A ban on imports of refurbished medical devices, notified recently, by the Central Drugs Standard Control Organisation (CDSCO), has sparked off a debate among domestic healthcare and medtech players.
While some have welcomed the ban as a step towards boosting local manufacturing, others have pointed at the need for a formal policy to regulate imports for safety and efficacy.
The CDSCO, the drug regulatory authority under the health ministry, said in a 10 January letter to the principal commissioner of Customs, that there are no provisions for regulation of refurbished medical devices under the existing Medical Devices Rules, 2017, and therefore no licence is issued for such devices.
The import of refurbished medical devices—largely high-tech equipment like MRIs, CT scans, and surgery robots—has been a point of contention with the domestic medtech industry, which has called for restrictions on growing imports.
However, others have pointed out that refurbished devices cost 30-70% less than new devices, making them more accessible for the Indian healthcare industry.
Most high-tech medical devices cost anywhere between ₹50 lakh and ₹5-6 crore. Refurbished devices sell at half the cost, and are important to a large number of healthcare providers and diagnostics labs, especially in tier III, IV cities, said an executive at a leading diagnostics chain, who spoke on the condition of anonymity.
“I don't subscribe to open import of refurbished equipment. It should be high quality equipment,” he added.
Many industry players believe that a formal policy regulating the import of refurbished medical devices would be better than a ban. “Refurbished products can be regulated to ensure safety and efficacy and it should not be seen purely from a manufacturing lens which may limit consumer choice,” Siddhartha Bhattacharya, secretary general of healthcare industry body NATHEALTH said.
Several countries in the developed world have specific frameworks and regulations in place for refurbished medical devices. “It is very important that we plug the regulatory gap, and create regulations along the lines of what we have in the developed world,” said Rishi Agrawal, CEO, TeamLease Regtech, a regulatory technology company.
“Ultimately patient safety should be kept at the highest level which means these devices need to meet certain regulatory standards, their calibration, their testing, their functioning, their features have to work as required so that they don't end up compromising diagnostics,” he added.
According to the Association of Indian Medical Device Industry (AiMeD), nearly 60% of the ₹40,000 crore of imports of medical electronic equipment are estimated to be preowned. India is already a net importer of medical devices, bringing in 80-85% of its domestic requirements from abroad, according to a report by EY.
In FY23-24, medical devices imports in the country reached $8.2 billion, up 13% from the previous year, and more than twice the value of total exports.
“At a time when the domestic industry is already grappling with issues like negligible import tariff of 0 to 7.5% on medical devices in India, allowing import of refurbished devices had further acted as a deterrent to the entrepreneurial spirits of the domestic manufacturing industry making India severely imports dependent,” Rajiv Nath, forum coordinator of AiMeD, said in a statement.
Unchecked import of medical equipment has also given rise to safety concerns, he added. “When you look at the dialysis field where we are [present], we see a rampant reuse of devices—70-80%,” Himanshu Baid, managing director, Poly Medicure, told Mint in an earlier interview.
“They are trying to make treatment more affordable by reusing the devices but we are compromising on quality of treatment, and maybe we compromise with the patient’s life,” he said. Baid recommended restrictions to focus on the quality of devices used in the country.
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