Medical devices as drugs? Opinion divided

Hyderabad: X-ray machines, MRI and CT scans will not be bracketed under medical equipment henceforth and will be treated like any other drug as per a new notification issued by the Union health ministry. The list of such machines includes bone marrow cell separator and dialysis and PET scan equipment.

Experts say the latest move is aimed at regulating the indiscriminate usage and purchase of these machines but not at ensuring reduction in costs to patients for various tests they undergo. “Merely issuing a notification is not enough. If patients are to reap some benefit, these machines should be included in the national list of essential medicines,” Malini Aisola, co-convenor, All India Drug Action Network, told TOI.

She said a majority of medical devices were completely unregulated in India. “These diagnostic tools should be brought under a regulatory framework so that it will be of great help to patients in the long run,” she said.

However, the medical fraternity has not welcomed the move. “How can a machine be considered a drug? It makes no sense and can only lead to more issues. How can a pacemaker or heart valve can be treated as a drug,” said a senior doctor from a corporate hospital on condition of anonymity.

At present, the Atomic Energy Regulatory Board (AERB) provides the guidelines in the radiation safety aspects in installation and usage of X-ray machines. Most of the dialysis machines which are used in India are imported from South Korea, Japan, China or Germany. Each machine costs Rs 5 lakh to Rs 10 lakh and can be used on three patients a day.

Some doctors, however, see a silver lining. “If everything in medical field is brought under one roof, including licences, certification, quality control and usage, it could pay dividends in future for patients,” a doctor said.

Though the government has not spelt out as to how it intends to ensure regulation of the notification, experts do no rule out possibilities of price capping on advanced tests using these medical devices.