) to innovate and bring their products to market.
Regulatory Oversight
The policy proposes to establish a regulatory body called the National Medical Device Authority (NMDA). The NMDA will be responsible for setting manufacturing standards, quality control, and regulatory oversight for medical devices. The authority will have the power to certify medical devices and impose penalties for non-compliance. The policy also proposes to create a risk-based classification system for medical devices, which will determine the regulatory requirements based on the level of risk associated with each device.
Clinical Research
The policy seeks to create a supportive environment for clinical research and the development of medical devices in India. It proposes to streamline the regulatory processes for clinical trials and create a platform for collaboration between industry and academia. The policy also proposes to create a registry for medical devices to monitor post-market safety and efficacy.
Medical Device Supply Chain
The policy aims to create a robust medical device supply chain, including provisions for purchase preference to domestically manufactured medical devices for public procurement. The policy also envisages the creation of a network of testing and certification centers to ensure quality control throughout the supply chain. The government hopes that this will support the growth of the domestic medical device industry and reduce dependency on imports.
Healthcare Professional Training
The policy proposes to establish training and skill development programs for healthcare professionals on the safe and effective use of medical devices. It acknowledges that the use of medical devices requires specialized training and knowledge, and the policy aims to bridge this gap by creating training programs for doctors, nurses, technicians, and other healthcare professionals.
The National Medical Device Policy of India is a comprehensive proposal that seeks to create a more conducive environment for the development of the medical device industry in India. It aims to promote local manufacturing, innovation, and regulatory oversight, as well as create a supportive environment for clinical research and the development of new medical devices. The success of this policy will depend on its implementation, and the government will need to work closely with industry stakeholders to ensure its success.
