International Harmonising of the standards and specifications will boost the Medical devices Industry in India: Dr P B N Prasad

Health and Pharmaceutical Manufacturing and Medical Devices Committee, PHDCCI in association with Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers, Government of India organised third series of Self Sufficiency in Medical Technology on “India to be an attractive destination for MedTech”.

The guest of honour of the session was Dr P B N Prasad, Joint Drugs Controller General of India, CDSCO. In his remarks he said that the regulator is the last part of the system. In the next decade India should be a medical devices hub and to make that possible, the government is focusing on the Harmonising the devices, policy framework, quality management system, harmonising and creative a conducive system for the manufacturer.

He further mentioned that regulators are also facing several technical challenges now a day, country is dependent on imports in this sector and there is a need for becoming Aatmanirbhar in this domain by reducing the dependency of imports and facilitating the home manufacturers.

Dr Prasad also encouraged for India to be a medical manufacturing hub including generics and medical devices both. He further said that India has large pool of engineers and pharmacists and COVID-19 has made us learnt many lessons in this sector.

He said that we need a robust ecosystem and we have high hopes that all challenges will be overcome within the decade itself. Right now regulators, investors and manufacturers are all in learning and evolving process. As necessity is the mother of the invention, Medical device industry will be a great boon for the country in the coming years.

He further mentioned that we do have the skilled manpower and now we need to have innovation in R&D and innovation hub as today it is the necessity to innovate, manufacture and become self reliant in the medical devices.

The webinar was also attended by Pradeep Multani, Sr Vice President, PHDCCI, Dr N Subramanian, Chair, Health Committee, PHDCCI & Director, Medical Services, Indraprastha Apollo Hospitals and Bhargav Kotadia, Co-Chair, Pharmaceutical Manufacturing & Medical Devices Committee, PHDCCI & Managing Director, Sahajanand Medical Technologies.

The other eminent panelists present were Pavan Choudary, DG and Chairman, MTaI and Managing Director, Vygon India, Nitin Mahajan, Director, J MItra and Co, Gaurav Agarwal, Managing Director, IITPL and Akriti Bajaj, Senior Manager / Healthcare Lead at Invest India

While giving the welcome remarks, Multani said that the healthcare sector in India has rapidly progressed in the last decade. Today, the country is favorably positioned in the medical devices domain for outsourced contract design, development, and manufacturing. The focus on design-to-cost and a robust manufacturing ecosystem makes India a suitable destination for design-led-manufacturing of medical devices.

Multani also mentioned about the five main reasons for India as fast emerging ideal base for medical equipment manufacturing like Presence of skilled resources, various Government initiatives like PLI Schemes, Medical technology parks and support to the MedTech industry, Cost-effective operations, Sensitivity to Intellectual Property rights and data security and last one as Robust ecosystem to support production.

Dr N Subramanian mentioned that technology advancement is making healthcare affordable, accessible and available to larger population. He further mentioned that risk of people dying from non-communicable diseases are raising and expenditure of more than 30 trillion will be there on treating such diseases if not prevented early. Prevention, early diagnosis and curative treatment are the points to be focused moving forward. He also mentioned that today we are so much of technology dependent but technology also comes at a cost. The MedTech industry in India should hold the path of innovation so that its products and solutions are custom-designed for the opportunities and constraints of the country.

Bhargav Kotadia said that the COVID-19 pandemic has presented a unique opportunity for India to emerge as the new manufacturing hub of the world. With India now taking centre stage in the fight against COVID, India’s MedTech sector is slated for a global presence which positions India as a global hub for medical devices. Further, post the Union Budget 2021, it is now clear that MedTech will be the next sunshine industry. Last two decades have seen many disruptive technologies in various industries, but the highly regulated market of medical devices was a dampener. Today, with more conducive policies announced in the healthcare and MedTech sector, especially sector specific reforms such as the PLI Scheme, making of Bulk, API, Medical Device parks and the “Atmanirbhar Bharat” approach by the government, will surely help the sector thrive and be resilient during this pandemic period.

This offers the medical device industry the opportunity to leapfrog and make fundamental and sweeping changes that will sustain for years to come, for both domestic and global players, making India a truly attractive destination.

Pavan Choudary said that our goal should be to capitalise on our strengths, while we build new ones. First, we should try to avoid bringing in policies that could destabilise the trend of rising FDI in MedTech that we are receiving, and channelise it towards existing manufacturers, dependable budding manufacturers and component manufacturers to form Joint Ventures and collaborations. Second, we should also build upon our Healthcare Worker Training capacities with collaborations between global innovators, local companies and the government.

Third, India is the third largest employer of R&D in MedTech (After US and Germany). The R&D specific investment of Rs 1200 crore by Medtronic just last year is another testimony to the fact that we have immense potential in R&D in MedTech, and we should try to tap it.

Gaurav Agarwal emphasised that India is among the fastest growing medical devices in the world and yet we are only under two per cent of the global market and heavily import dependent. We need to do the full to make India an attractive destination for MedTech.

Agarwal also emphasised on some points to look after like need of a predictable regulatory roadmap, nominal protective tariff barriers in areas of high import dependence, R&D ecosystem by bringing Academia, funding agencies together in incubators and Phased Manufacturing Program (PMP) by gradually increasing customs duties in finished goods in key areas.

Nitin Mahajan said that by another 15 years, we would find India to be more affluent and technology will support things for being accessible. Furthermore, technology would aid manufacturing by making production quicker. Technology will be at a cost, however what India needs is technology with sustainable costs-hence making in India is a long term solution and Atmanirbhar is in right spirit. High end technology being 90 per cent imported needs to be looked into as this is the biggest need and also the opportunity zone.

Mahajan further mentioned that COVID has accelerated the need for improvement in both healthcare plus education. The Government in its budget are focusing on both by increase in spend and maximising use of digital tech to connect. There are three axis approach for India Movement; first being manufacturing as in manufacturing, there has to be an entry barrier in the form of import duty else its easy to make in any part of the world (and claim export incentive) and import the same in NIL-duty much to loss of domestic manufacturer. Normally, each country has its own protection tariff structure in place; second being approvals for Licensing, Testing Labs, Certifications as Medial Device- Does not need Sampling, testing and approvals, as like Pharma. Also the limited number tesing labs creates delay and loss of opportunity and we should not limit to international CE/US FDA, which most Indian makers do not aim for and lastly third being the market acceptance as Indian makers, need domestic demand to sustain, else all efforts are in vain.

Akriti Bajaj, Healthcare and Medical devices lead at Invest India, the national investment promotion agency of India mentioned the government’s various initiatives to achieve this goal, such as the launch of Production linked incentives 1.0 and 2.0.