Domestic manufacturers of medical devices and equipment have urged the Central government to withdraw its recent official memorandum permitting the import of pre-owned medical devices.
The Central government recently issued a list of 50 high-end/high-value used medical devices that can be imported, other than critical care equipment.
India’s leading industry body, Federation of Indian Chambers of Commerce and Industry’s (FICCI) Medical Devices Division, has endorsed the move, causing further distress to local manufacturers, who have written to the Central government, asking the memorandum to be revoked immediately.
Explained | What is the National Medical Devices Policy, 2023?
“Nothing could have been worse than what FICCI Medical Devices Division is doing at the behest of the MNC (multinational company) lobby. It’s working against the interest of domestic medical device manufacturers,” Rajiv Nath, forum coordinator of the Association of Indian Medical Device Industry (AiMeD), said.
Mr. Nath added that the decision to permit the import of pre-owned medical devices is in contravention of India’s recently launched National Medical Device Policy 2023, which seeks to make India not only ‘Atmanirbhar’ (self-reliant) in medical devices but also the global leader in their manufacture.
“By allowing the import of refurbished equipment, India misses out on the opportunity to nurture a robust ecosystem of innovation, research and development in the medical technology sector,” Gaurav Agarwal, MD, Innvolution Healthcare Private Limited, said. He added that the utilisation of refurbished equipment is both misleading and potentially hazardous.
Also Read | Medical device industry asks Health Ministry to reconsider new regulatory Bill
Also cautioning against the policy of allowing free imports of old and used medical equipment from other countries, Suresh Vazirani, chairman, Transasia Bio-Medicals Limited, said that the use of old medical equipment could be dangerous for the lives of fellow Indians. “This retrograde policy will allow Western countries to ship all old equipment to India and thereby prevent their own countries from getting environmentally polluted with discarded pollutants in medical equipment,” Mr. Vazirani said.
AiMeD said that Indian medical device manufacturers not only meet domestic demands but also export equipment to over 100 countries across the world, meeting international standards and safety certifications.
“The import of pre-used medical devices from MNCs not only goes against the spirit of ‘Make in India’ but will also deal a body blow to indigenous MSMEs (micro, small and medium enterprises) engaged in making world-class medical devices and equipment,’’ the AiMeD said.
Meanwhile, Pavan Choudary, chairman, Medical Technology Association of India (MTaI), explained that Indian hospitals in Tier 2 and Tier 3 cities, including rural areas, do not have the purchasing power to buy expensive equipment, and that most of these healthcare facilities aspire to buy refurbished equipment.
“While some medical devices are designed for single use, such as intravenous catheters, tubing, syringes, needles, etc., high complexity devices such as medical imaging equipment like CT scan machines, MRI and X-ray machines, are designed for long lifespans,’’ he said.
The FICCI, defending its stand, has noted that the cost differential between new equipment and refurbished equipment will be around 20-25% lower for the latter. It added that medical equipment is usually upgraded after five years of usage in developed countries because of reimbursement policies.
Also Read | Regulation for all medical devices from October 1, says DCGI
“After buyback of pre-owned equipment, it will be subjected to complete re-manufacturing/refurbishing process in line with latest technology and based on device history record. It will be further subjected to stringent quality assurance testing process before releasing in the domestic or global market. In case of importation to India, the equipment will be evaluated by Chartered Engineer both for residual self-life and value of the product. Entire re-manufacturing/ refurbishing complies various quality management systems in India,’’ the FICCI said.
The FICCI noted that whether it is new or refurbished products, they must be disposed safely at the end of product’s life cycle, in accordance with the directives of the Central Pollution Control Board.
