New Drugs Manufacturing Approval Process in India

Aryan Panwar

Aryan Panwar

Published on: May 28, 2026

Shatakshi Sharma

Updated on: May 28, 2026

★★★★★(1 Rating)

Introduction

A person who wishes to manufacture New Drugs or any Investigational New Drugs for the purpose of Clinical Trial or Bioavailability or Bioequivalence Study, or for examination, test and analysis should mandatorily hold a permission under Form CT-11 issued by the Central Licensing Authority.

Applicable Provisions

Details	Provision
New Drugs and Clinical Trials Rules, 2019	Rule 52, 53, 54 and 55

Documents Required

1 Chemical and pharmaceutical information – as per Table 2 of the Second Schedule

2 Copy of the official registration certificate from the Central Licencing Authority

3 Prescribing information

4 Signed original on company letterhead complying with Third Schedule (Table 4) rules.

5 Official signed authorization letter on the sponsor’s letterhead

6 Copy of registration of the Ethics Committee

7 Complete study protocols, synopsis, Patient Information Sheets (PIS), and Informed Consent Forms (ICF) inclusive of necessary audio-visual setups

8 Certificate of Analysis (COA)

9 Published clinical reports in humans detailing safety, tolerability, and pharmacokinetic/pharmacodynamic traits

10 Supplementary safety and PK/PD data covering the entire intended study duration.

11 Sub-acute toxicity testing metrics covering a minimum of 14 days across at least two species

12 Comprehensive scientific justification focusing on human subject/patient safety alongside a concrete risk mitigation strategy.

Process For License

Any person who intends to manufacture a formulation as well as API of a new drug or investigation new drug for CT or BA/BE study or for examination, test and analysis shall submit application in Form CT-10 for obtaining permission from the Central Licensing Authority to manufacture such new drug along with required documents and fees as mentioned below:

Particulars	Fees
Application for permission to manufacture new drugs or investigational new drugs for clinical trial or bioavailability or bioequivalence study	5000 per product

The Central Licensing Authority shall scrutinise the Form CT-10 application and conduct any necessary enquiries. If satisfied, the authority will grant approval to manufacture new drug or investigational new drug for clinical trial or bioavailability and bioequivalence study or for examination, test and analysis in Form CT-11.

License Validity

Form CT-11 shall remain valid for a period of three (3) years from the date of its issue. Unless suspended or cancelled by the Central Licensing Authority.

Essential Requirements

After making an application for a grant of permission to manufacture a new drug or an investigational new drug for a clinical trial, or bioavailability or bioequivalence study, or for examination, test and analysis, the Permission Holder shall ensure the following conditions are met:

1 Make use of new drug manufactured under Form CT-11 only for the purposes of conducting clinical trial or bioavailability and bioequivalence study or for examination, test and analysis and no part of it shall be sold in the market or supplied to any other person or agency or institution or organization.

2 Manufacture new drugs for the purposes of clinical trial or bioavailability and bioequivalence study or for examination, test and analysis in small quantities in accordance with the provisions of these rules and at places specified in the permission and in accordance with the principles of Good Manufacturing Practices.

3 Maintain a record of new drugs manufactured and persons to whom the drugs have been supplied for clinical trial, bioavailability and bioequivalence study, or for examination, test and analysis.

4 Where a new drug manufactured for purposes of clinical trial or bioavailability or bioequivalence study or for examination, test and analysis is left over or remains unused or gets damaged, or its specified shelf life has expired or has been found to be of sub-standard quality, the same shall be destroyed, and action taken in respect thereof shall be recorded.

Suspension or cancellation

Where the Permission Holder fails to comply with any provision of the Act and Rules, the Central Licensing Authority may, after giving that person an opportunity to show cause and after affording an opportunity of being heard, by an order in writing, take one or more of the following actions, namely:

Suspend the permission for such period as considered appropriate;
Cancel the permission granted in Form CT-11.

Frequently Asked Questions (FAQ)

Anyone manufacturing new or investigational drugs for clinical trials, BA/BE studies, or testing.

Submit an application using Form CT-10 with required documents and fees.

You must destroy them and maintain a formal written record of the destruction.

You must comply with the principles of Good Manufacturing Practices (GMP).

Manufacture of New Drugs or Investigational New Drugs Approval Process in India

Introduction
A person who wishes to manufacture New Drugs or any Investigational New Drugs for the purpose of Clinical Trial or Bioavailability or Bioequivalence Study, or for examination, test and analysis should mandatorily hold a permission under Form CT-11 issued by the Central Licensing Authority.

Applicable Provisions

Details
          Provision
       
        
          New Drugs and Clinical Trials Rules, 2019
          Rule 52, 53, 54 and 55

Documents Required

1
            Chemical and pharmaceutical information - as per Table 2 of the Second Schedule

2
            Copy of the official registration certificate from the Central Licencing Authority

3
            Prescribing information

4
            Signed original on company letterhead complying with Third Schedule (Table 4) rules.

5
            Official signed authorization letter on the sponsor's letterhead

6
            Copy of registration of the Ethics Committee

7
            Complete study protocols, synopsis, Patient Information Sheets (PIS), and Informed Consent Forms (ICF) inclusive of necessary audio-visual setups

8
            Certificate of Analysis (COA)

9
            Published clinical reports in humans detailing safety, tolerability, and pharmacokinetic/pharmacodynamic traits

10
            Supplementary safety and PK/PD data covering the entire intended study duration.

11
            Sub-acute toxicity testing metrics covering a minimum of 14 days across at least two species

12
            Comprehensive scientific justification focusing on human subject/patient safety alongside a concrete risk mitigation strategy.

Process For License
Any person who intends to manufacture a formulation as well as API of a new drug or investigation new drug for CT or BA/BE study or for examination, test and analysis shall submit application in Form CT-10 for obtaining permission from the Central Licensing Authority to manufacture such new drug along with required documents and fees as mentioned below:

Particulars
          Fees
       
        
          Application for permission to manufacture new drugs or investigational new drugs for clinical trial or bioavailability or bioequivalence study
          5000 per product

License Validity

Form CT-11 shall remain valid for a period of three (3) years from the date of its issue.
    Unless suspended or cancelled by the Central Licensing Authority.

Essential Requirements
After making an application for a grant of permission to manufacture a new drug or an investigational new drug for a clinical trial, or bioavailability or bioequivalence study, or for examination, test and analysis, the Permission Holder shall ensure the following conditions are met:

1
        Make use of new drug manufactured under Form CT-11 only for the purposes of conducting clinical trial or bioavailability and bioequivalence study or for examination, test and analysis and no part of it shall be sold in the market or supplied to any other person or agency or institution or organization.

2
        Manufacture new drugs for the purposes of clinical trial or bioavailability and bioequivalence study or for examination, test and analysis in small quantities in accordance with the provisions of these rules and at places specified in the permission and in accordance with the principles of Good Manufacturing Practices.

3
        Maintain a record of new drugs manufactured and persons to whom the drugs have been supplied for clinical trial, bioavailability and bioequivalence study, or for examination, test and analysis.

4
        Where a new drug manufactured for purposes of clinical trial or bioavailability or bioequivalence study or for examination, test and analysis is left over or remains unused or gets damaged, or its specified shelf life has expired or has been found to be of sub-standard quality, the same shall be destroyed, and action taken in respect thereof shall be recorded.

Suspension or cancellation
Where the Permission Holder fails to comply with any provision of the Act and Rules, the Central Licensing Authority may, after giving that person an opportunity to show cause and after affording an opportunity of being heard, by an order in writing, take one or more of the following actions, namely:

Suspend the permission for such period as considered appropriate;
    Cancel the permission granted in Form CT-11.

Frequently Asked Questions (FAQ)

Who needs this permission?
            
        
        
            
                Anyone manufacturing new or investigational drugs for clinical trials, BA/BE studies, or testing.

How do I apply for the permission?
            
        
        
            
                Submit an application using Form CT-10 with required documents and fees.

What should I do with unused study drugs?
            
        
        
            
                You must destroy them and maintain a formal written record of the destruction.

What manufacturing standards must I follow? 
            
        
        
            
                You must comply with the principles of Good Manufacturing Practices (GMP).

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Industry Specific

Manufacture of New Drugs or Investigational New Drugs Approval Process in India

Aryan Panwar

Shatakshi Sharma

Introduction

Applicable Provisions

Documents Required

Process For License

License Validity

Essential Requirements

Suspension or cancellation

Frequently Asked Questions (FAQ)

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