Clinical Trial Permission from CDSCO (Form CT-04 / CT-06)
A sponsor needs permission from the Central Licensing Authority at CDSCO before starting a clinical trial of a new drug or investigational new drug in India. The application goes in Form CT-04 under the New Drugs and Clinical Trials Rules, 2019, and is decided within 90 working days, or 30 working days for drugs developed in India.
What it is
Clinical trial permission is the written approval, in Form CT-06, that lets a sponsor run a clinical trial on human participants in India. The Drugs Controller General of India heads CDSCO and acts as the Central Licensing Authority (CLA). Without it, no new drug or investigational new drug can be tested on people here.
The law is the New Drugs and Clinical Trials Rules, 2019 (G.S.R. 227(E), 19 March 2019), made under the Drugs and Cosmetics Act, 1940. The sponsor files Form CT-04 with the documents in the Second Schedule and the fee in the Sixth Schedule on CDSCO’s SUGAM portal. If you only need to bring in trial material, that is a separate CDSCO test licence, and product licences after approval sit under CDSCO registration.
Who it applies to
You are developing a new drug
Indian or foreign sponsors running Phase I to Phase IV trials of a new drug or investigational new drug in India.
You run trials for a sponsor
Contract research organisations (CROs) often file and manage the trial. The sponsor remains responsible under the Rules.
Your drug was discovered in India
Think of a Bengaluru biotech start-up whose molecule was discovered, researched and is made here. Its CT-04 runs on the shorter 30-working-day clock.
Why it matters
Start enrolment legally
No participant can be enrolled until the CT-06 permission, ethics committee approval and CTRI registration are all in place.
Build towards marketing approval
Trial data generated under a valid permission supports the later application to import or manufacture the new drug in India.
Settle duties before dosing
Consent, safety reporting and compensation are fixed by the Rules before anyone is dosed.
Documents required
From the sponsor
- Cover letter and Form CT-04, signed by the authorised person
- Company registration, and the Indian agent’s authorisation for a foreign sponsor
- Fee payment as per the Sixth Schedule
- Regulatory status of the drug in other countries
Scientific dossier
- Clinical trial protocol and investigator’s brochure
- Chemistry, manufacturing and quality data
- Animal toxicology and pharmacology data
- Data from earlier phases, where available
Site and ethics papers
- Informed consent documents and case record form
- Investigator undertakings and site details
- Ethics committee approval for each site, registered in Form CT-02
- Plan for CTRI registration before enrolment
How it works
Map the pathway
We check whether you need a full trial permission, a BA/BE permission or a test licence. In practice, a foreign sponsor with an orphan drug already approved in the US may qualify for the Rule 101 waiver of a local trial.
Register on SUGAM and build the file
We set up the sponsor’s SUGAM login and assemble the Second Schedule dossier with your medical team or CRO.
File CT-04 and pay the fee
We submit Form CT-04 with the fee and track it. CDSCO may refer it to a Subject Expert Committee for review.
Answer queries
We coordinate replies to CDSCO queries so the clock is not lost, and prepare an appeal, due within 45 days, if the application is rejected.
Start and stay compliant
After CT-06, the trial is registered on CTRI before enrolment, and we diarise the two-year validity and reporting dates.
Clinical trial, BA/BE study or academic trial?
| Clinical trial | BA/BE study | Academic trial | |
|---|---|---|---|
| Application | Form CT-04 | Form CT-05 | No CLA permission if conditions are met |
| Permission | Form CT-06 | Form CT-07 | Ethics committee approval only |
| Decision time | 90 working days (30 for India-developed drugs) | 90 working days | Not applicable |
| Validity / start | Two years from issue | First subject within one year | Not applicable |
An academic trial needs no CLA permission when it studies an approved drug for a new indication, route or dose purely for academic purposes, has ethics committee approval, and its results are not submitted to the CLA or used for promotion.
Here is the catch. Say a Faridabad medical college wants to study an approved diabetes drug at a new dose. With ethics approval, that is an academic trial. If a company later plans to use those results for a label change, it needs CT-04 and CT-06 like any other trial.
Timelines
90 working days
The general time for the CLA to grant or reject a CT-04 application under Rule 22.
30 working days
For a drug discovered, researched and manufactured in India (Rule 23). If the CLA does not reply, the application is deemed approved; you then inform CDSCO in Form CT-04A before starting.
Two years
CT-06 permission is valid for two years from its issue, unless extended.
What happens if the conditions are breached
The permission lapses
CT-06 is valid for two years from issue. A permission not acted on in that time lapses unless the CLA extends it.
Sponsor bears injury costs
The sponsor must give free medical management to an injured participant and pay compensation for trial-related injury or death, as decided under the Rules.
CDSCO can inspect
Rule 29 allows officers to inspect trial sites, sponsor premises and records. Keep consent forms and safety reports inspection-ready.
Frequently asked questions
How long does CDSCO take to grant clinical trial permission?
CDSCO must decide within 90 working days of receiving Form CT-04, under Rule 22 of the New Drugs and Clinical Trials Rules, 2019. For a drug discovered, researched and manufactured in India, the limit is 30 working days under Rule 23, and silence means deemed approval. Queries and Subject Expert Committee reviews eat into that time. A complete dossier on day one is the surest way to stay inside the window.
What is the fee for a clinical trial application in India?
The Sixth Schedule fee is ₹3,00,000 for a Phase I trial and ₹2,00,000 each for Phase II, Phase III and Phase IV. Trials sponsored by the Central or State Government pay no fee, and neither do trials of orphan drugs. The fee is paid online with the CT-04 application. Our professional fee is quoted separately before you commit, so the full cost is clear upfront.
How long is clinical trial permission valid?
CT-06 permission is valid for two years from the date of issue, unless the CLA extends it. The trial should begin within that period, after the ethics committee approval and CTRI registration are in place. If the trial cannot start in time, apply for an extension before the permission lapses. We track the expiry date from the day the permission arrives, so it never catches you out.
Is ethics committee approval needed before CDSCO permission?
The trial cannot start at any site without that site’s ethics committee approval, whatever stage your CDSCO application is at. The committee itself must be registered with CDSCO in Form CT-02, valid for five years, after applying in Form CT-01. It needs at least seven members with the mix the Rules prescribe. Most sites already use a registered committee, so in practice this step runs alongside the CDSCO filing.
Do I need to register the trial on CTRI?
Yes. Every clinical trial must be registered on the Clinical Trials Registry – India (CTRI), run by ICMR, before the first participant is enrolled. CTRI registration is a condition of the CT-06 permission. Registration makes the trial’s basic details public. It is a short online process once the protocol and approvals are final, and we keep it on the start-up checklist.
Can a trial already approved abroad skip the Indian trial?
Sometimes. Under Rule 101, CDSCO’s August 2024 order under Rule 101 allows a local trial waiver for drugs approved in the US, UK, Japan, Australia, Canada or the EU. The waiver covers orphan drugs, gene and cellular therapies, new drugs for pandemics or special defence purposes, and new drugs with significant therapeutic advance. Other drugs still need a local trial or a justified waiver request. We check your drug against the list first.
What is a BA/BE study permission and how is it different?
A bioavailability or bioequivalence (BA/BE) study needs permission in Form CT-07, applied for in Form CT-05, not a CT-06 clinical trial permission. CDSCO decides within 90 working days. The first subject should be enrolled within one year of the permission. BA/BE studies are common for generic drugs. We tell you at the start which form your study needs, so the file goes in once.
What must be reported once the trial is running?
Serious adverse events must be reported to the CLA within 24 hours of the investigator learning of them, with a detailed report within 14 days. A participant injured in the trial gets free medical management, and compensation where the injury or death is trial-related. Set up a reporting calendar at the start and these deadlines take care of themselves.
Can Taxhint run the clinical trial?
No, and we do not claim to. The protocol, investigators, sites and medical content come from you, your CRO and your investigators. Our role is regulatory filing support: the pathway check, SUGAM registration, assembling and filing Form CT-04, fee payment, query replies, preparing appeals within 45 days, and diarising validity and reports. Your scientific team stays on the science; the paperwork sits with us.
What it costs
Our fee plus the government fee that applies to your case, quoted before you commit. Tell us the situation and we will price it exactly.
Government fees for a clinical trial application in Form CT-04 (Sixth Schedule):
| Phase | Fee |
|---|---|
| Phase I | ₹3,00,000 |
| Phase II | ₹2,00,000 |
| Phase III | ₹2,00,000 |
| Phase IV | ₹2,00,000 |
No fee is charged for trials sponsored by the Central or State Government, or for trials of orphan drugs.
Ready to begin?
Share your protocol synopsis and target phase, and we will map the CDSCO pathway and file Form CT-04 on SUGAM.