The Ministry of Health & Family Welfare has recently come up with a release of notification on 21 October 2020 to extend the timeline from 1 November 2020 to 1 November 2021 for ultrasound equipment, the apex drug regulatory body, specifying the Ultrasound equipment intended for internal or external use in human beings as drugs last year, Central Drugs Standard Control Organization or CDSCO, notified Ultrasound Device as Drugs that was effective from 1ST November 2020. A medical ultrasound machine is a diagnostic imaging technique based on an ultrasound application that proposes finding a source of disease and excluding pathology using ultrasound equipment. The machine is often misused, violating the provisions of the Pre-Natal Diagnostic Techniques (PC-PNDT) and Pre-Conception Act after conception through conducting illegal sex determination tests. The stage of government objectives to regulate to Import, manufacture, and sale of Ultrasound Equipment will be allowed only under the legal purview of the Drugs and Cosmetics Act of 1940[1]. According to the ministry, this is due to the drastic decline in the sex ratio in India. This blog will discuss Regulations on Ultrasound Equipment imported into India.
Ultrasound Equipment Import in India: What is Ultrasound equipment?
Ultrasound imaging uses high frequency sound waves to view the human or animal body. Because ultrasound images are captured in real time, they can also show the movement of the internal body organs and blood flowing through the blood vessels. Unlike X-ray imaging, there is no ionizing exposure associated with ultrasound imaging. In an ultrasound exam, a transducer is placed directly on the inside of a body and skin opening. A thin gel layer is applied on the skin so that ultrasound waves are transmitted from the transducer through the gel into the human body. The ultrasound image is produced based on the waves’ reflection off the human body structures. The amplitude (strength) of the sound signal and the time it takes for the wave to travel through the human body give the details essential to produce an image.
Ultrasound Equipment Import in India: Uses of Ultrasound Equipment
Ultrasound imaging is a medical device that can assist a physician in evaluating and treating a medical condition and diagnosis. Some common ultrasound imaging processes include:
- Abdominal ultrasound
- Breast ultrasound (to visualize breast tissue)
- Ophthalmic ultrasound (to visualize ocular structures
- Bone sonometry (to assess bone fragility)
- Doppler ultrasound (to visualize flow of blood through organs, blood vessels, or other structures)
- Doppler fetal heart rate monitors (to listen the fetal heartbeat)
- Echocardiogram (to view the heart)
- Ultrasound guided biopsies (to collect a sample of tissue)
- Fetal ultrasound (to view the fetus in a woman’s pregnancy)
- Ultrasound guided needle placement (in blood vessels or other tissues of interest)
Ultrasound Equipment Import in India: Indian Governments Notification for Medical Devices under CDSCO Regulation
The Ministry of Health & Family Welfare, Government of India, has, through three notifications dated 27 December 2019 and 21 October 2021, extended the effective date of earlier notifications that consecutively brought 13 new categories of medical devices under CDSCO regulation, also called New Device Notification.
Expansion of Devices
India’s pharmaceutical regulator and medical device, the Central Drugs Standard Control Organisation or CDSCO, has now further granted an extension for several medical devices to register for market authorization. The CDSCO has expanded and included more types of devices formerly expected to register under India’s Medical Device Rules, 2017, by 1 January 2020, but now has extended the registration deadline to January 2021 under the first notification.
- Nebulizers
- Glucometers
- Digital thermometers
- Blood pressure monitoring equipment
CDSCO will be extended the compliance deadlines for various types of other imaging devices in addition to the above medical devices to 1April under the second notification, and these include:
- Implantable devices
- MRI equipment
- X-Ray machines
- CT scan equipment
- Bone marrow cell separation device
- Defibrillators
- Dialysis systems
- PET equipment
New Regulation on Ultrasound Equipment Import in India
The government of India Will decide to make the regulations more strict for ultrasound equipment and other imaging machinery to prevent importing these machineries without proper registration. Hence, companies have permission from CDSCO to import these machineries into India. As per a recently held meeting, it has been decided by the Drug Technical Advisory Board, which is an apex body advising CDSCO on matters related to drugs & cosmetics, to include the equipment mentioned above and organ preservative solutions as medical devices under currently existing drug regulations of the country. The equipment mentioned above herein, now called medical devices, would be included under section 3(b) of the Drugs & Cosmetics Act, 1940. The government has taken the move to regulate the manufacture, Import, and sale of this equipment to ensure that they are of high-quality standards and easier for the government to track to see that device-related abuse is prohibited, like the use of ultrasound equipment for sex determination. Earlier, license were not required to import ultrasound equipment and other imaging machinery, so it was difficult to check the quality of these equipment. Although the sale & registration of ultrasound machines are already provided for under the Pre Conception and Pre Natal Diagnostic Techniques or PC-PNDT Act, 1994 but the recent decision taken from the government would assist in strengthening the adherence to the regulation.
Conclusion
The Health ministry feels that the move is crucial to saving the girl child as it shall check misuse of such techniques for child sex selection after conception. Imported ultrasound machines have flooded the market, and under regulatory law, they cannot be tracked. The move is streamlining the health ministry DTAB or Drug Technical Advisory Board roadmap that aims to regulate each medical equipment in a phased manner and an adequate transition time of nearly four years for high-risk and near-high-risk equipment.
Read Our Article:Regulation for all Medical Devices under CDSCO Directive
