Download New Drugs, FDC, Clinical Trial – Notifications
The Govt. of India issues notifications from time to time, which are published by the 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 on the below links for more information:
2026
GSR 50(E) dt 21-01-2026 Notification for application of unapproved drugs for conduct of BA BE Studies for export purpose under NDCT Rules 2019
GSR 46(E) dt 20-01-26 Notification about Changes to requirements of Test License under NDCT Rules 2019 NDCT Rules (Amendment) 2026
2025
GSR 810 (E) dt 31.10.2025 Corrigendum to G.S.R 587 (E) dt 27.08.2025 w.r.t. Draft Notification for application of unapproved drugs for conduct of BA BE studies for export purpose under NDCT Rules 2019
GSR 588 (E) dt 27-08-2025 Draft notification of New Drugs and Clinical Trials (…. Amendment) Rules, 2025 regarding permission of new drug, Working days etc.
GSR 587 (E) dt 27-08-2025 Draft notification of New Drugs and Clinical Trials (…. Amendment) Rules, 2025 regarding Application, Sample Size, BABE Studies, Fee etc.
2024
GSR No. 581(E) dt 19-09-2024 New Drugs and Clinical Trials (Amendment) Rules, 2024.
GSR No. 581(E) dt 19-09-2024 New Drugs and Clinical Trials (Amendment) Rules, 2024
2023
GSR No. 364(E) dt 11-05-2023 Draft New Drugs and Clinical Trials (Amendment) Rules, 2022
GSR 175(E) dt 09-03-2023 New Drug and Clinical Trial (Amendment) Rules 2023 – additional testing methods to assess safety & efficacy of iPSC included
2022
GSR No. 835(E) dt 22-11-2022 Draft notification – Specific requirements on non-clinical studies – New Drugs and Clinical Trials Rules, 2022
GSR 778(E) dt 14-10-2022 New Drugs and Clinical Trials (Third Amendment) Rules, 2022
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
2021
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-No.-524-dt-02-08-2021-DRaft-New-Drugs-and-Clinical-TrialAmendment-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
2020
GSR No. 354(E) dt 05-06-2020 – Regarding New Drugs and trial (Amendment) Rules 2020 draft
2019
GSR 227 (E) dt 19-03-2019 – New Drugs and Clinical Trials Rules 2019
2018
G.S.R-360-E-dt.-10-04-2018-New-Drug-word-Patent-and-proprietary-substituted-as-word-Drug
2011
GSR 45(E) dt 24-01-2011 – Vaccines and Recombinant are new drugs – Drugs and Cosmetics (1st Amendment) Rules 2011
2009
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
