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INTERNATIONAL JOURNAL OF PHARMACEUTICAL RESEARCH

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IJPR included in UGC-Approved List of Journals - Ref. No. is SL. No. 4812 & J. No. 63703

Published by : Advanced Scientific Research
ISSN
0975-2366
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IJPR 9[3] July - September 2017 Special Issue

July - September 9[3] 2017

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Article Detail

Label
Label
Evaluation of Drug Package Inserts in Malaysia

Author: HEETHAL JAIPRAKASH, AMEETA PATIL, VEENA JOSHI, GAURI KRISHNASWAMY, SUNIL KALE
Abstract: This study aimed to analyse the completeness of the information provided in the package insert as per the Asean labelling guidelines and to compare it between local and multinational companies. Three hundred twelve package inserts(PI) were collected from one of the largest pharmacies in Malaysia. The PIs were analysed based on the Asean labelling requirements for Malaysia, and we looked into 18 requirements. Descriptive statistics were used to analyse the data. Among 292 PIs investigated we found that 64 PIs were from local companies and 228 from multinational companies. PIs analysed were maximum for antihypertensive drugs (24%) followed by antihistamines (14%), endocrine drugs (12%) and chemotherapeutic agents (11%), most of the formulations were tablets (93%). All the PIs had a product name, dosage form, name of the active ingredient and the strength of the drug. The route of administration was not mentioned in 1% of the PIs. None of the PIs had the manufacturing and expiry dates. The words ‘Keep medicine out of reach of children’ was absent in 70% of the PIs, out which most were from multinational companies. Not all relevant information was mentioned in the package inserts. Multinational companies followed the labelling guidelines better than the local companies.
Keyword: Drugs, Package insert, Labelling, Malaysia
DOI: https://doi.org/10.31838/ijpr/2020.12.03.051
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0.12
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