Draft Medical Devices Bill 2022
On 8th July, 2022, the Central Government released a draft of a proposed The Drugs, Medical Devices and Cosmetics Bill, 2022 to replace the existing The Drugs and Cosmetics Act, 1940.
Need
- The Drugs and Cosmetics Act, 1940 is a pre-independence legislation enacted by the Central Legislative Assembly.
- With the need to review obsolete laws and to “periodically repeal and amend laws”, the bill has been proposed.
Salient Features
New Definitions
- It introduces various new definitions or provisions like bioequivalence study, bioavailability study, clinical trial, clinical investigation, controlling authority, manufacturer, medical device, new drugs, over the-counter (OTC) drugs, adulterated ....
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