Medtech sector inches towards self-reliance

The medical device industry seeks Government support in terms of various policy initiatives to realise its potential

The number of Indian firms manufacturing, ventilator manufacturers went up from 8 to 15.
The number of Indian firms manufacturing, ventilator manufacturers went up from 8 to 15.

Pavan Choudary, Chairman and Director General, Medical Technology Association of India

The highly import dependent medical devices sector had posed several challenges during the outbreak of the COVID-19 pandemic situation. Thus, the Government of India through its flagship ‘Make in Indi' ’initiative relied heavily on the Indian manufacturers to meet the rising demand of essential healthcare equipments for the country, egging the Indian medical devices sector to become self-reliant.  It all started when Prime Minister Narendra Modi, on 12th May 2020, made a clarion call for an ‘Atma Nirbhar Bharat’ - a self-reliant India to rejuvenate the industries. And DV Sadananda Gowda,  the Minister of Chemicals and Fertilizers, said, “The ‘Atma Nirbhar Bharat’ campaign and development of three bulk drugs parks and four medical device parks will not only reduce India’s dependency on imports but will also be helpful in making India a major player in global pharma / medical devices exports.”

The government interventions have helped the medical devices industry scale up production during the pandemic. “We enjoyed an unprecedented teamwork and rapid proactive communication from NPPA who became a facilitator instead of a Regulator and Dept of Pharma, DPIIT, Invest India and MSME Ministry, as they set up help desks to address production bottlenecks of all medical devices especially, those related to COVID viz sanitisers, masks, ventilators, gloves & COVID IVD test kits. There were only 20 firms manufacturing 62 lakh per year personal protective equipment (PPE) before the outbreak of COVID-19. But within two-three months, the number of manufacturers listed with us increased to 136 with 26 crore annual capacity,” said Rajiv Nath, Forum Coordinator of the Association of Indian Medical Device Industry (AiMeD).

Similarly, the number of Indian ventilator manufacturers went up from 8 to 15, mask manufacturers from 21 to 49, swab manufacturers from zero to three and sanitiser manufacturers from 35 to 48 and RT PCR kit manufacturer from 0 to 8. For instance, Pune-based molecular diagnostics company Mylab Discovery Solutions Pvt Ltd which specialises in molecular diagnostic kits has developed the first made in India test kits for COVID-19 in a record time of six weeks.  And Healthium Medtech, one of the largest medical device companies in India, announced the launch of the first of its kind anti-microbial gloves. Said Anish Bafna, Group CEO and Managing Director, Healthium," Around 85% of medical devices in India are imported. As an Indian player delivering to global standards with US FDA (510k), CE and ISO approval, we are working relentlessly to reduce the dependence on imported technology and support a self-reliant India.”

The medtech companies have seen a decrease in demand for products related to procedures such as bariatric surgery, joint replacements and other implantable devices, while there is increased demand for devices like ventilators, PPE and diagnostic kits. Says Dr Anish Desai, Strategic Medical Affairs – Adroit Biomed & Director – Intellimed Healthcare Solutions, "There will be a realignment of devices demand in near term. Medtech companies need to be agile and ready to respond to a robust demand for services and products once situation normalises. Portfolio optimisation will be critical."

Now when India surges to become self-sustainable, the medical device industry seeks Government support in terms of various policy initiatives to create an enabling ecosystem for the indigenous medical device industry to realise its potential. An article published in the International Journal of Drug Regulatory Affairs, in the month of June and  authored by Rajiv Nath of AiMeD and Dr Suchita Markan, Assistant General Manager of Biotech Consortium India (BCIL) covers the various challenges and opportunities faced by the Indian medical device industry during COVID-19 pandemic, and how the indigenous industry responded to these challenges and the way forward for making India self-sustainable and a leading exporter of the world in the medical device sector.

According to experts, the key challenges faced by the Indian medical device industry at the onset of COVID pandemic includes the supply chain issues, operational challenges, infrastructure related issues, policy challenges, serum sample availability related challenges and limited indigenous capacities as against the requirements to effectively address the huge upsurge in unprecedented demand during the pandemic.

"Government needs to undertake major reforms for Indian Industry to play a key role in the global supply chain and be self-reliant. Many of the components being imported such as. semiconductor display, magnets, capital intensive equipments can only be made at scale by Indian manufacturers, if they are given high degree of policy certainty as they require high upfront investments,” says Dr Suchita Markan of BCIL.

As the labour and electricity cost of manufacturing the components in the country is high, the manufacturers are not able to reach economies of scale. To decrease the input costs of manufacturing products, there is need for the Government to provide infrastructure and logistic support to enable manufacturers to decrease the cost of inputs and produce products at a much cheaper rate, point out experts. The medical device industry also seeks tax incentives.

Procedural training and operation theatres procedural support and product training are significant in the device industry. "Medtech companies need to rapidly embrace these newer technological solutions to deliver value of their products and services. New product interventions will have to be done by innovative technology platforms," says Dr Desai.

Pavan Choudary, Chairman and Director General, Medical Technology Association of India (MTAI), opines, “Atma 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.”

According to him, Atma Nirbhar in the medtech sector can be achieved, when ‘Make in India products’ are competitive on quality as well as cost. “Make in India should include designing innovative solutions locally through a strong R&D to meet our needs, and commercialising these into reliable products with the help of global and local medtech companies alike,” he said.