Unlocking the benefits of Drug Master File filing in the Indian pharmaceutical industries.

IF 1.4 4区医学 Q4 PHARMACOLOGY & PHARMACY

Indian Journal of Pharmacology Pub Date : 2024-09-01 Epub Date: 2024-12-16 DOI:10.4103/ijp.ijp_297_23

Rahul Pathak, Rajat Singal, Sandip Mitra, Sanjay Koul, Supriya Sharma

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引用次数: 0

Abstract

Abstract: Ensuring the safety and quality of drugs is a crucial component for the development of any pharmaceutical industry. This requires stringent regulation in the process of drug manufacturing and marketing. A Drug Master File (DMF) serves as a comprehensive document containing information about the quality, safety, and manufacturing procedure/facility of a drug or drug substance. Many countries with highly regulated markets use the DMF system extensively to protect their intellectual property rights while providing accurate and detailed information about their products to regulatory bodies. In India, the regulatory body, the Central Drug Standard Control Organization, does not currently mandate the submission of a DMF. However, adopting a DMF system may have immense benefits to regulatory bodies, pharmaceutical industries, as well as to patients. This review aims to provide a comprehensive overview of DMF and highlight the significance of its adoption in India.

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解锁药品主文件在印度制药业备案的好处。

摘要：确保药品的安全和质量是任何制药业发展的关键要素。这就要求对药品生产和营销过程进行严格监管。药品主文件（DMF）是一份包含药品或药物的质量、安全性和生产程序/设施等信息的综合文件。许多市场监管严格的国家广泛使用 DMF 系统来保护其知识产权，同时向监管机构提供有关其产品的准确而详细的信息。在印度，监管机构--中央药品标准控制组织--目前并不强制要求提交 DMF。然而，采用 DMF 系统可能会给监管机构、制药行业以及患者带来巨大的好处。本综述旨在全面概述 DMF，并强调在印度采用 DMF 的重要意义。

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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来源期刊

Indian Journal of Pharmacology 医学-药学

CiteScore

4.00

自引率

4.20%

发文量

审稿时长

4-8 weeks

期刊介绍： Indian Journal of Pharmacology accepts, in English, review articles, articles for educational forum, original research articles (full length and short communications), letter to editor, case reports and interesting fillers. Articles concerning all aspects of pharmacology will be considered. Articles of general interest (e.g. methods, therapeutics, medical education, interesting websites, new drug information and commentary on a recent topic) are also welcome.