CDSCO Current Affairs - 2020

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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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Cabinet approves MoU between CDSCO and Saudi FDA

Union Cabinet has given ex-post facto approval to Memorandum of Understanding (MoU) between Central Drugs Standard Control Organization (CDSCO) and Saudi Food and Drug Authority in field of Medical Products Regulation. The MoU was signed on 29 October 2019 during the visit of Prime Minister Narendra Modi to the kingdom of Saudi Arabia.

Highlights of MoU

It would facilitate better understanding of regulatory aspects between two sides and will also enable better coordination in international fora. It will also help in increasing India’s export of medical products to Saudi Arabia.

About Central Drugs Standard Control Organization (CDSCO)

It is Central Drug Authority for discharging functions assigned to Central Government under Drugs and Cosmetics Act. It is the national regulatory body for Indian pharmaceuticals as well as medical devices. It functions under the Union Ministry of Health and Family Welfare.

It serves parallel function to European Union’s European Medicines Agency (EMA), Japan’s PMDA, United State’s Food and Drug Administration (FDA) and Medicines and United Kingdom’s Healthcare products Regulatory Agency.

Major CDSCO Functions: Approval of new drugs and clinical trials; Approval of certain licenses as Central License Approving Authority, Regulatory control over import of drugs; and meetings of Drugs Consultative Committee (DCC) and Drugs Technical Advisory Board (DTAB).

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