A Study of Package Insert Analysis of Available Drugs in Local Market

Context: The primary source of drug information is a Package Insert (PI) which is accurate and reliable. In India, the package insert is governed by the ‘Drugs and Cosmetics Act (1940) and Rules (1945). The section 1 of Schedule Y of the rules lists the headings according to which information should be provided in the PIs. Aim: This study was undertaken to assess the completeness of information provided in PIs available in local pharmacies. Settings and Design: A prospective observational study was conducted from September 2023 to November 2023. Total 100 package inserts were taken in this study and they were collected from pharmacies located in various parts of Rajkot city. Methods and Material: 100 package inserts were analyzed based on 16 criteria mentioned in the Indian Drugs and Cosmetics Act (1940) and Rules (1945), under section 1 of schedule Y. Results: Only 5 PIs had all 16 criteria. 31% of PIs lacked information about Incompatibility, List of excipients, Instruction for Handling and about containers. 65% of PIs lacked same as above mentioned and additionally about overdosing, effects on ability to drive and use in pregnancy and lactation. Remaining 4% PIs contained information only about Posology and drug administration, contraindications, special warnings and D-D interactions. Conclusions: The information provided by PIs in India is inadequate, only 5 among 100 complied to the regulation, and they may not serve as a reliable source of information. It is, therefore recommended for strict compliance of PIs with criteria mentioned in Indian Drugs and Cosmetics Act (1940) and Rules (1945), under section 1 of schedule Y. Increased awareness, regular audits, and national-level policy reinforcement are essential steps to make PIs a more effective tool in rational drug use.