MTaI seeks predictable policies, streamlined regulations to propel medical devices sector

The medical devices sector in India, estimated to be $11 billion (Rs 90,000 crore) in 2020, is projected to reach $50 billion by 2030. Cognizant of the importance of the sector, a few months ago the government came out with National Medical Device Policy 2023. However, issues like high tariffs and multiplicity of regulatory authorities still plague the industry. To shed light on the intricacies and hurdles faced by the industry, Bizz Buzz spoke with Pavan Choudary, the Chairman of the Medical Technology Association of India (MTaI). As the voice of leading MedTech players, MTaI's insights provide a comprehensive understanding of the challenges and opportunities that define the sector’s narrative

What challenges MTaI member companies are facing? What are the possible remedies?

The MedTech sector, while in its nascent stage in India, faces various challenges ranging from overlapping regulations to policy predictability and high tariffs and taxes which impact the ease-of-doing business in the country.

For instance, India’s customs duties are the highest in South Asia, imposing a significant cost burden on patients. This also amplifies the risk of counterfeiting and smuggling. This issue warrants immediate attention.

Another important area where government intervention is required is regarding compliance with Quality Control Orders (QCOs) and Compulsory Registration Orders (CROs) issued by various ministries from time to time. In India, medical devices are already regulated under the Medical Device Rules, 2017, by the Central Drugs Standard Control Organisation (CDSCO), which ensures that products and services are safe, reliable, and of good quality.

However, these QCOs and CROs add to the compliance burden without any additional value addition to the already regulated medical devices. Furthermore, it affects local manufacturing, R&D, service, and maintenance of installed medical devices in the country, impacting their uptime for patient diagnosis and timely treatment.

Therefore, MTaI has recommended a broad exemption for medical devices from additional QCOs and CROs.

Is there any other drag on the industry?

The additional labeling requirement under the Legal Metrology (Packaged Commodities) Rules, 2011, adds a redundant compliance burden to the medical technology industry, as most labeling rules are already enforced through the Medical Device Rules.

In addition to this, we also strongly recommend a predictable pricing policy for the medical device industry. This should follow with the proven and predictable pathway of trade margin rationalization as adopted successfully during the pandemic for certain medical devices.

The government has been focusing on Make in India. How do MTaI and its members contribute towards it and what is the road ahead?

During the global pandemic, India emerged as a significant exporter of PPE kits, masks, gloves, etc. We feel that the key to this success was in recognizing and capitalizing on our existing proficiency in textiles. This experience underscores the importance of aligning our Make in India initiative with our inherent strengths and building upon them.

We must look at other examples like Make in Brazil which, despite government efforts, investments, and time, has faded into obscurity. The reason behind its failure was that it was attempting to manufacture what was beyond its readiness. Instead of focusing on its strengths and then moving on to more advanced products, it pursued the unattainable. India should learn from these lessons and focus its efforts on areas where our competencies already shine. By doing so, we can set a solid foundation for the future and ensure the success of our initiatives.

To cut dependence on imports, the government recently came out with Medical Devices Policy. What is the MTaI’s take on the policy and by what percentage the imports may fall over the next five years?

We feel that the National Medical Device Policy 2023 is a welcome move by the government. The policy aims to build on some existing strengths present in the country, for instance in R&D. India, despite having only 1.5 per cent of the global medical device market, has 8 per cent of the MedTech R&D workforce, indicating a fertile and proven area of potential.

Furthermore, the focus on skilling and up-skilling healthcare workers bodes well for patient care in the country as well as for the export of skilled manpower.

The medical device sector is an intricate, high-capital, and technology-intensive industry. It has long gestation periods. It also requires constant training of healthcare workers to adapt to the new technologies. International collaboration is the key to accelerating the Make in India initiative.

Therefore, we believe that a phased approach is most suited, focusing on areas where there is already some underlying current and then moving on to more complex technologies. We feel it is not practical for a single geographical location to have the manufacturing and ancillary ecosystem suitable for manufacturing all types of medical devices and equipment.

Most MedTech hubs specialize in a few segments that they robustly export. Most of the medical equipment is manufactured in just a couple of locations worldwide, catering to the needs across the globe. Even nations with great industrial bases such as the United States, the United Kingdom, Germany, France, and Japan rely on imports for components and medical devices that are not domestically produced.

How many members does MTaI have and how much investment has been made by MTaI members in the last five years?

MTaI embarked on its journey in 2016 with a modest number of seven distinguished companies as its members. Through its committed and resolute efforts, MTaI membership has grown to 48, comprising leading MedTech players.

These companies have made remarkable investments by setting up a large number of R&D centers and manufacturing plants in the country. MTaI members operate 12 state-of-the-art manufacturing facilities and maintain nine cutting-edge R&D centres across the country.

Furthermore, MTaI members also contribute substantially to the skilling of healthcare workers by training more than 250,000 healthcare professionals in India. MTaI has always been collaborating with governmental bodies, sharing its expertise, resources, and experience in order to shape policies that benefit the well-being of patients and advance the growth of overall healthcare.

How has MTaI helped the MedTech industry in India?

As I said, MTaI has been thoroughly engaged with the government, advocating for policies that promote innovation, quality, patient safety, and patient access to advanced medical technologies.

It has also played an important role in busting misinformation which is rampant in this age of digital platforms. In collaboration with the government, MTaI has also strived to encourage ethical practices in marketing and promotion pertaining. The Uniform Code of Medical Device Marketing Practices is an example.