COMPARATIVE STUDY OF PATIENT PACKAGE INSERT OF MARKETED BRANDS OF ANTIBIOTIC EYE DROPS
Keywords:Package insert, Drugs and cosmetic act, Antibiotic Eye drop
Objective: In Indian scenario, there is a huge gap between the patient and health care workers leading to self-medication practices, antibiotic resistance, and adverse drug reactions. These emerging issues aggravate the need of providing a detailed package inserts (PI) in every drug formulations. Hence, this study was conducted with the objective to assess the completeness of a package insert and evaluate the content of information in PI among national and international pharmaceutical brands.
Methods: A prospective, cross-sectional, and observational study was conducted over 50 PI belonging to different class of antibiotic eye drops and same antibiotic from different pharmaceutical companies. Medication belonged to both international and national pharmaceutical companies and they were evaluated according to standards laid down by Drugs and Cosmetic Act (1940) and Rules (1945) covered under the section 6.2 and 6.3.
Results: The content of information was haphazard in both national and international PI but international PI was more valuable. International PI had clear information regarding warning and precautions and adverse effects. List of excipients, shelf life, storage indication, and handling were very well demarcated in both the level of pharmaceuticals.
Conclusions: The study revealed major lacunae in the context of package insert with reference to prevailing guidelines. The most of the brands did not have PI and the quality of information in package insert of international brand was more superior to national brands.
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