Health Ministry Accused of Violating Medical Devices Policy.

Mahesh Dhoundiyal – Delhi

- Industry leaders urged the Prime Minister to intervene on the issue of allowing import of refurbished medical devices.
- Indigenous manufacturers expressed concern over the confusing policies of Ministry officials, which pose a major threat to the ‘Make in India’ and ‘Atmanirbhar Bharat’ vision.
- Used and refurbished medical devices compromise patient safety as these devices with outdated technology are not reliable and have short warranties.

         New Delhi, October 25, 2024: PHD Chamber of Commerce and Industry (PHDCCI) and Association of Indian Medical Devices (AiMed) in collaboration with Manufacturers of Imaging, Therapy and Radiology Devices Association (MITRA), Association of Diagnostic Manufacturers of India (ADMI) and stakeholders from the MedTech industry organized a press conference at PHD House. Where serious issues were discussed in the context of the recent Office Memorandums issued by the Ministry of Environment, Forest and Climate Change (MoEFCC), Director General of Health Services (DGHS) and Ministry of Health and Family Welfare (MoHFW). These Memorandums allow the import of refurbished and used medical devices, despite the fact that similar devices are manufactured in India. Industry leaders believe that this poses a major threat to making India self-reliant in medical device manufacturing, and also hampers the efforts made towards the Prime Minister’s vision of ‘Make in India’ and ‘Atmanirbhar Bharat’. It hampers the indigenous manufacturing capacity of the country. Apart from this, serious issues have also been raised regarding patient safety, as refurbished medical devices may not meet the same quality standards as newly manufactured devices, which can be a cause of serious concern for patient safety.

            Industry leaders have stressed that the Memorandum undermines the indigenous medtech sector, which has grown rapidly in recent years due to investments under the Make in India initiative. Despite India’s ability to manufacture high quality medical devices, allowing imports of refurbished devices could act as a major impediment to the growth of the domestic sector. By encouraging imports of used and refurbished medical devices, the policy hinders innovation and investment by Indian entrepreneurs, and hampers the growth of India’s competitive medtech industry.

               Further the policy also raises questions about the quality and safety outcomes of patient care, as refurbished devices may not be at par with new devices in terms of safety standards. This will compromise the health and well-being of patients. Dependence on imports of refurbished devices poses a risk not only to industry but also to start-ups and MSMEs, as manufacturing units may be forced to shut down.

             The Government’s vision to make India a leader in the global medtech sector and to promote innovation and exports is clearly visible in the life sciences and pharmaceutical industries. Efforts by various ministries are aimed at establishing India as a world-class destination for medical devices and reducing dependence on imports over time. However, the Government’s orders for 2023 and 2024 allow the use of refurbished devices, despite the fact that these products are manufactured in India. This could be a major obstacle in realising the Prime Minister’s vision of Aatmanirbhar Bharat.

           In addition industry experts believe that the industry has developed devices to meet international quality standards, which are widely used in Indian and international healthcare institutions. In such a situation, allowing import of refurbished medical devices instead of locally manufactured new products appears irrational. Over the last ten years, India has made significant progress in local content development and has become export oriented for many critical, advanced and high value medical devices.

             Refurbished devices with repairs and cosmetic updates cannot be equivalent to new devices in any way, be it in terms of practicality or reliability. New medical devices always offer better performance, and last for about 10 years. On the other hand, refurbished devices that have been used for a long time do not have very good functionality. Moreover, such devices are not based on modern technology, come with a shorter warranty, do not have adequate service support, and hence have a higher failure rate. All these aspects can impact the quality of treatment and surgical outcomes.

                The indigenous companies whose similar products are listed in the 2023 OM have submitted detailed details of their investments, manufacturing capacity, employment generation potential to MOHFW, DOP, MOEFCC, DGHS either directly or through their consortiums. It is surprising that the new order received from DGHS and MOEFCC in October 2024 allows such products without considering the consequences. Apart from this, the mandatory provision that ‘devices manufactured in India should not be allowed for import’ has also been removed.

            The Association of Indian Medical Device Industry has warned that refurbished imported devices are often mislabeled, which can be a major threat to patient safety. The lack of clear guidelines on refurbishment in India allows unscrupulous traders to import substandard devices without any oversight.

              Expressing disappointment on the occasion, Shri Rajeev Nath, Forum Coordinator, spoke about the deleterious effect of this Memorandum on local manufacturing and said, “The Office Memorandum issued by the DOM violates the National Medical Devices Policy 2023, which was launched by the Hon’ble Prime Minister last year. This Memorandum allows import of already used medical devices. In such a situation, it is a big threat to India’s indigenous manufacturing under the ‘Make in India’ initiative. Some of these devices are such that they have been subsidized by the Government of India under the PLI scheme. In such a situation, both the steps of the government seem to be contradictory to each other. Investors will be able to bring manufacturing technologies to India only if the policy environment is conducive and in line with the National Medical Devices Policy 2023. This permission has not only hindered indigenous manufacturing of many modern medical devices but has also raised questions on patient safety. Treating patients with unregulated medical devices is a major compromise with their safety. India is being used to dump e-waste. At the same time, foreign manufacturers are doubling their sales, harming India's indigenous manufacturing. These devices are first sold to the western world, and then refurbished and sold to India for the second time. In such a situation, we have to prevent India from becoming a dumping ground for medical devices.'

               Dr Sudhir Srivastava, Former Chairman, Medical Devices Committee, PHDCCI, speaking on the issue said, 'Import of refurbished medical devices to India will hamper the progress of medical technologies in the country. Indian manufacturers are investing in R&D and modern high-tech solutions in line with the 'Make in India' vision. Importing refurbished medical devices not only compromises the quality of patient care but also hampers investment in indigenous advancement. While foreign companies are recovering their R&D costs from India, we are hampering our own medical advancement. Hence, we must frame our policies in a way that ensures the best care for patients without compromising the integrity of the industry.

            Mr. Atul Sharma, Co-Founder, Involution Healthcare Pvt. Ltd. said, “Being one of the largest cath lab manufacturers in Asia, we have developed devices that are at par with global standards and cater to the healthcare needs of every segment of the country with cost effectiveness and reliability. It is a false claim that refurbished devices may be more affordable for smaller cities but have higher maintenance costs and shorter life span. India’s Aatmanirbhar approach to healthcare promotes local innovation. We urge the government to prioritise domestic manufacturing and curb unnecessary imports that could hinder industrial development.”

            Srinivas Reddy, Senior Vice President, SS Innovations, said, “India is a global leader in the pharmaceutical industry and is also considered the world’s vaccine manufacturing hub, contributing 60% of the global vaccine supply. Similarly, the medtech industry has immense potential to integrate India into the global supply chain. However, the government’s policy on import of refurbished devices could hinder the country’s progress and success.”

                 Ms Shalini Sharma, Assistant Secretary General, PHD Chamber of Commerce & Industry said, “PHD Chamber of Commerce & Industry reaffirms the Government’s commitment towards modernization of healthcare. However, import of refurbished medical devices may pose a major threat to indigenous manufacturing, given that most of these manufacturers are members of the Chamber. We expect the Government to create a fair environment for products manufactured in India to promote the vision of ‘Make in India’ and ‘Atmanirbhar Bharat’.

              Ms Chandra Ganjoo, Group CEO, Trivitron Healthcare said, “Import of refurbished medical devices will have a long-term impact on India’s healthcare system and poses a major threat to India’s vision of Aatmanirbhar Bharat. This will hamper the growth of India’s medical device industry. This approach will reduce the focus on innovation and R&D, which is essential to drive the country’s healthcare system forward.”

                    Mr. Viswanathan Santhanagopalan, CEO & MD, Sequoia Healthcare said, “Hospitals and diagnostic centres charge patients the same amount whether they use new or refurbished equipment. This means that patients do not pass on the benefits of cost reduction and are instead treated with outdated technology. India’s auto industry grew because import duty was increased to reduce imports of cars, thereby encouraging local manufacturing. A similar approach should be adopted in the medical device industry to promote domestic manufacturing of medical devices in India and also ensure the development of modern, reliable healthcare technology in the country.”

              Mr. R.S. Kanwar, Director, Ellengers Medical Systems Ltd. said, “As a company committed to modernizing healthcare technology in India, we believe that importing refurbished medical devices poses a major threat to patient safety and quality of healthcare. Refurbished machines often have outdated technology, do not provide reliable performance and do not comply with modern standards. This can lead to reduced diagnostic accuracy and treatment outcomes. Instead of relying on outdated imports, we must invest in modern equipment manufactured in India that is in line with global standards so that Indian healthcare providers have the right equipment to provide the best care to patients.”

               Increasing imports of refurbished medical devices poses a major threat to patient safety and the survival of Indian manufacturers. These used devices can fail and lead to incorrect diagnostic and treatment results. Many patients are unaware that the machinery being used to care for them is outdated and possibly unsafe. In addition, these imported products without safety testing impede patients' right to safe medical care.

           Given all these issues, industry leaders urged the Prime Minister to address these challenges at the earliest and ban the import of refurbished devices that are manufactured in India. They said that policies should be introduced in a way that promotes domestic manufacturing and reduces dependence on imports. Also, the safety and efficacy of all medical devices used in India should be monitored so that patient safety is given top priority.

             The event emphasized on protecting India's medtech sector and the Prime Minister's vision of Aatmanirbhar Bharat. The spokespersons urged the government to take immediate action to resolve this serious issue and provide all necessary support to the medical device manufacturers of the country.