Ethics & regulatory
The approval pathway under the New Drugs and Clinical Trials Rules, 2019 — Ethics Committee registration on Form CT-01, protocol review and approval, notification to the Central Licensing Authority within 15 days, and trial permission on Form CT-04 through the SUGAM portal.
Ethics Committee workflow board
Columns follow the real NDCT approval sequence. Cards move left to right as a protocol progresses.
After EC approval the Central Licensing Authority must be notified within 15 days; the trial permission application then goes to CDSCO on Form CT-04 through SUGAM, with the protocol, investigator's brochure, informed consent documents, EC approval letter and Second Schedule data.
EC composition checker
Institutional Ethics Committee, All India Institute of Ayurveda · ECR/AIIA/DL/2026/CT-01/0147
- Registered with
- Central Licensing Authority (CDSCO)
- Registration form
- Form CT-01
- Registered on
- 26 Aug 2024
- Valid until
- 25 Aug 2029 (5 yrs)
9 members appointed against a minimum of 7, spanning medical, non-medical, scientific and non-scientific backgrounds.
Approval workflow reference
The ten stages of the NDCT pathway, with the real artefact at each step
EC registration with CLA
Form CT-01 · valid 5 years
Protocol submission to the registered EC
Protocol, PIS, ICD, compensation plan
EC review
Protocol, investigator qualifications, patient information sheet, informed consent, compensation
EC approval / clarification / rejection
Decision minuted and communicated
Notification to Central Licensing Authority
Within 15 days of approval
Trial permission application to CDSCO
Form CT-04 via the SUGAM portal, with IB, ICD, EC approval letter and Second Schedule data
DCGI and Subject Expert Committee review
SEC recommendation to DCGI
Permission granted
Trial may commence
Ongoing EC oversight
Amendments, SAE reports, annual progress reports
Renewal / continuing review
Before the 5-year registration lapses
Trial registry tracker
Prospective registration with the Clinical Trials Registry – India (ctri.nic.in) is mandatory. Public records are refreshed six-monthly.
| Registration number | Study | Registered | Last updated | Next update due | Form CT-01 | Form CT-04 / SUGAM |
|---|---|---|---|---|---|---|
| CTRI/2026/XX/SYN001Synthetic | Efficacy of Ashwagandha Ghrita in Sandhivata (osteoarthritis of the knee) | 11 Nov 2025 | 08 Jul 2026 | 06 Jan 2027 | Registered — valid 5 years | Submitted via SUGAMSUGAM/CT04/2026/4100 |
| CTRI/2026/XX/SYN002Synthetic | Nishamalaki and lifestyle intervention in Madhumeha (type 2 diabetes mellitus) | 22 Jan 2026 | 20 Apr 2026 | 19 Oct 2026 | Registered — valid 5 years | Submitted via SUGAMSUGAM/CT04/2026/4107 |
| CTRI/2026/XX/SYN003Synthetic | Kutajarishta in Grahani Roga (diarrhoea-predominant irritable bowel syndrome) | 07 Mar 2026 | 08 Aug 2026 | 06 Feb 2027 | Registered — valid 5 years | Submitted via SUGAMSUGAM/CT04/2026/4114 |
| CTRI/2026/XX/SYN004Synthetic | Vasavaleha as add-on therapy in Tamaka Shwasa (mild persistent bronchial asthma) | 20 Apr 2026 | 12 May 2026 | 10 Nov 2026 | Registered — valid 5 years | Submitted via SUGAMSUGAM/CT04/2026/4121 |
| CTRI/2026/XX/SYN005Synthetic | Simhanada Guggulu with Shodhana in Amavata (rheumatoid arthritis) | 29 Mar 2026 | 25 Jul 2026 | 23 Jan 2027 | Registered — valid 5 years | Submitted via SUGAMSUGAM/CT04/2026/4128 |
| CTRI/2026/XX/SYN006Synthetic | Panchatikta Ghrita Guggulu in Kitibha Kushtha (plaque psoriasis) | 23 Oct 2021 | 05 Mar 2026 | 03 Sept 2026 | Registered — valid 5 years | Submitted via SUGAMSUGAM/CT04/2026/4135 |
| CTRI/2026/XX/SYN007Synthetic | Brahmi Vati and Shirodhara in Chittodvega (generalised anxiety disorder) | 24 May 2026 | 12 Aug 2026 | 10 Feb 2027 | Registered — valid 5 years | Submitted via SUGAMSUGAM/CT04/2026/4142 |
| CTRI/2026/XX/SYN008Synthetic | Arogyavardhini Vati in non-alcoholic fatty liver disease (Yakrit Vikara) | 08 May 2026 | 04 Jun 2026 | 03 Dec 2026 | Registered — valid 5 years | Submitted via SUGAMSUGAM/CT04/2026/4149 |
| CTRI/2026/XX/SYN009Synthetic | Guduchi and Ashwagandha in chemotherapy-induced fatigue | 23 Jun 2026 | 18 Aug 2026 | 16 Feb 2027 | Registered — valid 5 years | Submitted via SUGAMSUGAM/CT04/2026/4156 |
| CTRI/2026/XX/SYN010Synthetic | Pathyadi Kwatha in Ardhavabhedaka (episodic migraine) | 18 Jul 2026 | 24 Aug 2026 | 22 Feb 2027 | Registered — valid 5 years | Submitted via SUGAMSUGAM/CT04/2026/4163 |
| CTRI/2026/XX/SYN011Synthetic | Medohar Guggulu in Medoroga (dyslipidaemia with central obesity) | 05 Aug 2026 | 29 Aug 2026 | 27 Feb 2027 | Registered — valid 5 years | Drafted— |
| CTRI/2026/XX/SYN012Synthetic | Kati Basti with Yogaraja Guggulu in Katigraha (chronic low back pain) | 03 Sept 2026 | 03 Sept 2026 | 04 Mar 2027 | Registered — valid 5 years | Drafted— |
| CTRI/2026/XX/SYN013Synthetic | Punarnava Mandur in Pandu Roga (iron deficiency anaemia in women) | 20 Aug 2026 | 01 Sept 2026 | 02 Mar 2027 | Registered — valid 5 years | Not started— |
| CTRI/2026/XX/SYN014Synthetic | Jatamansi Churna with Padabhyanga in Anidra (chronic primary insomnia) | 04 Sept 2026 | 04 Sept 2026 | 05 Mar 2027 | Registered — valid 5 years | Not started— |
| CTRI/2026/XX/SYN015Synthetic | Varunadi Kwatha in Mutraghata (benign prostatic hyperplasia) | 24 Jul 2025 | 09 Feb 2026 | 10 Aug 2026 | Registered — valid 5 years | Not started— |
No verified CTRI registration numbers were supplied to this build, so every study is displayed as synthetic and its registration number uses a deliberately invalid SYN block. Replacing these with verified numbers removes the tag automatically.
Regulatory milestone calendar
Every dated obligation across the portfolio, soonest first
MUT · Registry record update due (6-monthly)
10 Aug 2026
MED · Notify Central Licensing Authority (15 days from EC approval)
12 Aug 2026
YAK · Monitoring visit OVERDUE
19 Aug 2026
MAD · Monitoring visit OVERDUE
26 Aug 2026
TAM · Monitoring visit OVERDUE
02 Sept 2026
KIT · Registry record update due (6-monthly)
03 Sept 2026
KAT · Notify Central Licensing Authority (15 days from EC approval)
11 Sept 2026
MUT · Monitoring visit scheduled
20 Sept 2026
AMV · Monitoring visit scheduled
23 Sept 2026
SAN · Monitoring visit scheduled
29 Sept 2026
KIT · EC approval expires — renewal review required
01 Oct 2026
KIT · Monitoring visit scheduled
08 Oct 2026
CHT · Monitoring visit scheduled
12 Oct 2026
GRH · Monitoring visit scheduled
16 Oct 2026
MAD · Registry record update due (6-monthly)
19 Oct 2026
ONC · Monitoring visit scheduled
19 Oct 2026
ARD · Monitoring visit scheduled
23 Oct 2026
SAN · EC approval expires — renewal review required
24 Oct 2026
MED · Monitoring visit scheduled
28 Oct 2026
PAN · Monitoring visit scheduled
01 Nov 2026
ALL · Periodic Safety Update Report (PBRER format) — annual submission
09 Nov 2026
TAM · Registry record update due (6-monthly)
10 Nov 2026
KAT · Monitoring visit scheduled
25 Nov 2026
YAK · Registry record update due (6-monthly)
03 Dec 2026
ANI · Monitoring visit scheduled
04 Dec 2026
SAN · Registry record update due (6-monthly)
06 Jan 2027
AMV · Registry record update due (6-monthly)
23 Jan 2027
GRH · Registry record update due (6-monthly)
06 Feb 2027
CHT · Registry record update due (6-monthly)
10 Feb 2027
ONC · Registry record update due (6-monthly)
16 Feb 2027
ARD · Registry record update due (6-monthly)
22 Feb 2027
MED · Registry record update due (6-monthly)
27 Feb 2027
PAN · Registry record update due (6-monthly)
02 Mar 2027
KAT · Registry record update due (6-monthly)
04 Mar 2027
ANI · Registry record update due (6-monthly)
05 Mar 2027
Approval documents
Protocols, consent documents, EC letters and regulatory forms with version and validity
| Document | Version | Issued | Valid until | Status |
|---|---|---|---|---|
| Form CT-01 — Ethics Committee registration certificateRegulatory form | 1.0 | 26 Aug 2024 | 25 Aug 2029 | Current |
| Protocol — SANProtocol | v2.1 | 06 Mar 2025 | — | Current |
| Informed consent document — SAN (v2.1)ICD | v2.1 | 25 Apr 2025 | — | Superseded |
| EC approval letter — AIIA/IEC/2026/140EC letter | 1.0 | 24 Oct 2025 | 24 Oct 2026 | Current |
| Form CT-04 — trial permission application (SUGAM/CT04/2026/4100)Regulatory form | 1.0 | 01 Nov 2025 | — | Current |
| Protocol — MADProtocol | v1.0 | 16 Jul 2025 | — | Current |
| Informed consent document — MAD (v1.4)ICD | v1.4 | 23 Aug 2025 | — | Current |
| EC approval letter — AIIA/IEC/2026/143EC letter | 1.0 | 10 Jan 2026 | 09 Jan 2031 | Current |
| Form CT-04 — trial permission application (SUGAM/CT04/2026/4107)Regulatory form | 1.0 | 18 Jan 2026 | — | Current |
| Protocol — GRHProtocol | v1.0 | 05 Oct 2025 | — | Current |
| Informed consent document — GRH (v1.2)ICD | v1.2 | 04 Nov 2025 | — | Current |
| EC approval letter — AIIA/IEC/2026/146EC letter | 1.0 | 23 Feb 2026 | 22 Feb 2031 | Current |
| Form CT-04 — trial permission application (SUGAM/CT04/2026/4114)Regulatory form | 1.0 | 03 Mar 2026 | — | Current |
| Protocol — TAMProtocol | v2.1 | 24 Dec 2025 | — | Current |
| Informed consent document — TAM (v1.1)ICD | v1.1 | 17 Jan 2026 | — | Superseded |
| EC approval letter — AIIA/IEC/2026/149EC letter | 1.0 | 08 Apr 2026 | 07 Apr 2031 | Current |
| Form CT-04 — trial permission application (SUGAM/CT04/2026/4121)Regulatory form | 1.0 | 15 Apr 2026 | — | Current |
| Protocol — AMVProtocol | v1.0 | 14 Nov 2025 | — | Current |
| Informed consent document — AMV (v2.0)ICD | v2.0 | 11 Dec 2025 | — | Superseded |
| EC approval letter — AIIA/IEC/2026/152EC letter | 1.0 | 16 Mar 2026 | 15 Mar 2031 | Current |
| Form CT-04 — trial permission application (SUGAM/CT04/2026/4128)Regulatory form | 1.0 | 25 Mar 2026 | — | Current |
| Protocol — KITProtocol | v1.0 | 01 Oct 2017 | — | Current |
| Informed consent document — KIT (v1.3)ICD | v1.3 | 24 Jul 2018 | — | Superseded |
| EC approval letter — AIIA/IEC/2026/155EC letter | 1.0 | 08 Oct 2021 | 01 Oct 2026 | Expiring |
| Form CT-04 — trial permission application (SUGAM/CT04/2026/4135)Regulatory form | 1.0 | 15 Oct 2021 | — | Current |
| Protocol — CHTProtocol | v2.1 | 13 Feb 2026 | — | Current |
| Informed consent document — CHT (v1.0)ICD | v1.0 | 05 Mar 2026 | — | Current |
| EC approval letter — AIIA/IEC/2026/158EC letter | 1.0 | 11 May 2026 | 10 May 2031 | Current |
| Form CT-04 — trial permission application (SUGAM/CT04/2026/4142)Regulatory form | 1.0 | 20 May 2026 | — | Current |
| Protocol — YAKProtocol | v1.0 | 26 Jan 2026 | — | Current |
| Informed consent document — YAK (v1.2)ICD | v1.2 | 16 Feb 2026 | — | Current |
| EC approval letter — AIIA/IEC/2026/161EC letter | 1.0 | 26 Apr 2026 | 25 Apr 2031 | Current |
| Form CT-04 — trial permission application (SUGAM/CT04/2026/4149)Regulatory form | 1.0 | 04 May 2026 | — | Current |
| Protocol — ONCProtocol | v1.0 | 15 Mar 2026 | — | Current |
| Informed consent document — ONC (v1.1)ICD | v1.1 | 04 Apr 2026 | — | Current |
| EC approval letter — AIIA/IEC/2026/164EC letter | 1.0 | 11 Jun 2026 | 10 Jun 2031 | Current |
| Form CT-04 — trial permission application (SUGAM/CT04/2026/4156)Regulatory form | 1.0 | 19 Jun 2026 | — | Current |