Analysis of completeness of information in package inserts of Indian and foreign multinational pharmaceutical companies: an Indian perspective

Authors

  • Vikas . Department of Pharmacology, Pt. BD Sharma PGIMS, Rohtak, Haryana
  • Mahesh Chander Gupta Department of Pharmacology, Pt. BD Sharma PGIMS, Rohtak, Haryana

DOI:

https://doi.org/10.18203/2319-2003.ijbcp20202172

Keywords:

Package insert, Schedule D, Regulatory

Abstract

Background: A package insert (PI) should contain all the information required for safe and effective use of the medicine. The present study evaluated and compared the completeness of information in package inserts of Indian and foreign multinational pharmaceutical companies based in India.

Methods: A total 150 PI’s consisting of 75 package inserts of Indian and foreign multinational pharmaceutical companies in India were collected and analyzed based on the criteria of Indian drugs and cosmetics rules, 1945 under section 6.2, 6.3 of schedule D, which consists of 25 parameters. Each criteria was scored for presence of information as ‘1’, absence as ‘0’. Total score was 25, score >20 was graded as ‘A’, 10-20 as ‘B’ and <10 as ‘C’. Data was expressed as numbers and percentage.

Results: Total 150 PI evaluated included antimicrobials, antipsychotics etc. Out of all the PIs 26% belonged to grade A, 70% belonged to grade B and 4% belonged to grade C. Lack of information was found in both the categories of PIs. Foreign PIs performed better in comparison to Indian PIs as in grade A, 27 out of 41 PIs were foreign whereas 56 PI’s in grade B were Indian and 47 were foreign. Both categories of PI showed good information about active ingredient, dosage form, warnings, contraindications and lacked information about retail price and references etc.

Conclusions: Both categories of PIs were deficient in completeness of information. The pharmaceutical companies, both national and foreign, must provide the information as per regulatory norms.

 

Author Biography

Vikas ., Department of Pharmacology, Pt. BD Sharma PGIMS, Rohtak, Haryana

Resident, Department of Pharmacology. PGIMS, Rohtak

References

India New Delhi: Government of India. Ministry of Health and Family welfare: National Health Accounts; 2006.

Berman A. Reducing medication errors through naming, labeling, and packaging. J Med Syst. 2004;28(1):9-29.

Vinker S, Eliyahu V, Yaphe J. The effect of drug information leaflets on patient behavior. Isr Med Assoc J. 2007;9(5):383-6.

Khafeel H. Medication Package inserts, concept among doctors’ pharmacists and laypersons-A beneficial guidance or a source of confusion. JMR. 2016;2(3):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(2):104.

Research C for DE and the FDA Announces New Prescription Drug Information Format FDA 3rd Nov 2018. Available at: http://www.fda.gov/drugs/laws-acts-and-rules/fda-announces-new-prescription-drug-information-format. Accessed on 19th December 2019.

Sawalha A, Sweileh W, Zyoud S, Jabi S. Comparative Analysis of Patient Package Inserts of Local and Imported Anti-Infective Agents in Palestine. Libyan J Med. 2008;3(4):181-5.

Joubert PH, Skene D. Attitudes of private medical practitioners towards package inserts and other drug information sources. South Afr Med J Suid-Afr Tydskr Vir Geneeskd. 1984;66(8):306-7.

Fuchs J, Hippius M, Schaefer M. Analysis of German package inserts. Int J Clin Pharmacol Ther. 2006;44(1):8-13.

Manali M, Mahajan, Dudhgaonkar S, Swapnil N, Sachin K, Deshmukh, et al. Analysis of completeness of drug package inserts available in pharmacies of central India. Eur J Pharm Med Res. 2016;3(1):273-7.

Narzaree P, Gupta MC. A critical appraisal of medication package inserts. IJPR. 2015;5(10):226-30.

Ramdas D, Chakraborty A, Faizan S, Kumar VP. A Study of Package Inserts in Southern India. J Clin Diagn Res. 2013;7(11):2475-7.

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Published

2020-05-21

How to Cite

., V., & Gupta, M. C. (2020). Analysis of completeness of information in package inserts of Indian and foreign multinational pharmaceutical companies: an Indian perspective. International Journal of Basic & Clinical Pharmacology, 9(6), 863–869. https://doi.org/10.18203/2319-2003.ijbcp20202172

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Original Research Articles