A Comparative Study of United States and Developing Countries Recall Procedures and Regulations for Drug Products

Author(s)	Mr. Bane Singh Rajput, Prof. Dr. Mukesh Kumar Gupta
Country	India
Abstract	Drug product recalls are critical pharmacovigilance tools that protect public health by removing unsafe or defective medicines from the market. The United States operates under a highly structured and science-driven recall system led by the U.S. Food and Drug Administration, whereas developing countries often face regulatory, infrastructural, and compliance challenges. This study comparatively evaluates recall procedures, regulatory frameworks, classification systems, communication mechanisms, and effectiveness between the U.S. and developing countries. The analysis reveals significant disparities in regulatory enforcement, surveillance capacity, and recall efficiency, while highlighting emerging trends in harmonization. The study proposes innovative strategies for strengthening recall systems globally, including in developing countries.
Keywords	Drug Recall, USFDA, Drug Regulatory Affairs, Developing Countries, CDSCO.
Field	Medical / Pharmacy
Published In	Volume 17, Issue 2, April-June 2026
Published On	2026-04-25
DOI	https://doi.org/10.71097/IJSAT.v17.i2.10900

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International Journal on Science and Technology