India continues to strengthen its clinical research framework with regulatory updates that support faster and more efficient study execution. One such recent development is the CDSCO prior intimation pathway (CT-05) introduced under the NDCT Rules amendment dated 21 January 2026.

This pathway enables eligible bioavailability (BA) and bioequivalence (BE) studies to be initiated without requiring prior approval from CDSCO, significantly reducing study start timelines for sponsors.

What is the Prior Intimation Pathway (CT-05)?

Under this pathway, certain BA/BE studies can be initiated through prior intimation to CDSCO, instead of undergoing the standard approval process. Only the acknowledgement from the CDSCO on prior intimation will be required for initiation of the eligible study. This regulatory approach is particularly relevant for generic drug development programs, where timelines and predictability are critical.

Applicability Criteria

The prior intimation pathway applies to BA/BE studies that meet the following conditions:

• Standard BA/BE study design (Single dose, two period, two sequence, two treatment study design)
• Conducted in healthy adult volunteers for >18 sample size.
• Export purpose studies
• Oral dosage forms approved with same formulation and strength

In addition, the drug must meet regulatory acceptance criteria: Approved in India or in at least one major regulated market (USA, EU, Japan, Australia, Canada, or UK).

The pathway does not apply to:

• Cytotoxic, hormonal, narcotic, or psychotropic drugs
• Narrow therapeutic index drugs
• Highly variable pharmacokinetic drugs

What This Means for Sponsors

The introduction of the CT-05 pre-intimation pathway offers clear operational advantages:

Faster Study Start

Sponsors can initiate eligible studies without waiting for formal regulatory approval. Only acknowledgement from the authority will give go ahead for initiation of the study.

Reduced Regulatory Timelines

Eliminates approval-related delays, enabling quicker project initiation.

Improved Planning and Predictability

Greater control over timelines supports better coordination across clinical, bioanalytical, and regulatory functions.

Suitable for Standard Generic Programs

Particularly relevant for oral solid dosage forms under development for global markets.

Strategic Impact on Global Development Programs

For companies developing generic products for regulated markets, this pathway provides an opportunity to:

• Optimize development timelines
• Accelerate market entry strategies
• Reduce uncertainty in study initiation
• Align clinical execution with global submission timelines

India’s established clinical infrastructure, combined with this regulatory flexibility, further strengthens its position as a preferred destination for BA/BE studies.

Conclusion

The CDSCO prior intimation pathway (CT-05) marks a significant step toward improving efficiency in clinical research in India. By enabling faster study initiation for eligible BA/BE programs, it supports both sponsors and CROs in achieving tighter development timelines. For sponsors planning generic drug development programs, understanding and leveraging this pathway can offer a clear advantage in execution speed and predictability.

Lambda delivers full-service CRO solutions to innovator, biotech, and generic pharmaceutical companies worldwide. With a global presence across India, the USA, Canada, the UK, Spain, and Poland, Lambda brings specialized expertise to every project.

Lambda provides integrated capabilities for efficient execution of BA/BE studies aligned with global regulatory expectations. With experience of over 8500 studies across diverse dosage forms, Lambda offers established expertise and operational reliability. A well-established infrastructure and experienced teams enable efficient subject recruitment, screening, and study conduct. Lambda has experience across a wide range of oral dosage forms and follows structured workflows to support timely study initiation and execution.

Lambda also supports submissions to US FDA, EMA, and other global regulatory agencies, with a clear understanding of CDSCO requirements, including compliance with the prior intimation pathway. Study documentation and reporting are aligned with regulatory expectations. An integrated approach across clinical, bioanalytical, and data management functions ensures seamless execution, with end-to-end support from study planning to final report generation, while maintaining timelines without compromising data quality.

With the CT-05 pathway, eligible studies can be initiated efficiently within Lambda’s infrastructure, supporting faster execution with consistent quality and compliance.

Connect with our experts at BD@lambda-cro.com to leverage our end-to-end capabilities.

Reference

• https://www.cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTM4Mjk=