India Inc. Backs Ban on Import of Refurbished Medical Devices
The import of pre-owned and refurbished medical devices into India will remain prohibited until a regulatory framework is established for such equipment, as clarified by senior officials of the Central Drugs Standard Control Organization (CDSCO) – India’s national regulatory body for cosmetics, pharmaceuticals and medical devices. This announcement reinforces India’s stance on ensuring strict compliance with medical device regulations.
CDSCO regulates quality, safety, and performance of the Medical Devices under Drugs and Cosmetic Act, 1940 and Medical Devices Rules, 2017 thereunder. All the Medical Devices are regulated under Medical Devices Rules, 2017. However, in a communication dated January 10, Aseem Sahu, Deputy Drugs Controller (I) at CDSCO, stated in a letter to the Office of Principal Commissioner of Customs: “There is no specific provision for regulation of refurbished medical devices under the said rules. Hence, no license is issued for import of such devices, and it cannot be imported in the country under Medical Devices Rules, 2017 for sale and distribution.”
Welcoming the move, Rajiv Nath, Forum Coordinator of the Association of Indian Medical Device Industry (AiMeD), emphasized its alignment with India’s broader vision for the medical device sector. “We hope the ongoing policy review by the Health Ministry will align with the National Medical Devices Policy 2023, which aims to position India as a global manufacturing hub for medical devices. We encourage multinational corporations to invest in India, produce high-tech equipment locally, and make them affordable for Indian patients, similar to the success seen in the mobile phone and automobile industries. Healthy competition is always welcome,” Nath remarked.
Prof. Bejon Kumar Misra, Founder of the Patient Safety and Access Initiative of India Foundation, also emphasized patient safety. “Consumers must speak up against violations that undermine their rights. The next logical step is to recall all illegally imported medical devices from every corner of the country and destroy them in the interest of patient safety,” he stated.
Dr. Jitendra Sharma, Managing Director of Andhra Pradesh MedTech Zone (AMTZ) in Visakhapatnam, highlighted the broader implications of this decision. “A stop to import of refurbished medical equipment is a true policy intervention that will guard the domestic industry against dumping of equipment with uncertain quality and will also help the patients in receiving appropriate medical care thereby bringing the best value of cost for them and for the payers, including insurance agencies. This is a welcomed and much awaited long due intervention,” he stated.
Gaurav Agarwal, Managing Director of Innvolution, highlighted the positive impact of the move on domestic manufacturing and support industries. “We applaud CDSCO for clearing the mixed signals we had been receiving. On one hand, the Government of India supports us with an excellent PLI scheme to manufacture high-end Cath labs and imaging equipment domestically. On the other hand, we struggled to compete with low-priced, second-hand imports.”
He further explained: “The Medical Device Rules do need a provision for extra safeguards needed for refurbishing or re-manufacturing equipment beyond their extended warranty periods. The existing informal sectors that had been repairing and refurbishing imported preowned equipment can now use their skills to do so for the indigenously produced equipment. With a growing domestic market driven by stable and competitive manufacturing, this support industry will have ample opportunities to expand.”