MoEFCC accused of National Medical Devices Policy violations by Industry Associations

• Industry leaders call for the Prime Minister’s intervention in the long-lasting issue of allowing imports of refurbished medical devices.
• Domestic manufacturers raise concerns about the ministry officials’ confused policies, which pose a threat to the growth of the ‘Make in India’ initiative and the vision of a self-reliant India.
• Refurbished and pre-owned devices may compromise patient safety due to diminished reliability, lack of warranties, and outdated technology

New Delhi, October 29, 2024: The PHD Chamber of Commerce and Industry (PHDCCI) and the Association of Indian Medical Devices (AiMed), in alliance with the Manufacturers of Imaging, Therapy and Radiology Devices Association (MITRA), the Association of Diagnostic Manufacturers of India (ADMI), and key stakeholders from the MedTech industry, held a press meet at PHD House to discuss serious concerns regarding recent Office Memorandums issued by 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 memorandums permit the import of refurbished and pre-owned medical devices, despite similar devices being manufactured in India. Industry leaders believe this 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. This development is seen as a major setback for domestic manufacturing capabilities and India’s push toward self-sufficiency. Additionally, concerns have been raised about potential risks to patient safety, as refurbished devices may not meet the rigorous quality standards of newly manufactured equipment, further intensifying the issue.

Industry leaders stressed that this memorandum significantly undermines the domestic MedTech sector, which has experienced remarkable growth and investment in recent years under the ‘Make in India’ initiative. Despite India’s ability to manufacture high-quality medical devices, allowing refurbished imports jeopardizes the hard-won progress made in the domestic sector. By favouring imported refurbished and pre-owned medical devices, this policy undermines the innovation and investments of Indian entrepreneurs, hindering the growth of a strong and competitive MedTech industry in India.

Moreover, there are serious concerns about safety outcomes and the quality of patient care, as refurbished devices may not adhere to the stringent safety protocols required for new devices. This could potentially compromise patient well-being and diminish healthcare delivery. The reliance on refurbished imports not only threatens the industry but also causes trauma to startups and MSMEs, leading to the potential shutdown of manufacturing units.

The Government of India’s vision to make India a global MedTech leader, with a focus on promoting innovation and export orientation, has been demonstrated in the life sciences and pharmaceutical industries. All initiatives and efforts from various ministries aim to position India as a global destination for medical devices while reducing import dependency over time. However, the recent government orders in 2023 and 2024 allowing the import of refurbished and pre-owned devices, despite the availability of similar products manufactured in India, threaten the long-term efforts of Indian manufacturers to meet the Prime Minister’s vision of Aatmanirbhar Bharat.

Furthermore, industry experts highlight 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.

Refurbished devices, which undergo repairs and cosmetic updates, cannot replicate the functionality and reliability of new equipment. New medical devices maintain optimal performance throughout their lifecycle, typically lasting around ten years, while refurbished options may show diminished functionality due to prior use. Additionally, refurbished devices often lack the latest technological advancements and come with lower warranties, inadequate service support, and higher failure rates, all of which can impact the quality of treatment and surgical outcomes.

Domestic companies, whose similar products are listed in the 2023 Office Memorandum issued by the MOEF and DGHS orders, have made representations detailing their investments, manufacturing capabilities, and employment generation, along with lists of installations in India and overseas, to the MOHFW, DOP, MOEFCC, and DGHS, both directly and through associations. It was shocking to see a new order from the DGHS and MOEFCC in October 2024 allowing the same products without any consideration of industry requests. Additionally, the mandatory clause stating that ‘Equipment manufactured in India should not be allowed for import’ has been removed.

The Association of Indian Medical Device Industry (AiMeD) warns that imported refurbished devices are often inaccurately labelled, posing a significant risk to patient safety. The lack of clear refurbishment guidelines in India allows unscrupulous traders to import substandard equipment without proper oversight.

Visibly disappointed Mr. Rajiv Nath, Forum Coordinator, AiMeD (AiMed) rued the detrimental impact of this memorandum on local manufacturing, and said, “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. The 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. India must not become a dumping ground for obsolete medical equipment.”

Dr. Sudhir Srivastava, Past Chair of the Medical Device Committee at PHDCCI, highlighted critical concerns regarding refurbished medical devices, and said  “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 disincentivize investment in homegrown advancements. Overseas companies may view India as a market to recover R&D costs, but for us to truly lead in healthcare innovation, our policies must safeguard and prioritize our own ecosystem of excellence, ensuring patients receive the best care without compromising the integrity of our industry.”

Mr. Atul Sharma, Co-Founder of Innvolution Healthcare Pvt. Ltd, said, “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.”

Srinivasa Reddy, Senior Vice President of SS Innovations, said, “India is a global leader in the pharmaceutical industry and is highly regarded as the world’s vaccine manufacturing hub, contributing 60% 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”

Ms. Shalini Sharma, Assistant Secretary General, PHD Chamber of Commerce and Industry, said, “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. 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.”

Ms. Chandra Ganjoo, Group Chief Executive Officer, of Trivitron Healthcare, said, “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.”

Mr. Viswanathan Santhanagopalan, CEO & MD, of Sequoia Healthcare, said, “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. 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.”

Mr. R.S. Kanwar, Director, Allengers Medical Systems Limited, said, “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. Rather than relying on outdated imports, we should invest in modern, locally manufactured equipment that aligns with global standards and ensures that Indian healthcare providers have access to the best tools for delivering superior patient care.”

The increasing import of refurbished and reconditioned medical equipment raises significant safety concerns and poses a threat to Indian manufacturers. These pre-owned devices may fail to deliver accurate diagnoses, jeopardizing patient safety. Many patients remain unaware that the equipment used in their care may be outdated and potentially unsafe. Additionally, without stringent regulatory checks, these imports often introduce substandard products into the market, undermining patients’ fundamental right to safe healthcare.

In light of these issues, industry leaders collectively urged the Prime Minister to address the current challenges and order an immediate ban on the import of refurbished devices that are manufactured locally. They emphasized the importance of aligning policies with national manufacturing initiatives to support domestic manufacturers and reduce reliance on imports. Furthermore, they called for enhanced post-market surveillance to monitor the safety and effectiveness of all medical devices used in India, ensuring that patient safety remains a top priority.

The event underscored the pressing need to protect India’s MedTech sector and uphold the Prime Minister’s vision of a self-reliant India. Speakers called on the government to take immediate action to address these critical issues and support the country’s medical device manufacturers in their vital role within the healthcare ecosystem.

Corporate Comm India (CCI Newswire)