Abstract

A RECENT STUDY ON PHARMACEUTICAL DRUG RECALL OF DIFFERENT REGIONS WORLDWIDE

Ronak Drall, Sonam, Preeti, Manjul Pratap Singh and Lalit Rana*

ABSTRACT

In order to assess drug recalls that have taken place in the last five years, including 2025, the current study details pharmaceutical drug recalls in six distinct countries. The laws governing drug recalls vary from nation to nation. A drug product recall occurs when a batch or a complete production run of a drug product is pulled out of distribution or returned to the manufacturer. Usually, it is carried out because of inadequacies in efficacy, safety, and quality. In Australia, section 65F of the Trade Practices Act of 1974 outlines procedures for drug product recalls. It falls under section 25 of the Natural Health Products Regulations (NHPR) in Canada. Guidelines for drug product recalls in the United States are outlined in 21 CFR Parts 7, 107, and 1270. In India, it falls under category M, paragraphs 27 and 28. Drug product recall regulations in South Africa are governed by guidelines issued by the South African Health Products Regulatory Authority, or SAHPRA. Drug product recall regulations in China are governed by the National Medical Products Administration's (NMPA) guidelines. The majority of medication recalls in the US happen for a variety of reasons. We can infer from the observation that there have been fewer recalls in Australia and Canada over the past five years.

Keywords: India, China, USFDA, South Africa, Canada, Australia, Drug recall.