The Union health ministry has notified ultrasound equipment under the Drugs and Cosmetics (D&C) Act to regulate its import, manufacture and sale.
As per the notification dated October 16, 2019, “The Central Government, in pursuance of sub-clause (iv) of clause (b) of section 3 of the D&C Act, 1940 has notified Ultrasound equipment intended for external or internal use in human beings as drug with effect from November 1, 2020.”
The Central Drugs Standard Control Organization (CDSCO), the national regulatory body for Indian pharmaceuticals and medical devices, is the approving authority for the import, manufacture and sale of ultrasound equipment.
Companies that deal in these will also have to apply for permission from the Drug Controller General of India (DCGI) which is responsible for approval of licences, before they can sell the medical devices in India.
Union health ministry’s chief technical advisory body on drugs known as DTAB in its meeting on February 12, 2019 decided to include ultrasound equipment under the purview of the D&C Act, 1940.
Stringent regulation of ultrasound machines is thought to be critical in addressing the drastic imbalance in India’s sex ratio and helping save the girl child.
“The DTAB deliberated the matter and agreed to include ultrasound equipment under the purview of section 3 9b) (iv) of the D&C Act, 1940,” according to minutes of the DTAB meeting.
Regulation of ultrasound machines will help prevent the misuse of sex selection techniques used unabated after conception.
The Pre-Conception and Pre-Natal Diagnostic Techniques (PC-PNDT) Act, 1994 currently regulates the sale of ultrasound machines only to entities registered under the law. However, stringent oversight of these equipment is aimed at addressing the continual decline in the sex ratio with each national census.
India’s sex ratio has declined from 945 females for every 1,000 males in the zero to six years age range in 1991 to 927 females in 2001, according to census data. It declined further to 914 females in 2011.