Considering the lack of regulatory provisions further posing risks to patient safety, the Central Drugs Standard Control Organisation has prohibited the import of second-hand or refurbished medical devices in the country.
How Does This Affect?
The move is aimed to protect the domestic industry from low-quality equipment.
Moving ahead, this would ensure that only appropriate medical care should be provided.
At the same time, the med-tech companies should support local manufacturing.
Confirming the development, the Central Drugs Standard Control Organisation has said that the import of second-hand or refurbished medical devices is not allowed.
Further, they have written a letter to the office of the principal commissioner of Customs recently.
In this letter, they have asked Customs dept to not release such devices from the port of entry.
Refurbished Equipment Posing Serious Risk To Patient
So far, there is no specific provision for regulation of refurbished medical devices under the Medical Devices Rule, 2017, mentioned in the letter.
This is why, no licence is issued for import of such devices, and it cannot be imported into the country for sale and distribution, noted in the letter.
According to the proponents of this policy, the import of refurbished equipment helps keep cost of care in check.
While those who are against it are of the view that the policy poses serious risks to patient safety and reliability of the tests performed.
It appears that nearly 60% of the Rs 40,000 crore of imports of medical electronic equipment is estimated to be of pre-owned equipment, as per the Association of Indian Medical Device Industry.
The move is appreciated by MD of AMTZ, Visakhapatnam, Dr Jitendra Sharma, he said, “A stop to import of refurbished medical equipment is a true policy intervention that will guard domestic industry against dumping of equipment with uncertain quality and will help patients in receiving appropriate medical care.
This is a welcome and much awaited long due intervention.”
Similarly, the refurbished machines have significant concerns regarding radiation emissions, which can pose harm to patients, said Founder-partner of City Imaging & Clinical Labs, Dr Aakaar Kapoor.
Adding that the newer imaging systems are designed to emit significantly lower radiation, addressing concerns around exposure during scans.
With the mix of responses, one side med-tech companies favoured the move, saying it would promote local manufacturing and the use of updated machines.
On the other hand, hospitals and diagnostic facilities said it could increase investment and, therefore, the cost of care.
Considering a mid way, the owner of a Delhi hospital said, “Cost of imaging tests is lower in India as compared to developed nations. One of the reasons behind this is the utilisation of refurbished machines. Instead of banning their use, govt should bring in regulations to ensure that devices are up to date.”
