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Original Research

Evaluation of completeness of package inserts in South India

D. Govindadas, S. C. Somashekara, P. Ramesh, G. Meghavani.


Background: A drug package insert (PI) is a document provided along with the drug. It provides information about the safe and effective use of the drug for the prescribers and also for the general population. The information provided in the PIs sometimes is suboptimal, which may lead to medical errors. Hence, this study was undertaken.

Aims and Objectives: To study the completeness of PIs of allopathic medicines in South India.

Materials and Methods: A total of 323 PIs were collected from SVS Hospital Pharmacy and from local pharmacy stores. They were analyzed for the completeness of information in accordance with the Drugs and Cosmetic Act (1940) and Rules (1945), Sections 6.2 and 6.3 of Schedule D (II). If the information was present under the relevant heading, it was scored as one otherwise a score of zero was assigned. A total score for each heading was calculated by adding the score from the individual PIs. The total scores were expressed as absolute numbers and also in percentages.

Results: Out of 323 PIs, 60 duplicate inserts were excluded and the remaining 263 were used for further analysis. None of the reviewed inserts contained all the sections mentioned in the Drugs and Cosmetic Act (1940) and Rules (1945), Sections 6.2 and 6.3 of Schedule D (II). The indications and generic name were found in all the PIs (100%). The information given in Section 6.2 was present in 75-95% of PIs. Whereas, antidote for overdosing was mentioned in only 39% of PIs. A wide discrepancy of data was noted in Section 6.3 which mandates the pharmaceutical information. Special precautions for the storage were mentioned in 86% and the nature, and the specifications of the container were mentioned in 90% of PIs.

Conclusion: From the study, it was concluded that none of the PIs were complete as per the Indian regulatory guidelines. Accurate drug product information is important for safe and effective use of medicines. Hence, the regulators should ensure that accurate and up to date product information is provided in PIs.

Key words: Drugs and Cosmetic Act; Package Inserts; Therapeutic Indications

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