Analysing India’s Medical Devices Rules which kicked in this January, Sundeep Shrivastava, Senior Director, Clinical Operations, Asia Pacific Medical Devices, IQVIA INDIA, tells that we need an exclusive medical device sector policy, incentivised manufacturing of med tech products and more relaxed import duties on high risk product segments that still have a manufacturing lag in India
India’s Medical Devices Rules have kicked in from January 2018. Are they at par with global regulations and do they give leeway to India’s own socio-economic health requirements?
India’s Medical Devices Rules are framed in line with the guidelines of the Global Harmonization Task force with salient features like clear mention of quality management systems; risk-based device classification, essential principles for safety and performance of medical devices in compliance with or at par with global regulations. Their implementation will provide the Indian medical device industry — both R&D and commercialisation — a boost and a level playing ground in the $390 billion global device market growing ~5 per cent annually.
Have the Indian government and policy makers done enough to create an ecosystem conducive to innovative, affordable and quality medical devices?
While we see a lot of innovations and high opportunity in India and device therapy looks promising, we need to evolve towards therapies that are more affordable and will allow a better quality of life and improved survival. There are many Indian companies who have excelled in developing world class devices and are recognised internationally as well.
The Indian medical device industry in still in its nascence but the consultative and collaborative approach by the Government of India augurs well for the development of a conducive ecosystem for the industry. This is evidenced in what we are seeing around us with 100 per cent FDI permitted through the automatic route, academic researchers investing in tailored, affordable solutions for the Indian market, and incubation centres being set up to encourage research and innovation.
Medical devices players will need to build collaborative relationships with key local and global stakeholders to ensure development and commercialisation strategies align with regulations, and market need and demands.
What are the challenges that still exist and require policy reform?
India needs an exclusive medical device sector policy which covers all aspects and segments of the sector. We need to identify and prioritise specific medical devices to work on in collaboration with all the relevant stakeholders, including the regulators, industry and patient groups.
- The Medical Devices Rules which have been implemented from January 1, 2018 are still within the ambit of the Drugs and Cosmetics Act and there is a need for a separate set of rules for Medical Devices.
- Manufacturing of Med Tech products exclusively must be incentivised. “Cluster” status and benefits must be accorded to existing med tech manufacturing hubs in parallel with building new medical technology parks.
- For high-risk product segments that still have a manufacturing lag in India, a more relaxed approach should be adopted on import duties so that patients can benefit.
Has India’s indigenous medical devices industry invested enough in medical device research and innovation? Do we see enough alternatives to imported medical devices to support the Prime Minister’s Make in India programme?
The government’s initiatives to promote the medical devices sector are a step forward in making Make in India a reality for the sector. However, it will take time for the ecosystem to develop and for us to see a Make in India for medical devices that embraces both manufacturing and R&D. There will be a slow transition where indigenous and imports devices will have to be carefully balanced to meet the needs of the patient population.
Focal areas for med device exports to the EU
Caroline Freeman, Principal Consultant, Consulting Services, IQVIA highlights four inter-linked focal areas that Indian device players looking to the EU regulated market should focus on
a) Good quality, well-ordered technical documentation which demonstrates the safety profile of the device evidencing the compliance of the device with established international standards
b) Robust clinical data to support the safety and performance of their devices. The Clinical Evaluation Report is a key element in technical documentation.
c) Compliance with the ISO 13485:2016 quality system standard to show that high quality devices can be manufactured consistently.
d) Thorough ongoing post-market surveillance systems, including vigilance, to collect information from the use of the devices in the field.
Policy makers recently changed the definition of medical devices to encourage FDI, in the hopes that global medical devices players would invest in manufacturing facilities in India. Will this work?
This is a very positive move. Additionally, the implementation of the Medical Device Rules which makes India at par with other nations will boost FDI.
Your views on the recently announced National Health Protection Scheme, i.e. Modicare announced as part of the Budget. Where are the challenges/ gaps and how can they be resolved? What will it take in terms of resources (funding, manpower) to make this a viable plan?
While this is a great initiative by the Government of India and a positive for the devices industry with the Government also becoming a large consumer/buyer in India, it is too premature to comment on the details.