By Ashok Patel, Founder and CEO, Max Ventilator

For many years, the pharmacy of the world has carried itself with confidence and conviction. Whether it is generics or branded formulations, or vaccines, India has established itself as a force to reckon with in several respects in the international market. Its recent Covid-related supplies particularly to the lesser developed world has, as expected, won many admirers. However, the ongoing pandemic has also laid bare multiple challenges that the country’s healthcare including the medical device sector faces today internally. Again, there are countless instances wherein rising to those challenges, Indian companies innovated, reworked the supply chains effectively reinventing themselves with an eye on meeting the products and services demand arising out of the exigencies of the pandemic. And Indian medical device companies have been no exception in that regard.

Now if we wish to build on and solidify the successes of Indian companies during the peak of the pandemic and make those innovations and reinventions a permanent feature of Indian healthcare and medtech industry, an all-out policy push to R&D is in order.

Covid emergency reaffirmed the resilience and enterprise of Indian companies

We have all seen how during the peak of the pandemic, not only existing companies recast their assembly lines and processes bringing out products relevant to the time and the market, but altogether new startups showed up with their products making Covid management easier for the authorities as well as patients. For instance, a remote health monitoring device made by a startup from Bangalore was used at quarantine centres in many states. Then amid several Covid-focused robotic systems and devices that were made, one could screen patients for Covid, sanitize the surrounding areas and even double up as a doctor/nurse’s assistant. Another robot could deliver food and medicines to Covid patients. Then an AI-based solution allowed the screening of a Covid patient through x-ray image reading over WhatsApp. Given the all-round focus on sanitization and cleansing, several companies also came up with an array of disinfectants and sterilizers. Indeed, as the government’s own draft policy to catalyze R&D and Innovation in Pharma-Medtech sector in India admits, “the industry demonstrated capacity for scale, innovation and cost efficiency in manufacture of ventilators, diagnostic kits, followed by pulse oximeters, oxygen concentrators and similar equipment”.[1] At the same time, there were innovations in healthcare delivery models with some employing advanced AI-based technologies riding on the wave of increased telemedicine and online pharmacy uptake, a phenomenon accelerated by Covid-19.

A flourishing R&D, cornerstone of product innovation and engineering  

With such potential already available, there can be no dispute that a well-oiled indigenous R&D ecosystem within the country can serve as the engine of our next onward journey towards making India a world-class manufacturer of medical devices and equipment. After all, it is in the laboratories where the best of ideas are first sought to be converted into the best of products. From the conceiving of an idea to product design to new product development to prototyping to validation and testing, a thriving R&D ecosystem can become the perfect nurturing ground for the development of globally competitive and top-of-the-line products.

The government has shown intent

Without doubt, the government has shown serious intent on making healthcare/medtech R&D a priority attention area. In her budget 2022 speech, the finance minister had made it categorically clear vis-à-vis the sunrise sectors, “supportive policies, light-touch regulations, facilitative actions to build domestic capacities, and promotion of research & development will guide the government’s approach. For R&D in these sunrise opportunities, in addition to efforts of collaboration among academia, industry and public institutions, government contribution will be provided.”[2] Earlier in October last year, the Department of Pharmaceuticals had released a draft policy with an eye on “catalyzing research & development and innovation in the pharma- medtech sector in India” while also “acknowledging the need for greater emphasis on encouraging R&D, through indigenously developed cutting-edge products and technologies across the value chain.”[3] Notably, medical devices were recognized as a sunrise sector under the ‘Make-in-India’ campaign in 2014.[4]

What more can be done?

Of course, R&D is highly capital-intensive and fraught with enormous risks. So in order to attract increased investment from private players in R&D, adequate policy support and protection must be provided. While the size of the company and the scale of its output are important enough, companies, SMEs and startups which are specifically innovation-inclined must be extended due to fiscal and other policy support. Towards that end, the government should extend full support including enabling access to easy and cheap finance as well as tax exemptions to players interested in setting up an R&D infrastructure. There should also be import duty relaxations or exemptions on the sourcing of capital equipment and machinery necessary for the creation of an R&D infrastructure. This is especially relevant in light of the need for an impetus for a high-end electronic medical device ecosystem in the country. In addition, while seed capital must be provided to innovation and technology-focused startups, a special R&D fund exclusively for the medical device sector could be set up. At the same time, the government should expand the size and scope of the existing innovation hubs such as common R&D infrastructure facilities provided under the PLI and medical device parks schemes by way of increased allocation of funds. Simultaneously, with an aim to upskill and train our human capital, the allocation of funds for research scholarships and fellowships to students and entrepreneurs invested in the medical device segment must be raised substantively. Also, the academic curriculum must be updated in tune with the latest research and advancements made in developed countries. While fostering greater university-industry collaboration, expert academicians should be encouraged to set up companies for making innovative medical device products. And finally, while regulatory processes for registration of innovation in medical devices must be simplified, there should be a stronger intellectual property protection regime for innovation in medical device products in the country.

Therefore, if given the right policy stimulus, a thriving R&D ecosystem for the medical device sector can in a relatively short period of time make India a world-beater for this much important healthcare segment. The pharmacy of the world can also become the fountainhead and storehouse of medical devices and equipment—for the whole wide world.

[1] Government’s Draft Policy to Catalyze Research & Development and Innovation in the Pharma-Medtech Sector in India, https://pharmaceuticals.gov.in/sites/default/files/Draft%20Policy.pdf

[2] Finance Minister’s Budget 2022 Speech

[3] Government’s Draft Policy to Catalyze Research & Development and Innovation in the Pharma-Medtech Sector in India, https://pharmaceuticals.gov.in/sites/default/files/Draft%20Policy.pdf

[4] https://www.ibef.org/industry/medical-devices.aspx#:~:text=The%20Government%20of%20India%20has,in%20India’%20campaign%20in%202014.