India’s drug regulatory authority has directed Customs officials to prohibit the import of refurbished medical devices, citing the lack of specific provisions under the existing Medical Devices Rules, 2017. The move, outlined in a January 10 letter, aims to address safety and regulatory gaps linked to these unlicensed products.
The regulator highlighted that no licences are issued for the import, sale, or distribution of refurbished medical devices in India, underscoring the risks associated with such unregulated equipment. Concerns over patient safety and reliability have been escalating, with domestic manufacturers flagging unchecked imports of uncertified devices as a threat to the healthcare ecosystem.
Last year, the Patient Safety and Access Initiative of India Foundation (PSAIIF) filed a public interest litigation in the Delhi High Court, emphasizing the dangers posed by these devices. Rajiv Nath, forum coordinator at the Association of Indian Medical Device Industry, hailed the decision as a “game-changer” for boosting local manufacturing under the ‘Make in India’ initiative. “We urge global companies to invest in India to manufacture high-tech equipment, replicating the success seen in the mobile and automobile sectors,” Nath added.
Jitendra Sharma, managing director of the Andhra Pradesh MedTech Zone, described the ban as a significant step to protect domestic manufacturers from low-quality imports and ensure better healthcare for patients.
As reported by economictimes, the Medical Technology Association of India, while supporting the regulator’s stance, called for expedited policy development by the Ministry of Health and Family Welfare to allow regulated imports with necessary approvals. The association noted that refurbished equipment constitutes about 10% of India’s medical device market, serving critical needs in smaller cities and rural areas.
Until a policy framework is established, imports of refurbished medical devices remain suspended, signaling a strong push for safer and locally manufactured solutions in the healthcare sector.