50% market swamped with used imported medical equipment, PSAIIF

India has witnessed a surge in the import of refurbished medical devices without the necessary approvals mandated by the government. The shocking revelation has called into doubt the reliability of these gadgets crucial to saving patients’ lives.

According to the data shared by the Patient Safety and Access Initiative of India Foundation (PSAIIF), nearly 50 percent of the market is allegedly swamped with refurbished imported medical equipment that enters the country illegally. Those who believe that the health care services in India are improving rapidly are shocked by the disclosure.

“The reused devices, many of which lack proper safety certification from the necessary authorities, are said to pose serious risks to patients,” said Bejon Kumar Misra, founder of PSAIIF.

“We found out that numerous companies today are flouting regulatory norms to import substandard, second-hand medical equipment into the country. This market of imported refurbished medical devices is flourishing as many companies bypass the permission rules,” Misra said, speaking exclusively to Mirror.

He continued: “Indian medical industry is accused of cheating its patients by providing them with double standards in healthcare, relying on second-hand medical devices that are extremely unsafe for use. These refurbished devices, including CT scanners, MRI machines, ultrasound equipment, and even surgical robots, are being imported without necessary certifications or approvals from the Ministry of Environment, Forest and Climate Change (MoEFCC).

“This is not only about reused devices, but it is mainly about the illegal import of these machines that are entering India without any checks or approvals. This is a direct threat to the lives of patients in medical facilities across the country.”

Misra was seconded by other national associations like AiMeD and FICCI, who shared their concerns with Mirror. Rajiv Nath, a national coordinator of AiMeD, said, “We have now urged the government to take immediate action against the illicit imports of these medical devices, which are bypassing critical safety checks and endangering patients’ lives.”

Expired surgical robots in service!
Speaking about surgical robots, Misra said: “There are serious violations of medical device regulations. We have, in fact, firsthand information on the loopholes that exist in our system, where refurbished medical devices are slipping through without the proper approvals, putting countless lives in jeopardy.

“Surgical robots, for example, are being used according to their longevity or expiration date in a particular country, but are later dumped in India and used rampantly in local hospitals. This is threatening to the patient, who is least aware of the scam but is being charged in full. The question is, what if this robotic surgery goes wrong and the patient has to pay with his life?

“During our investigation, we also found out that these second-hand devices are not just being imported but are also installed in hospitals and clinics across India. Under India’s Medical Device Rules, 2017, all medical devices, including refurbished ones, are required to meet stringent safety standards. Many of these devices entering the market lack certification and hence, pose a direct threat to patients during critical medical procedures.”

Calls for Make in India grow louder
However, when Mirror reached out to medical experts from large medical bodies like the Indian Medical Association (IMA) and Indian Radiological & Imaging Association (IRIA), they said it is a huge economic issue for the healthcare industry in India, and hence, this malpractice continues.

“It is not only second-hand but also third-hand devices that are being dumped in Asian and African countries. We need the Make in India initiative to grow well and for Indian manufacturers to take on the industry. Also, many times, the cost paid is almost 75 percent less as the machine is of substandard quality; but unfortunately, the patient is paying in full which the latter is unaware of. We need high-quality devices that are safe and pass all necessary permissions. The regulatory authorities are answerable for this,” said Dr Sandeep Kavthale, secretary of IRIA.

Action demanded
Sharing similar sentiments, Dr Rajan Sancheti, president of IMA, Pune, said, “In the largest medical corporate sector, such refurbished machines may not be used, but yes, in two- or three-tier hospitals, this racket does work. However, it boils down to cost and affordability, as our patient pool is not the one that can pay according to the healthcare we provide. Hence this, if the rules and regulations are being flouted, is a serious offence, and we demand that the authorities check if such illegal imports are happening.”

Hospitals too need to educate themselves about this market and check their medical devices and software so that no patient safety is compromised, he said.

Lastly, senior medical expert and former dean of KEM Hospital, Mumbai, Dr Avinash Supe, said, “Such imported medical devices need to be checked for sterility, as we need to confirm patient safety so that no patient can be harmed. However, given the regular updates in machines, this practice has become extremely common, but can be controlled if the hospitals or Indian manufacturers bring in more local devices.”

PIL to safeguard patients
To deal with such illegal medical imports and save patients from more harm, PSAIIF has now filed a PIL. Misra said, “Since it is a national concern, we have now filed a PIL in the Delhi High Court as it was revealed that massive violations, including the import of equipment worth over Rs 250 crore took place this year without relevant approvals. We have now demanded urgent regulatory reform to safeguard lives and restore integrity to the healthcare system.” Pune Mirror