New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has issued a directive halting the import of refurbished medical devices, citing the absence of specific regulations under the Medical Devices Rules, 2017. The directive, issued on January 10, 2025, to the Principal Commissioner of Customs, emphasized that refurbished devices cannot be imported for sale or distribution in India due to the lack of proper licensing provisions.
This move aims to address concerns regarding the safety and reliability of refurbished medical devices entering the market without the necessary certification. Rajiv Nath, forum coordinator of the Association of Indian Medical Device Industry (AiMED), welcomed the move, calling it a significant enabler for the “Make in India” initiative and a step toward improving patient safety.
Background:
The CDSCO’s decision follows growing concerns about the potential risks associated with refurbished medical devices. The Patient Safety and Access Initiative of India Foundation (PSAIIF) had filed a Public Interest Litigation (PIL) in the Delhi High Court, highlighting the hazards posed by such devices.
While the move has been praised by the domestic medical device industry, some stakeholders have expressed concerns about the impact on underserved areas. The Medical Technology Association of India (MTaI) estimates that refurbished medical equipment accounts for about 10% of India’s Rs 1,500 crore medical equipment industry, providing affordable healthcare solutions in Tier-II, Tier-III, and rural areas.
Industry Response:
While some industry leaders view the decision as a safeguard against the import of low-quality equipment, others, including the MTaI, have urged the government to allow imports under necessary approvals until a formal policy framework is established.
Jitendra Sharma, Managing Director of the Andhra Pradesh MedTech Zone, praised the decision, calling it a “true policy intervention” to protect the domestic industry from the dumping of equipment with uncertain quality. He noted that the move would promote patient safety and bolster the local manufacturing sector.
Regulatory Framework Development:
The Ministry of Health and Family Welfare is in the process of forming a high-level expert committee to develop a regulatory framework for refurbished medical devices. Until this framework is in place, any consignments of refurbished devices currently held at ports will need to be returned, as confirmed by Deputy Drugs Controller (India) Aseem Sahu.
Previous Import Rules:
Previously, the import of refurbished medical devices was allowed under the Hazardous and Other Wastes (Management and Transboundary Movement) Second Amendment Rules, 2023, enacted by the Ministry of Environment, Forest and Climate Change (MoEFCC). These rules allowed imports of devices up to five years old, initially covering 50 high-value medical devices, later trimmed to 38 devices in October 2024.
Looking Ahead:
Rajiv Nath emphasized that, similar to the approach on pre-owned cars and iPhones, India should adopt a similar stance on refurbished medical devices. He encouraged multinational corporations to invest in India and manufacture high-tech medical devices locally, citing the automotive and mobile phone industries as examples of successful local manufacturing ecosystems.
The CDSCO’s action aligns with the National Medical Devices Policy, 2023, which aims to position India as a global hub for medical device manufacturing. The industry is eagerly awaiting the development of a regulatory framework that balances patient safety, domestic manufacturing, and affordable healthcare for underserved regions.
