India is growing as a key market for medical devices. The tremendous growth of the medical devices industry over the last decade and the current development trends are indicative of the industry’s great potential. Probir Das, Managing Director, Terumo and Chairman-Medical Devices Forum, FICCI, in conversation with Rajbala of Elets News Network (ENN), highlights future prospects of the industry in the light of fresh reforms introduced to push growth.

Please share your views on the future of medical device industry in India.

The medical device industry in India has a huge potential. As per reports, the industry is projected to grow from its current $7-8 billion size to about $20 billion through an organic growth model, and to reach $50 billion through an inorganic growth model.

This growth will come on the back of new policies, regulations, infrastructure, technology collaborations and strategic alliances with international players to focus on relevant markets globally.

Increase in number of hospitals, healthcare service delivery and, consequently, a greater need for accessible as well as quality medical devices,is also expected to drive the growth of medical devices and equipment industry.

Medical device will soon be delinked from the pharma sector and form a separate ministry. How is it going to boost the medical devices sector?

The potential formation of a separate ministry for the medical devices industry will shape the industry in a more structured manner. It will facilitate new rules and policies for this industry. It will also help to develop end-to-end support system on regulatory as well as policy front, provide a boost to the R&D infrastructure, promote investment, offer a platform for improving the start-up ecosystem; facilitate development of a focused approach to foster innovation, promote education and skill development for the medical devices industry, create deep understanding of the industry, and help develop a distinct identity of the industry.

What are the key opportunities for Indian medical devices and equipment industry?

As a country, we have huge need and, therefore, a big opportunity. However, whether that big opportunity translates into demand and that demand translates into market size are dependent on several things like improvement in healthcare penetration. Medical devices is an ancillary industry and adoption of technology in India, as the current adoption level of medical devices at $3 per capita is one of the lowest in the world.

In the growing medical technology market, it is important for enterprises and the government to build global competitiveness and adopt a risk-based approach to develop a sound and comprehensive global supply chain management system that ensures the product quality, integrity and identity which is preserved throughout the supply chain.

The important fact is that global supply chain will determine our competitiveness.

Please tell us about the implications of new rules and regulations for the Medical Devices notified recently. How will the new rules remove regulatory bottlenecks?

The medical devices industry was regulated under the Drugs and Cosmetics Act for several years. But after years of dialogue, the government has finally notified a draft of new rules and regulations for medical devices industry by separating it from the pharmaceutical industry.

• New rules will be able to ease norms for obtaining license and conducting clinical trials.
• Will reduce manufacturer-regulator interface by promoting digital platform.
• Boost government’s ‘Make in India’ campaign by providing an environment conducive to domestic manufacturers that could lead to greater long-term investments.

The new rules will be effective from January 2018. In this transition period necessary changes or distinct interventions can be made such as:

• Expiry of medical devices
• Classification of devices on categories
• Formulation of totally separate act for medical devices from Drugs and Cosmetics Act.

FICCI and the Central government hosted ‘India Medical Device 2017’ in Bengaluru recently to increase overall growth of domestic production and growth in the sector. What were the key takeaways from this international event?

The ‘India Medical Device 2017’ forum brought together the highest decision makers from the industry, government, policy makers, international regulators, etc to discuss on overall growth of the industry and encourage ‘Make in India’ for manufacturing of medical technology. The outcomes of the forum meet were:

• Realisation to craft a medical technology 2020 vision.
• Appropriate debate on whether to support protectionism or drive competitiveness of domestic manufacturing.
• Debate on whether to only focus on Make in India or also ‘Develop in India’.
• Introduction of Health Technology Assessment.

Medical device sector is to be included as one of the 25 flagship industries of the Indian economy. What does it mean for the industry?

The medical devices industry has gained its rightful place in the list of 25 flagship industries of the Indian economy. This will cause a shift in the industry’s structure, conduct and performance. Medical device industry is comparatively very young and complex. Being a part of the ‘Make in India’ initiative will be valuable for its growth. The government’s task force will address the pressing issues and make recommendations to assist the industry.

What are the key targets the industry should try to achieve in the next few years to become a global hub for medical device manufacturing?

• Setting up manufacturing hub under Public Private Partnership (PPP) model.
• Setting up Centre of Excellences for medical technology innovation.
• Skilling of more manpower for the growth of the industry.
• Capital funding for startups and research projects, etc.
• Creating necessary bodies to drive the policies and domestic manufacturing.

MEDICAL DEVICES CONSUMPTION IN US DOLLARS

India is compared on healthcare delivery parameters with countries like China, Brazil, Russia, etc. Seeing the medical devices consumption across the world, there is a pressing need to improve per capita medical device consumption in India.

Medical devices consumption per capita in terms of US dollar:

CHINA – $178

RUSSIA – $43

BRAZIL – $28

INDIA – $3