Central Drugs Standard Control Organization

Directorate General of Health Services
Ministry of Health & Family Welfare
Government of India

New Drugs and Clinical Trials Rules, 2019

S.no Title Release Date Download Pdf Pdf Size
1 THE NEW DRUGS AND CLINICAL TRIALS RULES 2019 2022-Nov-21 1683 KB
2 New Drugs 2022-Nov-01 20 mb
3 NDCTR_G.S.R. 778(E) dt_14.10.2022_Insertion of Provisions for deemed approvals in various rules under NDCTR 2019 2022-Oct-14 1290 KB
4 2022.02.09_S.O. 553(E)_ Stockpiling of new drug under phase 3 of clinical trial_NDCTR 2019 2022-Feb-09 1106 KB
5 NDCTR_G.S.R. 21(E) dt_18.01.2022_Amendment in Eighth Schedule, Form CT-03 2022-Jan-18 1361 KB
6 NDCTR_G.S.R. 14(E) dt_13.01.2022_To amend rule 2 to substitute cell or stem cell derived product under NDCTR 2019 2022-Jan-13 1169 KB
7 NDCTR_G.S.R. 605(E) dt_31.08.2021_Standalone Bioanalytical laboratory_Rule2 NDCTR 2019 2021-Aug-31 1343 KB
8 NDCTR_G.S.R. 227(E) dt_19.03.2019_New Drugs & Clinical Trial Rules, 2019 2019-Mar-19 2458 KB