Manufacture of New Drug for Sale or Distribution Approval Process in India

Aryan Panwar

Aryan Panwar

Published on: May 29, 2026

Shatakshi Sharma

Updated on: May 29, 2026

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Introduction

This procedure outlines the legal framework and compliance steps for obtaining authorisation to manufacture new drugs or formulations in India. It defines the mandatory documentation, fee structures, and application forms required by regulatory authorities to verify safety and quality standards. Once granted, the manufacturing permission remains valid subject to continuous compliance with applicable rules, provided the permission holder strictly adheres to post-marketing safety reporting and specialized product labeling rules.

Applicable Provisions

Documents Required

1. For Unapproved New Molecules:
   • General data and particulars as per the Second Schedule
   • Specific scientific data as per Table 1 of the Second Schedule
   • Reports and results of the local clinical trial
2. For Already Approved New Drug
   • Data and particulars specified in the Second Schedule
   • Data specified in Table 2 of the Second Schedule
3. For New Claims for an Existing Approved Drug
   • Data and particulars specified in the Second Schedule
   • Data specified in Table 3 of the Second Schedule
   • Results of local clinical trials.
4. Fixed Dose Combination (FDC)
   • Data and particulars specified in the Second Schedule
   • Data specified in Table 1, Table 2, or Table 3 (depending on the type of FDC)
   • Results of local clinical trials
5. Phytopharmaceutical Drugs
   • Data specified in Table 4 of the Second Schedule.
6. Treasury challan or receipt showing payment of the fee specified in the Sixth Schedule

Process For Grant of Permission

A person/organization who intends to manufacture a new drug in the form of active pharmaceutical ingredient or pharmaceutical formulation, as the case may be, for sale or distribution, shall make an application for grant of permission to the Central Licencing Authority in Form CT-21 along with relevant documents and fees as specifies below:

No fee shall be required to be paid along with the application for the manufacture of a new drug based on successful completion of clinical trials from Phase I to Phase III under these Rules in India, where a fee has already been paid by the same applicant for the conduct of such clinical trials.

Permission may be granted within 90 working days from receipt of Form CT-21 application. If the Central Licensing Authority is satisfied with the safety, quality, and relevant documents, it will grant manufacturing permission using one of two specific forms:

• Form CT-22: Issued for the manufacture of an Active Pharmaceutical Ingredient (API) for sale or distribution.
• Form CT-23: Issued for the manufacture of a finished Pharmaceutical Formulation for sale or distribution.

Validity of Permission

The Licence issued remains valid unless suspended, cancelled or surrendered, subject to compliance with conditions prescribed under New Drugs and Clinical Trials (NDCT) Rules, 2019 and Drugs and Cosmetics Rules, 1945.

Essential Requirements

After the grant of approval to manufacture a new drug in the form of active pharmaceutical ingredient or pharmaceutical formulation, for sale or for distribution in India, the Permission Holder shall ensure the following conditions are met:

1. New drugs shall conform to the specifications approved by the Central Licensing Authority
2. Labelling of the drugs shall conform to the requirements specified in the Drugs and Cosmetics Rules, 1945
3. Label on the immediate container of the drug, as well as the packing in which the container is enclosed, should contain the following warning: “WARNING: To be sold by retail on the prescription of a ……………only” which shall be in a red box.
4. As post marketing surveillance, the applicant shall submit Periodic Safety Update Reports as specified in the Fifth Schedule;
5. All reported adverse reactions related to the drug shall be intimated to the Central Licensing Authority, and regulatory action resulting from their review shall be complied with
6. No claims except those mentioned above shall be made for the drug without prior approval of the Central Licensing Authority;
7. Specimen of the carton, labels, and package insert that will be adopted for marketing the drug in the country shall be approved by the Central Licensing Authority before the drug is marketed
8. If long-term stability data submitted do not cover the proposed shelf-life of the product, the stability study shall be continued to firmly establish the shelf-life and the complete stability data shall be submitted.

Cancellation or Suspension

Where the Manufacturer 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 (FAQ)

Who needs to file an application in Form CT-21?

Any person or organisation intending to manufacture an Active Pharmaceutical Ingredient (API) or a finished pharmaceutical formulation for sale or distribution.

Are there any exemptions for paying the CT-21 application fee?

Yes, no fee is required if the applicant has already paid for and successfully completed Phase I to Phase III clinical trials for that drug in India.

Which approval forms are issued by the Central Licensing Authority (CLA)?

Form CT-22 is issued for manufacturing an API, and Form CT-23 is issued for manufacturing a finished formulation.

Are manufacturers required to track drug safety after launch?

Yes, the permission holder must submit Periodic Safety Update Reports (PSUR) as post-marketing surveillance and report all adverse reactions to the CLA.

Manufacture of New Drug for Sale or Distribution Approval Process in India Introduction This procedure outlines the legal framework and compliance steps for obtaining authorisation to manufacture new drugs or formulations in India. It defines the mandatory documentation, fee structures, and application forms required by regulatory authorities to verify safety and quality standards. Once granted, the manufacturing permission remains valid subject to continuous compliance with applicable rules, provided the permission holder strictly adheres to post-marketing safety reporting and specialized product labeling rules. Applicable Provisions Details Provision New Drugs and Clinical Trials Rules, 2019 Rule 80, 81, 82 and 84 Documents Required For Unapproved New Molecules: General data and particulars as per the Second Schedule Specific scientific data as per Table 1 of the Second Schedule Reports and results of the local clinical trial For Already Approved New Drug Data and particulars specified in the Second Schedule Data specified in Table 2 of the Second Schedule For New Claims for an Existing Approved Drug Data and particulars specified in the Second Schedule Data specified in Table 3 of the Second Schedule Results of local clinical trials. Fixed Dose Combination (FDC) Data and particulars specified in the Second Schedule Data specified in Table 1, Table 2, or Table 3 (depending on the type of FDC) Results of local clinical trials Phytopharmaceutical Drugs Data specified in Table 4 of the Second Schedule. Treasury challan or receipt showing payment of the fee specified in the Sixth Schedule Process For Grant of Permission A person/organization who intends to manufacture a new drug in the form of active pharmaceutical ingredient or pharmaceutical formulation, as the case may be, for sale or distribution, shall make an application for grant of permission to the Central Licencing Authority in Form CT-21 along with relevant documents and fees as specifies below: Particulars Fees Application for permission to manufacture fixed dose combination having approved ingredients for sale or distribution 3,00,000 Application for permission to manufacture fixed dose combination already approved for sale or distribution 2,00,000 Application for permission to manufacture fixed dose combination for new claims, new indication or new dosage form or new route of administration or new strength for sale or distribution 3,00,000 Application for permission to manufacture new drug (Active Pharmaceutical Ingredient) or to manufacture finished formulation 5,00,000 Permission to manufacture new drug for sale or distribution 50,000 No fee shall be required to be paid along with the application for the manufacture of a new drug based on successful completion of clinical trials from Phase I to Phase III under these Rules in India, where a fee has already been paid by the same applicant for the conduct of such clinical trials. Permission may be granted within 90 working days from receipt of Form CT-21 application. If the Central Licensing Authority is satisfied with the safety, quality, and relevant documents, it will grant manufacturing permission using one of two specific forms: Form CT-22: Issued for the manufacture of an Active Pharmaceutical Ingredient (API) for sale or distribution. Form CT-23: Issued for the manufacture of a finished Pharmaceutical Formulation for sale or distribution. Validity of Permission The Licence issued remains valid unless suspended, cancelled or surrendered, subject to compliance with conditions prescribed under New Drugs and Clinical Trials (NDCT) Rules, 2019 and Drugs and Cosmetics Rules, 1945. Essential Requirements After the grant of approval to manufacture a new drug in the form of active pharmaceutical ingredient or pharmaceutical formulation, for sale or for distribution in India, the Permission Holder shall ensure the following conditions are met: New drugs shall conform to the specifications approved by the Central Licensing Authority Labelling of the drugs shall conform to the requirements specified in the Drugs and Cosmetics Rules, 1945 Label on the immediate container of the drug, as well as the packing in which the container is enclosed, should contain the following warning: "WARNING: To be sold by retail on the prescription of a ……………only" which shall be in a red box. As post marketing surveillance, the applicant shall submit Periodic Safety Update Reports as specified in the Fifth Schedule; All reported adverse reactions related to the drug shall be intimated to the Central Licensing Authority, and regulatory action resulting from their review shall be complied with No claims except those mentioned above shall be made for the drug without prior approval of the Central Licensing Authority; Specimen of the carton, labels, and package insert that will be adopted for marketing the drug in the country shall be approved by the Central Licensing Authority before the drug is marketed If long-term stability data submitted do not cover the proposed shelf-life of the product, the stability study shall be continued to firmly establish the shelf-life and the complete stability data shall be submitted. Cancellation or Suspension Where the Manufacturer 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 (FAQ) Who needs to file an application in Form CT-21? Any person or organisation intending to manufacture an Active Pharmaceutical Ingredient (API) or a finished pharmaceutical formulation for sale or distribution. Are there any exemptions for paying the CT-21 application fee? Yes, no fee is required if the applicant has already paid for and successfully completed Phase I to Phase III clinical trials for that drug in India. Which approval forms are issued by the Central Licensing Authority (CLA)? Form CT-22 is issued for manufacturing an API, and Form CT-23 is issued for manufacturing a finished formulation. Are manufacturers required to track drug safety after launch? Yes, the permission holder must submit Periodic Safety Update Reports (PSUR) as post-marketing surveillance and report all adverse reactions to the CLA.