CDSCO's New Export NOC Rules 2025

CDSCO's New Export NOC Rules 2025 . The Central Drugs Standard Control Organisation (CDSCO), India's national regulatory body for pharmaceuticals and medical devices, has introduced a significant reform in its export No Objection Certificate (NOC) guidelines. The updated rules titled "CDSCO's New Export NOC Rules 2025" bring clarity, uniformity, and efficiency to the export process for unapproved and approved new drugs meant solely for export. These changes, which came into effect from May 15, 2025, were made after a year-long effort to centralize the NOC issuance process. The updated regulations are expected to benefit exporters by reducing bureaucracy and enhancing compliance. In this article, we take a detailed look at the new rules, their impact, and the rationale behind the reform.
Why Did CDSCO Revise the Export NOC Rules?
The CDSCO decided to revise the export NOC rules to improve oversight and compliance in drug exportation. Earlier, the power to issue export NOCs was vested in State and Union Territory Licensing Authorities. However, this led to inconsistencies, delays, and compliance issues.
To streamline the process, CDSCO withdrew the powers delegated to State authorities on May 15, 2024. From that date onwards, only the CDSCO, through its zonal offices, has the authority to issue NOCs. This shift to a centralized system ensures uniformity and prevents regulatory loopholes.
Moreover, CDSCO instructed all State and UT Licensing Authorities to hand over previously issued export NOCs (from August 20, 2018, to May 14, 2024) to the respective zonal offices. This move strengthens central oversight and minimizes risks associated with fragmented regulation.
CDSCO Revises Guidelines for Issuance of Export NOC for Unapproved, Approved New Drugs
Under the updated rules, both unapproved and approved new drugs manufactured for export are covered. These include drugs that have not yet received marketing approval in India but are required by other countries under their regulatory frameworks. The new guidelines clearly differentiate between categories of drugs and specify when special conditions apply. For example, stringent rules still apply to Narcotic Drugs and Psychotropic Substances (NDPS) and banned drugs, which require quantity-specific and purchase order-specific NOCs.
Main Highlights of CDSCO's New Export NOC Rules 2025
Let us now explore the major changes introduced under CDSCO's New Export NOC Rules 2025, each explained in detail.
One-Year Validity of Export NOC
One of the most important changes is the introduction of a one-year validity for export NOCs. Previously, companies had to apply frequently for renewals, which created administrative burdens and uncertainties. Now, once an export NOC is issued, it remains valid for one year from the date of registration or until the sanctioned export quantity is exhausted—whichever occurs first. This change provides greater predictability and helps exporters plan better.
Seven-Day Timeline for NOC Issuance
To reduce delays, CDSCO has fixed a seven-day timeline for the issuance of export NOCs. This change is particularly beneficial for exporters who often face tight deadlines and logistical constraints. By mandating a clear timeline, the new rules ensure timely processing of applications and enhance India's credibility as a reliable exporter of pharmaceutical products.
Two-Step Application Process
CDSCO has simplified the application process into two major steps:
Step 1: One-Time Online Registration
Exporters must submit the following documents:

Export NOC application form (Integrated Registration Form)

Legal undertakings

Manufacturing license copy

Reconciliation data

Approval status from the National Regulatory Authority (NRA) of the importing country

Separate sets of documents are required depending on whether the drug is an API (Active Pharmaceutical Ingredient), finished formulation, R&D product, or new chemical entity.
Step 2: Consignment Release at Port Office
Once registered, companies need to submit relevant documents online for each consignment at the port office during actual shipment. This online process eliminates manual handling and ensures traceability of the consignment.
Discontinuation of Quantity-Specific and PO-Specific NOCs (With Exceptions)
Under the new rules, quantity-specific and purchase-order-specific NOCs are no longer required for most categories of drugs. This means that exporters do not have to apply for a fresh NOC every time a new purchase order is received. However, for Narcotic Drugs and Psychotropic Substances (NDPS) and banned drugs, the previous system continues. Each order or consignment must be supported by a separate, quantity-specific NOC, ensuring strict monitoring and compliance for sensitive substances.
Shelf Life and Usage Conditions for Leftover Stock
The rules also address what happens to unexported drug stock:
For Finished Formulations
If the leftover quantity has more than 60% residual shelf life, it can be used for the next export order. If it has less than 60% shelf life, the remaining stock must be destroyed in the presence of the State Licensing Authority (SLA).
For APIs:
If the leftover quantity has at least 3 months of residual shelf life, it can be used for another export. If it falls below 3 months, it must be destroyed in the presence of the SLA.
This ensures that expired or nearly-expired drugs are not exported, maintaining the integrity and safety of Indian pharmaceutical exports.
Updated Legal Undertakings for APIs and Formulations
The revised guidelines also include changes to the legal undertakings required during application.
For APIs
Companies must commit to submitting labels as per Rule 94 of the Drugs and Cosmetics Act, 1940. Any falsification of documents will lead to cancellation of the NOC, and the company will be barred from reapplying for one year. Companies must also commit to destroy leftover stock with less than 3 months' shelf life within a specified timeline.
For Finished Formulations
Similar undertakings are required, with added emphasis on destroying stocks with less than 60% residual shelf life. Companies (like Private Limited Company, Public Limited Company, LLP, etc.) must submit appropriate labeling under Rule 94. Falsified submissions will result in NOC cancellation and a one-year ban on applications for all products. These measures aim to hold manufacturers accountable and ensure adherence to high regulatory standards.
Use of Sugam Portal for Online Applications
All applications for export NOC must now be submitted through the Sugam Portal, the central digital platform of CDSCO. This move aligns with the Union Health Ministry’s direction to simplify and digitize the application process. Manufacturers are now required to complete their NOC application before obtaining a manufacturing license from the State Licensing Authority. This ensures alignment between export permissions and manufacturing approvals.
Background of the Policy Shift
The policy change was initiated based on a communication from the Union Health Ministry in June 2023, following a proposal from CDSCO. The Ministry emphasized the need for a centralized, online, single-point-of-contact system for the issuance of NOCs for unapproved, banned, or new drugs meant for export. The Drugs Controller General of India (DCGI), Dr. Rajeev Singh Raghuvanshi, accordingly issued a notice on April 30, 2024, stating that from May 15, 2024, NOCs can only be obtained through zonal offices via the online Sugam portal.
This replaced the earlier system based on the DCGI’s notification dated August 2, 2018, which had empowered State Licensing Authorities to issue such NOCs.
Role of Drugs Consultative Committee (DCC) in the Reform
The Drugs Consultative Committee (DCC) played an important role in evaluating the pros and cons of the new system. In 2024, the DCC recommended forming a sub-committee to examine the industry’s proposal for a one-time export NOC and manufacturing license for unapproved or new drugs meant solely for export. The industry also requested relaxation of destruction norms for excess stock, highlighting the economic losses incurred due to destruction. The DCC took note of these concerns and advised that further recommendations be made after stakeholder consultations.
Impact on the Pharmaceutical Industry
The new NOC rules are poised to bring about positive changes for both exporters and regulators:

For Exporters:

Reduced paperwork

Faster approvals

Better planning through extended NOC validity

Simplified online process via Sugam Portal

For CDSCO:

Centralized control for better compliance

Uniform application of standards

Easier monitoring and accountability

These changes collectively boost India’s position as a global pharmaceutical supplier, promoting trust among international stakeholders.
Conclusion
The overhaul of the export NOC procedure under CDSCO's New Export NOC Rules 2025 represents a milestone in India’s regulatory sector. By shifting to a centralized, transparent, and time-bound system, CDSCO ensures both ease of doing business and regulatory stringency. Manufacturers of unapproved, banned, or new drugs intended solely for export must now follow a unified application procedure through the Sugam Portal, backed by proper documentation and compliance commitments.
While challenges such as destruction rules for excess inventory remain under discussion, the framework introduced is expected to streamline operations, reduce costs, and uphold high quality and safety standards for Indian pharmaceutical exports.
If you need any support in CDSCO Registration or issuance of export NOC, feel free to connect with us through mail at info@ccoffice.in or Call/Whatsapp at +91 9988424211.
FAQs
Q1. What is the purpose of CDSCO's New Export NOC Rules 2025?
Ans. CDSCO's New Export NOC Rules 2025 aim to centralize and streamline the process of obtaining export No Objection Certificates for unapproved and approved new drugs. The new rules are designed to ensure regulatory uniformity, faster approvals, and improved compliance for pharmaceutical exports.
Q2. Who can issue export NOCs under the new rules?
Ans. As per the new guidelines, only the Central Drugs Standard Control Organisation (CDSCO) through its zonal offices is authorized to issue export NOCs. This authority was earlier with State and Union Territory Licensing Authorities but was withdrawn from May 15, 2024.
Q3. What is the validity period of the new export NOC?
Ans. The export NOC issued under CDSCO's New Export NOC Rules 2025 is valid for one year from the date of registration or until the sanctioned quantity is fully utilized, whichever occurs earlier.
Q4. What is the timeline for the issuance of an export NOC?
Ans. CDSCO has fixed a timeline of seven days from the date of application submission for the issuance of an export NOC. This time-bound processing helps in reducing delays and enhances export efficiency.
Q5. Are quantity-specific or purchase-order-specific NOCs still required?
Ans. Under the new rules, quantity-specific and purchase-order-specific NOCs have been discontinued for most drugs. However, they are still required for Narcotic Drugs, Psychotropic Substances (NDPS), and banned drugs to maintain strict regulatory oversight.
Q6. What happens to leftover drug stock that is not exported?
Ans. For finished formulations with more than 60% residual shelf life, the stock can be reused for the next export. If shelf life is below 60%, it must be destroyed in presence of the State Licensing Authority. For APIs, the reuse threshold is a minimum of three months' residual shelf life.
Q7. What are the consequences of submitting falsified documents during the NOC application?
Ans. If any company submits falsified documents, the issued NOC will be cancelled, and the company will be barred from reapplying for an export NOC for a period of one year. This applies to both APIs and finished formulations.
Q8. Is it mandatory to use the Sugam Portal for NOC applications?
Ans. Yes, all applications for export NOC must be submitted through the Sugam Portal. This portal serves as the central digital platform for registration and documentation, ensuring transparency and ease of access for applicants.

The Central Drugs Standard Control Organisation (CDSCO), India's national regulatory body for pharmaceuticals and medical devices, has introduced a significant reform in its export No Objection Certificate (NOC) guidelines. The updated rules titled "CDSCO's New Export NOC Rules 2025" bring clarity, uniformity, and efficiency to the export process for unapproved and approved new drugs meant solely for export. These changes, which came into effect from May 15, 2025, were made after a year-long effort to centralize the NOC issuance process. The updated regulations are expected to benefit exporters by reducing bureaucracy and enhancing compliance. In this article, we take a detailed look at the new rules, their impact, and the rationale behind the reform.

Why Did CDSCO Revise the Export NOC Rules?

The CDSCO decided to revise the export NOC rules to improve oversight and compliance in drug exportation. Earlier, the power to issue export NOCs was vested in State and Union Territory Licensing Authorities. However, this led to inconsistencies, delays, and compliance issues.

To streamline the process, CDSCO withdrew the powers delegated to State authorities on May 15, 2024. From that date onwards, only the CDSCO, through its zonal offices, has the authority to issue NOCs. This shift to a centralized system ensures uniformity and prevents regulatory loopholes.

Moreover, CDSCO instructed all State and UT Licensing Authorities to hand over previously issued export NOCs (from August 20, 2018, to May 14, 2024) to the respective zonal offices. This move strengthens central oversight and minimizes risks associated with fragmented regulation.

CDSCO Revises Guidelines for Issuance of Export NOC for Unapproved, Approved New Drugs

Under the updated rules, both unapproved and approved new drugs manufactured for export are covered. These include drugs that have not yet received marketing approval in India but are required by other countries under their regulatory frameworks. The new guidelines clearly differentiate between categories of drugs and specify when special conditions apply. For example, stringent rules still apply to Narcotic Drugs and Psychotropic Substances (NDPS) and banned drugs, which require quantity-specific and purchase order-specific NOCs.

Main Highlights of CDSCO's New Export NOC Rules 2025

Let us now explore the major changes introduced under CDSCO's New Export NOC Rules 2025, each explained in detail.

One-Year Validity of Export NOC

One of the most important changes is the introduction of a one-year validity for export NOCs. Previously, companies had to apply frequently for renewals, which created administrative burdens and uncertainties. Now, once an export NOC is issued, it remains valid for one year from the date of registration or until the sanctioned export quantity is exhausted—whichever occurs first. This change provides greater predictability and helps exporters plan better.

Seven-Day Timeline for NOC Issuance

To reduce delays, CDSCO has fixed a seven-day timeline for the issuance of export NOCs. This change is particularly beneficial for exporters who often face tight deadlines and logistical constraints. By mandating a clear timeline, the new rules ensure timely processing of applications and enhance India's credibility as a reliable exporter of pharmaceutical products.

Two-Step Application Process

CDSCO has simplified the application process into two major steps:

Step 1: One-Time Online Registration

Exporters must submit the following documents:

Export NOC application form (Integrated Registration Form)
Legal undertakings
Manufacturing license copy
Reconciliation data
Approval status from the National Regulatory Authority (NRA) of the importing country

Separate sets of documents are required depending on whether the drug is an API (Active Pharmaceutical Ingredient), finished formulation, R&D product, or new chemical entity.

Step 2: Consignment Release at Port Office

Once registered, companies need to submit relevant documents online for each consignment at the port office during actual shipment. This online process eliminates manual handling and ensures traceability of the consignment.

Discontinuation of Quantity-Specific and PO-Specific NOCs (With Exceptions)

Under the new rules, quantity-specific and purchase-order-specific NOCs are no longer required for most categories of drugs. This means that exporters do not have to apply for a fresh NOC every time a new purchase order is received. However, for Narcotic Drugs and Psychotropic Substances (NDPS) and banned drugs, the previous system continues. Each order or consignment must be supported by a separate, quantity-specific NOC, ensuring strict monitoring and compliance for sensitive substances.

Shelf Life and Usage Conditions for Leftover Stock

The rules also address what happens to unexported drug stock:

For Finished Formulations

If the leftover quantity has more than 60% residual shelf life, it can be used for the next export order. If it has less than 60% shelf life, the remaining stock must be destroyed in the presence of the State Licensing Authority (SLA).

For APIs:

If the leftover quantity has at least 3 months of residual shelf life, it can be used for another export. If it falls below 3 months, it must be destroyed in the presence of the SLA.

This ensures that expired or nearly-expired drugs are not exported, maintaining the integrity and safety of Indian pharmaceutical exports.

Updated Legal Undertakings for APIs and Formulations

The revised guidelines also include changes to the legal undertakings required during application.

For APIs

Companies must commit to submitting labels as per Rule 94 of the Drugs and Cosmetics Act, 1940. Any falsification of documents will lead to cancellation of the NOC, and the company will be barred from reapplying for one year. Companies must also commit to destroy leftover stock with less than 3 months' shelf life within a specified timeline.

For Finished Formulations

Similar undertakings are required, with added emphasis on destroying stocks with less than 60% residual shelf life. Companies (like Private Limited Company, Public Limited Company, LLP, etc.) must submit appropriate labeling under Rule 94. Falsified submissions will result in NOC cancellation and a one-year ban on applications for all products. These measures aim to hold manufacturers accountable and ensure adherence to high regulatory standards.

Use of Sugam Portal for Online Applications

All applications for export NOC must now be submitted through the Sugam Portal, the central digital platform of CDSCO. This move aligns with the Union Health Ministry’s direction to simplify and digitize the application process. Manufacturers are now required to complete their NOC application before obtaining a manufacturing license from the State Licensing Authority. This ensures alignment between export permissions and manufacturing approvals.

Background of the Policy Shift

The policy change was initiated based on a communication from the Union Health Ministry in June 2023, following a proposal from CDSCO. The Ministry emphasized the need for a centralized, online, single-point-of-contact system for the issuance of NOCs for unapproved, banned, or new drugs meant for export. The Drugs Controller General of India (DCGI), Dr. Rajeev Singh Raghuvanshi, accordingly issued a notice on April 30, 2024, stating that from May 15, 2024, NOCs can only be obtained through zonal offices via the online Sugam portal.

This replaced the earlier system based on the DCGI’s notification dated August 2, 2018, which had empowered State Licensing Authorities to issue such NOCs.

Role of Drugs Consultative Committee (DCC) in the Reform

The Drugs Consultative Committee (DCC) played an important role in evaluating the pros and cons of the new system. In 2024, the DCC recommended forming a sub-committee to examine the industry’s proposal for a one-time export NOC and manufacturing license for unapproved or new drugs meant solely for export. The industry also requested relaxation of destruction norms for excess stock, highlighting the economic losses incurred due to destruction. The DCC took note of these concerns and advised that further recommendations be made after stakeholder consultations.

Impact on the Pharmaceutical Industry

The new NOC rules are poised to bring about positive changes for both exporters and regulators:

For Exporters:

Reduced paperwork
Faster approvals
Better planning through extended NOC validity
Simplified online process via Sugam Portal

For CDSCO:

Centralized control for better compliance
Uniform application of standards
Easier monitoring and accountability

These changes collectively boost India’s position as a global pharmaceutical supplier, promoting trust among international stakeholders.

Conclusion

The overhaul of the export NOC procedure under CDSCO's New Export NOC Rules 2025 represents a milestone in India’s regulatory sector. By shifting to a centralized, transparent, and time-bound system, CDSCO ensures both ease of doing business and regulatory stringency. Manufacturers of unapproved, banned, or new drugs intended solely for export must now follow a unified application procedure through the Sugam Portal, backed by proper documentation and compliance commitments.

While challenges such as destruction rules for excess inventory remain under discussion, the framework introduced is expected to streamline operations, reduce costs, and uphold high quality and safety standards for Indian pharmaceutical exports.

If you need any support in CDSCO Registration or issuance of export NOC, feel free to connect with us through mail at info@ccoffice.in or Call/Whatsapp at +91 9988424211.

FAQs

Q1. What is the purpose of CDSCO's New Export NOC Rules 2025?

Ans. CDSCO's New Export NOC Rules 2025 aim to centralize and streamline the process of obtaining export No Objection Certificates for unapproved and approved new drugs. The new rules are designed to ensure regulatory uniformity, faster approvals, and improved compliance for pharmaceutical exports.

Q2. Who can issue export NOCs under the new rules?

Ans. As per the new guidelines, only the Central Drugs Standard Control Organisation (CDSCO) through its zonal offices is authorized to issue export NOCs. This authority was earlier with State and Union Territory Licensing Authorities but was withdrawn from May 15, 2024.

Q3. What is the validity period of the new export NOC?

Ans. The export NOC issued under CDSCO's New Export NOC Rules 2025 is valid for one year from the date of registration or until the sanctioned quantity is fully utilized, whichever occurs earlier.

Q4. What is the timeline for the issuance of an export NOC?

Ans. CDSCO has fixed a timeline of seven days from the date of application submission for the issuance of an export NOC. This time-bound processing helps in reducing delays and enhances export efficiency.

Q5. Are quantity-specific or purchase-order-specific NOCs still required?

Ans. Under the new rules, quantity-specific and purchase-order-specific NOCs have been discontinued for most drugs. However, they are still required for Narcotic Drugs, Psychotropic Substances (NDPS), and banned drugs to maintain strict regulatory oversight.

Q6. What happens to leftover drug stock that is not exported?

Ans. For finished formulations with more than 60% residual shelf life, the stock can be reused for the next export. If shelf life is below 60%, it must be destroyed in presence of the State Licensing Authority. For APIs, the reuse threshold is a minimum of three months' residual shelf life.

Q7. What are the consequences of submitting falsified documents during the NOC application?

Ans. If any company submits falsified documents, the issued NOC will be cancelled, and the company will be barred from reapplying for an export NOC for a period of one year. This applies to both APIs and finished formulations.

Q8. Is it mandatory to use the Sugam Portal for NOC applications?

Ans. Yes, all applications for export NOC must be submitted through the Sugam Portal. This portal serves as the central digital platform for registration and documentation, ensuring transparency and ease of access for applicants.