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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