The Central Drugs Standard Control Organisation (CDSCO) has issued an order halting the import of pre-owned, refurbished medical devices into India until a comprehensive regulatory framework is established. This move has sparked intense debate within the medical device manufacturing industry, with domestic manufacturers applauding the decision as a step toward self-reliance, while others warn of potential setbacks to healthcare accessibility.
A Push for ‘Make in India’
The CDSCO’s decision, communicated to the Principal Commissioner of Customs on January 10, underscores the absence of specific regulations under the Medical Devices Rules, 2017 governing refurbished devices. Consequently, no licenses for such imports will be issued.
Rajiv Nath, forum coordinator of the Association of Indian Medical Device Industry (AiMED), described the move as a “huge enabler” for investments under the ‘Make in India’ initiative. Echoing his sentiment, Gaurav Agarwal, Managing Director of Innvolution Healthcare, emphasized that the decision aligns perfectly with the Atmanirbhar Bharat initiative, promoting self-reliance, innovation, and high-quality manufacturing in India’s medical technology sector.
Domestic manufacturers highlighted the potential safety risks posed by second-hand devices, with Prof. Bejon Kumar Misra, founder of the Patient Safety and Access Initiative of India Foundation (PSAIIF), advocating for the destruction of illegally imported devices to protect patient safety.
Concerns Over Accessibility and Transition
On the other hand, multinational corporations (MNCs) and healthcare providers have expressed concerns about the abrupt nature of the decision, which they claim was implemented without prior notice or transitional provisions.
A spokesperson for an MNC device manufacturer revealed that the halted imports had previously been permitted by the Union Environment Ministry, including 38 high-end and high-value (HEHV) devices approved by the Directorate General of Health Services (DGHS). “This sudden move disrupts supply chains critical for hospitals in Tier-II, Tier-III, and rural areas,” the spokesperson added.
Industry insiders estimate the value of the pre-owned medical equipment market in India at approximately ₹1,500 crore, constituting 10% of the country’s total medical equipment industry. Experts argue that these devices play an essential role in addressing the growing demand for affordable healthcare in underserved regions.
Calls for a Comprehensive Policy Framework
Amid the controversy, several industry bodies, including Nathealth and the Medical Technology Association of India (MTaI), have called for the swift establishment of a regulatory framework for refurbished medical devices.
Siddhartha Bhattacharya, Secretary General of Nathealth, stressed the need for well-defined guidelines with input from stakeholders across the value chain. “A policy with proper guardrails for safety and efficacy would benefit both domestic and global manufacturers while ensuring no dumping of unsafe devices,” he said.
The MTaI also urged the health ministry’s expert committee to expedite the creation of a policy, emphasizing the importance of approvals from the DGHS and the environment ministry to prevent disruptions.
The Way Forward
While the CDSCO’s order aligns with India’s vision of fostering domestic manufacturing and ensuring patient safety, the lack of an immediate regulatory alternative has left a gap in the market. As the debate continues, stakeholders from both sides are united in their demand for a well-considered policy that balances innovation, accessibility, and safety.
The decision’s long-term impact will depend on how swiftly the government can implement a robust framework, ensuring equitable access to affordable medical technology across India.
