Patient Safety and Access Initiative of India Foundation, a not-for-profit organisation, has moved a public interest litigation at the Delhi High Court raising objections against the government’s lax regulatory framework to assess the quality, safety and efficacy of second- hand or used medical devices. Well-placed industry sources told the source that the writ petition moved recently has called for a comprehensive review of government regulations for medical equipment and devices that are used but refurbished and then imported into the country. A key point of the petition is to issue orders to ‘illegal importers’ while also identifying and furnishing a list of all second-hand and refurbished high-end and high value used medical equipment that have been imported into India since 2019 without the permission of the ministry of environment. It further calls for imposition of penalty on importers of such illegal imports. 

The industry executive quoted above termed recent office memorandums from government institutions as a ‘disappointing step’, adding those who invested in building manufacturing capacity over the last few years in response to PM Modi's call for self-reliance are now confused about the policies. “This bulldozes the Make in India dream of Prime Minister Narendra Modi,” he noted. Experts say the market for medical devices in India is largely dominated by imports of used and refurbished and reconditioned products. For MNC device makers, the person noted, that portion comprises as much as 80%of total sales. This however could not be independently verified. “The rampant increase in the import of such devices requires a stringent regulatory mechanism to ensure the safety of the citizens is never compromised,” the person said, backing the PIL. Last year, news reports said the government had allowed imports of about 50 pre-owned medical devices such as MRIs and CT-scans other than critical care medical equipment, with the aim of making expensive devices available to smaller hospitals. That decision however sparked a controversy with rival groups – the domestic device makers and representatives from global companies – trading charges against each other. The domestic device makers noted the decision will lead to dumping of obsolete medical devices even while such devices are available from indigenous companies, those supporting the MNCs maintained that the decision was progressive and enabled access to sophisticated equipment and will lead to better healthcare outcomes.

(Source: ET Health World)