Last Updated on March 13, 2025 by The Health Master
Export NOC
The Indian pharmaceutical sector just got a significant boost, courtesy of the Central Drugs Standard Control Organisation (CDSCO) regarding the Export NOC.
In a move designed to drastically reduce the administrative burden on pharmaceutical companies, the CDSCO has unveiled a new system for issuing Export No Objection Certificates (Export NOC), granting approvals for a full year under specific conditions.
This initiative, coupled with a simplified one-time registration process, promises to streamline exports and accelerate the industry’s growth.
Easing the Compliance Burden
Dr. Rajeev Singh Raghuvanshi, Drugs Controller General (India), announced the implementation of the one-year NOC system, emphasizing its role in alleviating the regulatory load on pharma companies.
“Further to reduce the compliance burden, CDSCO has initiated the issue of a 1-year NOC, subject to prescribed conditions for such drugs,” he stated in a public notice dated 07-03-2025.
CDSCO’s notice dated 07-03-2025 is detailed with the Export NOC Guidance and User Manual.
Simplified Registration and Application Process
To facilitate this new system, the CDSCO has introduced a one-time Integrated Registration Form (IRF) that applicants must complete at their respective zonal offices.
This single registration, valid for a year, eliminates the need for repeated applications for each export consignment, significantly reducing paperwork and processing time.
The CDSCO has also updated the checklist on the Sugam portal, ensuring a transparent and straightforward application process.
Applications for export NOC, including unapproved and approved new drugs, are now submitted through the Sugam portal along with the required documents.
Key Features of the New System:
- One-Year NOCs: Approvals are now granted for a year, subject to conditions, reducing the frequency of applications.
- One-Time Registration: The IRF, valid for a year, simplifies the registration process.
- Streamlined Sugam Portal: The revised checklist on the Sugam portal ensures a clear and efficient application process.
- Reduced NOC Volume: The CDSCO anticipates a reduction in the number of NOCs issued annually to around 5,000 or less.
- Faster Processing: Zonal offices are mandated to verify the IRF and issue NOCs within seven working days.
- Dynamic Details Submission: Companies must submit real-time data at port offices, including export NOC, reconciliation details, test certificates, and purchase order/shipping details.
- Narcotic Drugs and Psychotropic Substances (NDPS) Exception: Quantity-specific and purchase order-specific NOCs will continue for NDPS drugs.
- Shelf Life Considerations: Un-exported quantities can be exported in subsequent orders if the remaining shelf life is above 60%; otherwise, destruction under the State Licensing Authority is required.
Detailed Application Requirements:
- Completed Export NOC form.
- Legal undertaking from the manufacturer that the new drug is solely for export.
- Copy of the manufacturing license.
- Reconciliation details.
- Approval status in the importing country.
- Dynamic documents for port submission.
Impact and Benefits:
This initiative is expected to have a profound impact on the Indian pharmaceutical export landscape.
By reducing the compliance burden, the CDSCO is fostering a more conducive environment for growth and innovation.
The streamlined process will enable companies to focus on manufacturing and exporting high-quality drugs, contributing to the nation’s economic development.
Table of Key Changes:
| Feature | Old System | New System |
|---|---|---|
| NOC Validity | Consignment Specific | One Year (Subject to Conditions) |
| Registration | Multiple Registrations | One-Time IRF (Valid for One Year) |
| Application Process | Variable | Streamlined Sugam Portal |
| NDPS Drugs | Existing Guidelines | Existing Guidelines Maintained |
| Processing Time | Variable | 7 Working Days (IRF Verification) |
Q: What is the purpose of the new Export NOC system by CDSCO?
A: The purpose is to reduce the compliance burden on pharmaceutical companies by issuing one-year NOCs and simplifying the registration process.
Q: How does the one-time registration process work?
A: Applicants must fill out the Integrated Registration Form (IRF) once at their zonal CDSCO office. This registration is valid for one year.
Q: What documents are required for the export NOC application?
A: Documents include the export NOC form, legal undertaking, manufacturing license copy, reconciliation details, and approval status in the importing country.
Q: Are there any exceptions to the one-year NOC system?
A: Yes, Narcotic Drugs and Psychotropic Substances (NDPS) require quantity-specific and purchase order-specific NOCs.
Q: What happens to un-exported quantities of drugs?
A: If the remaining shelf life is above 60%, they can be exported in subsequent orders; otherwise, they must be destroyed.
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.
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