Download Latest Notifications: New Drugs and Clinical Trials

The Government of India issues notifications from time to time, which are published by the Department of Publication and printed regularly by the Government of India Printing Presses.

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

2022

GSR-No.-835E-dt-22-11-2022-Draft-notification-Specific-requirements-on-non-clinical-studies-New-Drugs-and-Clinical-Trials-Rules-2022

GSR-778E-dt-14-10-2022-New-Drugs-and-Clinical-Trials-Third-Amendment-Rules-2022

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.-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.-21E-dt-18-01-2022-Designated-Registration-Authority-in-Form-CT-3-New-Drugs-and-Clinical-Trials-2nd-Amendment-Rules-2022

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

2021

GSR-767E-dt-27-10-2021-Draft-to-amend-rule-2-to-substitute-cell-or-stem-cell-derived-product-under-NDCTR-2019

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

GSR-No.-524-dt-02-08-2021-DRaft-New-Drugs-and-Clinical-TrialAmendment-Rules-2021

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.-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

2018

G.S.R-360-E-dt.-10-04-2018-New-Drug-word-Patent-and-proprietary-substituted-as-word-Drug

2011

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

2009

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

Compiled by:Rakesh Dahiya, SDCO cum Licensing Authority, FDA Haryana

For more Notifications on following topics, click below links:

Banned Drugs

Blood Bank / Centre

Cosmetics

COTPA

DPCO / NPPA

Drugs Act

DMROA

EC Act

General

Homoeopathic

Hospital – RMI

Medical Devices

NDPS Act

Testing Laboratories
https://thehealthmaster.com/2021/04/04/latest-notifications-new-drugs-and-clinical-trials/