‘60% of medical device imports are pre-owned’: Govt steps in to ban unsafe equipment

Hyderabad: The Central Drugs Standards Control Organisation (CDSCO) has decided to stop the import of used, pre-owned and refurbished medical equipment to India. The decision has been made considering the lack of regulations for imports and the possible risks to patient safety.

The Association of the Indian Medical Device Industry (AiMED), an umbrella organisation of Indian manufacturers of medical devices, has stated that nearly 60 per cent of the Rs 40,000 crore of imports of medical electronic equipment were estimated to be of preowned equipment being dumped into India.

With no regulations existing, domestic medical equipment manufacturers have been demanding a policy intervention to end the dumping of used machines for healthcare diagnosis in the country.

Imported machines include MRI, CT scan, ventilators

Several high-end medical equipment is being imported by India from countries like the US, Germany, China, Netherlands and Singapore.

Rajiv Nath, forum coordinator, of the Association of Indian Medical Device Industry (AiMeD) said, “India is importing used medical equipment including ultrasound machinery, MRI, CT scan, X-Ray equipment, Cath Labs, ventilators and auto analysers.”

The equipment is generally used by private hospitals and clinics for carrying out various tests, scans and other forms, used for identifying medical conditions in patients.

Disadvantages of using pre-used medical equipment

With the increase in population, there is a proportional increase in the number of testing labs, clinics, diagnostics centres and hospitals in India. Given the increase in demand for medical equipment, the Union environment and health ministries permitted the import of refurbished medical equipment in 2023.

However, the use of pre-used medical equipment comes with many risk factors for the patients.

“The disadvantages and challenges include risk of exposure and radiation, lack of accuracy if not calibrated and the process is validated and retested to IEC standards,” Rajiv Nath said.

‘Industry prepared to meet demands’

The restriction to import used equipment could possibly trigger a demand spike, even as the medical equipment manufacturing industry is expecting massive investments from multinational companies.

Raji Nath stated that the industry is ready to cater to the demands of the healthcare sector and insisted on resorting to safe equipment rather than relying more on cheap equipment.

“For a few items that are not made, there are new and safe equipment available. Affordable access is not affordable if it is not safe for use,” he emphasised.