The National Medical Devices Policy (NMDP) 2023 is a comprehensive policy that aims to regulate the medical device industry in India. The policy is designed to improve the quality, affordability, accessibility, and safety of medical devices in the country. In this article, we will discuss the key provisions of the National Medical Devices Policy 2023, its impact on the medical device industry in India, and the benefits it brings to patients.
Modi cabinet has approved the National Medical Device Policy 2023. Medical devices sector is an essential and integral part of the Indian healthcare sector. This sector became even more important when India mass-produced medical equipment such as ventilators, rapid antigen test kits, RT-PCR kits, IR thermometers, PPE kits and N95 masks, and in the fight against Corona. supported the world.
Domestic production of 37 goods under PLI scheme-
The medical device sector is rapidly emerging in India. Its market size in India is estimated to be Rs 90 thousand crore. The Indian medical sector is growing rapidly and has full potential to become self-sufficient. Already Government of India is helping to set up 4 Medical Devices Parks in Himachal Pradesh, Madhya Pradesh, Tamil Nadu and UP under PLI scheme. Under this scheme, 26 projects have been approved. While 14 projects have been commissioned, in which 37 products are being manufactured at the domestic level. This includes Linear Accelerator, MRI Scan, CT-Scan, Mammogram, C-Arm, MRI Coil, State-of-the-Art X-Ray Tube etc. Soon 12 more products will be prepared in it.
A policy is needed to develop the medical device sector even faster. The purpose of this policy is to prepare a comprehensive plan for development in the focus areas. There is a need to bring together all the departments related to it at the central and state level under one plan, so that it can be used as much as possible. The National Medical Device Policy 2023 is expected to facilitate orderly development of the medical device sector to meet the objectives of public health.
What is special in the policy-
With the help of the National Medical Device Policy, the government will work to make the medical device sector a leader. The target is to make India a global leader in manufacturing and innovation of medical devices. The target is to increase India’s share in the global market to 10-12 per cent in the next 25 years. This policy will help in increasing the medical device sector from US$ 11 billion to US$ 50 billion by the year 2030.
In this policy, a roadmap has been prepared for the medical device sector, so that quality, research, innovation and skilled manpower can be further improved.
Overview of the National Medical Devices Policy 2023
The National Medical Devices Policy 2023 was released by the Ministry of Health and Family Welfare on 15th February 2021. The policy is based on three main pillars: patient safety, quality, and affordability. The policy aims to achieve these pillars by regulating the entire lifecycle of medical devices – from manufacturing to disposal. The policy covers all medical devices, including diagnostics, implants, and consumables.
Regulatory Framework of the National Medical Devices Policy 2023
The National Medical Devices Policy 2023 aims to establish a robust regulatory framework for medical devices in India. The policy proposes to create a new regulatory authority, the National Medical Devices Administration (NMDA), which will be responsible for regulating medical devices in the country. The NMDA will replace the Central Drugs Standard Control Organization (CDSCO) as the primary regulatory body for medical devices.
Key Provisions of the National Medical Devices Policy 2023
The National Medical Devices Policy 2023 proposes several key provisions that will impact the medical device industry in India. These provisions include:
1. Classification of Medical Devices
The policy proposes a risk-based classification system for medical devices. Medical devices will be classified into four classes based on their level of risk: low-risk, moderate-risk, high-risk, and very high-risk.
2. Quality Standards
The policy proposes to establish quality standards for medical devices. The standards will be based on international best practices and will cover the entire lifecycle of medical devices – from manufacturing to disposal.
3. Pricing of Medical Devices
The policy proposes to regulate the pricing of medical devices in India. The pricing will be based on a formula that takes into account the cost of production, research and development, and other relevant factors.
4. Import and Export of Medical Devices
The policy proposes to regulate the import and export of medical devices in India. All medical devices will require registration with the NMDA before importation or exportation.
5. Clinical Trials
The policy proposes to establish a robust regulatory framework for clinical trials of medical devices. The framework will be based on international best practices and will ensure patient safety and ethical conduct.
Impact of National Medical Devices Policy 2023
The National Medical Devices Policy 2023 is expected to have a significant impact on the medical device industry in India. The policy will improve the quality, affordability, accessibility, and safety of medical devices in the country. The policy will also encourage innovation and entrepreneurship in the medical device industry.
Benefits of National Medical Devices Policy 2023 for Patients
The National Medical Devices Policy 2023 brings several benefits to patients. These benefits include:
1. Improved Quality
The policy will ensure that medical devices meet international quality standards. This will improve the quality of medical care in the country.
2. Affordable Medical Devices
The policy will regulate the pricing of medical devices in India. This will make medical devices more affordable for patients.
3. Accessibility of Medical Devices
The policy will ensure that medical devices are accessible to patients in all parts of the country. This will improve healthcare outcomes in the country.
4. Human Resource Development
Work will also be done on the development of human resources. It envisages a policy for supply of skilled work force in the field of scientists, regulators, health experts, managers, technicians. The resources of the Ministry of Skill Development and Entrepreneurship can be leveraged to enhance skilling, reskilling and skills in the medical device sector.
5. Brand positioning and awareness generation
Under this policy, it has been said to form an Export Promotion Council. Which will be able to solve all the problems related to the market. It also includes working on projects to learn manufacturing and skilling systems at the global level. From this, it can be ascertained that the models which are working well at the global level have potential in India.
6. Facilitate research and development
Research and development and innovation will be promoted in the National Medical Device Policy. Its purpose is to create academic and research institutions, innovation centers, plug and play infrastructure and help startups.
Conclusion:
The National Medical Devices Policy 2023 is a significant step towards regulating the medical device industry in India. The policy proposes several key provisions that will impact the industry, including the establishment of a new regulatory authority, quality standards for medical devices, and a risk-based classification system. The policy is expected to improve the quality, affordability, accessibility, and safety of medical devices in the country, and bring several benefits to patients.