New Drugs, FDC, Clinical Trial: Notifications

Last Updated on February 12, 2022 by The Health Master

Download New Drugs, FDC, Clinical Trial – Notifications

Gazette of India

Govt. of India issues Notifications time to time which are published by Department of Publication and are printed by the Government of India Printing Presses regularly.

We have provided some of the notifications relevant to the above said topic, Click below links for more information:


S.O. 553(E) dt 09-02-2022 Stockpiling of new drug under phase 3 of clinical trial New Drugs and Clinical Trials Rules 2019

GSR No. 32(E) dt 21-01-2022 Draft notification -Insertion of Proviso for deemed approvals in Rule 8 under New Drugs and Clinical Trials Rules 2019

GSR No. 21(E) dt 18-01-2022 – Designated Registration Authority in Form CT-3 -New Drugs and Clinical Trials (2nd Amendment) Rules, 2022

GSR No. 14(E) dt 13-01-2022 – Final notification Rule 2 – New Drugs and Clinical Trials (Amendments) Rules 2022

GSR 767(E) dt 27-10-2021 Draft – to amend rule 2 to substitute cell or stem cell derived product under New Drugs and Clinical Trial Rules 2019


GSR 605(E) dt 31-08-2021 Standalone Bioanalytica New Drugs and Clinical Trials (Amendment) Rules 2021

GSR No. 524 (E) dt 02-08-2021 Draft – New Drugs and Clinical Trial (Amendment) Rules 2021


GSR 99(E) dt 05-02-2021 -Draft notification For inclusion of provisions related to the registration of stand alone bio analytical laboratories in the NDCT Rules, 2019


GSR No. 354(E) dt 05-06-2020 – Regarding New Drugs and trial (Amendment) Rules 2020 draft


GSR 227 (E) dt 19-03-2019 – New Drugs and Clinical Trials Rules 2019




GSR 45(E) dt 24-01-2011 – Vaccines and Recombinant are new drugs – Drugs and Cosmetics (1st Amendment) Rules 2011



GSR 738(E) dt 09-10-2009 Amendment in the notification number G.S.R. 578(E), 23rd July, 1983 Substitutes FDC of Corticosteroid with any other drug for internal use


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