A Critical Appraisal of Package Inserts in India

Abstract

Accurate and reliable drug information is essential for safe and effective use of marketed products. The primary source of drug information is a Package Insert. It is a printed leaflet that contains information based on regulatory guidelines for the safe and effective use of a drug. Incomplete and incorrect product information may have serious consequences including disability or death. In India, the concept of package insert is governed by the Drugs and Cosmetics Act (1940) and Rules (1945). Keeping this in mind, this study was designed to assess the presentation and completeness of drug information provided in the currently available package inserts for allopathic drugs in India. AIMTo evaluate the presentation and completeness of drug information provided in the currently available package inserts for allopathic drugs in India. OBJECTIVESTo evaluate drug information in package inserts according to headings mentioned in Section 6.2 and 6.3 of Schedule D, Drugs and Cosmetics Rules, 1945. MATERIAL AND METHODSPackage inserts accompanying allopathic medicines were obtained from a drug store and three pharmacies around a tertiary care centre in Western India on request over a 1-month period. The package inserts were included in the study and analysed for the presentation and completeness of information according to the headings mentioned in Section 6.2 and Section 6.3 of Schedule D, The Drugs and Cosmetics Rules, 1945. RESULTS110 package inserts were analysed in the study. None of the reviewed package insert contained all the sections as required by the Drugs and Cosmetic Rules. CONCLUSIONTo avoid medication errors due to deficits in drug information in package inserts, tighter monitoring of package inserts by regulatory authorities is recommended. Steps should be taken to ensure that the information in the package inserts follows a standard layout for easy and convenient comprehension.