Informational use only. Verify every automatic mapping against the signed Gazette before regulatory reliance.
Legal View · Rules and Gazette chain Practical View · Regulatory pathways rules · NDCTR-2019
New Drugs and Clinical Trials Rules, 2019 Open official consolidated Rules → chapter · NDCTR-CH-I
Chapter I Open official consolidated Rules → chapter · NDCTR-CH-II
Chapter II Open official consolidated Rules → chapter · NDCTR-CH-III
Chapter III Open official consolidated Rules → chapter · NDCTR-CH-IV
Chapter IV Open official consolidated Rules → chapter · NDCTR-CH-V
Chapter V Open official consolidated Rules → chapter · NDCTR-CH-VI
Chapter VI Open official consolidated Rules → chapter · NDCTR-CH-VII
Chapter VII Open official consolidated Rules → chapter · NDCTR-CH-VIII
Chapter VIII Open official consolidated Rules → chapter · NDCTR-CH-IX
Chapter IX Open official consolidated Rules → chapter · NDCTR-CH-X
Chapter X Open official consolidated Rules → chapter · NDCTR-CH-XI
Chapter XI Open official consolidated Rules → chapter · NDCTR-CH-XII
Chapter XII Open official consolidated Rules → chapter · NDCTR-CH-XIII
Chapter XIII Open official consolidated Rules → schedule · SCH-1
FIRST SCHEDULE — (Refer rules 19 and 31) GENERAL PRINCIPLES AND PRACTICES FOR CLINICAL TRIAL 1. General Principles Open official consolidated Rules → schedule · SCH-2
SECOND SCHEDULE — (Refer rules 21, 75, 80 and 97) REQUIREMENTS AND GUIDELINES FOR PERMISSION TO IMPORT OR MANUFACTURE OF NEW DRUG FOR SALE OR TO UNDERTAKE CLINICAL TRIAL Open official consolidated Rules → schedule · SCH-3
THIRD SCHEDULE — (Refer rules 8,10,11, 25, 35, 42 and 49) CONDUCT OF CLINICAL TRIAL 1. Conduct of clinical trial Open official consolidated Rules → schedule · SCH-4
FOURTH SCHEDULE — (Refer rules 33, 45,48,49 and 52) REQUIREMENTS AND GUIDELINES FOR CONDUCT OF BIO AVAILABILITY AND BIOEQUIVALENCE STUDY OF NEW DRUGS OR INVESTIGATIONAL NEW DRUGS Open official consolidated Rules → schedule · SCH-5
FIFTH SCHEDULE — (Refer rules 77 and 82) POST MARKET ASSESSMENT 1. Post marketing assessment of new drug Open official consolidated Rules → schedule · SCH-6
SIXTH SCHEDULE — (Refer rules 21, 22, 33, 34, 45, 47, 52, 53, 60, 67, 68, 75, 76, 80, 81, 86, 91, 97 and 98) FEE PAYABLE FOR LICENCE, PERMISSION AND REGISTRATION CERTIFICATE Open official consolidated Rules → schedule · SCH-7
SEVENTH SCHEDULE — (Refer rules 39, 40, and 42) FORMULAE TO DETERMINE THE QUANTUM OF COMPENSATION IN THE CASES OF CLINICAL TRIAL RELATED INJURY OR DEATH Open official consolidated Rules → schedule · SCH-8
EIGHTH SCHEDULE — Open official consolidated Rules → Complete Gazette change chain Date pending verification Automatic Informational
2599918096eb96b0b349 — New Drugs and Clinical Trials Rules, 2019 Open official source → 2019-03-19 Principal Rules
G.S.R. 227(E) / 2019-03-19 — New Drugs and Clinical Trials Rules, 2019 Open official source → 2021-08-31 Final In Force
G.S.R. 605(E) / 2021-08-31 — NDCT amendment — standalone bioanalytical laboratory Open official source → 2022-01-13 Final In Force
G.S.R. 14(E) / 2022-01-13 — NDCT amendment — cell or stem-cell derived product definition Open official source → 2022-01-18 Final In Force
G.S.R. 21(E) / 2022-01-18 — NDCT amendment — Eighth Schedule and Form CT-03 Open official source → 2022-10-14 Final In Force
G.S.R. 778(E) / 2022-10-14 — NDCT Third Amendment Rules, 2022 — deemed approvals Open official source → 2022-11-22 Final In Force
G.S.R. 835(E) / 2022-11-22 — NDCT amendment — non-clinical testing for pluripotent stem-cell products Open official source → 2023-03-09 Final In Force
G.S.R. 175(E) / 2023-03-09 — NDCT amendment — induced pluripotent stem-cell testing methods Open official source → 2023-05-11 Draft Not Current Law
G.S.R. 364(E) / 2023-05-11 — Draft notification for registration of Clinical Research Organisations Open official source → 2024-09-19 Final In Force
G.S.R. 581(E) / 2024-09-19 — NDCT amendment — registration of Clinical Research Organisations Open official source → 2025-08-27 Draft Not Current Law
G.S.R. 587(E) / 2025-08-27 — Draft amendment — BA/BE studies of unapproved drugs for export Open official source → 2025-08-27 Draft Not Current Law
G.S.R. 588(E) / 2025-08-27 — Draft amendment — test licence requirements Open official source → 2025-10-31 Draft Corrigendum Not Current Law
G.S.R. 810(E) / 2025-10-31 — Corrigendum to draft G.S.R. 587(E) Open official source → 2026-01-20 Final In Force
G.S.R. 46(E) / 2026-01-20 — NDCT amendment — changes to test licence requirements Open official source → 2026-01-21 Final In Force
G.S.R. 50(E) / 2026-01-21 — NDCT amendment — online intimation for BA/BE export studies Open official source → 2026-02-02 Draft Not Current Law
G.S.R. 97(E) / 2026-02-02 — Draft amendment — submission of post-approval changes Open official source → 2026-02-02 Draft Not Current Law
G.S.R. 98(E) / 2026-02-02 — Draft amendment — omission of provisional Ethics Committee certificate Open official source → 2026-06-22 Draft Not Current Law
G.S.R. 504(E) / 2026-06-22 — Draft amendment — annual PSUR submission until marketing Open official source → 