Domestic medical device manufacturers have asked the central ministries of Environment, Forest, and Climate Change (MoEFCC) and the Health & Family Welfare (MoHFW) to review the permission given for the import of refurbished and pre-owned medical devices, despite similar devices being manufactured in India.
The import permission poses a significant threat to India’s self-reliance in medical device manufacturing, undermining the nation’s efforts under the Prime Minister's vision of 'Make in India' and 'Aatmanirbhar Bharat' initiatives, they complained.
In a press conference organised in Delhi on Friday, representatives of the Association of Indian Medical Devices (AiMed), Manufacturers of Imaging, Therapy and Radiology Devices Association (MITRA) and the Association of Diagnostic Manufacturers of India (ADMI) said that while the industry has developed devices meeting international quality standards, which are widely used in both Indian and international healthcare institutions, it is irrational to permit refurbished medical devices to compete with locally made new products. Over the last ten years, India has shown significant growth in local content and has become export-oriented for many critical, high-end, and high-value medical devices, they added.
"As one of Asia’s largest Cath Lab manufacturers, we’ve developed equipment that meets global standards and suits India’s healthcare needs across all city tiers, ensuring cost-efficiency and reliability. Claims that refurbished equipment is more affordable for smaller cities are misleading, as these devices incur higher maintenance costs and shorter lifespans. India’s self-reliant healthcare vision relies on fostering local innovation, and we urge the government to prioritize domestic manufacturers and consult CDSCO’s data to prevent unnecessary imports that hinder industry growth" Atul Sharma, Co-Founder of Innvolution Healthcare Pvt. Ltd, said.
Industry representatives also raised concerns about potential risks refurbished and pre-owned medical devices could pose to patient safety, as refurbished devices may not meet the rigorous quality standards of newly manufactured equipment.
“The Office Memorandum (OM) issued by the MoEFCC undermines the National Medical Devices Policy 2023, which was launched by the Prime Minister last year. The OM allows the import of pre-owned medical equipment into India, putting the investments made by Indian and overseas manufacturers under the "Make in India" initiative at risk of becoming Non-Performing Assets (NPAs), some of which are ironically subsidised by the Government of India under its PLI scheme. This 'two steps forward by one government department and one step backwards by another' approach is confusing and unsettling for investors”, Rajiv Nath, Forum Coordinator, AiMeD said. According to Nath, investors will only bring manufacturing technologies to India if the policy environment is predictable and consistent with the National Medical Devices Policy 2023, intended to be binding on all government departments. “Not only are many projects recently initiated for high-end medical equipment now jeopardised, but patient safety is also at risk. Patients could be treated with non-calibrated, non-regulated medical equipment, compromising safety. India is being treated as a dumping ground for e-waste, with obsolete equipment being resold in the country, while overseas manufacturers benefit from doubling their sales— once through replacement sales to hospitals in the Western world and again through second sales of pre-owned equipment to India. This severely harms the domestic industry, which is still in its nascent stage", Nath said.
