National Medical Devices Policy 2023: Opportunities & Challenges

The newly announced National Medical Devices Policy, 2023, intends to expand India's footprint in the global medical device industry from 1.5% to 10-12% over the next 25 years, resulting in increased sector growth from $11 billion to $50 billion. The policy would help pave the path for India to become an end-to-end healthcare resource centre not just for the country, but also for global accessibility, affordability, quality, and innovation demands.

The policy is aligned with the government's "Atmanirbhar Bharat" and "Make in India" initiatives, which aim to increase domestic investment and medical device production. The goal is to promote missions such as improving access and universality, affordability, quality, patient-centred and quality treatment, preventative and promotive health, security, research and innovation, and skilled people to accelerate the expansion of India's medical devices business. The Policy provides a set of initiatives in six important areas to achieve these aims, including regulatory simplification, enabling infrastructure, supporting R&D and innovation, attracting investments, human resource development, and trade promotion.

The Medical Devices Rules of 2017 classify medical devices into four categories based on their level of risk, with Class A having the lowest and Class D having the highest level of risk. Class A devices are considered low-risk and do not require regulatory approval. On the other hand, Class D devices are high-risk and require the most stringent regulatory scrutiny.

Class A devices include low-risk items such as stethoscopes, thermometers, and blood pressure monitors, which are exempt from Central Drugs Standard Control Organisation (CDSCO) registration but must adhere to prescribed standards. Class B devices include moderate-risk items such as syringes, surgical drapes, and nebulisers. Manufacturers of Class B devices must register their products with the CDSCO and obtain a registration certificate while complying with prescribed standards.

Class C devices include high-risk items such as blood glucose monitors, implantable devices, and pacemakers. Manufacturers of Class C devices must obtain a license from the CDSCO, conduct clinical trials, and secure a no-objection certificate (NOC) from the CDSCO. Finally, Class D devices include very high-risk items such as artificial hearts, critical care ventilators, and heart-lung machines. Manufacturers of Class D devices must obtain a license from the CDSCO, conduct clinical trials, and secure a NOC from the CDSCO.

India has enormous potential to become self-reliant in this sector and contribute to the goal of universal healthcare.  To date, the government has approved 26 projects under the PLI Scheme with a committed investment of Rs. 1206 Crore, of which Rs. 714 Crore has been invested so far. Under the scheme, 14 projects producing 37 high-end medical devices such as linear accelerators, MRI scans, CT scans, mammograms, C-arms, MRI coils, and high-end X-ray tube products have been commissioned and the remaining 12 will be shortly commissioned. In addition, five projects have been approved for domestic manufacturing of 87 products under Category B. The government has also extended its support in setting up 4 Medical Devices Parks in the States of Himachal Pradesh, Madhya Pradesh, Tamil Nadu and Uttar Pradesh.

 

New Trends in Medical Devices

Medical technology and medical devices continue to evolve rapidly, bringing innovative solutions. From Big Data to Wearables to Robotics, the industry is seeing rapid innovation and growth. Here are some of the latest trends in medical devices:

Big Data: Companies are using predictive analytics models to gather patients’ vital data to make informed decisions for the patient's health. For example, Medtronic and IBM have developed a mobile personal assistant application that provides real-time glucose insights helping the individual understand the links between glucose readings, lifestyle choices and drug administration. Cipla launched 'Spirofy', India's first pneumotach-based portable, wireless spirometer to monitor lung condition.

New Devices: Innovative devices are being developed to address challenges in the healthcare system, such as the InsuliCool product range by Godrej Appliances for insulin storage. Medtronic India launched Micra AV - a miniaturised, fully self-contained pacemaker that delivers advanced pacing technology to atrioventricular (AV) block patients via a minimally invasive approach.

Wearables: Wearables such as glucose monitors, exercise trackers and wearables for mental health are becoming increasingly popular among consumers due to their ease of use. Recently launched Ultrahuman Ring, which can track users' metabolism, and measure movement, sleep, and other body dynamics in real-time.

Robotics: India has witnessed significant developments in robotics, particularly in the field of surgical robots. The Rajiv Gandhi Cancer Institute and Research Center received its first Made-in-India surgical robotic system, while Medtronic launched a Surgical Robot Experience Center to train surgeons in robot-assisted surgery. Siemens Healthineers also introduced Corindus, a robotic system for cardiovascular interventions. Startups such as SS Innovations are developing surgical robotic systems, and Medtronic's SREC focuses on surgeon education and training.

The National Institute of Pharmaceutical Education and Research now offers a Master in Technology in Medical Devices, highlighting the promising future of the industry in India due to continuous investment, innovation, and research.