Ultrasound Devices Classified As Drugs By CDSCO
Summary: Classification of ultrasound devices as drugs with affect the medical equipment registration process in India since now manufacturers will have to follow the drug license application process to legally sell medical devices.
The primary drug regulatory body, Central Drugs Standard Control Organization or CDSCO, in its latest notification has clearly stated that Ultrasound devices will be considered as ” Drugs” from 1st November 2020. According to the rule, the devices used for all external and internal use in human beings will be categorised as drugs. Under this new rule, the manufacture, sale and import of the ultrasound machines will be permitted only under the legal range of the Drugs and Cosmetics Act,1940 With effect from 1st November 2020.
The medical ultrasound which is also called diagnostic sonography or the ultra sonography is one of the diagnostic imaging processes based on the use of the ultrasound for finding any possible source of diseases or to implement pathology by using the ultrasound machine.
But lately, the machine has been largely misused by violating the rules of The Pre-Conception and pre Natal Diagnostic Techniques (PC-PNDT) act by performing all illegal sex determination tests after conceiving.
PC-PNDT at present regulates the ultrasound machine sale only to those who are registered under law but Ministry found that the present rules are not sufficient in avoiding the misuse. Since medical diagnostic devices are highly unregulated in India.
CDSCO, the national regulatory body of medical devices and Indian pharmaceuticals, will be the approving body for import, manufacture and the sale of ultrasound machines. The companies involved in the manufacture, import and distribution of ultrasound machines will also have to take permission from the Drug Controller General of India for import license of Ultrasound device prior to undertaking import activities.
This classification of the ultrasound machine as Drugs is expected to increase the horizon of the equipment regulation. Prior to this notification, the ministry had also notified other medical devices like CT scan machines, defibrillators, PET, dialysis machine, X-ray machine along with the bone marrow cell separator to be classified as drugs to offer the required safety to patients and properly regulate all diagnostic as well as medical devices in India.