{"title":"CDSCO alerts: A retrospective dosage form - Wise analysis of quality control alerts issued to pharmaceutical companies from 2018 to 2023","authors":"Akanksha Dashawant , Richa Khadke , Amol Shete , Vinod Gaikwad","doi":"10.1016/j.yrtph.2025.105775","DOIUrl":null,"url":null,"abstract":"<div><div>This study comprehensively analyses drug alerts issued by the Central Drugs Standard Control Organization (CDSCO) from 2018 to 2023, focusing on various pharmaceutical dosage forms and related quality control parameters. By categorizing alerts and counting them individually, the research identifies prevalent quality issues and their impact on specific dosage forms. Tablets, parenteral formulations, capsules, and syrups were among the most frequently alerted categories, while expectorants, mouthwashes, and tinctures received fewer alerts. The study underscores the importance of rigorous testing protocols and continuous vigilance in maintaining pharmaceutical quality. Recommendations include adopting global standard quality measures by Indian manufacturers to ensure pharmaceutical safety and efficacy, ultimately benefiting patients and healthcare systems.</div></div>","PeriodicalId":20852,"journal":{"name":"Regulatory Toxicology and Pharmacology","volume":"156 ","pages":"Article 105775"},"PeriodicalIF":3.0000,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Regulatory Toxicology and Pharmacology","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0273230025000054","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"MEDICINE, LEGAL","Score":null,"Total":0}
引用次数: 0
Abstract
This study comprehensively analyses drug alerts issued by the Central Drugs Standard Control Organization (CDSCO) from 2018 to 2023, focusing on various pharmaceutical dosage forms and related quality control parameters. By categorizing alerts and counting them individually, the research identifies prevalent quality issues and their impact on specific dosage forms. Tablets, parenteral formulations, capsules, and syrups were among the most frequently alerted categories, while expectorants, mouthwashes, and tinctures received fewer alerts. The study underscores the importance of rigorous testing protocols and continuous vigilance in maintaining pharmaceutical quality. Recommendations include adopting global standard quality measures by Indian manufacturers to ensure pharmaceutical safety and efficacy, ultimately benefiting patients and healthcare systems.
期刊介绍：
Regulatory Toxicology and Pharmacology publishes peer reviewed articles that involve the generation, evaluation, and interpretation of experimental animal and human data that are of direct importance and relevance for regulatory authorities with respect to toxicological and pharmacological regulations in society. All peer-reviewed articles that are published should be devoted to improve the protection of human health and environment. Reviews and discussions are welcomed that address legal and/or regulatory decisions with respect to risk assessment and management of toxicological and pharmacological compounds on a scientific basis. It addresses an international readership of scientists, risk assessors and managers, and other professionals active in the field of human and environmental health.
Types of peer-reviewed articles published:
-Original research articles of relevance for regulatory aspects covering aspects including, but not limited to:
1.Factors influencing human sensitivity
2.Exposure science related to risk assessment
3.Alternative toxicological test methods
4.Frameworks for evaluation and integration of data in regulatory evaluations
5.Harmonization across regulatory agencies
6.Read-across methods and evaluations
-Contemporary Reviews on policy related Research issues
-Letters to the Editor
-Guest Editorials (by Invitation)
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