Analysis of the drug package inserts in India as per the CDSCO guidelines

Ansh P. Vyas; Alpa P. Gor

doi:10.18203/2319-2003.ijbcp20251060

Authors

Ansh P. Vyas Department of Pharmacology, Pramukhswami Medical College, Karamsad, Anand, Gujarat, India
Alpa P. Gor Department of Pharmacology, Pramukhswami Medical College, Karamsad, Anand, Gujarat, India

DOI:

https://doi.org/10.18203/2319-2003.ijbcp20251060

Keywords:

Package inserts, Healthcare professionals, Central drugs standard control organisation guidelines, Accessibility, Knowledge

Abstract

Background: The package insert (PI) is provided along with the drug in its manufactured container by pharmaceutical companies. This is one of the ways to provide essential information related to drugs to healthcare professionals and patients. Pharmaceuticals follow the regulations mentioned in the drugs and cosmetics act (1940) and rules (1945) under Schedule D and the central drugs standard control organisation (CDSCO).

Methods: A cross-sectional, observational, prospective study was conducted at Shree Krishna Hospital, Anand, Gujarat. From December 2023 to January 2024, a total of 98 PIs were collected from pharmacy stores within the hospital. All PIs were analyzed according to CDSCO guidelines.

Results: A total of 98 PIs were analyzed. After the analysis,>90% of the information is present in half of the parameters. There is 25-65% information present regarding the drug details in the rest of the parameters.

Conclusions: Our study has revealed that the information on package inserts is currently inaccessible. If drug companies can present this crucial information in a manner that is easily accessible to patients, it has the potential to greatly improve compliance. In our country, where concerns regarding the quality of medicines arise, implementing high-quality package inserts can effectively address these concerns.

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References

Ved JK. Package Inserts in India: Need for a Revision. Int J Pharma Sci Res. 2010;1(11):454–6.

Government of India ministry of health and family welfare (department of health) the drugs and cosmetics act and rules. Available at: http://naco.gov.in/sites. Accessed on 21 November 2024.

Rajan M, Sreedhar, Khan S, Thiyagu R, Rao P. Information seeking behaviour of clinicians in a semi urban town in southern India. J Clin Diagnostic Res. 2008;2(2):1069–73.

Morris LA. Patient package inserts: a new tool for patient education. Public Health Rep. 1977;92(5):421–4.

Chhaya MU. Analysis of package inserts of orally administered drugs available in the Indian market. Int J Res Med Sci. 2017;5(2):529. DOI: https://doi.org/10.18203/2320-6012.ijrms20170145

Sudha M, Viveka S, Remya S, Udupa A. Drug package inserts: how accessible is the information? Int J Basic Clin Pharmacol. 2015;4(6):1132–5. DOI: https://doi.org/10.18203/2319-2003.ijbcp20151346

Hotha PP, Tanna PJ. An audit of drug package insert: a survey-based study in India. Int J Basic Clin Pharmacol. 2017;6(3):629. DOI: https://doi.org/10.18203/2319-2003.ijbcp20170826

Govindadas D, Somashekara SC, Ramesh P, Meghavani G. Evaluation of completeness of package inserts in South India. Natl J Physiol Pharm Pharmacol. 2016;6(6):500–4. DOI: https://doi.org/10.5455/njppp.2016.6.0514104062016

Patel KN, Shah P, Vyas P. A study of package inserts: how accurate is the information provided. Asian J Pharm Clin Res. 2024;17(9):41–4. DOI: https://doi.org/10.22159/ajpcr.2024v17i9.51724