ABSTRACT
Background: Package Insert (PI) contains detailed information about indications, warnings, precautions, side effects, dosage, administration, and clinical pharmacology. Package insert must bear adequate information for its use including indications, effects, dosages, routes, methods, & frequency duration of administrations &any relevant hazards, contraindications, side-effects & precautions under which practitioners licensed by law to administer the drug can use the drug safely &for the purposes for which it is intended including for all purposes for which it is advertised or represented.
Material & Methods: 200 Package inserts of allopathic parenteral & oral medicines of different pharmaceutical companies were randomly collected from pharmacists. Out of which 100 package inserts were of oral formulations, 100 were of parenteral formulations. Qualitative and Quantitative analysis was done on the basis of criteria given by WHO and FDA.
Results: The package inserts of oral formulations have been significantly better in all the aspects compared to the parenteral formulations.
Conclusion: Oral formulations are mainly used directly by the patients themselves and they don’t know the details about medical terminologies and concepts, whereas the parenteral formulations are mainly used by the doctors directly and they do not require the initial information and the details about the drug or formulation. The difference may be due to the package inserts of different pharmaceutical companies.
Key words: Allopathic, Oral, Parenteral, Package Insert, Completeness.