Published: 30 Sep 2026
CDSCO Clarifies Internal Routing for New Drug Applications Supported by Global Clinical Trials
Omega QMS Compliance Insights
Omega QMS
The Central Drugs Standard Control Organization (CDSCO) has issued an administrative circular clarifying the appropriate internal division for a specific category of applications seeking permission to import and market new drugs that have not been approved anywhere in the world.
The clarification applies where the application is supported by Phase III Global Clinical Trials (GCTs) that are either ongoing or completed and include participation of Indian subjects. Such applications are to be examined and processed by the IND (Investigational New Drug) Division at CDSCO Headquarters, New Delhi, rather than the New Drugs Division.
The circular, bearing F. No. ND-11011(13)/2/2026-eoffice, is dated 10 August 2026 and is effective immediately.
What Has CDSCO Clarified?
CDSCO noted that it had been receiving applications with the following characteristics in the New Drugs Division:
- The drug has not yet been approved anywhere in the world
- The applicant seeks permission to import and market the drug in India
- The application is supported by ongoing or completed Phase III GCTs with Indian subjects
After review by an internal CDSCO technical committee, it was decided that these applications should instead be handled by the IND Division. The reason stated is that they concern drugs still under active review by foreign regulatory authorities and require comprehensive evaluation of non-clinical and clinical trial data under the New Drugs and Clinical Trials (NDCT) Rules, 2019.
Where Should Such Applications Now Be Submitted?
For this specific category, applicants should submit their applications to the IND Division at CDSCO Headquarters, New Delhi. They should no longer be directed to the New Drugs Division.
Submit to: IND Division, CDSCO Headquarters, New Delhi. Correct internal routing is now an important consideration for sponsors preparing submissions.
Which Applications Are Covered?
The clarification concerns applications for permission to import and market new drugs not approved anywhere in the world, where the application relies on Phase III GCTs that are either ongoing, or completed with participation of Indian subjects.
It addresses a specific category of new drug applications. It does not change the general routing of all applications submitted to CDSCO.
Why Has CDSCO Made This Clarification?
According to the circular, these applications involve drugs still under active review by foreign regulatory authorities and require comprehensive assessment of non-clinical and clinical trial data under the NDCT Rules, 2019. The clarification directs them to the division responsible for the relevant investigational drug and clinical-trial aspects.
Correct routing can also help applicants avoid delays from submitting to the wrong division.
What Has Not Changed?
The circular does not introduce a new approval requirement or substantive regulatory standard. It does not:
- Introduce new approval criteria
- Change the substantive evaluation standard
- Amend the NDCT Rules, 2019
- Create a new clinical trial requirement
- Change the underlying framework for new drug applications
It only clarifies which CDSCO division should examine and process this particular category of application.
Practical Impact for Pharmaceutical Companies
The clarification is particularly relevant for companies and sponsors that are:
- Preparing an application for an unapproved new drug
- Conducting Phase III GCTs involving Indian subjects
- Managing simultaneous submissions in India and other jurisdictions
- Awaiting action on an application filed with the New Drugs Division
- Reviewing their internal CDSCO filing procedures
Companies should assess whether any existing or planned application falls within the covered category.
What Should Applicants Do?
Identify the Correct CDSCO Division
Determine whether your application concerns an unapproved new drug supported by the specific Phase III GCT circumstances covered by the clarification.
Route New Applications to the IND Division
Where the clarification applies, submit to the IND Division, CDSCO Headquarters, New Delhi.
Review Pending Applications
Check the status of applications already filed with the New Drugs Division and confirm whether they need to be routed to the IND Division. The circular specifically flags these pending filings.
Update Internal Regulatory SOPs
Update submission checklists and SOPs to reflect the clarified routing requirement.
Does This Change the NDCT Rules, 2019?
No. The circular is an administrative clarification on which internal CDSCO division handles the specified applications.
The NDCT Rules, 2019 remain applicable. CDSCO has specifically stated that no new approval criteria, evaluation standard or regulatory requirement has been introduced.
Applications That May Require Attention
| Situation | Action to Consider |
|---|---|
| New drug not approved anywhere in the world | Review whether the application falls within the clarified category |
| Phase III GCT ongoing | Assess applicability of IND Division routing |
| Phase III GCT completed with Indian subjects | Assess applicability of IND Division routing |
| Application already filed with New Drugs Division | Confirm whether re-routing is required |
| New application under preparation | Route to the IND Division where applicable |
| Internal regulatory SOPs | Update submission-routing procedures |
Key Takeaways
CDSCO has clarified internal routing for a specific category of new drug applications.
Applications to import and market new drugs not approved anywhere in the world, supported by Phase III GCTs that are ongoing or completed with Indian subjects.
The IND (Investigational New Drug) Division, CDSCO Headquarters, New Delhi, not the New Drugs Division.
No new approval criteria or regulatory requirements have been introduced.
The clarification took effect on 10 August 2026.
How Omega QMS Can Help
Navigating CDSCO’s drug regulatory framework requires careful attention to the applicable rules, submission requirements and internal regulatory processes. Omega QMS assists pharmaceutical companies and sponsors with India’s regulatory requirements, including:
- CDSCO new drug approval procedures
- IND Division submissions
- NDCT Rules, 2019 compliance
- Clinical trial regulatory requirements
- Import and marketing permission for new drugs
- Regulatory documentation and submission support
- CDSCO liaison and regulatory follow-up
If you plan to seek permission to import and market a new drug not yet approved anywhere in the world, particularly with Phase III GCTs involving Indian subjects, Omega QMS can help assess the applicable submission pathway and requirements.
Planning a New Drug Application in India?
Need help confirming your CDSCO submission pathway under this clarification?
Primary Source: Central Drugs Standard Control Organization (CDSCO), New Drugs Division, Government of India — F. No. ND-11011(13)/2/2026-eoffice, “Clarification on the submission of applications for grant of Permission to Import and Market New Drugs not approved anywhere in the world, wherein phase III Global Clinical Trials (GCT) are ongoing or completed with participation of Indian subjects under the New Drugs and Clinical Trials Rules, 2019,” dated 10 August 2026, signed by Dr. Rajeev Singh Raghuvanshi, Drugs Controller General (India).
Disclaimer: This article is for general regulatory and informational purposes only and does not constitute legal advice. Companies should review the applicable CDSCO requirements and their specific circumstances before making regulatory submissions.
