India’s healthcare sector has seen substantial improvements in the 21st century. According to a survey, India has achieved a 10% growth rate in this sector. The industry is expected to reach a value of USD280 billion by 2025. The healthcare industry is not only India’s largest revenue generator, but it is also one of the fastest-growing job sectors. Medical care services include hospitals, medical equipment, clinical trials, outsourcing, telemedicine, medical insurance, and diagnostic supplies. Medical devices play a role in restoring patients to normal lifestyles, and they involve regularly monitoring health indicators to combat and manage disease, in addition to screening, diagnosing, and treating patients. Numerous innovative improvements in the healthcare field have been made, including an increase in the use of technology.
At the start of the pandemic, India’s pharmaceutical and biotechnology sectors bore a greater burden and faced numerous challenges, owing to reliance on other supply chains and disruption of the supply and demand system. These difficulties included the need to rapidly manufacture and make products available to the public, as well as the need to facilitate adequate access to those products. The pandemic created opportunities in the form of a call for aatmanirbhar, or self-sufficiency, providing a bright side to the situation.
Medical devices (MDs) have emerged as an essential component of the healthcare industry in all developing nations with sensitive healthcare systems. They are used in the healthcare industry for a variety of purposes, including screening and diagnosis, treatment and care, restoration, and monitoring. Diagnostic devices, digital healthcare, IT-linked technologies, and telemedicine are the most promising segments of the healthcare and medical equipment sector. Some advances, like interventional radiology, electro-healthcare products, orthopaedic and prosthetic devices, cancer diagnostics, ophthalmic devices, orthodontic equipment, dental implants, and point-of-care testing (POCT), make it easier for patients to follow their treatment plans.
Recent developments in the healthcare sector
Increased public and private investment, in addition to innovations in healthcare technology, have contributed to India’s booming healthcare sector. Considering India’s existing substantial employment levels, this sector accounts for 15% of the country’s GDP and more than 40% of total job creation. Indian lawmakers first passed the National Health Policy in 1983, updating it in 2002 and again in 2017. To date, public healthcare policies have been the most consequential factor in the expansion of the private healthcare sector. Ayushman Bharat is a programme that was started by the government of India in 2018 to improve healthcare. It remains in place and its number of users continues to grow.
Market status of the healthcare and medical devices sector in India
Home medical equipment
The Indian public healthcare system serves nearly half of the country’s population. The availability of home medical equipment has grown in lockstep with the growing number of people suffering from chronic illnesses. Having medical devices and wearables at home offers a number of benefits, including the ability to monitor vital signs in a familiar and comfortable environment. Home medical equipment is still in high demand and internet searches are increasing. Self-monitoring at home can assist both patients and caregivers in lowering the risk of infection. Remote monitoring is now possible with newer medical devices via network connections such as the internet and mobile phones.
Medical device sector growth
The India Brand Equity Foundation (IBEF) reports that the medical equipment market in India is projected to grow from USD10.36 billion in 2020 to USD50 billion in 2025, a compound annual growth rate (CAGR) of 37.5%. The Government of India (GOI) has started a number of programmes to help the medical device industry grow. These programmes focus on R&D and are completely open to foreign direct investment (FDI) in the medical devices market.
The diagnostic imaging market is expected to grow at a CAGR of 13.5% between 2020 and 2025. The medical device industry has developed its own distinct approach to successfully combining engineering and medical practice. The biomechanics method has been created to help engineers in developing life-sustaining technologies. Medical devices incorporate engineering, electronics, materials science, information technology and other fields in carrying out their many different functions.
Pursuing sector growth
Lack of adequate infrastructure and logistics, concentrated supply chains, and high financing costs are among the primary barriers to medical device manufacturing in India. Medical device manufacturing is one of the “sunrise sectors” targeted by the “Make in India” programme, which aims to increase domestic manufacturing and reduce reliance on imported goods. To spur economic growth, the GOI must set priorities and strike a balance between being business-friendly and relying on internal resources. According to the International Biomedical Equipment Federation, India’s medical equipment market is the world’s 22nd largest. The federation predicts the value of the market to increase from USD5.2 billion in 2020 to USD50 billion by 2025.
Recent regulatory developments and initiatives by government
Draft National Policy for Medical Devices, 2022
The Ministry of Chemicals and Fertilizers’ Department of Pharmaceuticals (DoP) recently published an approach paper for the draft National Policy for Medical Devices, 2022. The proposed policy’s main components are:
- regulatory simplification to optimise regulatory processes;
- agency proliferation to ease business; and
- adherence to global standards to ensure device uniformity and safety.
Competitiveness is increased by providing financial and tax incentives to encourage private sector investment in the local manufacturing environment. Infrastructure is being built to provide top-tier physical facilities, such as medical device parks, with shared amenities such as testing facilities in order to increase cost competitiveness and to attract domestic manufacturers. Improving collaboration between key stakeholders, international collaborators and joint ventures with a focus on R&D and innovation will contribute to closing the gap between what academics need and what the market wants.
The strategy aims to achieve cost, safety and quality objectives, while also emphasising innovation and self-sufficiency. The policy envisions that the number of India’s National Institutes of Medical Device Education and Research (NIMERs) would be increased by 2047. The medical technology sector will be worth USD100-300 billion, with a 10-12% global market share. The medical device sector is an important part of the Indian healthcare system, especially when it comes to preventing, diagnosing, treating, and managing a wide range of medical problems, conditions, and impairments.
Existing policy framework
Prior to the Central Drugs Standard Control Organization (CDSCO) establishing the Medical Device Rules in 2017, the industry was largely unregulated. The Drugs and Cosmetics Act of 1940 established rules for the complete, progressive control of MDs, with a focus on quality, safety, and efficacy. This industry broadly corresponds to the categories for electronics equipment, implants, consumables and disposables, in vitro diagnostics (IVDs) reagents and surgical instruments. It was clear that the Indian medical device industry was involved when Indian creators produced ventilators, reverse transcriptase polymerase chain reaction (RT-PCR) kits, infrared thermometers, personal protective equipment (PPE) kits and N-95 masks to help the world fight the COVID-19 pandemic.
ICMR at IITs and production-linked incentive plans
The Union budget 2022–23 allocated INR86,200 crores (USD11.3 billion) to the pharmaceutical and healthcare sectors. The Indian Council of Medical Research (ICMR) and Indian Institutes of Technology (IITs) collaborated to create “ICMR at IITs” in November 2021 by establishing centres of excellence (CoE) for the development and commercialisation of “made in India” medical devices and diagnostics. For FY 2021-28, the DoP set up a production-linked incentive plan (PLI) for making medical devices in India. This plan will cost INR3,420 crore (USD468.78 million) in total.
A PLI for pharmaceuticals, costing INR15,000 crore, was launched in March 2021. This initiative aims to boost India’s manufacturing capacity by increasing investment and output in the pharmaceutical and medical device industries, as well as providing access to low-cost drugs. The PLI encourages the domestic production of medical devices. Medical equipment parks promote domestic production and the medical device industry’s “Make in India” growth segment.
The New Drugs, Medical Devices, and Cosmetics Bill, 2022
On 8 July 2022, the GOI proposed the New Drugs, Medical Devices, and Cosmetics Bill, 2022. The proposed bill aims to regulate medical devices and online pharmacies, and it includes stronger punishment for failing to compensate people injured or killed during drug or medical device clinical trials. The draft also includes guidelines for conducting clinical trials for novel medications and medical devices. The bill also seeks to establish rules for Sowa Rigpa (a traditional medicine system) and homoeopathy in a separate chapter for ayurveda, yoga & naturopathy, unani, siddha and homeopathy (AYUSH) medicines for the first time.
The proposed draft adds a number of new definitions or provisions for greater clarity, efficient operation, and effective implementation, such as bioequivalence study, bioavailability study, clinical trial, clinical investigation, controlling authority, manufacturer, medical device, new drugs, over-the-counter (OTC) drugs, adulterated cosmetics, and so on. To provide technical advice to the GOI, the establishment of a separate Drugs Technical Advisory Board (DTAB) and Medical Devices Technical Advisory Board (MDTAB) comprised of experts from various associations has been proposed.
Furthermore, the GOI has the authority to decide for the central licensing authority to waive clinical trials for the manufacture or import of new drugs or investigational new drugs into the country in the interest of public health or when the drug is in desperate need. The operation of an e-pharmacy requires prior approval. Measures have also been put in place to allow the GOI to select or build medical device testing facilities that will be used by regulators and the industry itself to evaluate and test medical devices.
Emerging opportunities and developments amid COVID-19 and its impacts in the medical device sector in India
In India’s medical apparatus market, an excellent new opportunity has emerged. India’s medical equipment market is worth approximately USD11 billion, ranking it 19th in the world. Several government programmes, such as the Ayushman Bharat programme, have helped the industry grow to the point where it is expected to reach USD50 billion in the next five years. During COVID-19, the government’s push for self-sufficiency opened up new markets for a variety of products and services, including medical device production. The current market situation means that India is a profitable location for medical device production.
The GOI’s research think tank, the National Institute for Transforming India (NITI Aayog), has devised a strategy to increase domestic production of medical equipment. Furthermore, the GOI has automatically approved 100% FDI for medical product manufacturing firms. The GOI has taken steps to position India as a global leader in the production of medical devices by removing all barriers to investment and providing tailored solutions.
The response of India’s healthcare sector to the COVID-19 pandemic
The Indian healthcare sector appears to be on the verge of rapid expansion in the near future. This is demonstrated by the fact that when the COVID-19 outbreak hit India, the country’s healthcare system stepped up to the plate. As a result, the GOI has shifted its focus to ensuring the country’s own supply of pharmaceuticals and medical supplies. By addressing the issues brought on by the pandemic, the healthcare industry has laid the groundwork for future growth. India not only manufactures but also exports vaccines as part of the national COVID-19 immunisation programme. Covaxin was developed by Hyderabad-based Bharat Biotech and is currently manufactured by the Serum Institute of India (SII). Covishield was developed by Oxford-AstraZeneca and is now manufactured by SII. The main distributor of Russia’s Sputnik V vaccine is Dr. Reddy’s Laboratories.
The GOI’s agency for encouraging and facilitating investment, Invest India, predicts that the telemedicine market will be worth USD5.42 billion by 2025, which is a CAGR of 31%.
Medical devices and COVID-19
Medical equipment is another rapidly growing industry. According to government reports, India’s medical devices industry, the fourth largest in Asia, is currently worth around USD15 billion and has grown at a CAGR of 15% over the last three years. The market is expected to reach USD50 billion by 2025. Medical device manufacturers and suppliers will find plenty of opportunities in India. As a result of massive investments in cutting-edge diagnostic facilities, the country has also emerged as a top destination for high-end diagnostic services, making it more accessible to a broader range of people. R&D opportunities in India also offer options for medical tourism.
Despite the fact that COVID-19 has resulted in the growth of diagnostics and equipment, as well as the outstanding growth of virtual and homecare device segments, there has been a shift in focus toward the development of inexpensive lifesaving devices such as ventilators and oxygen concentrators. In the coming years, disease prediction in India will gain traction with the use of cutting-edge technologies such as big data, artificial intelligence, and machine learning. According to the IBEF, the size of India’s healthcare infrastructure is expected to reach USD349.1 billion by FY2022, with the e-health sector expected to reach USD10.6 billion by 2025. According to Invest India, India’s healthcare market will grow at a 39% CAGR from USD190 billion in 2020 to USD372 billion in 2022. Experts in public health think that the pandemic presented India with a huge challenge, but also with a chance to build up its own healthcare infrastructure.
As a result, medical facilities and diagnostic centres rose to the challenge of treating such a large number of patients, and as a result, their output increased dramatically. Millions of people who were infected with COVID-19 were able to get the care they needed because of how quickly new care methods, like telemedicine and home health, were adopted.
India’s nutraceutical sector
According to the International Trade Administration, India’s nutraceutical sector will account for at least 3.5% of the global market by 2023. Experts predict that India’s nutraceutical market will be worth USD18 billion by 2025. Over 65% of the rapidly expanding nutraceutical market can be attributed to the dietary supplement subsector alone. With a focus on disease prevention, this industry is expected to grow at a rate of 22% per year. The nutraceutical industry has also expanded significantly in order to attract foreign investors. The Indian Medicines Pharmaceutical Corporation Ltd, the Ministry of AYUSH’s public sector manufacturing unit, achieved a turnover of INR164.33 crore in 2020–21, the highest in its history, reflecting the public’s increased demand for AYUSH products and services in the aftermath of the pandemic. Although COVID-19 was indeed a disaster, it pushed India’s healthcare system forward.
Objectives and prospects for the healthcare sector
It is anticipated that healthcare development in India will accelerate in the years following the pandemic. The GOI’s Ayushman programme has helped underprivileged citizens gain access to healthcare. A project of this nature will assist in elevating the profile of rural healthcare providers. There are many challenges and opportunities in the healthcare system, but with the help of government programmes, it stands a good chance of succeeding.
Opportunities abound for healthcare providers and investors, and in medical technology in India’s vast healthcare market. Despite the fact that these services are more expensive and only accessible to a smaller proportion of the population, the country has seen significant investment in high-tech diagnostic facilities, making it a popular choice for those seeking diagnostic services. Patients in India are increasingly worried about their general health. Increasing public health spending to 2.5% of GDP by 2025 is part of the GOI’s long-term healthcare strategy. The country has a lot of opportunities for R&D, as well as for medical tourism.
Lastly, the healthcare infrastructure in India’s cities and rural areas is an attractive prospect for investment. Supporting policies are needed so that the Indian medical device industry can make quality affordable healthcare available to the general public, achieve its aim of making India one of the top five global manufacturing hubs for medical devices, and help India end its 80%–85% reliance on imports and reduce its ever-growing import bill, which is currently over INR46,000 crores.
Achieving an improved healthcare system
The industry requires specific co-ordination and communication between the industry and stakeholders due to its diverse nature, continuous innovation and variation. In tandem with medical and technological advancements, emphasis should be placed on increasing the competency of the Indian medical devices industry through skilling, upskilling, and reskilling. Through collaborative policy initiatives, the goal should also include bolstering the supply and demand aspects of the medical device industry. By making the supply chain flexible and managing its parts well, patients can get better care while the industry can observe the growth and potential of the healthcare sector.
Medical Devices form a significant part of the healthcare sector. In this article, the authors @ Manisha Singh, @ Rajeev Kumar and @ Pankaj Musyuni, discuss the market and regulatory trend of medical devices and the emerging opportunities in India.
Read more at @ Chambers & Partners: https://practiceguides.chambers.com/practice-guides/medical-devices-consumer-health-products-2022/india/trends-and-developments