Medication package inserts: how far do they adhere to the guidelines?

Neha Deep, Roslin Jose, Ananya Chakrabo


Background: Package Insert (PI) is a document that is provided with the package of a drug. It is chiefly directed at the prescribers and is set to provide information for the safe and effective use of the respective drug. This study was conducted to assess the completeness of clinical information provided in the currently available PIs.

Methods: PIs were collected from pharmacies located at various parts of Bangalore over three months. A total of 310 drugs were checked for package inserts (PI) and 192 PI’s were collected. They were analysed based on the criteria mentioned in Schedule D of Drug and Cosmetic act 1945.

Results: Out of 192 PIs, 33 were repeated and so were not taken into account. Hence, 159 PIs were analysed. Among 159 PIs, 43 (27.04%) were of Cancer chemotherapy drugs; 19 (11.94%) of antibiotics, 18 of anti-diabetic drugs, 13 (8.17%) of Vitamins and minerals, 10 (6.28%) of Cardiac drugs, 9 (5.66%) of Respiratory drugs, 6 (3.77%) of CNS drugs, 5 (3.14%) of Ophthalmic eye solutions, 4 (2.51%) of Hormones and reproductive system, 4 (2.51%) of GIT, 4 (2.51%) of Antifungals, 3 (1.88%) of steroids, and 21 (13.20%) of miscellaneous drugs respectively. Out of them, the PIs that belonged to “A”, “B”, and “C” categories were 5 (3.14%), 150 (94.33%), and 4 (2.51%) respectively. It was observed that the PIs were inadequate in many aspects. Majority of the PIs had unclear instructions about drug usage, special precautions, ability to drive and use machines and adverse effects to name a few.

Conclusions: This study showed that many of the drugs now days come without PI. Also of the available ones, very few fulfil all the criteria mentioned in the guidelines. With the growing sales of over the counter drugs in India, it is important for companies to dispense PIs with all the drugs. PIs oriented toward educating the patient are the need of the hour.


Drug information, Package insert, Prescription label

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