Indian Medical Device Sector - Blue Print & Regulatory Policy Roadmap

Abstract

Good quality, affordable and comprehensive healthcare to all its citizens is the new age universal mantra in Government lexicon. While healthcare infrastructure and indigenous medical device manufacturing are the areas in which most countries have achieved self-sufficiency, the medical device sector in India with about 80% import dependency needs focused attention and policy interventions to achieve self-sufficiency. In 2015, Government of India included medical device sector in its ambitious Make in India program. Since then, there have been various policy initiatives by the Government to address ecosystem requirements including rolling out of the Medical Device Rules 2017 to regulate devices, introduction of 100% FDI policy to attract foreign investments, addressing infrastructure gaps by setting-up Medical Device parks, incubators, accelerators, boosting innovation by supporting start-ups etc. The policies in this sector are evolving, changing frequently which brings in unpredictability and lack of confidence in manufacturers and importers e.g. notification of medical devices to be regulated as drugs, price capping etc. Indigenously developed medical devices lack credibility due to lack of comprehensive regulation of devices. The medical device industry in India is at its surge with about 800 manufacturers and 1000+ start-ups. The industry has expectations in terms of policy roadmap for catalyzing this sector and making it self-sustainable. This article covers key policy initiatives to boost medical device sector by the Government of India, highlights medical device industry expectations and the envisaged roadmap for developing a conducive ecosystem for fostering this sector in India with immense growth potential.