The Covid-19 pandemic situation was initially dreadfully challenging in India with a huge population and highly import dependent medical devices sector. The Government of India through its flagship “Make in India” initiative relied heavily on the Indian manufacturers to meet the rising demand of essential healthcare equipments for the country, pushing the Indian medical devices sector to become self-reliant or Atmanirbhar Bharat.

An article published in the International Journal of Drug Regulatory Affairs, this month authored by Rajiv Nath, Forum Coordinator of the Association of Indian Medical Device Industry (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, how the indigenous industry responded to these challenges and the way forward for making the country Self-Sustainable and a leading exporter of the world in the medical device sector.

Now when India surges to become self-sustainable or Aatm Nirbhar, 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.

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 eg. 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.” Said Dr. Suchita Markan of BCIL.

As the labor and electricity cost of manufacturing the components in the country is very 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.

The medical device industry seeks flexibility in labour laws and tax incentives. Many exclusive medical device parks, like Andhra Pradesh Medtech Zone (AMTZ), were required to be developed & supported which will serve as medical device manufacturing hubs for the country.

Ecosystem requirements of Indian Medical Device Industry to be self – sustainable:

Shri. D. V. 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.”

Mr. Rajiv Nath recognized that the government interventions 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 & 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 Sanitizers, Masks, Ventilators, Gloves & COVID IVD Test Kits. There were only 20 firms manufacturing 62 lacs per year personal protective equipment (PPE) before the outbreak of Covid-19. But within two-three months, the number of manufacturers listed with AiMeD increased to 136 with 26 Crore annual capacity.

Similarly, the number of Indian firms manufacturing, ventilator manufacturers went up from 8 to 15, mask manufacturers from 21 to 49, swab manufacturers from zero to three and sanitizer manufacturers from 35 to 48 and RT PCR Kit manufacturer from 0 to 8.

“Prime Minister Narendra Modi’s call for self-reliance Aatmanirbhar Bharat will not only see India emerging as a manufacturing superpower but will also strengthen India to vie for being the 2nd factory in world for Medical Devices & a dependable Manufacturer of quality products in Global supply chain.” We have shown the ability and capability of Indian Entrepreneurs to Make in India when we have the support of Govt.” Said Mr. Rajiv Nath.