How will the suspension of imported refurbished medical devices impact the healthcare sector? Experts are divided Premium

CDSCO halts imports of refurbished medical devices in India, sparking debate over impact on healthcare industry.

Seeking to regulate the ₹1,500 crore Indian market for imported pre-owned and refurbished medical devices, the Central Drugs Standard Control Organisation (CDSCO) has halted imports until a regulation is established for such devices. Any consignment containing refurbished devices present at ports, will, at present, not be released.

The direction comes following a letter to the Principal Commissioner of Customs dated January 10, where CDSCO clarified that refurbished medical devices cannot be imported into the country for sale and distribution, as there is no specific regulation for such devices under the Medical Devices Rules, 2017.

These imports however, play a key role in making medical devices accessible in smaller cities and in rural India. According to experts, India’s import bill for medical devices is going up every year, with a 13% jump in 2023-24 alone. Imports currently contribute to around 10 per cent of the total medical equipment industry in India.

The latest directive therefore, has been received with mixed reactions and has the industry divided and debating.

The Medical Technology Association of India said that globally, even developed regions like the United States and the European Union have a 7%-9% dependency on pre-owned medical equipment, underscoring its importance in ensuring affordable healthcare solutions. Countries like U.S., several European nations, Japan, U.K., Canada, South Korea, New Zealand and Australia permit the import and sale of pre-owned medical equipment in accordance with their regulations.

“The pre-owned equipment industry in India supports the livelihoods of thousands of employees across its ecosystem. If a swiftly implementable policy is not introduced soon, it could lead to irreversible damage to both healthcare providers and the workforce. In this context, it is critical for the expert committee to prioritize this matter and expedite its decision. Currently, the import of refurbished devices remains at a standstill, posing a threat to both the healthcare system and the industry itself,’’ noted the group.

It added that to safeguard the interests of the healthcare system and the refurbished medical device sector, it is imperative that the expert committee expedites the creation of this policy and, to avoid any disruption, allows imports through necessary approvals.