Ultrasound Equipment now classified as DRUGS.

One more inspector for sonologists!
In a significant move to provide safety to patients and regulate the quality of diagnostic and medical devices in India, the health ministry has notified eight medical equipment, including all implantable devices, as “drugs” under Section 3 of the Drugs and Cosmetics Act, effective from April 1, 2020.

Through a Gazette notice, the Central Government, after consultation with the Drugs Technical Advisory Board, specified the following devices intended for use in human beings as drugs with effect from the 1st day of April 2020, namely:—

• All implantable medical devices;
• CT scan Equipment;
• Ultrasound machine.
• MRI Equipment;
• Defibrillators;
• Dialysis Machine;
• PET Equipment;
• X-Ray Machine; and
• Bone marrow cell separator.

All implantable medical devices, CT scan, MRI equipment, defibrillators, dialysis machine, PET equipment, X-ray machine and bone marrow cell separator will be regulated as “drugs”.

The Ministry of Health and Family Welfare has recently come up with a released dated October 16, 2019, that stated; In pursuance of sub-clause (iv) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with the Drugs Technical Advisory Board, hereby specifies the following device intended for external or internal use in human beings as drug with effect from the 1st day of November, 2020, namely:― “Ultrasound equipment”.

The classification of the ultrasound machine as DRUGS will expand the horizon of regulating the equipment.