Lobby groups have asked the health minister JP Nadda to intervene and recall the policy that allows unregulated influx of second-hand medical equipment such as CT scanners, MRI machines, and surgical robots into the country.
The ministry of environment, forest and climate change recently issued a memorandum stating a revised list of high end and high value used or refurbished medical equipment. According to Rajiv Nath, forum coordinator, AiMeD, the office memorandum is in violation of the National Medical Devices Policy 2023 launched by the PM as it permits import of pre owned medical equipment into India. The investments made by Indian and overseas manufacturers under the Make in India initiatives by the government are now under threat of becoming non-performing assets, he said.
He said the ministry has expanded the list of equipment which is “very confusing and unsettling for investors who will only bring manufacturing technologies to India if the policy environment is predictable and consistent with the National Medical Devices policy 2023 that was meant to be binding on all government departments. Now not only many projects recently put up for high end medical equipment are jeopardised, but also patients are at risk of being treated with non-calibrated non-regulated medical equipment,” he said.
Nath said India is being treated as a dumping ground for e-waste as obsolete equipment gets resold in the country while overseas manufacturers make hay “doubling sales.”Earlier in May, the Patient Safety and Access Initiative of India Foundation (PSAIIF), a not-for-profit organisation based in Delhi that works on improving access to quality healthcare, filed a Public Interest Litigation (PIL) before the Delhi High Court raising objections over the regulatory framework concerning the quality, safety, and efficacy of second-hand or used medical devices in India. The writ petition filed before the court had demanded a complete review of the regulatory mechanism related to the import of medical devices into the country that are used or refurbished. In a letter to the health minister, medical device manufacturers have sought intervention to stall and recall the inter-ministerial policy issue from further execution. They have also sought setting up an expert committee to propose regulatory controls and amendments for enabling re-manufacturing and resale of Indian made refurbished equipment by the original equipment manufacturer beyond the warranty life cycle to ensure patient safety and calibrated accuracy.
