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Why Refurbished Medical Gear is Now Illegal in India
Why Refurbished Medical Gear is Now Illegal in India

Why Refurbished Medical Gear is Now Illegal in India

India’s drug regulatory authority has instructed Customs to stop the import of refurbished medical devices. The directive highlights that there are no specific rules for regulating such devices under the existing Medical Devices Rules, 2017, making their import illegal.

Concerns Over Patient Safety and Certification

The influx of refurbished medical equipment has raised concerns among healthcare professionals and domestic manufacturers. Many of these imports lack proper certification, posing potential risks to patient safety. Domestic medical device makers have long voiced their apprehensions about the unchecked entry of these products into the Indian market.

Legal Action Sparks Regulatory Clarification

Last year, the Patient Safety and Access Initiative of India Foundation (PSAIIF) filed a public interest litigation in the Delhi High Court. The case drew attention to the risks associated with refurbished medical devices and underscored the need for regulatory clarity. In response, the recent directive has been widely welcomed as a step toward enhancing patient safety and boosting domestic manufacturing.

Industry Leaders Laud the Move

Rajiv Nath, forum coordinator at the Association of Indian Medical Device Industry, called the directive a “welcome move” and an enabler for ‘Make in India’ investments. He emphasized that India does not permit importing pre-owned cars or electronic devices like iPhones. Similarly, disallowing refurbished medical devices will encourage multinational corporations to invest in India, manufacture high-tech medical equipment locally, and make them affordable for Indian patients.

Supporting Domestic Manufacturing

Jitendra Sharma, managing director of the Andhra Pradesh MedTech Zone, echoed similar sentiments. He stated that restricting refurbished imports protects the domestic industry from low-quality equipment and ensures patients receive reliable medical care. Sharma hailed the move as a crucial policy intervention.

Call for a Policy Framework

While the government has temporarily halted all imports of refurbished medical devices, industry bodies like the Medical Technology Association of India have stressed the need for a clear policy framework. They argue that a regulated approach could address the growing demand for affordable medical equipment in smaller cities and rural areas. Notably, refurbished devices currently make up around 10% of India’s medical equipment market, playing a vital role in underserved regions.

Way Forward

The association has urged the Ministry of Health and Family Welfare to expedite the formation of a policy for importing refurbished medical devices. In the interim, it has suggested that imports be permitted with necessary approvals to avoid disruption in the healthcare system.

Conclusion

The government’s decision to halt the import of refurbished medical devices underscores its commitment to patient safety and developing a robust domestic medical device industry. By addressing the challenges posed by unregulated imports, this move aims to ensure that healthcare delivery remains safe, reliable, and aligned with national priorities. A clear and effective policy framework will be key to balancing the needs of patients and the industry.

Source: Inputs from various media Sources 

I’m a pharmacist with a strong background in health sciences. I hold a BSc from Delhi University and a pharmacy degree from PDM University. I write articles and daily health news while interviewing doctors to bring you the latest insights. In my free time, you’ll find me at the gym or lost in a sci-fi novel.

Priya Bairagi

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