The Indian Medical Devices Industry: On the Cusp of Transformation

The medical devices industry forms a miniscule 6.4% of the Indian healthcare sector. Of course, it is growing faster than the entire healthcare sector put together, but that is little consolation when local players continue to battle challenges of scalability, credibility and brand value. I have always felt that the government wasn’t doing enough to support the industry. So when Indian Prime Minister Narendra Modi launched his 'Make in India' plan last year, I hoped that the industry would at last be able to overcome its pain points and carve a larger share for itself in the healthcare pie.

Finally, in June 2015, the Department of Pharmaceuticals (DoP) set the ball rolling. It issued the draft for National Medical Device Policy (NMDP) 2015 that aims at reducing dependence on imports of medical devices and equipment. The policy focuses on promotion of industry, quality and skills which is as it should be. I’m sure this will go a long way in boosting the quality, reliability and competitiveness of the Indian Medical Device industry.

Indian manufacturers, I think will now be able to compete at the global level. Meanwhile, the level playing field that the policy offers will encourage MNCs to set shop in India giving a new impetus to the industry. With stiff competition from MNCs, Indian players will have no option but to focus on quality. The expansion of the industry will naturally lead to creation of skilled workers in large numbers. That is not all. I can see the rapid growth in the medical devices industry leading to a strong domino effect, positively impacting related industries such as testing labs, raw material providers, manufacturing equipment suppliers and IT service providers. In a nutshell, the entire medical technology ecosystem is sure to develop and flourish.

However, first - the DoP should ensure that the policy is clear-cut and also build a strong regulatory framework.They need to ask themselves a few questions: Are supporting regulations aligned to the policy? Or take the case of device approvals - currently,hospitals and users opt for devices approved in tier 1 countries/regions; e.g. only CE marked devices are imported from Europe. What standard should we fix for approval? Next, what quality standards do we adopt? Canada, for instance, has adopted ISO 13485 for Medical Device Quality Management System (QMS). I think the DoP also needs to prioritize based on the needs of the Indian market. For instance, a category like diagnostic devices needs to be regulated on a priority basis.

If formulated and implemented well, the NMDP policy will surely fulfill its objective of helping build a strong base for medical device manufacturing and reduced dependence on imports. While the presence of the MNCs will ensure product quality, local manufacturing coupled with price control will extend the reach of affordable healthcare. Talking about MNCs, I think that the local players should take a leaf from the auto industry’s book and collaborate with MNCs. This will result in support not only in terms of investment, but also R&D and manufacturing expertise.

I am confident that NMDP 2015 is going to be a game changer for the medical devices industry in terms of business volume, product quality, job creation and collaboration. With ‘Make in India’ having the backing of nobody less than India’s Prime Minister, I am optimistic of the policy being formalized and implemented at the earliest.

About the Author

Pavan Kumar Garikapati is a Regulatory, Quality and IT Compliance professional with about 20 years of experience. Pavan currently heads Regulatory domain practice for Medical Devices business unit at Wipro. He has expertise in US, Europe and emerging market medical device regulations. Pavan is a Six Sigma Master Black belt and Certified Lead Auditor. He has spoken at various conferences and authored papers on these topics

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