Abstract

NEW REGULATIONS FOR MEDICAL DEVICES IN INDIA- TAKING THE INDUSTRY TO NEXT LEVEL

*Prashant Soni and Prof. (Dr.) S.K.Gupta

Abstract

In India, the medical technology sector is pegged at USD 6.3 billion, which is small as compared to rest of the global business but rapidly growing annually at CAGR of 15 percent. In India, the medical devices sector is mostly import driven with approximately 75 percent of devices are imported. There were lots of complaints about the overcharging of medical devices in hospitals by various governmental and non-governmental organizations (NGOs). Because of this, Maharashtra Food and Drug Administration (FDA) conducted a sixmonth long inquiry against major importing companies. The report of FDA exposed that, there is an exaggeration of around 300-700 percent from the price of stents at which they were imported. In spite of chances of very huge potential and growth, the Indian Medical device industry is full of challenges like import dependency, non adequate regulatory standards and the absence of tax incentives. There are a series of measures taken by the government like 100 percent foreign direct investment (FDI), hike in basic customs duty by 5 percent of imported medical devices, and providing funds for functioning of medical equipment in public health facilities. Task force constitution and draft National Medical Device Policy-2015 (NMDP-2015) were the other steps to promote domestic production. Access, affordability and return on innovation are the three pillars of medical device industry, which should be balanced to get fruitful result. Sufficient resources are present to open the right doors of opportunities and present India as a global hub for innovation and technology.

Keywords: Medical Devices, FDI, National Pharmaceutical Pricing Authority, equipment, implants, diagnostic.