An Analysis of India's Medical Device Regulations, with Analogies to the European Union and Future Recommendations

Abstract

The Indian healthcare industry is rapidly expanding, with revenues forecasted to reach $280 billion by 2025. India's medical equipment market is among the world's top 20. It is currently worth $5.2 billion, and by 2025, it is predicted to be worth $50 billion. India, on the other hand, does not manufacture many medical devices in-house and now imports more than 70% of its medical gadgets. Medical device manufacturing and monitoring are heavily regulated operations. There were no special medical device rules in India, and devices were governed under the 1940 Drugs and Cosmetics Act. The Central Drug Standard Control Organization issued the Indian Medical Device Rules in 2017 to fill this research gap. They are the new medical device regulations in the country. In order to keep up with the demands, the Medical Devices (Amendment) Rules, 2020 were enacted, which took effect in April 2020. These regulations encompass a wide range of device-related issues, such as categorization, registration, production and import, labelling, sales, and post-market procedures, among others. The regulations are a positive initiative forward because they cover the majority of the European Union (EU) approval process, which confirms that devices are safe and functional. With rapid advances in medical device technology, however, more clarification and restructuring of the current regulatory structure is needed to standardize standards and bring them in line with sophisticated regulations such as those in the EU.