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Original Research

Analysis of completeness of drug package inserts available in India

Nagaraja Prasad S, Shreenivas P Revankar, Vedavathi H, Harini Manjunath, Sriti Hegde.


Background: Information about the drug used can be obtained from various sources of drug information. One of the easily available sources of drug information is package insert (PI). The PI is the primary source of drug information. The PI or leaflet is the leaflet containing information about the medicinal product which accompanies the medicinal product. A good PI contains the approved, essential, and accurate information and it contains information in a language that is not promotional, false, or misleading. It is evidence based and periodically updated. However, not all PIs conform to all the above standards. Hence, the present study was undertaken to evaluate the appropriateness of presently available drug PIs.

Aims and Objectives: The aim of this study is to evaluate the completeness of the presently available PIs and grade them.

Materials and Methods: The present study was cross-sectional, observational, prospective study. 55 PIs were collected from various pharmacies in request. Out of them, 5 were found to be duplicated and were rejected. Remaining 50 PIs were analyzed based on criteria laid under the Drugs and Cosmetics Rules 1945 under section 6.2 and 6.3 of schedule D.

Results: Among the 50 PIs, 35 (70%) were of Indian companies and 15 (30%) were of multinational companies. Furthermore, 31 (62%) were parenteral preparations, 15 (30%) were oral formulations, and 04 (8%) were topical preparations. PIs were inadequate as to retail price of drug (0%), references (14%), effect on ability to drive machines(26%), updated information, and provision of full information on request (38%). 52% of PIs were A category, 48% of PIs were B category, and none of PIs were C category.

Conclusions: The present study shows that there is still paucity of information and requirement of standardization of the presently available PIs, especially with regard to the size and shape of PIs, font size, references, effect on ability to drive machines, updated information, and provision of full information on request. Furthermore, PIs should be made mandatory with all medications.

Key words: Package Inserts; Drug Information; India; Patient Information Leaflets; Patient Information Package Inserts

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