COMPARATIVE STUDY ON PRIMARY LABEL, PRIMARY CARTON LABEL AND PATIENT INFORMATION LEAFLET OF DICLOFENAC INJECTION

This project's primary goal was to study the primary labels (PL) and primary cartons labels and patient information leaflets (PIL) for their suitability, harmonisation, and compliance with legal and regulatory standards.In the study, the PL, primary carton label, and PIL of innovator and generic products were evaluated side by side.For this study, three distinct marketed brands of diclofenac injection IP-the innovator product, classified as brand A, and two generic versions, coded as brands B and C-were taken into consideration.The purpose of the survey study, which was question-based, was to determine if nurses were aware of labelling problems.The study found that the PL, primary carton label, and PIL of the innovator product were devoid of negative, significant, and minor findings.However, it was discovered that all three types of observations were present in generic brands' PL, primary carton labels, and PIL.Nursing personnel were unaware of the mistakes detected in the labels and believed the information to be accurate because of their normal workload and the hectic hospital ward activities.It's necessary to assure uniform and standard text matter content across PL, primary carton labels and PIL, thus, avoiding misleading information to healthcare professionals and patients.