FDC Clinical Trials In India

FDC Clinical Trials in India require a clear therapeutic rationale, appropriate clinical evidence, CDSCO review, and chemical and Pharmaceutical information to demonstrate the safety, quality and suitability of the fixed dose combination for use.

Fixed Dose Combinations (FDCs) are medicines that contain two or more active ingredients intended to treat a particular condition or indication.1 An FDC may be considered a New Drug when separately approved Drugs are combined for the first time in a fixed ratio, or when the ratio of an existing combination is changed for specified claims.

FDCs can be grouped based on the approval status of their ingredients, whether the combination is already marketed, and whether changes are proposed. These categories help determine what type of scientific, clinical, chemical and pharmaceutical evidence may be needed before approval.

FDC Therapeutic Rationale and Classification

The therapeutic rationale for an FDC should explain why the ingredients are combined and whether each ingredient contributes to the claimed effect. It should also consider Drug-Drug interactions, food effects, dosage schedules, and whether the dose and proportion of each ingredient are appropriate.

The table below summarises the main FDC categories described by CDSCO and the broad regulatory considerations associated with each category.

FDC category	Key characteristics	Main consideration
Group 1	One or more active ingredients is a New Drug	Data similar to that needed for a New Drug, including Clinical Trials where applicable, should be submitted
Group 2	Individually approved ingredients are combined for the first time and may have significant pharmacodynamic or pharmacokinetic interactions	Requires appropriate chemical, pharmaceutical and stability data, with additional requirements depending on the FDC’s regulatory status and available clinical evidence
Group 3	An already marketed FDC has a changed ingredient ratio or a new therapeutic claim	Appropriate rationale and supporting published information, where available
Group 4	Ingredients have been widely used together and the FDC is intended mainly for convenience	Stability, acceptable rationale and absence of significant interactions should be demonstrated3

Table1

Fixed Dose Combination Regulatory Requirements and Approval

The fixed-dose combination regulatory requirements for clinical trials depend on whether the combination is already marketed and the evidence available for its ingredients or the combination. The key requirements are as follows:

FDC not marketed anywhere: FDC Clinical Trials may be required from Phase I onwards, as appropriate, to generate evidence on the safety and effectiveness of the combination.
FDC marketed abroad: Phase III Clinical Trial data generated in India are required when the FDC is marketed in another country.
Clinical evidence: Safety and efficacy data for the same-strength FDC should be submitted, including relevant published clinical information, where sufficient literature is not available, evidence supporting the safe and effective use of the ingredients together may be required.1
Application for approval: A person or organisation planning to conduct a Clinical Trial of a New Drug must apply to the Central Licensing Authority using Form CT-04 and submit the required information and documents listed in the Second Schedule of the New Drugs and Clinical Trials Rules, 2019.2

CDSCO Review and FDC Clinical Trial Protocol Requirements

CDSCO checks the fixed-dose combination clinical trial application for the required administrative and technical information before accepting it for detailed review. The clinical-trial protocol should clearly describe the study rationale, objectives, design, study population, treatment, adverse events, ethical considerations, monitoring and statistical analysis.1 For a PIV trial FDC India application, the submitted information should support the proposed clinical study and provide the necessary details for regulatory assessment.

The figure shows the main steps followed when an FDC clinical-trial application is submitted for regulatory review in India.

Figure 1

Chemical and Pharmaceutical Requirements for Fixed-Dose Combination Clinical Trials

Chemical and pharmaceutical information is required to show that the FDC has the correct identity, quality, purity and strength. This may include details of the active ingredients, formulation, manufacturing process, quality tests, analytical methods and stability data. Information about inactive ingredients, finished product specifications and excipient compatibility may also be required.1

A complete fixed dose combination approval submission should therefore bring together the required clinical, pharmaceutical and regulatory information according to the type of FDC.

Short Summary

FDCs contain two or more active ingredients, and their classification depends on approval status, marketing status and changes made to the combination.
A proper therapeutic rationale should explain why the ingredients are combined and whether their doses, proportions and possible interactions are appropriate.
Clinical requirements may include Phase I to Phase III studies, Clinical Evidence, protocol review and submission of Form CT-04 to the Central Licensing Authority.
Pharmaceutical information such as formulation, quality tests, analytical methods and stability data helps show that the FDC has the required quality for Clinical Trial use.

Conclusion

FDC Clinical Trials in India require a proper therapeutic rationale, clinical evidence and pharmaceutical information based on the type of FDC.
The regulatory process may include Clinical Trials, protocol review, quality information and submission of the required documents to the Central Licensing Authority.
CliniExperts can help sponsors with Clinical Trial management, regulatory support and medical writing during FDC Clinical Trial development in India.4

References

- Central Drugs Standard Control Organization. System of Preliminary Scrutiny by CDSCO at the Time of Receipt of Application for Approval of Fixed Dose Combinations (FDCs). Central Drugs Standard Control Organization. Accessed September 8, 2026. https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzI1MQ==
- Ministry of Health and Family Welfare. New Drugs and Clinical Trials Rules, 2019. G.S.R. 227(E). Accessed September 8, 2026. https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/NewDrugs_CTRules_2019.pdf
- Central Drugs Standard Control Organization. Fixed Dose Combinations (FDC). CDSCO. Accessed September 8, 2026. https://cdsco.gov.in/opencms/opencms/en/Drugs/FDC/
- Pharma Regulatory Consultants, Regulatory Affairs Services in India -CliniExperts. Accessed September 8, 2026. https://cliniexperts.com/