Ultrasound Equipment now classified as DRUGS, under purview DCA: Gazette notification
New Delhi: Through a recent notification, apex drug regulatory body, Central Drugs Standard Control Organization (CDSCO) has notified Ultrasound Device as "Drugs" effective from November 2020. With this, import, manufacture and sale of the ultrasound machines will be allowed only under the legal ambit of the Drugs and Cosmetics Act, 1940.
Medical ultrasound (also known as diagnostic sonography or ultrasonography) is a diagnostic imaging technique based on the application of ultrasound that generally aims to find a source of a disease or to exclude pathology using an ultrasound machine. However, the machine is often misused, violating the provisions of The Pre-Conception and Pre Natal Diagnostic Techniques (PC-PNDT) Act by conducting illegal sex determination tests after conception.
The classification of the ultrasound machine as DRUGS will expand the horizon of regulating the equipment. In 2018, the Drug Technical Advisory Board (DTAB) had decided to include ultrasound equipment under the purview of the Drugs and Cosmetics Act, 1940 in order to save the girl child as the stern rule of ultrasound machines is thought to be critical in addressing the drastic imbalance in India’s sex ratio.
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”.
Prior to this, the ministry had notified 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” to provide safety to patients and regulate the quality of diagnostic and medical devices in India.