Food and Drugs Administration, (FDA) Haryana, India. |
Email ID: dahiya19@yahoo.com
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Last Updated on August 16, 2025 by The Health Master
Dual Use NOC
The Central Drugs Standard Control Organization (CDSCO) has launched a new online system for Dual Use NOC on its SUGAM Portal to enhance the “ease of doing business” (EoDB).
The CDSCO has issued an important circular on 01-08-2025, having the details of the online process of obtaining a No Objection Certificate (NOC) for drugs imported in bulk for non-medicinal purposes.
The new online system, which becomes fully functional from August 31, 2025, is set to decrease the compliance burdens and enhance transparency in the regulatory process.
The Importance of Dual Use NOC
The regulation of “Dual Use” substances is critical for public health and safety.
These are drugs that, while having a mainly medicinal purpose, are also used in industries such as pharmaceuticals, food, and non-medicinal applications.
The new system provides clear guidance and a transparent process for importers, which ensures that all substances imported for non-medicinal use are fully in compliance with all regulatory requirements described under Schedule D of the Drugs and Cosmetics Rules, 1945.
The new system is having a two-step procedure, reducing the third-party interference and improving efficiency.
A Step-by-Step Guide
The new online system simplifies the NOC application, divided into two distinct phases, both managed through the SUGAM online portal.
Phase I:
Zonal/Sub-Zonal Office Application:
- This initial phase I is used for the registration and obtaining a one-year Dual Use NOC.
- Applicants must first register on the SUGAM portal and select the “Dual Use NOC” user role.
- The application, along with a set of mandatory documents, will be submitted.
- This application will be reviewed and verified by the officers of CDSCO Headquarters and the relevant zonal or sub-zonal office.
Mandatory Documents for Registration (Phase I):
- Address Proof: For address proof, a government-issued document is required, i.e., a Certificate of Incorporation, GST Certificate, or IEC Certificate. The details on this document must match exactly with the details submitted on the portal.
- Undertaking: A duly filled, signed, and stamped undertaking form is required.
- ID Proof of Authorized Person: A valid ID proof for the authorized person is mandatory.
Phase II:
Port Office Consignment Release
- After approval of a one-year NOC in Phase I, the applicant can proceed to Phase II for the release of specific consignments at the port of entry.
- Some documents are required to be submitted on the online portal, which are to be verified by the officers of the concerned port office at the time of import of the substance.
Required Documents for Consignment Release (Phase II):
- Covering Letter: A letter outlining the purpose, drug name, quantity, and manufacturer’s details.
- Certificate of Analysis (CoA): The firm must upload the CoA document.
- Bill of Entry Details: The bill of entry number, date, customer name, country, and quantity must be filled out in the specified format.
- Label and Invoice: The original product label and purchase invoice are mandatory.
Key points for Importers
Applicants/importers must keep in mind the following several key points:
- Timely Application: It is advised that Dual Use NOC clearance be applied for at least two months before import to avoid any delays.
- Clear Labeling: Imported items and all accompanying documents, such as the Certificate of Analysis and Bill of Entry, must clearly state “Not for Medicinal Use” or “for use as pharma aid.”
- Ineligible Imports: The new system is not applicable for imports intended for purification or sterilization.
- Jurisdiction: The application must be filed with respect to the actual importer’s address and not that of the Custom House Agent (CHA).
Q: Who can apply for a Dual Use NOC on the new portal?
A: From September 1, 2025, only users who are registered and approved by the CDSCO as Dual Use NOC Traders/Actual Manufacturers will be able to apply.
Q: How long is the Dual Use NOC valid for?
A: The NOC is valid for one year.
Compiled by:
Rakesh Dahiya, Asstt. State Drugs Controller, FDA Haryana
Disclaimer: This article contains information obtained from the source mentioned below. Our team made changes in the format to rewrite and present the news or article in a unique format.
