Assessment of the availability and rationality of unregistered fixed dose drug combinations in Nepal: a multicenter cross-sectional study

Table 15 Toolkit developed by HAI-AP to identify irrational FDCs

Requirements	Scenario 1	Scenario 2	Scenario 3	Scenario 4	Scenario 5
Rationale for the combination	Not usually	Not usually	✓	✓	✓
Balancing advantages and disadvantages of the combination	Not usually	Not usually	✓	✓	✓
Marketing status in other countries	✓	✓	✓	✓	✓
Analysis of literature data in the submission	Possibly for pharmaceutical development	Possibly for pharmaceutical development	✓	✓	✓
Pharmaceutical development studies	✓	✓	✓	✓	✓
Good Manufacturing Practice (GMP) certification of sites of manufacture	✓	✓	✓	✓	✓
A full quality data set	✓	✓	✓	✓	✓
Bioavailability data	Not usually	Not usually	Sometimes	✓	✓
Bioequivalence data	✓	✓	Sometimes	Sometimes	✓
Preclinical pharmacology and safety	Not usually	Not usually	Sometimes	✓	✓
Clinical safety and efficacy	Not usually	Not usually	✓	✓	✓
Product information	✓	✓	✓	✓	✓
Plan for passive post marketing surveillance	✓	✓	✓	✓	✓
Plan for active post marketing surveillance	Not usually	Not usually	✓	✓	✓
Assurances	✓	✓	✓	✓	✓