Regulation/Guidelines

Notification For Ultrasound Equipment From CDSCO: Extension Of Timeline

  • 5th January, 2021
Notification for Ultrasound equipment from CDSCO: Extension of Timeline

The Ministry of Health and Family Welfare has recently come up with a release of notification dated 21st October 2020 to extend the timeline from 1st day of November, 2020” to the 1st day of November, 2021 for Ultrasound Equipment, specifying the Ultrasound equipment intended for external or internal use in human beings as drug Last year, the apex drug regulatory body, Central Drugs Standard Control Organization (CDSCO), notified Ultrasound Device as “Drugs,” which was effective from 1st November 2020.With this, import, manufacture and sale

Medical ultrasound (also known as diagnostic sonography or ultrasonography) is a diagnostic imaging technique based on the application of ultrasound that aims to find a source of a disease or exclude pathology using an ultrasound machine. Sometimes, the machine is often misused, violating the provisions of The Pre-Conception and Pre Natal-Diagnostic Techniques (PC-PNDT) Act after conception by conducting illegal sex determination tests.

The step of the government aims to regulate the import, manufacture and sale of the of the ultrasound equipment will be allowed only under the legal purview of the Drugs and Cosmetics Act, 1940.This is due to the drastic decline in India’s sex ratio, as per the Ministry. This followed recommendation from the Drug Technical Advisory Board (DTAB), the Government’s chief advisory body on drugs.

Ultrasound will be regulated as “drugs” to provide safety to patients and regulate the quality of diagnostic and medical devices in India.

The health ministry feels that the move is crucial to save the girl child as it will check misuse of such techniques for sex selection after conception. Imported ultrasound machines have flooded the market, in the absence of any regulatory law, they cannot be tracked. The move is also streamlining the Health Ministry- DTAB Roadmap that aimed to regulate all medical devices in a phased manner and an adequate transition period of nearly four years for high Risk and near High Risk Devices.

References:

  1. S.O. 3722(E) dated 21.10.202.Available at: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NjU5OQ== .Accessed on 12 th December, 2020.
  2. 2019.10.16_S.O.3721 (E) Notification for Ultrasound equipment under 3b(iv) of D&C Act. Available at: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTE3NA== .Accessed on 12 th December, 2020.