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We see a shift towards increased regulation on devices

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The regulatory scenario within medical device manufacturing environment in India is currently changing. Nikhilesh Tiwari, Founder & Director ColMed, in conversation with Raelene Kambli, explains the impact and challenges associated

What are the new trends or innovations in the medical device sector in India?
The market size of the medical devices industry in India is expected to touch $8.6 billion by 2020. With the rapid growth of technology, medical devices sector is more than just hardware. Digital technology, which has been a cornerstone of every sector, has also started penetrating the medical devices sector. More organisations today are investing heavily in digital technology to transform medical devices and employ greater usage of data analytics. Also IOT (internet of things) is becoming important in preventive maintenance of medical devices. Another trend is the growing shift towards more user-centric products that focus on prevention. For example, diabetes management devices are proving to be crucial in patients’ management of the disease. Connected devices to bridge access to specialists are another key emerging trend.

What are the biggest changes you see in the regulatory scenario for medical devices in India?
As the technology and design behind medical devices changes rapidly, leading them to become smarter, smaller and more complex, regulation has become a multi staged process. Verification and qualification need to be carried out at different stages of design and operation. However, current regulatory mechanisms in India are not fully equipped to provide regulations to international standards and lack of quality testing continues to be a major problem. A number of medical devices are still not regulated. This poses quality and safety risks. According to news reports, the NITI Aayog has prepared a roadmap on ensuring better regulation of medical devices under which all devices – imported or locally manufactured – will have to be certified by the Central Drugs Standard Control Organisation (CDSCO). In this light we see a shift towards increased regulation on devices as well as the number of devices covered plus stringent norms with higher penalties. While improving regulation is welcome, the authorities must ensure that the regulatory process remains smooth, hassle free and fast.

Tell us about the tax laws that impact the domestic manufacturing market?
The GST on devices currently stands at 12 per cent. On the other hand, customs duty on devices is low. The current tax policy negatively impacts indigenous production and supports imports, which is counter intuitive to the Make in India initiative. What the industry needs is a lower GST rate to increase consumption and an increase in the customs duty to make imports costlier. This will provide a boost to local manufacturing.

What are the best practices for cybersecurity that medical device manufacturers should follow in India?
With increasing penetration of digital devices, cybersecurity automatically becomes a concern. There have been demonstrations showing how implanted pacemakers and other lifesaving devices can be hacked, making it a serious issue all over. This is an area where India needs to significantly improve its security practices to be at par with the world. We need strong cyber security laws and strong tech teams along with strong organisational level practices to prevent cyber threats.

Tell us about the dynamics of online and offline products delivery in India and what are the strategies for developing successful business models in this space?
Online and offline modes have to co-exist and support each other. Although the online space is new, it can only witness success when it brings value to the entire ecosystem. Online has a tremendous advantage in product discovery, identification and providing delivery analytics, while offline is the key to actual timely delivery and payment collections. Blindly throwing money to fund growth like B2C is not a solution, as it will not create real value.

How can an engaging start-up ecosystem create job pools in healthcare?
As of late, the current healthcare delivery system is very fragmented, bedevilled by inefficiencies. The new emerging start-ups eco system must work to minimise the existing inefficiencies by leveraging the scope in under-served markets. They must also devise new strategies for improving healthcare delivery. Not only will this help to create tremendous value but also to generate jobs in the sector.

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