Adherence of Labeling Information of Marketed Reconstituted Type Antibiotics with Existing National Medicine Regulatory Authority Guidelines

Abstract

The label of a pharmaceutical product gives all the basic information that a manufacturer should provide on a medicine to the patient healthcare professionals.  Globally it was observed that discrepancy between the components in the label of marketed product. This study evaluated the adherence of labeling information of marketed reconstituted type antibiotics against the existing National Medicine Regulatory Authority (NMRA) guideline of labeling. 68 generics of antibiotics registered in NMRA were selected and the entire population of 297 of NMRA registered reconstituted antibiotics were considered as the sample. Product Information Leaflet (PIL), Label and smaller/primary label were checked against a checklist prepared based on NMRA Guidelines of labelling of medicine. Only 84.13% of reconstituted antibiotic products had at least 50% of required information of PIL. Regarding the essential information that should contain in the label only 64.9% product labels carry the specific instructions on how to reconstitute /dilute or prepare prior to use. 81.1% PILs had the period for which the product can be used after reconstitution. 86.5% had the name of the suitable diluents or solvents (if not accompanied with the product). Though a significant percentage carry the information required it has to be 100%. NMRA should carry out more inspections on labelling requirements also to ensure 100% adherence of labelling requirements.