Four more medical devices — nebulisers, glucometers, digital thermometers and blood pressure monitors — have been notified in the latest addition to product categories under the Drugs and Cosmetics Act, which will ensure their quality and performance.

This means such devices will be under regulation and their import, manufacture and sale will be under scrutiny. Twenty-seven product categories are now notified under the Act, said an official from the Ministry of Health and Family Welfare (MoHFW). The categories which are not notified for regulation are sold in the open market without adequate checks and balances, including for instance, pacemakers. “We are moving in the direction to now regulate all implantable devices,” said S Eswara Reddy, Drug Controller General of India (DCGI).

While the Ministry has notified four additional medical devices, the ex-Chairman of National Pharmaceutical Pricing Authority (NPPA) Bhupendra Singh argues, “More than glucometers, it is the test strips and diabetic needles used in insulin pens that need to be notified and be brought under price control. They are making diabetes management unaffordable for the poor as of now.” Once the devices are under regulation, the drug inspectors (medical devices) will examine the performance, defective and safety data, animal studies data, batch tests and so on. “A year-and-a half ago, we issued directions against use of biresorbable stents due to safety issues. The rate of thrombosis in these stents was very high,” said Reddy.

The ambit of the DCA will also be expanded to include implantable devices, CT scans, MRI, defibrillators, dialysis machines, X-ray machines, PET equipment and bone marrow cell separators.