CDSCO警报：2018年至2023年向制药公司发布的质量控制警报的回顾性剂型分析。

IF 3 4区医学 Q1 MEDICINE, LEGAL

Regulatory Toxicology and Pharmacology Pub Date : 2025-02-01 DOI:10.1016/j.yrtph.2025.105775

Akanksha Dashawant , Richa Khadke , Amol Shete , Vinod Gaikwad

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引用次数: 0

摘要

本研究综合分析了2018 - 2023年中央药品标准控制组织（CDSCO）发布的药品警报，重点分析了各种药品剂型及相关质量控制参数。通过对警报进行分类和单独计数，该研究确定了普遍存在的质量问题及其对特定剂型的影响。片剂、肠外制剂、胶囊和糖浆是最常收到警报的类别，而祛痰剂、漱口水和酊剂收到的警报较少。这项研究强调了严格的检测方案和持续警惕在保持药品质量方面的重要性。建议包括印度制造商采用全球标准质量措施，以确保药品安全性和有效性，最终使患者和卫生保健系统受益。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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

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.

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来源期刊

Regulatory Toxicology and Pharmacology 医学-毒理学

CiteScore

6.70

自引率

8.80%

发文量

147

审稿时长

58 days

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)