Medical devices play a critical role in modern healthcare systems, being part of the diagnosis, treatment, and monitoring of diseases and medical conditions. However, 70-80% of India’s medical device requirements are met through imports and very little is manufactured at home. The Indian medical devices market was valued at approximately $10-12 bn in 2020 and is projected to increase to $50 bn by 2025. India imports medical devices primarily from the USA, Germany, China, and Japan. Realizing the problem of high import dependency and to keep technology affordable, the Government of India approved the National Medical Devices Policy on 2 May 2023. The policy introduces several key initiatives to streamline regulations, foster innovation, attract investments, develop human resources, and develop Indian brands of medical devices. However, the manufacturing of various devices needs approval by various approving bodies. The Medical Devices (Amendment) Rules 2020 encompass various aspects of device regulation, such as classification, registration, manufacturing and import, labeling, sales, and post-market requirements. The Bureau of Indian Standards (BIS) has its own categorization based on domestic standards. It may be ideal to have a separate law and regulatory body which would take care of medical devices end to end along with import tariff rationalization and competitive domestic pricing.
Domestic manufacturing also needs a thrust in implementation, as the PLI scheme is in place. Under the PLI scheme for medical devices, the Government will provide an incentive of Rs 3,420 crore to new projects between 2022-23 and 2026-27. As of June 2023, 26 applicants had invested Rs 852 crore out of the committed investment of Rs 1,330 crore, which builds a case for a bigger push. There is also a difference in the implementation of new medical devices between public and private healthcare. For public hospitals, it is very difficult to procure and apply to patients while the private sector can easily do so. Bringing public and private procurement of devices at par would help a lot. Finally, a strong focus on R&D is essential to drive innovation and enhance the safety and quality of medical devices. Collaboration between industry, research institutions, and regulatory bodies can establish robust quality control measures, promote adherence to international standards, and ensure patient safety.