Abstract

Most of the industrial sectors of India have undergone major changes in the post-liberalization period. During this period, India has become self-reliant in drugs; however, still, 75% of the medical devices are imported in India. According to WHO, almost all devices present in the developing countries have been designed for use in the industrialized countries. With the increase in incidence of non-communicable diseases and decrease in communicable diseases; increase in survival rates and decrease in mortality rates, and increase in ageing population, the healthcare demands have changed in the last decade. In addition to these parameters, aware patients and healthcare professionals, requirement of achieving national targets of healthcare and close proximity to the developed world, is giving a push to the development of indigenous medical device industry. However, the rules and regulations governing medical devices are ambiguous and vague. The Health Ministry of India has notified Medical Devices Rules, 2016, for regulating manufacturing/import/sale/clinical investigation and other related matters concerning medical devices. In addition, the government is funding the start-up industries in medical devices sector. Furthermore, government has taken the initiative of inverted duty structure in India. Also, special med tech zones are being set-up, which will enhance the production at local levels for the local population and will also generate employment for local people.