New Drugs and Clinical Trials Rules, 2019
| S.no |
Title |
Release Date |
Download Pdf |
Pdf Size |
| 1 |
NDCTR_G.S.R. 364(E) dt_11.05.2023_Notification for registration of Clinical Research Organisation (CRO) |
2023-May-11 |
|
1203 KB |
| 2 |
NDCTR_G.S.R. 175(E) dt_09.03.2023_ Amendment in First Schedule regarding use of induced Pluripotent Stem Cells additional testing methods |
2023-Mar-09 |
|
605 KB |
| 3 |
THE NEW DRUGS AND CLINICAL TRIALS RULES, 2019 |
2023-Feb-20 |
|
1769 KB |
| 4 |
New Drugs |
2022-Nov-01 |
|
20 mb |
| 5 |
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 |
| 6 |
2022.02.09_S.O. 553(E)_ Stockpiling of new drug under phase 3 of clinical trial_NDCTR 2019 |
2022-Feb-09 |
|
1106 KB |
| 7 |
NDCTR_G.S.R. 21(E) dt_18.01.2022_Amendment in Eighth Schedule, Form CT-03 |
2022-Jan-18 |
|
1361 KB |
| 8 |
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 |
| 9 |
NDCTR_G.S.R. 605(E) dt_31.08.2021_Standalone Bioanalytical laboratory_Rule2 NDCTR 2019 |
2021-Aug-31 |
|
1343 KB |
| 10 |
NDCTR_G.S.R. 227(E) dt_19.03.2019_New Drugs & Clinical Trial Rules, 2019 |
2019-Mar-19 |
|
2458 KB |
