Bioequivalence and Bioavailability Forum

Dear Dr RCG,

❝ reference product details is a part of study design. If any study design is changed inculding reference product details (not matching with protocol),

As per the DCGI's Meeting conducted at IDMA office mumbai, DCGI states that those amendments which require prior permission before implementation of the amendments are

1. Change of Principal Investigator
   
2. Additional Patients to be recruited
   
3. Major changes in protocol with respect to study design, dose and treatment options

Source: Minutes of meeting on matters related to Global Clinical Trials,

CDSCO requires prior permission from DGCI before implementation of the protocol amendments only if there are major changes with respect to study design.
Only change in the Trade name and manufacturer details of the Reference product will not be considered as Major change and hence only intimation to DCGI is sufficient.
If the other reference product details changes such as dosage, formulation, frequency of administration, then they will be considered as Major change and we need to get approval from DCGI for the new version of protocol before conducting the study.