A Comparative Study of Medical Device Regulations in India: Before and After the Implementation of Medical Device Rules 2017

摘要

The medical device industry in India is one of the fastest growing commerce in the world as it is growing at a rate of 15.8% CAGR (Compound Annual Growth Rate) vis-a-vis a CAGR of 4.1% for the global medical device industry. Since 1940, medical devices were regulated as per Drug and Cosmetic Act 1940 and Rules 1945, CDSCO (Central Drug Standards Control Organization) regulated only a handful of medical devices through gazette notifications, these devices being called as notified devices. Many devices were classified as drugs in India. This system was not in consonance with the international standards and was rudimentary in character. Revamping the existing regulatory framework and creating harmonizes standards for all medical devices was the need of the hour. CDSCO, after thorough study overhauled the regulatory framework for medical devices in 2017 by passing Medical Device Rules and has brought it at par with international norms. It has also introduced various fiscal measures to promote research, development, manufacturing and import of medical devices in India. This review highlights the recent progress in Indian medical device regulation with the dawn of Medical Device Rules 2017 in the light of Drugs and Cosmetics Act 1940 and Rules 1945.