This news deals with the latest registration circular which has been published by the CDSCO. The CDSCO has released a new Amendment in the Drugs Rule, 1945  G.S.R 524(E). The amendment came into effect on 2nd August, 2021. This gazette notification would be taken into consideration in 30 days from the date of issue of the notification. The Draft rules are as follows –

  1. (i) These rules will be called the New Drugs and Clinical Trials (Amendment) Rules, 2021.

    (ii)  These will come into force on the date of their final publication in the Official Gazette.

2.  In the New Drugs and Clinical Trials Rules, 2019, in Eighth Schedule, in Form CT-03,─

     (i)  In para1, the word, “Regulation of”, will be omitted;

    (ii) For the words, “Central Licensing Authority”, the words “Designated Registration Authority” will be substituted.

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Source : CDSCO Gazette Notification


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