'We need to look at the rules on the shelf life of devices through a larger prism'

The development of a regulatory framework for medical devices is a major step in recognizing the unique requirements of this sector in India


Simranjit Singh, Medical Devices & Diagnostics Head, QuintilesIMS Asia

Will the new regulations introduced by the government of India bring positive change in the Indian medical devices' market?
Yes, that is the intent. The development of a regulatory framework for medical devices is a major step in recognizing the unique requirements of this sector in India. The Medical Devices Rules 2017 are in line with globally accepted practices and many of the rules, including the definition of medical devices, the classification and other requirements are in line with regional and global guidelines. While as with any regulation, there are areas that need to be improved upon, we should look at the bigger picture. The Rules are a first step towards harmonizing local regulations with global standards and will provide easier access to global markets for Indian players.

The shelf life of medical devices have been reduced to 5 years whereas, globally it is 10 years. Do you think it is going to affect the supply change and if yes, how?
I do not believe so. We need to look at the the rules on the shelf life of devices through a larger prism. Medical devices cover a broad spectrum of products from simple band-aids to complex heart-lung machines so it's more important to look at the classification/categorization of devices than shelf life. Also, over the last few years, we have seen rapid technological changes and advancements in medical devices. Innovation cycles have improved to an extent that one now sees a new innovation every three to five years. Shorter shelf lives could promote faster cycles of innovation which, in turn, could lead to better quality products and more innovations, ultimately resulting in greater benefit to patients.

Do you feel that manufacturing a separate product line for Indian customers will hike the prices of products especially in India?
The Medical Devices Rules have comprehensive labeling requirements for medical devices, including a mandate for companies to specify the physical manufacturer's address as well as the manufacturing date of the device. The requirements are more stringent than global norms. This may result in additional investments in production which are likely to increase the market price of the devices.

The government has also increased the basic custom duty on import of medical devices. Do you think this move will going to further curb the medical devices' market in India?
This decision has to be balanced against other policies being introduced by the Government of India to stimulate the domestic medical devices sector and give the Make in India initiative a fillip in this sector. Several factors, including setting up of a Task Force on Promotion of Domestic Production of High-end Medical Devices and Pharmaceutical Manufacturing Equipment, permitting FDI upto 100% under the automatic route for the manufacture of medical devices, setting up of Medical Devices Parks and Government owned medical device testing laboratories all augur well for the growth of a robust eco system for medical devices in the country. India's advantage is not just in manufacturing but also in research and development. With a talent supply of 1.5 million engineers and 50,000 doctors every year, India has a large pool of skilled talent who can support manufacturing growth and also engage in developing innovative and customized devices to support the local market and specific nuances of the Indian environment.

Globally, medical devices sector is blossoming well but in Indian corridor it is yet to grip the market what is the core reason behind it?
The fillip being given to the medical devices sector in India is likely to generate interest in both Indian and global devices players. This high potential of Asia Pacific, including India - given the favorable economic, demographic and healthcare trends - is attracting attention from medical device manufacturers looking for investment and expansion. According to a report issued by the HealthCare Federation of India (NATHEALTH), the Indian medical device industry would grow faster than the global medical devices industry by 2020. However, while the country holds much optimism for the growth of medical devices, there are some key challenges including a complex regulatory landscape, cultural diversity and variable healthcare models across the country. This dichotomy mandates device makers to carefully tread the line between risk and reward - meeting the medical needs of a growing population, while adhering to unique market rules and requirements. It also requires a high degree of connectivity, i.e. staying on top of constant market changes; and being agile so as to quickly and accurately execute strategies in a rapidly changing, multifaceted market.


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