 "medical devices")
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, has filed a Public Interest Litigation (PIL) before the Delhi High Court raising objections concerning the laxity in 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 has demanded a complete review of the regulatory mechanism related to the import of medical devices into the country that are used or refurbished in nature. Business Standard has a copy of the PIL.
“The cause of action also arises in view of these medical devices posing an inherent safety risk to the life of the general public at large, who are being operated/diagnosed in hospitals using these perused or refurbished or reconditioned medical devices,” PSAIIF has said in the PIL alleging that India is made a ‘dumping ground’ for such devices.
The PIL has sought issuing of orders to ‘illegal importers’ of second-hand high-end high-value (HEHV) medical devices that have been imported into the country since 2019 without the permission of the Ministry of Environment.
India is ranked in the top 20 global medical device economies and is estimated to amount to 5 per cent of the overall global medical device market. India is also the fourth largest Asian medical devices market after Japan, China, and South Korea. The medical devices industry in India was evaluated at $11 billion in 2020 and is projected to grow to $50 billion by 2030. The domestic medical device makers lobby, the Association of Indian Medical Device Industry (AiMeD), had recently urged the Centre to address the soaring import bill, which currently stands at over Rs 63,200 crore. Around 80 per cent of India’s medical devices requirements are imported; the US and China being the major countries from where we import.
A source close to the development alleged that despite the production-linked incentive (PLI) scheme triggering the setting up of several medical device parks for local manufacturing, the dependence on imports has resulted in what he called an ‘Un-make in India’ situation ‘bulldozing’ the Make in India ambition.
PSAIIF has alleged in the PIL quoting data from the Trade Vision portal for Export-Import that the wholly-owned subsidiary of one multinational surgical robot manufacturing company in the US has imported as many as 845 items of used and refurbished robotic-assisted surgical systems, including its components and accessories worth Rs 250 crore in the last five years.
In the past few years, domestic device makers' lobby groups like AiMeD have protested against the illegal imports, but these continue, PSAIIF said in the PIL.
Rajiv Nath, forum coordinator, AiMeD, told Business Standard that huge imports of medical electronics equipment to the tune of Rs 30,000 crore take place annually, and he claimed that over 60 per cent of this is estimated to be pre-owned and refurbished, imported without any regulatory controls.
“The importers lobby has somehow been able to prevail on the Ministry of Environment and got two memorandums in their favour permitting imports and as a deviation from the e-waste regulations,” he alleged.
The domestic lobby felt that local manufacturers who stepped forward to make these devices in India under PLI are left dismayed as a result.
The Medical Technology Association of India (MTal) that represents the MNC medical devices makers did not immediately respond to queries.
The decision to permit the import of pre-owned medical devices for private healthcare institutions is in contravention of India's recently launched National Medical Device Policy-2023, industry sources said.
The Technical Review Committee of the Ministry of Environment, Forest and Climate Change had recommended lifting the blanket ban on importing refurbished and used medical devices in May 2017. However, this was subject to certain conditions like such equipment has not been phased out from the importing country and is not considered obsolete in that country; such equipment does not contain any hazardous material or substances listed under any international regulation/law and or by the government of India; the equipment must have a residual life of 5 to 7 years etc.
