A Critical Analysis Study of Pharmacological and Clinical Information Provided in Drug Package Inserts Based on Drugs and Cosmetics Rules Guidelines

Document Type : Original Article

Authors

1 Assistant Professor of Pharmacology, Government Kilpauk Medical College, Chennai-600 010 Tamilnadu,India

2 Assistant Professor of Pharmacology, Government Kilpauk Medical College, Chennai-600010, Tamilnadu, India

10.22038/psj.2021.58640.1332

Abstract

Introduction:
Drug package inserts are officially approved documents provided along with the drugs by the drug marketing company. They act as an important source of information about the drug for both patients and physicians, which helps in proper administration and improving the safe use of medications. The pharmacological and clinical information presented in them for its consistency and completeness were analyzed in this study.
Materials and Methods:
The drug package inserts were collected and analyzed for the pharmacological and clinical information, based on the headings under Section 6.2 & Section 6.3 mentioned in Schedule D of Drugs and Cosmetics Act and Rules, 1945. The drug package inserts that were analyzed in this study included different drug formulations and drugs belonging to different systems.
Results:
This study shows that the generic name, the brand name of the drug, its active ingredient, therapeutic uses, dosage form, and manufacturer details are present in all the package inserts (100%). But details about safety and precautions are given only in about 90%. Information about pharmacokinetics, pharmacodynamics, pharmaceutical particulars, and the antidote for drug overdose are missing in many package inserts.
Conclusion:
From our study, we conclude that a majority of the package inserts provide adequate details regarding key information. However, we recommend mentioning the approximate cost of the drug, references for the information provided in it, along with the Toll-free number of the Pharmacovigilance Programme of India (PVPI) for reporting adverse drug effects.

Keywords