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

Aryan Panwar

Aryan Panwar

Published on: Jun 1, 2026

Shatakshi Sharma

Updated on: Jun 1, 2026

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20

Introduction

Person/organization having a valid drug manufacturing license for any drug issued under the Drugs and Cosmetics Act, 1940 and Rules, 1945 can file an application for grant of permission to import new drugs for sale or distribution

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 New Drugs Already Approved in India:
   • General data and particulars as per the Second Schedule
   • Specific scientific data as per Table 2 of the Second Schedule
3. For Approved New Drugs Proposed for New Claim, New Indication, New Dosage Form, New Route or New Strength.
   • General data and particulars as per the Second Schedule.
   • Specific scientific data as per Table 2 of the Second Schedule.
4. For Fixed Dose Combinations (FDCs)
   • General data and particulars as per the Second Schedule
   • Relevant data from Table 1, 2, or 3 of the Second Schedule (based on the type of FDC)
   • Reports and results of the local clinical trial (if applicable)
5. For Phyto-pharmaceutical Drugs:
   Specific botanical and scientific data as per Table 4 of the Second Schedule
6. Treasury challan or receipt showing payment of the fee specified in the Sixth Schedule

Process For Permission

A person who intends to import a new drug in the form of an active pharmaceutical ingredient or a pharmaceutical formulation, as the case may be, for sale or for distribution in India, shall make an application to obtain permission from the Central Licensing Authority in Form CT-18 along with required documents and fees as specified below:

The Central Licensing Authority shall scrutinise the Form CT-18 application and conduct any necessary enquiries. If satisfied, the authority will grant import permission within 90 working days from receiving the application in the following forms:

• Form CT-19 for active pharmaceutical ingredients or
• Form CT-20 for pharmaceutical formulations intended for sale or distribution.

Validity of Permission

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

Essential Requirements

After the grant of approval to import a new drug in the form of an active pharmaceutical ingredient or a pharmaceutical formulation, as the case may be, 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. In case of import, each consignment shall be accompanied by a test or analysis report;
9. 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 importer 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.