New Medical Devices being regulated under the Drugs and Cosmetics Act

The devices – nebulisers, glucometers, digital thermometers and blood pressure monitors – are the latest additions to product categories under the Drugs and Cosmetics Act (DCA), which will ensure their quality and performance.

The import, manufacture and sale of these devices will be under scrutiny. “We are moving in the direction to now regulate all implantable devices,” said S Eswara Reddy, Drug Controller General of India (DCGI).

However, 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.”

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.

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