CDSCO Implements Prior Intimation System for Export Drug Applications Effective April 21, 2026

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Dated: 21.04.2026

CDSCO Implements Prior Intimation System for Export Drug Applications Effective April 21, 2026

The Directorate General of Health Services, Central Drugs Standard Control Organization (CDSCO), has issued a circular announcing the implementation of a Prior Intimation System for certain export drug applications. This new system, effective from April 21, 2026, is in accordance with amendments to the New Drugs and Clinical Trials Rules, 2019, as notified in Gazette Notification G.S.R. 50(E) dated January 21, 2026. This article provides a comprehensive overview of the new requirements, who they apply to, and actionable steps for stakeholders.

Background and Rationale

The Prior Intimation System is designed to streamline the approval process for specific bioavailability and bioequivalence studies intended for export. By shifting from a prior approval to a prior intimation model for eligible applications, the CDSCO aims to facilitate faster and more efficient regulatory compliance, while maintaining robust oversight through ethics committee review and record-keeping.

Key Provisions of the Prior Intimation System

1. Applicability

The new system applies to online applications submitted for export purposes only, specifically for:

Single-dose, two-period, two-sequence, two-treatment bioavailability or bioequivalence studies in normal healthy adult human volunteers.
Oral dosage forms of drugs, excluding:
- Cytotoxic drugs
- Hormones
- Narcotic and psychotropic substances
- Drugs with a narrow therapeutic index
- Drugs with highly variable pharmacokinetics
Drugs already approved in India or in any of the following countries:
- United States of America
- European Union
- Japan
- Australia
- Canada
- United Kingdom

2. Application Requirements

Applications must be submitted online via the Sugam portal using Form CT-05.
Each application must include:
- Approval from an Ethics Committee registered with the Central Licensing Authority under rule 8 of the New Drugs and Clinical Trials Rules, 2019.
- A sample size of at least 18 participants.

3. Ethics Committee Responsibilities

Ethics Committees must maintain separate records of review and approval for studies conducted under the prior intimation system.
These records will be reviewed by the Central Licensing Authority during registration renewal, inspections, or as required.

4. Acknowledgment and Further Use

Upon submission of Form CT-05 on the Sugam portal, the acknowledgment of application submission serves as the official “prior intimation”.
Applicants can use this acknowledgment for subsequent regulatory or operational needs.

5. Scope and Limitations

The prior intimation system is only applicable to the categories specified above.
For all other drug categories or purposes not covered by the amended rules, the existing system of prior approval remains in force.

Example Implementation

Suppose a pharmaceutical company wishes to conduct a bioequivalence study for an oral drug already approved in Canada, intended for export. The company must:

Ensure the drug is not a cytotoxic, hormone, narcotic, psychotropic, or has a narrow therapeutic index/highly variable pharmacokinetics.
Obtain approval from a registered Ethics Committee.
Design the study with at least 18 healthy adult volunteers.
Submit the application online via the Sugam portal using Form CT-05.
Use the portal’s acknowledgment as prior intimation for further regulatory steps.

Compliance and Record-Keeping

All stakeholders, including applicants and Ethics Committees, must ensure compliance with the new requirements. Proper documentation and record maintenance are essential for smooth inspections and registration renewals.

Conclusion

The implementation of the Prior Intimation System marks a significant step towards simplifying the regulatory process for export-oriented drug studies. By following the outlined procedures and maintaining diligent records, stakeholders can ensure compliance and benefit from a more efficient application process.

In case you face any issues related to Indirect Tax-Customs, GST, Foreign Trade Policy (FTP), Arbitration matters and Central Licensing and related advisory matters in India then please feel free to get in touch with SJ EXIM Services.

We offer Legal advice and litigation support in matters related to Indirect Tax-Customs, FTP, other Indirect Tax matters & Arbitration law, all sorts of Central licensing and related matters. Come and explore the new way of doing business with us!

Source: CDSCO

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