A quality audit of the medicinal package insert information of drugs marketed in India

Abstract

Background: A package insert (PI) accompanying medicinal products is a concise and accessible source of evidence-based information for health professionals and consumers alike. In India, the supplied information should be adequate and fulfill the statutory regulations of the Drug and Cosmetics Rules (1945) to ensure the safe and effective use of the drug. Aim and Objectives: The present observational study aimed to evaluate the uniformity and adequacy of information on PIs available in India. Materials and Methods: PIs of approved and marketed drugs were collected from pharmacies and analyzed with the help of a 30-item checklist comprising of components of statutory guidelines and other quality indicators. Each item was assigned a weightage of two if the information was complete, one if inadequate, and 0 if absent. The total score was calculated for each PI. Results: The median score of the 150 analyzed PIs was 41 (Inter quartile range, 36.00–45.25) out of a maximum value of 60. The major deficiencies observed were in providing missed dose instructions (91.33%), further reading resources (84.67%), supporting references (83.33%), and drug disposal instructions (76%). Other notable missing information were laboratory parameter interference (68.67%), clinical trial data (62%), adverse drug reaction reporting contact information (56.67%), and a list of excipients (49.33%). Conclusion: There are important inadequacies in the clinical information provided in Indian PIs which can affect patient health and hinder rational drug use. Thorough evaluation and revision of the PIs is warranted to make them more reliable and popular among users.