In India, medical device industry is a multi-product industry covering the entire gamut from disposable gloves and syringes to high-end machines like CT scans and robotic surgery machines and worth $5 billion approximately growing at a Compound Annual Growth Rate (CAGR) of 15%. Over 75% of medical devices market is dependent on imports, mostly by multinationals that have no manufacturing facility in India. According to a survey conducted by us, the disposables ($1.57 billion), consumables ($0.83 billion) and surgical instruments ($0.06 billion) market depends on around 40-50% of imported products while the medical electronics ($1.57 billion), hospital equipments ($0.39 billion), implants ($0.20 billion) and diagnostics ($0.09 billion) categories on around 85-90%. Due to more dependency on imported products as well as absence of regulations for prices in India, doctors, hospitals and retailers overcharged the patients almost three to four times for certain devices e.g. Drug eluting stents (DES) manufactured by Abbott imported at $640 and sold at $2000, a mark-up of over 250% and that manufactured by Medtronics imported at $485 and sold at $2600, a mark-up of more than 400%. Recognising this policy deficit, the Department of Pharmaceuticals under the Ministry of Chemicals & Fertilizers, has published draft proposals which is National Medical Device Policy-2015 for the medical devices approval & pricing regulations. These proposals have recommended creating an autonomous body, the National Medical Devices Authority (NDMA) for pricing control of medical devices by including them under the Essential Commodities Act or through a Medical Devices Prices Control Order(MDPCO) and creating a separate pricing division in the National Pharmaceuticals Pricing Authority(NPPA). Ispor-India chapter has developed Pharmacoeconomic guidelines which will also include the above mentioned devices and the same will be presented in this presentation along with our survey data.