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Wed, Aug 12 2026
Raju Karn
The Central Drugs Standard Control Organization (CDSCO) has issued an important clarification regarding applications seeking permission to import and market new drugs in India that have not been approved anywhere in the world. The clarification was issued through a CDSCO circular dated 10 August 2026, bearing reference F. No. ND-11011(13)/2/2026-eoffice.
The circular addresses applications where Phase III Global Clinical Trials (GCTs) are ongoing or have been completed with participation of Indian subjects. CDSCO has clarified that such applications require comprehensive evaluation of clinical and non-clinical data and will therefore be examined and processed by the IND Division, CDSCO (HQ), New Delhi, under the applicable provisions of the New Drugs and Clinical Trials Rules, 2019 (NDCT Rules, 2019).
CDSCO observed that it had received applications for permission to import and market certain new drugs that were not approved anywhere in the world. In some of these cases, Phase III Global Clinical Trials had either already been completed or were still ongoing with participation of Indian subjects.
The matter was examined by an internal technical committee within CDSCO. Following detailed deliberations, the committee concluded that such applications require a comprehensive review of the available non-clinical and clinical data. As a result, CDSCO has clarified that these applications should be submitted to and processed by the IND Division, CDSCO Headquarters, New Delhi, under the applicable regulatory requirements of the NDCT Rules, 2019.
The main clarification is about the regulatory processing route for a specific category of new-drug applications. If a drug has not been approved anywhere in the world and has been or is being studied through a Phase III Global Clinical Trial involving Indian subjects, an application seeking permission to import and market the drug in India is to be examined by the IND Division of CDSCO (HQ), New Delhi.
The reason is that such applications require a detailed assessment of the available clinical and non-clinical evidence rather than being handled as a routine import or marketing application.
The circular specifically addresses applications involving a combination of circumstances:
Therefore, the circular should not be interpreted as applying to every new drug application submitted to CDSCO. It specifically addresses the category described in the clarification.
A new drug that has not received approval anywhere globally requires careful regulatory assessment before it can be considered for marketing in India. Even when Phase III clinical trials have been conducted, CDSCO needs to evaluate the complete evidence available for the drug.
This may include information relating to clinical safety, clinical efficacy, non-clinical studies, pharmacology, toxicology, clinical trial results, benefit-risk assessment, manufacturing and quality information, and other regulatory information applicable to the application.
No.
Completion of a Phase III Global Clinical Trial does not by itself mean that the drug automatically receives permission to be imported and marketed in India. The clinical trial generates evidence that can form part of the regulatory submission, but the competent regulatory authority still needs to evaluate the application and supporting data according to the applicable requirements.
This distinction is particularly important for drugs that have not yet received marketing approval in any country. The CDSCO clarification reinforces the need for comprehensive regulatory examination of such applications.
The Investigational New Drug (IND) Division is part of CDSCO's regulatory framework dealing with investigational and new-drug matters. For the applications covered by the 10 August 2026 clarification, the IND Division will be responsible for examining and processing the applications according to the applicable regulatory requirements.
This means applicants should ensure that their submissions are properly prepared and supported by the relevant clinical, non-clinical, quality and regulatory information required for comprehensive review.
According to the CDSCO clarification, applicants covered by this circular should submit their applications to:
IND DivisionCDSCO (HQ)New Delhi
Applicants should therefore carefully identify whether their proposed submission falls within the scope of this clarification before deciding the appropriate regulatory route.
The New Drugs and Clinical Trials Rules, 2019 are an important part of India's regulatory framework for new drugs and clinical trials. The rules cover areas including new drugs, investigational new drugs for human use, clinical trials, bioavailability studies, bioequivalence studies and Ethics Committees.
The rules also establish requirements concerning the conduct of clinical trials of new drugs and investigational new drugs. Therefore, applications falling within the scope of this CDSCO clarification will need to be examined in accordance with the applicable provisions and requirements of the NDCT Rules, 2019.
The clarification provides greater clarity about the regulatory route for a specific category of new-drug applications. Pharmaceutical companies and global sponsors working on drugs that are still unapproved worldwide should carefully assess the status of their drug and clinical development programme before filing an application for Indian market authorization.
The key practical implications are:
Applicants covered by the clarification should submit their applications to the IND Division, CDSCO (HQ), New Delhi.
Companies should be prepared for detailed evaluation of clinical and non-clinical data.
Participation of Indian subjects in a Phase III GCT does not itself establish marketing permission in India.
Sponsors should determine the appropriate application route based on the drug's global approval status, clinical development stage and applicable Indian regulatory requirements.
The exact submission requirements will depend on the nature of the drug and the applicable regulatory pathway. However, companies should expect the application to require comprehensive supporting information.
Depending on the case, this may include:
Applicant and sponsor information
Details of the new drug
Investigational New Drug information
Pharmaceutical and manufacturing information
Chemistry, Manufacturing and Controls (CMC) data
Non-clinical study reports
Pharmacology and toxicology information
Clinical development information
Phase I, II and III clinical data, where applicable
Global Clinical Trial information
Indian clinical trial participation details
Clinical study reports
Safety and efficacy data
Benefit-risk assessment
Proposed prescribing information and labelling
Other documents required under the applicable CDSCO requirements
Applicants should verify the current CDSCO checklist and applicable requirements before submission rather than relying on a generic document list.
First, establish whether the new drug has received marketing approval in any country. If it has not been approved anywhere in the world, further assessment is required to determine whether the application falls under the clarification.
Determine whether the Phase III Global Clinical Trial is ongoing or completed, and verify whether Indian subjects participated in the trial.
Applicants should assess the applicable provisions of the NDCT Rules, 2019 and determine the appropriate submission route.
The application should be supported by the relevant clinical, non-clinical, quality and other regulatory information.
For applications covered by the circular, the submission should be directed to the IND Division, CDSCO (HQ), New Delhi.
Applicants should be prepared to provide additional information or clarifications if requested during the regulatory review.
The most important points are:
CDSCO issued the clarification on 10 August 2026.
It concerns certain new drugs that are not approved anywhere in the world.
The relevant applications involve Phase III Global Clinical Trials with participation of Indian subjects.
The Phase III trial may be ongoing or completed.
Such applications require comprehensive evaluation of clinical and non-clinical data.
The applications will be examined and processed by the IND Division, CDSCO (HQ), New Delhi.
The applicable regulatory framework is the New Drugs and Clinical Trials Rules, 2019.
The clarification provides a clearer route for applicants dealing with this specific category of new drugs.
The CDSCO circular dated 10 August 2026 provides an important regulatory clarification for pharmaceutical companies and sponsors seeking permission to import and market new drugs in India that have not been approved anywhere in the world.
Where Phase III Global Clinical Trials are ongoing or completed with participation of Indian subjects, CDSCO has clarified that the relevant applications require comprehensive evaluation of clinical and non-clinical data. Accordingly, such applications are to be submitted to and processed by the IND Division, CDSCO (HQ), New Delhi, under the applicable requirements of the NDCT Rules, 2019.
For pharmaceutical companies, the key takeaway is that completion or ongoing conduct of a Phase III global trial should not be treated as automatic marketing approval. The regulatory dossier, clinical evidence and non-clinical data remain subject to CDSCO's review before the application can proceed through the applicable approval process.
Planning to import or market a new drug in India? Our regulatory experts can assist with CDSCO application preparation, IND Division requirements, clinical & non-clinical documentation, regulatory submissions, and compliance under the NDCT Rules, 2019.
📞 Call: +91 8796104190📧 Email: support@psrcompliance.com
CDSCO clarified the processing route for applications seeking permission to import and market new drugs that have not been approved anywhere in the world and where Phase III Global Clinical Trials involving Indian subjects are ongoing or completed.
Such applications will be examined and processed by the IND Division, CDSCO (HQ), New Delhi.
No. Completion of a Phase III clinical trial does not automatically grant permission to import or market the drug. The application remains subject to regulatory evaluation.
The applications require comprehensive evaluation of relevant non-clinical and clinical data, along with other information required under the applicable regulatory framework.
No. The clarification specifically concerns the category of applications described in the circular—new drugs not approved anywhere in the world where Phase III GCTs are ongoing or completed with participation of Indian subjects.
The applications will be examined according to the applicable regulatory requirements under the New Drugs and Clinical Trials Rules, 2019.
It provides clarity on the appropriate regulatory division for processing a specific category of new-drug applications and highlights the need for comprehensive evaluation of clinical and non-clinical evidence.
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