Procedure to Obtain Export No Objection Certificate (NOC) for Manufacture and Export of Unapproved or Approved New Drugs in India

Deepti Mudgal

Deepti Mudgal

Published on: Mar 31, 2026

Shatakshi Sharma

Updated on: Mar 31, 2026

★★★★★(1 Rating)

18

Introduction

An Export NOC is a legal permission from the Central Drugs Standard Control Organization (CDSCO) which allows the Indian manufacturers to export drugs that are not approved for the domestic market, ensuring they meet the quality standards, preventing misuse, and complying with regulations.

APPLICABLE PROVISIONS

Section 94 of the Drugs Rules, 1945 and Guidance Document for Issuance of No Objection Certificate for Manufacture of Unapproved/Approved New Drugs for Export Purpose

WHO CAN APPLY?

A manufacturer holding a valid license copy in Form-25/ Form-28/ Form 28D and their respective loan licenses can obtain Export No Objection Certificate (NOC) for Manufacture and Export of Unapproved or Approved New Drugs in India.

DOCUMENTS REQUIRED

1. Covering Letter
2. Valid Manufacturing License
3. List of products to be exported
4. Name of the drug
5. Whether the batch to be exported will undergo Quality Control Testing at Manufacturing site and/or will be tested at the destined site
6. Dosage form
7. Composition and strength
8. Quantity
9. Country/Countries to be exported
10. Place of manufacturing
11. Name & address of the firm
12. Copy of valid Purchase order/valid Export order /Performa invoice shall include following details:
    • From foreign buyer in the name of Manufacturer/in the name of trader duly signed by Competent Authority/Authorized Signatory.
    • If in the name of trader (Letter from trader in the name of Manufacturer along valid Purchase Order No. in favor the Manufacturer by Trader) required to be submitted along with application signed by the Competent authority/Authorized Signatory of the Manufacturer
    • Self-attested and recent order not more than 6 months prior to application made by the firm.
    • Proforma Invoice/Purchase Order of importing country should include details of Unapproved Drug/approved new drug/Banned drug.
    • Should be addressed to the manufacturer, mentioning the required quantity of drugs.

PROCEDURE

The manufacturer holding a valid license in Form-25, Form-28, or Form-28D, along with their respective loan licenses, shall submit an online application for issuance of a No Objection Certificate (NOC) to the Zonal Offices of the Central Drugs Standard Control Organisation (CDSCO) for the manufacture and export of unapproved or approved new drugs in India, which involves the following steps:

1. Registration and submission of the application at the respective Central Drugs Standard Control Organisation (CDSCO) Zonal Office, and
2. Evaluation of the application and documents by the Zonal Office, including verification of product details, manufacturing site, and quality control provisions.
3. Coordination with the CDSCO Port Office for the release of consignments, if applicable, through the Consignment Export Release Order (CERO) or other port clearance procedures.
4. Upon satisfactory evaluation, the Export NOC will be issued by the CDSCO Zonal Office.

VALIDITY

The Export No Objection Certificate (NOC) for the manufacture and export of unapproved or approved new drugs in India is valid for one (1) year from the date of issue.

PROCESS OF RENEWAL

Applicant shall file a fresh application through the CDSCO Sugam portal for a subsequent one (1) year Export No Objection Certificate before expiry of the existing certificate, along with updated documentation and applicable fees.