Industry Accuses MoEFCC Of Jeopardising National Medical Device Policy

In a recent press conference at PHD House, prominent industry associations, including the PHD Chamber of Commerce and Industry (PHDCCI), the Association of Indian Medical Devices (AiMed), the Manufacturers of Imaging, Therapy and Radiology Devices Association (MITRA), and the Association of Diagnostic Manufacturers of India (ADMI), united to express concerns over recent Office Memorandums (OMs) from the Ministry of Environment, Forest, and Climate Change (MoEFCC), the Directorate General of Health Services (DGHS), and the Ministry of Health & Family Welfare (MoHFW). These OMs allow for the import of refurbished and pre-owned medical devices, a decision the industry believes threatens the 'Make in India' initiative and could compromise patient safety.

Industry leaders argue that by permitting imports of refurbished devices, the policy undermines India’s self-reliance in medical manufacturing and negatively impacts domestic manufacturers. They highlight that this allowance could hinder the growth of the MedTech sector in India, which has seen significant development under the Prime Minister’s 'Aatmanirbhar Bharat' vision.

According to industry representatives, refurbished devices may not meet the safety and quality standards required of new equipment, posing a risk to patients. Concerns were also raised about the policy's potential to undermine the investments made by domestic manufacturers, many of whom have created products meeting international standards.

Rajiv Nath, Forum Coordinator of AiMed, voiced disappointment, stating, “The Office Memorandum (OM) issued by the MoEFCC undermines the National Medical Devices Policy 2023, which was launched by the Honourable 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.”

He further warned, “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.”

Dr. Sudhir Srivastava, Past Chair of the Medical Device Committee at PHDCCI, emphasised the policy’s impact on quality care, stating, “Allowing the influx of refurbished medical equipment undermines India's progress in medical technology and sends a mixed message to investors. As Indian manufacturers are investing in R&D and innovating high-tech solutions aligned with the 'Make in India' vision, refurbished imports not only compromise quality of care but also disincentivise investment in homegrown advancements.”

Atul Sharma, Co-Founder of Innvolution Healthcare , 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.”

Srinivasa Reddy, Senior Vice President of SS Innovations, cautioned that the policy might diminish India’s stature in the global MedTech market, saying, “India is a global leader in the pharmaceutical industry and is highly regarded as the world's vaccine manufacturing hub, contributing 60 per cent to the global vaccine supply. Similarly, the MedTech industry has a significant opportunity to integrate India into the global supply chain. However, inconsistent support and policy concerns regarding the import of refurbished devices from the government could significantly undermine India’s progress and success.”

Shalini Sharma, Assistant Secretary General at PHDCCI, conveyed the chamber’s support for India’s self-reliance goals but voiced concern over the policy’s implications for local manufacturers. “PHDCCI acknowledges the government's commitment to advancing healthcare. However, the import of refurbished medical devices poses challenges for domestic manufacturers, many of who are members of the chamber,” she said. “We seek to collaborate with the government to foster a fair marketplace for Indian-made products, reinforcing the spirit of 'Make in India' and 'Aatmanirbhar Bharat.'”

Chandra Ganjoo, Group Chief Executive Officer at Trivitron Healthcare, warned of the policy’s long-term impact on Indian healthcare, commenting, “The import of refurbished medical devices will have a long-term impact on the Indian healthcare ecosystem and pose a direct threat to India’s vision of Aatma Nirbhar Bharat. The refurbished equipment will be a hindrance to the growth of India’s medical device industry. This approach discourages focus on research and development and limits innovation, which are crucial for driving the country's healthcare forward.”

Viswanathan Santhanagopalan, CEO and MD of Sequoia Healthcare argued that the policy does not result in cost benefits for patients. “Hospitals and diagnostic centres charge patients the same fees, regardless of whether they use new or refurbished equipment, meaning no cost benefit is passed on to patients while outdated technology is employed,” he said. “The auto industry in India grew because high import duties on used cars discouraged imports and encouraged local manufacturing. A similar approach should be applied to the medical device industry to protect and foster domestic manufacturers, ensuring the growth of modern, reliable healthcare technology in India.”

R.S. Kanwar, Director of Allengers Medical Systems Limited, reiterated the potential risks posed by refurbished devices, stating, “As a company committed to advancing healthcare technology in India, we strongly believe that the import of refurbished medical equipment poses significant risks to patient safety and healthcare quality. Refurbished machines often bring obsolete technology, unreliable performance, and a lack of compliance with modern standards, which ultimately compromise diagnostic accuracy and treatment outcomes.”

Industry leaders appealed to the Prime Minister for an immediate review of the policy to restrict imports of refurbished devices when locally manufactured alternatives are available. They emphasised the need for aligned policies to support domestic manufacturing and maintain stringent quality checks on medical equipment used across India, ensuring patient safety remains a priority.