As per the government plans, all medical devices, including implants and contraceptives are to be brought under the Central Drugs and Standard Control Organisation to ensure improvement in their safety and quality.
As per the Draft notification released, the Ministry of Health and Family Welfare plans to elaborate all medical devices, which were earlier not under the scrutiny of the apex controller of drug, under the Drugs and Cosmetics Act.
In exceptions to from certain implants and contraceptives, the draft notification also plans to redefine medical devices that are required for life support, treatment, diagnosis or mitigation of any disease or disability, and even devices that are required for disinfection of other medical devices.
In the meeting conducted earlier this year, Drugs Technical Advisory Board (DTAB) which is the government’s top advisory body on drugs, recommends recategorization.
For the assurance of the CDSCO ability to the extra workload, the DTAB had recommended the branching of another post of additional drugs controller, with four joint drug controllers, as well as hiring over 200 new officers in various other posts.
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