Medical Device

The Patient Safety and Access Initiative of India Foundation (PSAIIF), a Delhi-based not-for-profit organization committed to enhancing healthcare access and quality, has filed a Public Interest Litigation (PIL) with the Delhi High Court. The PIL raises critical concerns about the lax regulatory framework overseeing the quality, safety, and efficacy of imported second-hand or refurbished medical devices in India.

The PSAIIF’s writ petition demands a thorough review of the existing regulatory mechanisms related to the importation of used or refurbished medical devices. According to the PIL that was shared to Elets eHealth, these devices pose significant safety risks to patients, alleging that India is being used as a dumping ground for such equipment. The petition highlights the need for stringent regulations to protect public health and ensure that medical devices used in healthcare settings are safe and effective.

The petition also seeks to halt the activities of ‘illegal importers’ who have been bringing in second-hand high-end high-value (HEHV) medical devices since 2019 without proper permissions from the Ministry of Environment. PSAIIF’s data, sourced from the Trade Vision portal for Export-Import, reveals that a US-based multinational surgical robot manufacturer has imported 845 used and refurbished robotic-assisted surgical systems and accessories worth Rs 250 crore over the past five years.

The PIL comes at a time when the domestic medical device industry, represented by the Association of Indian Medical Device Industry (AiMeD), is pushing for reduced dependency on imports and increased support for local manufacturers under the production-linked incentive (PLI) scheme. Despite the PLI scheme leading to the establishment of several medical device parks, India still imports around 80% of its medical devices, primarily from the US and China. This reliance has led to a situation contrary to the ‘Make in India’ initiative, undermining local manufacturing efforts.

Rajiv Nath, forum coordinator at AiMeD, highlighted that approximately Rs 30,000 crore worth of medical electronics equipment is imported annually, with over 60% estimated to be pre-owned and refurbished, often without adequate regulatory controls. He pointed out that the importers have managed to influence the Ministry of Environment to permit these imports, circumventing e-waste regulations.

The PIL argues that the importation of pre-owned medical devices contradicts India’s National Medical Device Policy-2023. The Ministry of Environment, Forest, and Climate Change’s Technical Review Committee had recommended in 2017 lifting the blanket ban on such imports, subject to stringent conditions. These conditions included ensuring the equipment is not obsolete, contains no hazardous materials, and has a residual life of 5 to 7 years.

As the court deliberates on this significant issue, the outcome will have far-reaching implications for patient safety, regulatory practices, and the future of domestic medical device manufacturing in India. The Medical Technology Association of India (MTal), representing multinational medical device makers, has yet to respond to the queries regarding this matter. 

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