DCGI & CDSCO Approval Services
India’s regulatory clock only runs in your favour when the application is right the first time. We prepare and file clinical trial applications, BE-NOCs, and test licences under the NDCT Rules, 2019 — and manage them through the DCGI’s statutory timelines.
Statutory Timeline
Framework
Facility
Execution
How Drug and Trial Approvals Work in India
Every clinical trial, bioequivalence study, and new drug approval in India runs through the Central Drugs Standard Control Organisation (CDSCO), headed by the Drugs Controller General of India (DCGI). Since 2019 the governing framework has been the New Drugs and Clinical Trials Rules — a defined system of application forms, statutory review clocks, and deemed-approval provisions that replaced the older Schedule Y regime. Applications move through CDSCO’s SUGAM online portal, and many are examined by Subject Expert Committees before permission is granted.
The rules give sponsors real, enforceable timelines — a clinical trial application must be decided within 90 working days, and just 30 for drugs discovered and developed in India. But the clock only helps when the application is complete: a deficiency letter or a Subject Expert Committee query resets months of progress. In practice, DCGI approval is won or lost at preparation, not at review.
Celesta Healthcare operates inside this system daily. Our clinical research facility in Pune is duly mandated by DCGI, and our regulatory team prepares and files clinical trial applications, BE-NOCs, test licences, and new drug dossiers as routine work — with the study data, ethics documentation, and CMC evidence assembled to answer the questions CDSCO actually asks.
The Central Drugs Standard Control Organisation — India’s national regulatory authority for drugs, clinical trials, and medical devices, operating through the SUGAM online portal.
The Drugs Controller General of India — the officer heading CDSCO who, as Central Licensing Authority under the NDCT Rules, grants or refuses clinical trial permissions and new drug approvals.
CDSCO Approvals — Forms and Statutory Timelines
The NDCT Rules, 2019 assign each approval a defined application form and a review clock. These are the ones sponsors use most.
| Approval | Forms (Apply → Grant) | Statutory Timeline |
|---|---|---|
| Clinical trial permission | CT-04 → CT-06 | 90 working days; 30 for drugs discovered and developed in India |
| BA/BE study permission | CT-05 → CT-07 | 90 working days, with deemed approval if no communication is received |
| Test licence (study supplies) | CT-10 → CT-11 | 45 working days under the 2026 Amendment Rules (previously 90) |
| BE-NOC (export studies) | Application to the DCGI office | No fixed statutory clock — complete dossiers move fastest |
What We File and Manage
Clinical Trial Applications
CT-04 applications with protocol, investigator brochure, ethics approvals, and trial site documentation assembled for first-pass review.
BE-NOC Applications
No Objection Certificates for bioequivalence studies, including studies on products intended for export markets.
Test Licences
CT-10 applications to manufacture new drugs in small quantities for tests, analysis, and clinical study supplies.
New Drug Approvals
New drug and subsequent new drug applications with the quality, nonclinical, and clinical evidence CDSCO expects.
SEC Representation & Queries
Preparation for Subject Expert Committee review and structured, deadline-tracked responses to CDSCO queries.
Post-Approval Compliance
Protocol amendments, safety reporting obligations, and status submissions managed after permission is granted.
The Path Through CDSCO
- 01
Pathway & Pre-Submission Strategy
Product classification, applicable rules, and the right application route confirmed before anything is drafted.
- 02
Application & Dossier Preparation
Forms, protocols, ethics documentation, and supporting data compiled and internally reviewed against CDSCO checklists.
- 03
SUGAM Portal Filing
The application submitted through CDSCO’s online portal with fees, covering documents, and a complete audit trail.
- 04
Review & Query Management
Subject Expert Committee scheduling tracked, queries answered in structured responses, timelines monitored against the statutory clock.
- 05
Permission & Post-Approval Duties
Permission received in the granting form, followed by amendment, safety, and reporting obligations managed through the study.
Why Sponsors Choose Us for DCGI & CDSCO Approvals
- Our clinical research facility is duly mandated by DCGI
- CT applications, BE-NOCs, and test licences filed as routine work
- Study data, ethics, and CMC evidence assembled under one roof
- Structured SEC preparation and query response management
- 150+ projects under execution across the division
- Statutory timelines tracked and enforced application by application
DCGI & CDSCO Approvals — Frequently Asked Questions
1. How long does DCGI approval take for a clinical trial?
2. What is the difference between CDSCO and DCGI?
3. What is a BE-NOC?
4. What is a test licence under the NDCT Rules?
5. What are the New Drugs and Clinical Trials Rules, 2019?
6. What is Form CT-04?
7. What happens if CDSCO does not respond within the statutory timeline?
More Regulatory Affairs Services
Every study type under one roof — explore the rest of our regulatory affairs capabilities.
Dossier Preparation
Module 1–5 compilation, gap analysis, and eCTD publishing — submission-ready for every target agency.
ANDA Dossiers
US FDA generic submissions with Module 3 CMC built by people who work with manufacturing daily.
ANVISA / Brazil
BE studies at our ANVISA-approved centre plus CTD dossiers and query management for Brazil.
Discuss Your DCGI & CDSCO Approvals Requirement
Share your molecule and target market — our scientific team responds with a study design, timeline, and detailed proposal within 24 business hours.