The Ministry of Health and Family Welfare vide its notification dated 21st October 2020 has notified that the Ultrasound Device intended for external or internal use in human beings shall be considered as a drug with effective from 1st November 2021.
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, the Ministry was not finding the existing rules sufficient to deter the medical professionals and the user, to avoid ultrasound to determine the sex of the foetus. Under the Medical Device Rules (MDR) and the D&C Act the government will regulate additionally the quality import and manufacturing of the equipment.
