COMPARATIVE STUDY OF PATIENT PACKAGE INSERT OF MARKETED BRANDS OF ANTIBIOTIC EYE DROPS

GUPTA VK; DESHPANDE A; NAYAK K; JAIN N

doi:10.22159/ajpcr.2022.v15i7.45804

Authors

GUPTA VK Department of Pharmacology, Shri Shankracharya institute of Medical Sciences, Junwani, Chhattisgarh, India
DESHPANDE A Department of Ophthalmology, Shri Shankracharya institute of Medical Sciences, Junwani, Chhattisgarh, India
NAYAK K Department of Pharmacology, Shri Shankracharya institute of Medical Sciences, Junwani, Chhattisgarh, India
JAIN N Department of Ophthalmology, Shri Shankracharya institute of Medical Sciences, Junwani, Chhattisgarh, India

DOI:

https://doi.org/10.22159/ajpcr.2022.v15i7.45804

Keywords:

Package insert, Drugs and cosmetic act, Antibiotic Eye drop

Abstract

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.

Downloads

Download data is not yet available.

References

Ramdas D, Chakraborty A, Hs S, Faizan S, Kumar VP, Bn S, et al. A study of package inserts in southern India. J Clin Diagn Res 2013;7:2475-7. doi:10.7860/JCDR/2013/6353.3583, PMID 24392376.

History of FDA patient package insert requirements. Am J Hosp Pharm 1980;37:1660-1. PMID 7004180

Govt of India, Ministry of Health and Family Welfare. Drug and Cosmetic Rules 1945. p. 265. Available from: http://www.cdso.nic.in/ html/Drugs and Cosmetic act.pdf [Last accessed on 2022 May 21].

Khafeel H. Medication package inserts, concept among doctors’ pharmacists and laypersons – A beneficial guidance or a source of confusion. JMR 2016;2:62-4.

Mahatme M, Dakhale G, Hiware S, Wankhede S, Salve A, Mahatme S. Comparison of Indian package inserts in public and private sector: An urgent need for self-regulation. Int J Basic Clin Pharmacol 2013;2:165.

Shivkar YM. Clinical information in drug package inserts in India. J Postgrad Med 2009;55:104. doi:10.4103/0022-3859.52840, PMID 19550054.

Vikas, Gupta MC. Analysis of completeness of information in package inserts of Indian and foreign multinational pharmaceutical companies: An Indian perspective. Int J Basic Clin Pharmacol 2020;9:863-9.

Barkondaj B, Mukhopadhyay K, Das S, Chatterjee C, Mukherjee S, Hazra A. Information adequacy of medicine package inserts in India: A critical evaluation. Perspect Clin Res 2021;12:87-92. doi:10.4103/ picr.PICR_177_18, PMID 34012905.

Kalam A, Anwar S, Fatima A. Drug package inserts in India: Current scenario. World J Pharm Pharm Sci 2014;3:385-92.

Solanki SN, Chhaiya SB, Mehta DS, Trivedi M, Acharya T, Patel D. Analytical evaluation of drug package inserts in India. Int J Basic Clin Pharmacol 2015;4:322-4.

Sudhamadhuri A, Kalasker V. Evaluation of completeness of package inserts in south India. Int J Res Stud Biosci 2015;3:102-5.