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:

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-No.-835E-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

GSR-778E-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

S.O.-553E-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.-32E-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.-21E-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-No.-14E-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-767E-dt-27-10-2021-Draft-to-amend-rule-2-to-substitute-cell-or-stem-cell-derived-product-under-NDCTR-2019

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

GSR-605E-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

GSR-99E-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

GSR-No.-354E-05-06-2020-New-Drugs-and-trial-(amendment)-Rules-2020-draft

2019

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

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

GSR-45E-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

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

Latest Notifications: D&C Rules 1945

Latest Notifications: D&C Act 1940

Latest Notifications: Cosmetics

Latest Notifications: Medical Devices

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