Abstract

ANALYSIS OF DRUG PACKAGE INSERTS IN SOUTHERN ASSAM, INDIA

Neeraj Sinha*, Dolly Roy and Sarajita Barman

ABSTRACT

Background: The package insert (PI) of a drug plays a crucial role as an information source for both the doctors and patients. The PI is supposed to provide detailed information in relation to the drug, thus helping the patients to have extra awareness about the drug. Methods: 100 PIs were collected from the Central Medical Store of and various departments of Silchar Medical College & Hospital and evaluated according to the Drugs and Cosmetics Act (1940) and Rules (1945), Sections 6.2 and 6.3 of Schedule D (II). Results: 99% of the PIs provided the posology and method of administration of the drug. 82% PIs gave information regarding the contraindications. 99% PIs gave information about precautions and special warnings. 89% PIs gave information about various interactions of the drug with other medications. Conclusions: There is a diversity of information present on the PIs of drugs which are present in the Indian market. The PIs must be thoroughly analysed in terms of completeness before marketing of the drug respectively.

Keywords: Package insert, Drug, Schedule D, Posology, Shelf Life.