Kanad Deepak, Ankit Gaur

First published March 2018


Background: Patient information leaflets (PILs) or drug package inserts are leaflets containing specific
information about medical conditions, doses, side effects that packed with medicines.

Objective: The objective of this study was to point out a wide-scope of improvement in manufacturer’s
way of presentation so that maximum benefits can be achieved by both the manufacturers and the

Materials & Methods: The survey was conducted in the southern region of Moga, Punjab, India over a
period from July 2017 to January 2018. Leaflets were sought from pharmacies located in the region for
drug products. The clinical information included in the package inserts was analyzed according to
Sections 6.2 and 6.3 of Schedule D of Drugs and Cosmetics Rules, 1945. The completeness of information
was verified by comparing it with product monograph. We also tried to find out the “Scope of
Improvement” of the product and scored regarding 10 different attributes under a Binary Scale Method.

Result: The 50 patient information leaflets studied included 25 oral, 15 injectable, and 10 topical
preparations marketed by 50 different pharmaceutical companies in India. None of the reviewed inserts
contained all 17 sections as required by the Drugs and Cosmetics Act. The best value of compliance was
82%. Only 16% of the inserts contained instructions for use of the medicinal product. However, shelf life
after dilution and shelf life after first opening the container was given much less importance as compared
to the shelf life as packed for sale. Incompatibilities were provided only in 30% of the inserts. In case of
“Scope of Improvement”. The obtained information content was scored out of 10 and was found to be in
the average score range of maximum 6.2 (scored by Antihypertensives) to minimum 3.4 (scored by
Vitamin Supplements).

Conclusion: Labels of medicines without sufficient information can be dangerous and inefficient in use by
the consumers. Therefore there is a need to frame strict regulations and focus on its proper
implementation to make the labels standard and of maximum-benefit both for producers and consumers.

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