CT, MRI and Ultrasounds under drugs and Cosmetics Act


eMediNexus    01 March 2018

Equipment like ultrasound machines, CT scanners, magnetic resonance imaging (MRI) and X-Ray machines are to be brought under the purview of the Drugs and Cosmetics Act. CDSCO will regulate their import, manufacture and sale.

CDSCO, the national regulatory body for Indian pharmaceuticals and medical devices, will become the approving authority for the import, manufacture and sale of these devices. Companies that deal in these will also have to apply for permission from the Drug Controller General of India, which is responsible for approval of licences, before they can sell the devices in India.

The Drug Technical Advisory Board (DTAB), the government’s chief advisory body on drugs in its meeting on 12 February decided to include ultrasound equipment under the purview of the Drugs and Cosmetics Act, 1940.

The DTAB has agreed to include ultrasound equipment and similar imaging equipments under the purview of section 3 9b) (iv) of the Drug and Cosmetics Act, 1940. {Live Mint]

The move will help prevent over invoicing, fair prise availability and transparent MRP of the equipments. Over a period of time the same should be done to all medical equipments.

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