NEW DELHI: Import of second-hand or refurbished medical devices is not allowed, the Central Drugs Standard Control Organisation has said. In a letter sent to the office of the principal commissioner of Customs recently, it has asked Customs dept to not release such devices from the port of entry.
The letter, a copy of which is with TOI, said there is no specific provision for regulation of refurbished medical devices under the Medical Devices Rule, 2017. Hence, it said, no licence is issued for import of such devices, and it cannot be imported into the country for sale and distribution.
While proponents of this policy said import of refurbished equipment help keep cost of care in check, those against it are of the view that the policy poses serious risks to patient safety and reliability of the tests performed.
According to the Association of Indian Medical Device Industry, nearly 60% of the Rs 40,000 crore of imports of medical electronic equipment is estimated to be of pre-owned equipment. “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,” said MD of AMTZ, Visakhapatnam, Dr Jitendra Sharma.
Founder-partner of City Imaging & Clinical Labs, Dr Aakaar Kapoor, said refurbished machines have significant concerns regarding radiation emissions, which can pose harm to patients. The newer imaging systems are designed to emit significantly lower radiation, addressing concerns around exposure during scans, Kapoor added.
While med-tech companies favoured the move, saying it would promote local manufacturing and the use of updated machines, hospitals and diagnostic facilities said it could increase investment and, therefore, the cost of care. “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,” said the owner of a Delhi hospital .