CDSCO Introduces Prior Intimation System for Form CT-05 Applications (Effective 21 April 2026)

CDSCO Introduces Prior Intimation System for Form CT-05 Applications (Effective 21 April 2026)

Introduction

The CDSCO Prior Intimation System for CDSCO Form CT-05, effective 21 April 2026, allows applicants to submit export-related bioequivalence and bioavailability study applications through the Sugam portal without prior approval in eligible cases.

The Central Drugs Standard Control Organization (CDSCO) has introduced a Prior Intimation System for Form CT-05 applications, effective from 21 April 2026, under Gazette Notification G.S.R. 50(E) dated 21 January 2026. This update modifies the New Drugs and Clinical Trials Rules, 2019 to simplify the approval process for export-related bioavailability and bioequivalence studies in India.

Under this new system, eligible applicants can submit a Form CT-05 application through the Sugam portal, where the acknowledgement itself acts as prior intimation eliminating the need for prior approval in specific cases. This change is a key part of the CDSCO export rules 2026, aimed at improving efficiency in the drug export India process while maintaining regulatory compliance.

The New Drugs and Clinical Trials Rules, 2019 amendment 2026, introduced through Gazette Notification G.S.R. 50(E), came into effect on 21 April 2026 after a mandatory 90-day transition period from its publication in the Official Gazette.

This update marks a key shift in the CDSCO export rules 2026, replacing the traditional prior approval system with a more efficient prior intimation system for eligible applications. The change is designed to streamline regulatory timelines and improve the overall efficiency of the drug export India process, while maintaining compliance with established clinical trial regulations.

To understand detailed regulatory updates, visit our official platform: Mace Coprorate Asssociaets 

What is the Prior Intimation System? 

The Prior Intimation System introduced by CDSCO in 2026 allows applicants to submit a Form CT-05 application online through the Sugam portal for export purposes without requiring prior approval in eligible cases.

Under this system, once the CT-05 application is submitted, the acknowledgement generated by the portal is treated as official prior intimation. This enables applicants to proceed with their activities immediately, significantly reducing approval timelines and improving efficiency in the pharma regulatory India framework, especially for export-related studies.

Applicability of the Prior Intimation System 

The Prior Intimation System by CDSCO (2026) applies only to specific study types, drug categories, and regulatory conditions. It is designed to streamline eligible applications while maintaining compliance under the Clinical Trials Rules 2019.

1. What type of studies are covered?

1. Single-dose studies

2. Two-period, two-sequence, two-treatment study designs

3. Bioavailability (BA) and Bioequivalence (BE) studies in India

4. Studies conducted on healthy adult human volunteers

5. Studies intended strictly for export purposes

2. Which drugs are eligible?

Only oral dosage forms are eligible under this system.

Excluded categories include:

   1. Cytotoxic drugs

   2. Hormonal drugs

   3. Narcotic and psychotropic substances

   4. Drugs with a narrow therapeutic index

   5. Drugs with highly variable pharmacokinetics

These exclusions ensure that high-risk drugs continue under the stricter CDSCO approval process in India.

3. What are the approval requirements?

To qualify under the CDSCO export rules 2026, the drug must already be approved in:

1. India, or

2. Any one of the following regulated markets:

    1. United States

    2. European Union

    3. Japan

    4. Australia

    5. Canada

    6. United Kingdom

This aligns with global standards under pharmaceutical export guidelines in India.

4. Is Ethics Committee approval required?

Yes. The application must include approval from an Ethics Committee registered with the Central Licensing Authority in India under Rule 8 of the 2019 rules. This ensures proper clinical research compliance in India.

5. What is the minimum sample size?

The study must include a minimum of 18 participants, as per bioequivalence study requirements in India.

6. What are the record maintenance requirements?

Ethics Committees must maintain separate records for studies conducted under the prior intimation system. These records will be reviewed by the Central Licensing Authority in India during:

    1. Inspections

    2. Registration renewals

    3. Regulatory audits

Important Clarification 

Once the Form CT-05 application under the CDSCO Prior Intimation System 2026 is submitted through the Sugam portal, the acknowledgement generated is considered valid prior intimation.

This means applicants can proceed with the study without waiting for formal approval, provided all eligibility conditions are met. This change significantly reduces delays in the CDSCO application process for export-related studies.

However, for studies or categories not covered under this amendment, the existing CDSCO prior approval system will continue to apply as per the New Drugs and Clinical Trials Rules, 2019.

Conclusion 

The CDSCO Prior Intimation System for Form CT-05 (2026) is a key regulatory reform designed to simplify the approval process for export-related pharmaceutical studies in India.

By replacing prior approval with a streamlined intimation process through the CDSCO online Sugam portal, the system reduces timelines and improves efficiency while maintaining compliance under the New Drugs and Clinical Trials Rules, 2019. This reform supports India’s growth in global clinical research and pharmaceutical exports.

Stakeholders should review the eligibility criteria carefully and ensure full compliance with the latest drug regulatory updates April 2026 to avoid delays or regulatory issues.

(FAQs)

1. What is Form CT-05 in CDSCO?

Form CT-05 is an online application form used under the CDSCO regulatory framework to submit prior intimation for conducting bioavailability and bioequivalence studies for export purposes. It is filed through the Sugam portal, and under the new system, the acknowledgement itself acts as proof of submission.

2. Is prior approval required under CT-05?

No, prior approval is not required in eligible cases under the CDSCO Prior Intimation System 2026. Once the Form CT-05 application is submitted online, the acknowledgement serves as valid prior intimation, allowing applicants to proceed without waiting for approval. However, studies not covered under this system still require prior approval.

3. Who can apply for the CDSCO prior intimation system?

Applicants involved in export-related clinical studies, such as pharmaceutical companies or research organizations, can apply under the CDSCO prior intimation system. The study must meet all eligibility criteria, including approved drugs, required study design, and Ethics Committee approval.

4. What studies are allowed under the CDSCO prior intimation system?

The system allows specific types of studies, including:

• Bioavailability (BA) and Bioequivalence (BE) studies
• Single-dose studies
• Two-period, two-sequence, two-treatment designs
• Studies conducted on healthy adult human volunteers
• Studies intended strictly for export purposes

Only eligible studies meeting CDSCO guidelines can proceed under this system.

Click here to Access the official guidance document
 

Note:
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