Regulatory policy

How an increased R&D-focused policy can truly spur India’s medtech sector to become self-sufficient, Health News, ET HealthWorld

by Ashok Patel

For many years, the pharmacy of the world has carried on with confidence and conviction. Be it generic or branded formulations, or vaccines, India has established itself as a force to be reckoned with in several regards in the international market. His recent COVID-related supplies, especially to the less-developed world, have, as expected, won many admirers. However, the ongoing pandemic has also laid bare the multiple challenges that the country’s healthcare, including the medical device sector, is now facing internally. Again, there are innumerable cases where, responding to these challenges, Indian companies have innovated, reworked supply chains effectively reinventing themselves to meet the demand for products and services arising from the demands of the pandemic. . And Indian medical device companies have been no exception in this regard.

Now, if we wish to harness and solidify the successes of Indian companies at the height of the pandemic and make these innovations and reinventions a permanent feature of India’s healthcare and medtech industry, an all-out political push towards R&D is appropriate.

The Covid emergency has reaffirmed the resilience and entrepreneurship of Indian businesses

We’ve all seen how during the peak of the pandemic, not only did existing companies revamp their assembly lines and processes bringing out products suited to the times and the market, but new startups emerged with their products facilitating the management of Covid for the authorities as well as the sick. For example, a remote health monitoring device made by a Bangalore startup has been used in quarantine centers in many states. Then, amid several Covid-focused robotic systems and devices that were made, one could screen patients, disinfect surrounding areas, and even double as a doctor/nurse assistant. Another robot could deliver food and medicine to patients. Then, an AI-based solution enabled the screening of a Covid patient by reading X-ray images on WhatsApp. Given the emphasis on disinfection and cleaning, several companies have also offered a range of disinfectants and sterilizers. Indeed, as admitted by the government’s own policy project to catalyze R&D and innovation in the Pharma-Medtech sector in India, “the industry has demonstrated its capacity for scale, innovation and profitability in the manufacture of ventilators, diagnostic kits, followed by pulse oximeters, oxygen concentrators and similar equipment.” At the same time, there have been innovations in healthcare delivery models, some using advanced AI-based technologies on the wave of increased use of telemedicine and e-pharmacy, a phenomenon accelerated by Covid-19.

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

With such potential already available, there is no doubt that a well-oiled indigenous R&D ecosystem in the country can serve as a driving force in our next journey towards transforming India into a manufacturer of medical devices and equipment of world class. After all, it is in the laboratories that the best ideas are first sought to be transformed into better products. From the conception of an idea to the design of a product, through the development of new products, prototyping, validation and testing, a thriving R&D ecosystem can become the ideal breeding ground for the development of competitive products at global and high-end.

The government has shown its intention

Undoubtedly, the government has shown a serious intention to make health care/medical technology R&D a priority area of ​​attention. In her speech on the 2022 budget, the Minister of Finance had been categorically clear vis-à-vis emerging sectors, “supportive policies, light regulations, facilitation actions to strengthen national capacities and the promotion of research and development will guide the government’s approach”. . For R&D in these emerging opportunities, in addition to collaborative efforts between universities, industry and public institutions, a government contribution will be provided. Earlier in October last year, the Department of Pharmaceuticals issued a draft policy with the aim of “catalyzing research and development and innovation in the pharmaceutical technology sector in India” while “recognizing the need to place more emphasis on encouraging R&D, through the development of cutting-edge products and technologies along the value chain.In particular, medical devices have been recognized as a booming sector as part of the “Make-in-India” campaign in 2014.

What more can we do?

Of course, R&D is very capital intensive and involves enormous risks. Thus, in order to attract more investment from private actors in R&D, adequate political support and protection must be provided. While the size of the company and the scale of its production are large enough, companies, SMEs and start-ups that are specifically inclined towards innovation must be given tax support and other policies. To this end, the government should provide full support, including providing access to easy and cheap funding as well as tax exemptions to actors interested in setting up an R&D infrastructure. There should also be relaxations or exemptions from import duties on the supply of capital goods and machinery needed to build R&D infrastructure. This is particularly relevant in light of the need to boost the high-end electronic medical device ecosystem in the country. Additionally, while seed capital is to be provided to innovation and technology-driven startups, a special R&D fund exclusively for the medical device industry could be set up. At the same time, the government should expand the size and scope of existing innovation hubs, such as joint R&D infrastructure facilities provided under the LIP and medical device park programs through an increased allocation of funds. At the same time, with the aim of increasing our skills and training our human capital, the allocation of funds for research grants and grants to students and entrepreneurs invested in the medical device segment must be increased substantially. In addition, the academic curriculum must be updated according to the latest research and advances made in developed countries. While promoting greater university-industry collaboration, expert academics should be encouraged to establish companies to manufacture innovative medical devices. And finally, while the regulatory processes for registering innovation in medical devices need to be simplified, there should be a stronger intellectual property protection regime for innovation in medical device products in the country. .

Therefore, given the right political stimulus, a thriving R&D ecosystem for the medical device sector can, in a relatively short period of time, make India a global leader for this all-important healthcare segment. . The World Pharmacy can also become the source and warehouse of medical devices and equipment – for the whole world.

by Ashok Patel, Founder and CEO, Max Ventilator

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