PHDCCI and AiMed call for action on policy violations affecting medical device manufacturing

On October 25, 2024, representatives from the PHD Chamber of Commerce and Industry (PHDCCI), the Association of Indian Medical Devices (AiMed), the Association of Diagnostic Manufacturers of India (ADMI), and the Medical Imaging Therapy Radiology Association (MITRA) gathered at the PHDCCI to discuss policy violations impacting the Prime Minister’s vision of ‘Make in India’ and ‘Self-Reliant India’. The meeting aimed to highlight the urgent need to address the import of refurbished and used medical devices in India.

The gathering focused on the implications of recent changes to the Office Memorandum regarding the Revised List of High-End and High-Value Used/Refurbished Medical Equipment. The Office Memorandum, issued by the Ministry of Environment, Forest, and Climate Change (MoEFCC) and the Directorate General of Health Services (DGHS) under the Ministry of Health & Family Welfare (MoHFW), permits the import of numerous refurbished medical devices. This decision raises concerns as similar medical devices are being manufactured in India. Industry leaders believe that this move undermines India’s self-reliance in medical device manufacturing and represents a setback for the nation’s ‘Make in India’ and ‘Aatmanirbhar Bharat’ initiatives.

The event featured prominent speakers, including Rajiv Nath, Forum Coordinator of AiMed, Dr Nasir Jamal, Senior Secretary of PHDCCI, Dr Sudhir Srivastava, Past Chair of PHDCCI’s Medical Device Committee, Atul Sharma, Co-Founder of Innvolution Imaging, Dr Ravi Padmanabhan, President of MITRA, and Jatin Mahajan, Secretary of ADMI. Also present were Gaurav Aggarwal, CEO of Involution Imaging Technologies, Amit Tiku, Vice President of Trivitron Healthcare, Sunil Singh, CEO of Univ Labs Technologies, Nanda Kumar, CEO of Perfint Healthcare, and Srinivasa Reddy, Senior Vice President of SS Innovations.

The speakers discussed how the growing trend of importing refurbished medical equipment challenges the growth of domestic manufacturers, raises risks to patient safety, and raises concerns about the reliability and effectiveness of these devices. They noted that the medical technology and healthcare sectors had engaged in discussions with the ministry regarding a ban on the import of refurbished medical equipment. However, recent orders from MoEFCC and DGHS, which failed to prioritise the ‘Make in India’ preference for domestically manufactured products, have caused distress within the industry. This has heightened concerns regarding India’s efforts to establish a self-reliant medical device manufacturing ecosystem, particularly impacting MedTech startups that have made significant investments in line with the Prime Minister’s vision of ‘Make in India’.