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DOI 10.1016/j.yrtph.2025.105775

Медицинская библиотека · Regulatory toxicology and pharmacology : RTP · 2025

CDSCO alerts: A retrospective dosage form - Wise analysis of quality control alerts issued to pharmaceutical companies from 2018 to 2023.

Dashawant Akanksha, Khadke Richa, Shete Amol, Gaikwad Vinod

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Аннотация

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.

Для цитирования: Dashawant Akanksha, Khadke Richa, Shete Amol, Gaikwad Vinod. CDSCO alerts: A retrospective dosage form - Wise analysis of quality control alerts issued to pharmaceutical companies from 2018 to 2023.. Regulatory toxicology and pharmacology : RTP. 2025. DOI: 10.1016/j.yrtph.2025.105775.

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