Pharmaceutical companies in India

8 more medical devices to be regulated as 'drugs' under law

Malini Aisola
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Malini Aisola of All India Drug Action Network

The Union Ministry of Health has notified that all implantable devices, CT Scan, PET and MRI equipment, defibrillators, dialysis machines and bone marrow separators will be treated as drugs for human beings with effect from April 1, 2020.

The notification, signed by Dr Mandeep K Bhandarim, Joint Secretary, Ministry of Health and Family Welfare, said, “The decision was taken in consultation with the Drugs Technical Advisory Board.”

The decision is aimed at regulating quality of these commonly used medical devices.

Malini Aisola of All India Drug Action Network told DTMT, “With this move, all implantable devices and some diagnostic equipment will be brought into the regulatory framework which is important from a patient safety perspective.”

Welcoming the Government decision she said, “However, we are disappointed about the delay with which the notification takes effect.

Ms Aisola added that it also sends mixed messages because the Government is deliberating a roadmap for bringing new and separate regulatory framework for devices.

Majority of medical devices in the country are completely unregulated which has led to serious harm for countless patients, she said.


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