Explained | What is the National Medical Devices Policy, 2023?

On April 26, the Union Cabinet approved the National Medical Devices Policy, 2023.Here are the various reasons why it is imporetant

The story so far: On April 26, the Union Cabinet approved the National Medical Devices Policy, 2023. The policy endeavours to facilitate an orderly growth of the sector and in turn, achieve the public health objectives of access, affordability, quality and innovation. It is expected to help the domestic medical devices sector market grow from $11 billion to $50 billion by 2030 alongside achieving a 10-12% global market share over the next 25 years. The aim is to provide the required support and direction, and help the sector become “competitive, self-reliant, resilient and innovative” to cater not only to domestic but global needs.  

The most significant of the introduced measures entail regulatory streamlining. The policy enhances the role of the Bureau of Indian Standards (BIS) along with designing a coherent pricing regulation.  

Pricing regulation is particularly important for addressing a broader challenge in the domestic device manufacturing sector. Rajiv Nath, Forum Coordinator at the Association of Indian Medical Devices Manufacturers (AiMeD) told The Hindu that some private hospitals give higher priced products instead of available low-cost options.

“Because of this, the manufacturer or importer of India is tied up in a system of market operating with artificially inflated MRP labelled on the device,” said Mr. Nath, adding separately, “we have been seeking MRP of imports be monitored and compared with imports’ landed prices and steps taken to control when found irrationally excessive.”  

He was optimistic that the policy would enable monitoring of prices and curbing of such practices.

Besides capping prices, the streamlining endeavour will also create a single window clearance system for licensing of medical devices, combining relevant departments like the Atomic Energy Regulatory Board (AERB), MeitY and the Department of Animal Husbandry and Dairying (DAHD). 

To ensure a skilled workforce and create future ready MedTech human resources, comprising scientists, regulators, health experts, managers, and technicians, the policy would support dedicated multidisciplinary courses for medical devices, including futuristic medical technologies, high-end manufacturing and research.