June 2016

UL: Indian Med-Tech Industry Promising, Despite Ambiguous Regulatory Framework

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Jibu-Mathew

Jibu Mathew, Business Development Head – Life and Health Sciences, South Asia, UL

Our primary goal is ensure medical devices comply with all regulatory and quality standards, shares Jibu Mathew, Business Development Head – Life and Health Sciences, South Asia, UL to T Radha Krishna of Elets News Network (ENN)

UL is a global independent safety science company with more than a century of expertise innovating safety solutions from the public adoption of electricity to new breakthroughs in sustainability, renewable energy and nanotechnology. What has been UL’s mandate in South Asia?

UL’s main mandate, especially in South Asia, is to work towards our corporate mission, i.e. create safer and healthier living environments in the areas we operate in. As a global leader in safety science, we want to provide our knowledge and expertise to our customers in navigating their manufacturing processes, supply chain and their products to be compliant. We also want to enable our clients to address regulatory issues emerging from global market access. With 120 years of experience, through our testing, auditing, certification and advisory services, we would like to ensure that manufacturers, especially in the Indian market, succeed in their global market expansion plans.

  • Large gap in understanding safety and regulatory framework, as well as the end-user framework

What’s the support extended by UL to the medical device industry?

Currently, the medical device industry in India is dominated by multinational companies (MNCs) that manufacture and import products. There are also small and medium businesses, mainly dealing with disposables, implants and medical electronics. The third segment is that of the start-up community.

These med-tech industries face numerous challenges. Firstly, they have to navigate the regulatory framework, especially when their products cater to the international markets. Some of these industries, particularly in the start-up domain, have a very good technological framework. However, there is a larger gap in understanding safety and regulatory framework, as well as the end-user framework, in markets where the product has to be sold.

UL assists these manufacturers right from the concept stage, when they have an idea and a technology, to address a clinical need. We take them through the entire product lifecycle from defining user requirements, understanding safety challenges and the risk aspect of devices. Therefore, the end benefit to the manufacturers is that while they can focus on their technological and enduser frameworks, UL supports them in navigating through the complex regulatory compliances required for international market access.

Key Highlights

• Assists manufacturers through the entire product lifecycle

• Helps manufacturers in navigating through the complex regulatory compliances

• Ensures safety for healthcare professionals, doctors, etc.

• Works actively with the government

What’s your perspective about the medical devices segment in the Indian context?

Despite its significant growth, the medical devices industry in India is still at a very nascent stage. In terms of market size, the total medical device consumption in the country at present is to the tune of $5.8 billion. When corresponded with the 1.2 billion plus population, the penetration of medical devices into healthcare sector is very minimal, especially in comparison to similar economies, such as China, Korea or Japan.

However, the medical devices sector in India is specifically focused on two aspects that include penetration and affordability. Keeping this in view, there is a lot of innovation, in pockets, that is contributing to the growth of this sector. This is specifically in the non-communicable diseases space, where screening devices for pointof- care testing are being created for diseases, such as cardiovascular diseases, diabetes, etc.

Additionally, the government’s support through ‘Make in India’ campaign to help India reach the $50 billion devices market by 2025 has laid the platform for the growth of the med-tech sector in India.

 • UL has been helping the government to build the regulatory framework around medical devices

Highlight the major concerns of life and health science industry in India from a regulatory standpoint.

Currently, the medical devices industry is faced with an ambiguous regulatory framework, wherein medical devices are treated as drugs under the Drugs and Cosmetics Act. As a result, the distinctive identity for medical devices has been absent for long. Nevertheless, there has been tremendous change over the last 12 to 18 months. A regulatory framework is currently developed by the Ministry of Health & Family Welfare and Central Drugs Standard Control Organization (CDSCO). And, we are witnessing a significant momentum in this area.

The medical devices industry is grappled within the ambiguous regulatory framework, wherein medical devices are treated as drugs under the Drugs and Cosmetics Act

How significant is the India market for UL? And, whom does UL work with in India in life and health science domain?

India is an important market for UL across various industry segments. Our primary goal is aligned to our mission to ensure medical devices and products, especially in life and sciences devices segment, comply with all regulatory and quality standards. UL also wants to ensure safety for healthcare professionals, doctors, patients, technicians or nurses using such devices.

For us, the life sciences industry is important, as medical device sector is not only evolving but has also seen tremendous growth, especially in the start-up domain. Med-tech start-ups are emerging with new and innovative technologies to help address clinical needs for diseases, such as cardiovascular diseases, ophthalmology, diabetes management, etc. These start-ups are paving the growth of the medtech industry and addressing the healthcare needs of India.

 • India aspires to grow to a $50 billion Medical Devices market by 2025 from the current $5.8 billion

Companies, such as Skanray, BPL and Forus, which began as start-ups now operate on a global scale and their products are sold across the world. Their products are accepted by bigger countries, such as the United States (US) and European countries, which have complex regulatory frameworks. Our solutions are highly customisable depending upon where the product is in the product lifecycle stage.

In the light of ‘Make in India’, ‘Digital India’, and similar campaigns and programmes initiated by the government, what are the focus areas and vision of UL?

In the larger sense, UL has been very actively working with the government in the areas of smart cities, water quality, solar power, healthcare, energy and electricity. We have been actively working with the Ministry of Health & Family Welfare and CDSCO in articulating how regulatory framework can work in India. We are also helping the government in identifying and developing standards for medical devices to bring harmonised standards that are accepted globally by various regulators, and how India can adopt them.

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