AN EVALUATION OF PACKAGE INSERTS OF ANTIMICROBIAL AGENTS MARKETED IN INDIA

Patel Suhani V, Desai Chetna K, Patel Prakruti P, Dikshit Ram K

PI (n=123) of marketed AMA were collected over 6 months period. Quality of information presented was assessed and scores were given for adherence to Indian i.e. Schedule D of Drugs and Cosmetics Rules, 1945 (DCR) of India (0- 20) and US guidelines (0- 35). Adequate font size was printed in 50% PI. Only 4% PI were complete as per DCR. Adequate information on contra-indications (25%), use during pregnancy/lactation (82%), warning/precautions (92%), drug-drug (59%) and drug-food interactions (36%), adverse drug reactions (61%), effect on ability to drive/use machines (17%), overdosage (36%), uses (48%), pharmacodynamic (32%) and pharmacokinetic properties (61%), use in children (80%) and elderly (52%), preclinical study data (33%), post- marketing surveillance data (7%), references (12%), recent major changes (10%) and patient counseling information (16%) was included in few PI. A more meticulous approach in preparation of PI to include approved, essential, accurate, evidence-based and updated prescribing information is needed.