Nonprofit Files PIL Against ‘Throwaway’ of Medical Equipment and Devices, ET HealthWorld

New Delhi: The Patient Safety and Access Initiative of India Foundation, a non-profit organization, has filed a public interest litigation in the Delhi High Court raising objections to the government’s lax regulatory framework for assessing the quality, safety and effectiveness of second therapy of hand-held or used medical devices.

Well-placed industry sources told ET HealthWorld that a recently moved petition called for a comprehensive review of government regulations on medical equipment and devices that are used but refurbished and then imported into the country.

The key point of the petition is to issue orders to “illegal importers”, while identifying and providing an inventory of all used and refurbished, high-end and high-value second-hand medical equipment that has been imported into India since 2019 without permission from the environment ministry. It further calls for penalties to be imposed on importers of such illegal imports.

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The industry executive quoted above described the recent government memorandums as a “disappointing step”, adding that those who have invested in capacity building over the last few years in response to Prime Minister Modi’s call for self-reliance are now confused about the policy adopted. “This is shattering Prime Minister Narendra Modi’s dream of Make in India,” he noted.

Experts say the medical device market in India is largely dominated by imports of used, refurbished and remanufactured products. For MNC equipment manufacturers, the person noted, this portion accounts for as much as 80 percent of total sales.

However, this could not be independently verified.

“The rampant increase in import of such devices requires a stringent regulatory mechanism to ensure that the safety of citizens is never compromised,” said a person supporting the PIL.

Last year, news reports said the government had allowed the import of about 50 used medical devices such as MRI and CT scans, other than intensive care medical equipment, in order to make the expensive equipment available to smaller hospitals.

However, this decision caused controversy among competing groups – domestic device manufacturers and representatives of global companies – exchanging fees among themselves. Domestic medical device manufacturers noted that the decision would lead to the disposal of obsolete medical devices, even if such devices are available in domestic companies. Advocates of supporting multinational corporations maintained that the decision was progressive and would allow access to advanced equipment and would lead to better health care outcomes.

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