Clinical Trial Approval in India : Process & Requirement

Aryan Panwar

Aryan Panwar

Published on: Jun 30, 2026

Shatakshi Sharma

Updated on: Jun 30, 2026

★★★★★(1 Rating)

13

Introduction

This procedure outlines the legal framework and compliance steps for obtaining permission to conduct a clinical trial of a new drug or an investigational new drug in India. It defines the mandatory documentation, fee structures and application forms required by the Central Licensing Authority to verify safety and quality standards.

Applicable Provisions

Documents Required

The applicant shall submit the following documents as per the Second Schedule along with the application in Form CT-04:

1. Chemical and pharmaceutical information
2. Animal pharmacology
3. Animal toxicology
4. Animal pharmacology
5. Human or Clinical pharmacology (Phase I)
6. Therapeutic exploratory trials (Phase II)
7. Therapeutic confirmatory trials (Phase III)
8. Special studies
9. Regulatory status in other countries
10. Prescribing information
11. Samples and Testing protocol/s
12. New chemical entity and Global clinical trial
13. Copy of license to manufacture any drug for sale granted by the State Licensing Authority (in case the application is for the manufacture for sale of a new drug)

Procedure

A Person, Institution or Organization which intends to conduct a Clinical Trial of a New Drug or Investigational New Drug shall make an application to the Central Licensing Authority, duly filled in Form CT-04, along with relevant documents and fees as specified below:

No Fee shall be payable for the conduct of a clinical trial by a person of an institution or organization funded or owned, wholly or partially, by the Central Government or by a State Government.

1. Approval

   The Central Licensing Authority, if satisfied after scrutiny of the information and documents furnished with the application, grant the permission to conduct a clinical trial for a new drug or investigational new drug in Form CT-06.

2. Automatic Approval

   If the applicant receives no communication from the Central Licensing Authority within the specified period, permission to conduct the clinical trial is deemed granted, provided that:

   • The drug was discovered in India; or
   • The Research and Development (R&D) of the drug is being conducted in India, and the drug is proposed to be manufactured and marketed in India.

   This deemed approval is legally valid for all purposes, and the applicant is authorised to initiate the trial in accordance with these rules. The Applicant under deemed approval shall intimate the Central Licensing Authority in Form CT-4A, which shall become part of the official record and be called Automatic Approval of the Central Licensing Authority.

3. Reconsideration of Application

   In case the Central Licensing Authority rejects the application under Form CT-04, the Applicant may request the Authority to reconsider the application within a period of sixty (60) working days from the date of rejection of the application on payment of the fee as specified in the Sixth Schedule and submission of the required information and documents.

4. Validity of Permission

   Approval granted under Form CT-06 or Automatic Approval granted in Form CT-4A shall remain valid for a period of two (2) years from the date of its issue, unless extended by the Central Licensing Authority.

5. Conditions of Permission for Conduct of Clinical Trial:

   After the grant of permission, the Permission Holder shall ensure the following conditions are met:

   • Each site must get approval from its own registered Ethics Committee before starting.
   • If a site lacks a committee, a local one within 50 km can approve and oversee it.
   • If an Ethics Committee rejects a protocol, notify the Central Licensing Authority before applying elsewhere.
   • Inform the Central Licensing Authority within 15 working days of receiving Ethics Committee approval.
   • Register the trial with the Clinical Trial Registry of India before enrolling the first participant.
   • Conduct the trial strictly according to the approved protocol, GCP Guidelines, and 2019 Rules.
   • Submit patient enrolment status quarterly or per treatment duration, whichever is earlier.
   • Upload a trial status report every six months electronically via the SUGAM portal.
   • Report detailed reasons for any early trial termination within 30 working days.
   • Forward analyzed Serious Adverse Event reports to authorities within 14 days of occurrence.
   • Provide full medical management and report injury compensation details within 30 working days of the order.
   • Provide legal compensation for trial-related death or disability, reporting details within 30 working days.
   • Allow authorities to inspect sites, seize records, and audit compliance without restriction.
   • Sponsor R&D laboratories are automatically deemed registered for official drug testing and analysis.
   • The Central Licensing Authority reserves the right to impose trial-specific conditions in writing.
   • Both sponsors and investigators must strictly maintain the integrity of all generated trial data.

Cancellation or Suspension

Where the Permission Holder fails to comply with any provision of the Act and these Rules, the Central Licensing Authority may, after giving a show cause notice and an opportunity of being heard, by an order in writing, suspend the permission for such period as considered appropriate or cancel the permission.

Frequently Asked Questions (FAQS)