Patient Safety Foundation Files PIL Against Lax Regulations

The petition emphasizes the need for stringent regulations to protect public health and ensure the safety and effectiveness of medical devices used in healthcare settings.

The Patient Safety and Access Initiative of India Foundation (PSAIIF), a Delhi-based not-for-profit organization dedicated to improving healthcare access and quality, has filed a Public Interest Litigation (PIL) with the Delhi High Court (HC).

The PIL addresses significant concerns regarding the insufficient regulatory framework governing the quality, safety, and efficacy of imported second-hand or refurbished medical devices in India.

The writ petition demands a comprehensive review of the current regulatory mechanisms related to the importation of used or refurbished medical devices.

The PIL raised several concerns including devices posing considerable safety risks to patients, suggesting that India is being used as a dumping ground for such equipment.

The petition also emphasizes the need for stringent regulations to protect public health and ensure the safety and effectiveness of medical devices used in healthcare settings.

Targeting Illegal Importers

The petition also seeks to halt the operations of 'illegal importers' who have been bringing in high-end, high-value (HEHV) medical devices without proper permissions from the Ministry of Environment since 2019.

According to PSAIIF's data, sourced from the Trade Vision portal for Export-Import, a US-based multinational surgical robot manufacturer has imported 845 used and refurbished robotic-assisted surgical systems and accessories worth INR 250 Cr over the past five years.

Domestic Industry Concerns

The PIL comes at a crucial time for the domestic medical device industry. The Association of Indian Medical Device Industry (AiMeD) is pushing to reduce dependency on imports and bolster support for local manufacturers under the production-linked incentive (PLI) scheme.

Despite the PLI scheme facilitating the establishment of several medical device parks, India still imports approximately 80% of its medical devices, mainly from the US and China. This reliance undermines the 'Make in India' initiative, contrary to efforts to promote local manufacturing.

Rajiv Nath, forum coordinator at AiMeD, highlighted that around INR 30,000 Cr worth of medical electronics equipment is imported annually, with over 60% estimated to be pre-owned and refurbished, often lacking adequate regulatory controls.

Nath pointed out that importers have influenced the Ministry of Environment to permit these imports, bypassing e-waste regulations.

Contradictions with National Policies

The PIL argues that importing pre-owned medical devices contradicts India's National Medical Device Policy-2023.

In 2017, the Ministry of Environment, Forest, and Climate Change's Technical Review Committee recommended lifting the blanket ban on such imports, subject to stringent conditions.

These conditions include ensuring the equipment is not obsolete, contains no hazardous materials, and has a residual life of 5 to 7 years.

Govt Notification & Industry Split

In June last year, the Union government issued a notification allowing the import of refurbished or pre-owned medical devices, excluding critical care medical equipment.

The notification permitted the import of 50 'high-end and high-value' pre-owned medical devices, including MRI and CT scan machines.

Other allowed equipment included mammography machines, blood cell count analyzers, high-end X-ray machines, PET-CT scan machines, and radiotherapy devices.

This decision sparked a significant division within the medical devices industry. While domestic manufacturers vehemently opposed the notification, multinational companies welcomed the government's move.

The domestic industry argued that permitting the import of pre-owned medical devices would negatively impact the 'Make in India' initiative and contradict the National Medical Device Policy-2023, which aims to achieve self-reliance in medical devices and position India as a global leader in manufacturing.

Govt's Justification

The government justified the decision by stating that allowing the import of refurbished or pre-owned medical devices would make them more available and affordable for small hospitals and healthcare establishments, especially in Tier II and III cities.

The Ministry of Environment issued the notification and explained that the decision was based on consultations with the Union Health Ministry. The Environment Ministry issued the notification because the import of used devices is also considered a potential environmental hazard.

As the Delhi HC deliberates on this critical 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 (MTaI), representing multinational medical device makers, has yet to respond to queries regarding this matter.