Labels and package inserts – A study to determine if official guidelines are being followed by pharmaceuticals in India

Abstract

Background: A package insert is a document within a medication package that provides information about the product. Labels similarly covey information regarding the product but are printed on the packaging rather than separately within. Aims and Objectives: This study aimed to determine whether pharmaceuticals in India adhere to the national guidelines laid down by CDSCO with regards to the packaging and labeling of drugs. Materials and Methods: 100 drugs (labels + package inserts) were collected within duration of 1 month, beginning June 6th, 2023,–July 5th, 2023, from the central drug store of a tertiary care government hospital and nearby pharmacies. After entering pertinent data into a Microsoft Excel sheet, analysis was carried out using descriptive statistics. Results: Most companies (in and around 70%) followed requirements with respect to drug labels barring “warning about the drug” and use of the “red line,” while package inserts showed divisive results, with patient-centric information such as posology, special warnings, and contraindications being followed by more than 80% of the manufacturer’s while taking a backseat with regards to technical details such as shelf life and incompatibilities. Conclusion: Labels and package inserts do largely convey the information that they intend to, with scope for improvement from both companies and regulatory authorities in order to perfect the balance of information conveyed.