CDSCO Notifies New Online Export NOC System

Indian drug regulatory, CDSCO has notified the new online Export NOC system for Unapproved Drugs / Unapproved New Drugs. As per the new system application for Export NOC shall be submitted online through CDSCOs Sugam portal @ https://cdscoonline.gov.in/. CDSCO has issued new guidance document with templates for documents to be submitted for export NOC applications through the Sugam portal.

Manufacturers holding valid license in Form 25, Form 28 or Form 28D can obtain No Objection Certificates (NOCs) for manufacture of Unapproved Drugs / Approved New Drugs for Export purposes from Zonal offices of the CDSCO

Easing of Compliance Burden

With the new Export NOC system, Quantity-Specific and Purchase Order (PO)-Specific NOCs have been discontinued. Instead, Export NOCs will now be issued with a one-year validity from the date of registration. The new system also allows unused quantities from previous export orders to be utilized for subsequent orders. Under the new system, Export NOCs will be processed within seven working days from registration.

According to the CDSCO notification, these changes aim to reduce the compliance burden on applicants and streamline the process.

Application Process

Applicants must complete a one-time registration through the Integrated Registration Form (IRF) and submit the following documents:

• Export NOC Form / Integrated Registration Form (IRF)
• Legal Undertaking by 1) Bulk Drug (API) Manufacturer), 2) Formulation Manufacturer as applicable. (Should be submitted in a Rs.100 /- non judicial stamp paper).
• Copy of valid Manufacturing License
• Product Reconciliation details (for previously issued Export NOCs)
• Document showing approval status of the product in the importing country
• While submitting the Form an applicant can select multiple countries under option for selecting countries where the drug will b exported.

Export Process

When exporting the drug, the applicant must submit relevant documents via the online portal for release of consignment clearance at the port. Required documents include:

• Valid Export NOC
• Reconciliation details for Quantity manufactured, exported
• Batch release certificate /COA
• Purchase Order (PO) copy / Export Invoice / Shipping bill

The port office will verify these documents before clearing the consignment.

The new Export NOC system replaces the older process where companies had to submit applications along with purchase orders (POs), and NOCs were issued only for specific POs and quantities. The updated process offers greater flexibility, reduces delays, and simplifies compliance for exporters.

CDSCO Notification and Guidance for New Online System for Export NOC (March 2025)