Medical Devices and Vaccines Atmanirbhar Manufacturing

Globally, healthcare industry is enlaced in fighting corona virus, which triggered sudden pause in all manufacturing activities, forcing nations into lockdowns. The face masking and sanitization has become an undeniable self-safety trend. The silent pandemic forced scientific opportunity for innovation and self-reliance in manufacturing medical devices, vaccine etc. Precisely, corona wave birthed a naïve term Atmnirbharta, readying India for new normal times … - Gopal Krishna Anand.

Technology and innovation forecast a nation’s growth, economic development and reducing import dependence. Innovation is important, yet at times, it is constructive to import technology, indigenize it and shape it as a manufacturing mechanism. The pandemic propels innovation and digital acceleration for production, in almost any field, from education to healthcare. Adding to the innovative paradigm, encouraging is: India climbed four spots in the 13th edition of Global Innovation Index 2020, attaining 48th position in the list of top 50 innovative countries, as per World Intellectual Property Organization (WIPO) annual ranking.

Atmanirbhar Manufacturing

Atmnirbharta infuses confidence and optimism – to jumpstart health and economy, instilling indigenous culture of developing technology to bring down pricing. The rise in medical technology and R&D investment will boost the next-gen medical device industry. The pandemic forced the need for self-reliance in manufacturing to reduce its dependence on imported products. An example of a self-reliant India is – growth of India’s personal protective equipment (PPE) sector ‘from zero before March 2020 to 1, 50,000’ pieces a day by beginning of May. PPE industry in India has become a Rs. 7,000 crore plus market, the second largest after China.

Prime Minister Narendra Modi, during May 2020, made a call for an ‘Aatma Nirbhar Bharat’ – a self-reliant India to invigorate the industries. He revealed the financial stimuli, the government had planned to revive the businesses. Self-reliant India is an approach to attain self-reliance by building capacities, skilling people and competing globally.

Made in India Covaxin, Covishield vaccines

Modi congratulated the scientists & innovators of Bharat Biotech and Serum Institute of India (SII) after the Drug Controller General of India (DCGI) approved the ingeniously developed Covaxin and Oxford’s Covishield for emergency use. Hailing approval of the vaccine as a ‘decisive turning point’ to strengthen a spirited fight against the coronavirus pandemic he said, Made in India will make every Indian proud and highlighted that it showed the spirit of the scientific community in India to fulfil the dream of an ‘Aatmanirbhar Bharat’.

Dr. Harsha Vardhan, Union minister for Health and family Welfare recently observed that even the cost of testing kits has been down with the local manufacturing kicking in. There used to be no one manufacturing PPE kits here, but now there are 110 manufacturers as well as 25 makers of ventilators in the country.

Serum Institute’s indigenous Pneumosil

Speaking on the PM’s commitment of Atmanirbhar Bharat and his vision of ‘Making In India for the World’, Dr. Harsh Vardhan, noted, “Pneumosil is an example of India’s capability in R&D; manufacturing high end sophisticated Vaccines. In fact, it is matter of pride for our country for this historical milestone during COVID-19 Pandemic because till now we are fully dependent on Pneumococcal Conjugate Vaccine manufactured by Foreign Manufacturers which are available at very high prices.” Serum Institute’s first Indigenous Pneumococcal Conjugate Vaccine will be available in the market under brand name Pneumosil at an affordable price.

Sharing what ‘self-reliance’ means for the MedTech industry, Pavan Choudary, Chairman and Director General, Medical Technology Association of India says, “We are fully aligned with the PM’s vision for a self-reliant India. After due reflection, MTaI has come to the view that Aatma Nirbharta in medical technology sector would be achieved when we can make competitive products in India, when people of India can be treated in India without having to travel abroad and without having to spend precious foreign exchange, when R&D flourishes to create innovative solutions and when every Indian healthcare worker gets trained as well as his best global counterpart.”

Medical devices notified as drugs

Medical devices are notified as ‘Drugs’ from 1st April 2020 vide order issued by Ministry of Health & Family Welfare, and shall be regulated as drugs for quality control and price monitoring. Therefore, MPRs of the medical devices would be monitored by government. National Pharmaceutical Pricing Authority (NPPA) held a consultation with medical devices industry associations and Civil Society Group during July 2020, wherein it was stressed that all the manufacturers/importers of critical medical equipment shall ensure sufficient availability of the same. In line with that, NPPA is monitoring price increase of critical medical equipments for COVID-19 Pulse Oximeter and Oyxgen Concentrators. Chairman, NPPA also urged the Industry that it is not ‘Business as usual’ and not the time to profiteer in times of public health emergency.

Schemes for domestic manufacturing

Currently, the medical device industry depends on imports to an extent of 86%. Domestic manufacturing is limited to surgical, cardiac stents and general medical devices and consumables. Country has 750–800 domestic medical devices manufacturers and six medical devices manufacturing clusters in the country: Andhra Pradesh, Telangana, Gujarat, Haryana, karnatka, Maharashtra and Tamil Nadu. Clusters have ‘Medical Device Parks’ developing around them. The scheme on promotion for financing Common Infrastructure Facilities in four Medical Device Parks has financial implications of Rs. 400 crore.

Production linked incentive (PLI) scheme for promoting domestic manufacturing of medical devices intends to boost domestic manufacturing of medical devices with financial implications of Rs. 3,420 crore in four target segments: cancer care / radiotherapy; radiology and nuclear imaging devices; anesthetics & cardio-respiratory and renal care medical devices and implants including implantable electronic devices, by giving financial incentives at a rate of 5% of the sales of domestically manufactured medical devices.

Rajiv Nath, MD – Hindustan Syringes & Medical Devices, Forum Coordinator, Association of Indian Medical Devices Industry (AiMeD) said, “PLI scheme is designed to attract investors in above select four high technology target segments of medical devices where import dependence is very high. AiMeD is in discussions with various state governments to set up medical devices parks and infrastructure to strengthen existing clusters to translate our vision to make India to be one of top five manufacturing hubs of medical devices. We are excited by the focus that medical devices industry is finally having and the keen interest being taken by Government of India in making medical devices in India to be a rewarding experience.” He tweeted, India needs to turn the pandemic into an opportunity, develop a large domestic market to position itself as an exporter in the MedTech space through innovative solutions, and with conducive policies, reduce import dependence.

It is expected that these schemes will make India self-reliant and will cater to the global demand for the selected bulk drugs and medical devices. The incentivisation to industry and infrastructure support will bring down the cost of production. According to government sources, the cumulative manufacturing investment in drugs and four medical devices parks has been estimated at Rs 77,900 crore and their job potential at 2,55,000.

Dr. G S K Velu, Chairman and Managing Director, Trivitron Group of Companies, said, “We have been focused on making world-class Made-in-India medical technology solutions for domestic and global markets. The current situation of COVID-19 pandemic demanded innovation in developing indigenous and economical testing kits for the Indian market and we have responded to this. We have a complete range of COVID testing portfolio which will enable scaling up of current testing needs of the Indian & International Healthcare Ecosystem.’’

Medical device market growth

The market is growing at a faster pace in emerging nations. Fortune Business Insights reports, global medical devices market to reach USD 612.7 billion by 2025 from USD 425.5 bn in 2018, growing at CAGR of 5.4% 2018-2025. USA is the dominant market for medical devices followed by European market with a share of 30% and Japan with a share of 10%. Medical devices sector in India is relatively small, though India is one of the top twenty markets for medical devices in the world and is the 4th largest market in Asia after Japan, China and South Korea. Dr. Praveen Gedam, Addl. CEO, Ayushman Bharat, during the webinar session mentioned, Indian medical device market is around $11 billion growing at 15% CAGR and expected to touch $50 Billion by 2025. Despite of having skilled manpower, scale and big market size, over $ 6.2 bn of medical devices are imported in India showing almost 75-80% of import dependency.

Geoff Martha, Chief Executive Officer, Medtronic says, “Everything we make and everything we do works to alleviate pain, restore health, and extend life. We provide health, and we provide hope. People are depending on us, and we cannot let them down. We must continue to innovate and fulfill our Mission.” Medtronic as the leading player with a strong presence across the globe, adhering to business expansions policies in emerging countries such as China, India etc., will drive the market in this region.

Our country is perched to become self-reliant in high-end medical devices. Medical devices industry has the highest growth potential among all sectors in the healthcare market. It is expected to reach to Rs. 86,840 crore by 2021-22. Recently, during inauguration of a virtual CII’s 12th MedTech Global Summit, Piyush Goyal, Commerce and Industry Minister spoke, “The medical devices industry laboured and helped us indigenously prepare products required to fight COVID-19. Our doctors, paramedics and medical fraternity have made the nation proud by serving the common man relentlessly through their commitment to ensure the safety and well-being of India.” He hoped that the domestic pharma and medical devices industry will be at the forefront in bringing cutting-edge technology to India and ensuring the country’s rightful place in the global trade. The healthcare and medical devices industry needs to leverage the tools of technology to recharge the domestic health system, said he, adding that they have shown to the world that India can be a trusted partner, when it comes to global engagement and trade. “Our industries of pharma, medical devices and the medical profession will evolve, with the realisation that being self-reliant is important to care for the lives of the people, says Piyush Goyal.

Resilient evolving future

Self-reliance is emerging the world over. Evolving healthcare infrastructure and faster adoption of novel medical technologies will boost medical devices market in Asia-pacific region. The government, allowing 100% FDI in medical devices industry, plans to attract Rs 40,000 crore of investment in the medical device sector alone. Further, as per government policy, procurement of medical devices that are under Rs. 200 crore by government institutions must be done from local companies. Nanotechnology, used for new medical devices like diagnostics and implantable devices as well as stents and catheters, along with healthcare awareness is also a factor to support growth of global market in near future.

Conclusively, to support medical innovation, health system innovation is a necessity. Preventive healthcare will ensure the availability of quality equipment and facilities. Perceptibly, resilience from long pause, with Atmanirbhar manufacturing, will accentuate growth and economic stimulation of domestic medical devices industry.

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