The Central Drugs Standard Control Organisation (CDSCO) has recently banned the import of used and refurbished medical devices in India. This has created a huge buzz in the Indian medical device industry. This order was sent by letter on 10 January 2025. According to this order, there is no rule for the same under Medical Devices Rules 2017, which means selling and distributing imported ones is a complete ban on them.

Support for the ban

Many local manufacturers are pleased with this decision. They believe it will help the "Make in India" initiative grow stronger. According to Rajiv Nath, an associate of the Association of Indian Medical Device Industry (AiMED), this move will clear confusion and support local innovation. Managing Director of Innvolution Healthcare, Gaurav Agarwal also said that the decision is quite in line with the government's vision of good quality healthcare coupled with local manufacturing. The decision is also interpreted as a patient protection measure as it will benefit the patients at the grassroots level, where safe medical equipment is the only thing that is needed. Uncontrolled second-hand equipment may be risky for patient safety.

Concerns from multinational corporations

On the other hand, some multinational companies are concerned about the speed of this decision. They state that imports were made earlier also but only with the due permissions from different authorities such as the Union Environment Ministry. An anonymous spokesperson for one of those companies said this would be highly disruptive to their supply chains, affecting healthcare providers that rely on the equipment, adding that warning could help healthcare providers adjust or even source comparable alternatives. India's market for used medical devices is approximately ₹1,500 crore, this accounts for around 10% of its total medical devices industry.

Need for regulation

Experts in the sector are demanding a clear set of rules to be able to address this issue. Siddhartha Bhattacharya of Nathealth emphasized that such guidelines would guarantee safety and effectiveness while keeping inferior devices out of the market. The Medical Technology Association of India (MTaI), has also called for policies to be designed quickly on refurbished devices so that health services do not get disrupted. Without the rules, healthcare delivery is said to suffer some severe setbacks.

Future implications

The CDSCO decision comes at a time when refurbished medical devices have increasingly been touted as a patient safety issue. These risks had led a public interest litigation filed in the court last year to demand stringent rules around the airing of such advertisements. While this may be helpful for the local manufacturer, it will also increase costs for various stakeholders providing healthcare. Because India finds itself trying to balance patient safety and accessibility, guidelines for the import of medical devices are important for future decisions.

Most local producers believe the decision by the CDSCO is good for safety and autonomy but raises concerns over healthcare costs and services. The rules should be strong to ensure security for patients while allowing access to medical tools for one and all. Balancing safety and accessibility is equally important towards improving health care.