Drugs and Cosmetics Act Current Affairs - 2020

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Medical Devices now to be regulated under Drugs and Cosmetics Act

On February 11, 2020, Ministry of Health and Family Welfare announced that medical devices are to be brought under Drugs and Cosmetics act (DCA). This is to come into effect from April 1, 2020

Highlights

According to the regulation, every product that is used to treat a patient will now be under the ambit of DCA. It includes MRI, CT scan, thermometer, dialysis machines, etc. A list of 37 devices has been included. This includes medical devices used on animals as well.

Drugs and Cosmetics Act

The DCA regulates manufacture, distribution and import of drugs in India. It was passed in 1940. The act was prepared based on the recommendations of Chopra Committee that was constituted in 1930.

The term Drug in the act includes substances and diagnostic devices as well. The act provides guidelines for sale, display, prescription and storage of drugs. The act has so far been amended in 7 times.

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NITI Aayog: List of high export potential medical devices created

The Government Think Tank Niti Aayog draws up list of medical devices that have high export potential. It has come up with 10 devices to provide priority subsidies. It includes surgical blades, orthopaedic implants, catheters, syringes and needles, X-ray machines, blood bags, MRI machines and CT scan.

Highlights

The devices included in the list are to be prioritized in order to boost their domestic manufacturing. Also, in order to boost their exports, GoI will create a framework to accelerate their standardization and certification.

In December 2018, NITI Aayog announced that all medical devices will be brought under one regulatory regime. This will aid in boosting the exports as well as it will fasten the certification process

National Register

Currently, the medical devices are governed under the Central Drugs Standard Control organization (CDSCO). It is a statutory body that was created under Drugs and Cosmetics Act. The GoI suggested to bring all the medical devices under the body. However, NITI Aayog turned down the proposal and suggested the creation of National Register of Medical Devices. According to NITI Aayog, it will act as an autonomous body on the lines of FSSAI. The body will have device experts and IIT labs will be used for testing the devices.

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