Assessment of compliance to packaging and labeling regulatory requirements of locally manufactured alcohol-based hand sanitizers marketed in Addis Ababa, Ethiopia

• Main Authors: Tesfa Marew Wallelign (Author), Muluken Nigatu Selam (Author), Gebremariam Birhanu Wondie (Author), Bruck Messele Habte (Author)
• Format: Book
• Published: Taylor & Francis Group, 2022-12-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.
• Notes: 2052-3211; 10.1186/s40545-022-00456-6
• Keywords: hand sanitizers; labeling requirements; packaging requirements; regulatory compliance; Therapeutics. Pharmacology; RM1-950; Pharmacy and materia medica; RS1-441
• Source: Journal of Pharmaceutical Policy and Practice, Vol 15, Iss 1 (2022)

Background Following the emergence of the global Coronavirus Disease-2019 (COVID-19) pandemic, alcohol-based hand sanitizers (ABHS) have been extensively used as one of the effective methods of preventing its transmission. The products are dispensed over the counter and used by the general population. Growing concerns have been reported, however, regarding the quality, efficacy and compliance to regulatory requirements calling for objective evidence that can facilitate proactive regulatory measures. Objectives The study aimed at assessing the level of compliance to packaging and labeling regulatory requirements of selected locally manufactured ABHS products marketed in Addis Ababa, Ethiopia. Methods A cross-sectional study design was employed to randomly collect 25 locally manufactured ABHS products from retail outlets located in Addis Ababa. The manufacturers were grouped under four categories considering their experience in manufacturing, resources and technical capacities. The collected samples were evaluated for compliance to packaging and labeling information regulatory requirements and the results subjected to descriptive analysis. Results Majority of the products were found to meet most of the packaging, general product description and manufacturer-related information requirements. However, concerning gaps were observed in storage, precaution and warning-related labeling information requirements. The overall compliance of the selected products (to a total of 29 requirements under 5 categories) was 56.9%. The highest level of compliance was for general product information requirements (80.2%) followed by packaging and manufacturer-related requirements accounting for 76.8% and 75.0%, respectively. Low level of compliance was observed for storage condition and precautions (10.2% and 42.4%, respectively). Better overall compliance to packaging and labeling requirements (62.9%) were observed by large pharmaceutical and cosmetics manufacturers, while the lowest compliance level was recorded for medium level pharmaceuticals and cosmetics manufacturers. Conclusions Even though most of the selected products were able to comply with the majority of packaging, product description and manufacturer-related requirements, gaps were observed in essential labeling information requirements. Considering the extensive use of ABHS products among diverse population groups and the potential risks associated with inappropriate use of the products, improving regulatory law enforcement practices, strengthening continuing education of manufacturing personnel and raising public awareness is very timely.