Compliance with pharmacopeial standards is mandatory to ensure the quality, safety, and efficacy of medicines. In India, allopathy, Ayurveda, Siddha, Unani, and homeopathy are the recognized systems of medicine and come under the provisions of different regulations. Promulgation of the “Drugs and Cosmetics Act, 1940” and the rules thereunder provide a regulatory framework for medicines of all of these systems and also prescribe “Pharmacopoeia and Formularies” for regulatory quality standards. Unlike in many other countries, the Act prescribes independent pharmacopeias for each system of medicine. The Unani Pharmacopoeia of India (UPI) and the National Formulary of Unani Medicine are the regulatory compendia for quality standards and manufacturing of Unani medicines, respectively. The Pharmacopoeia consists of Part I (single drugs) and Part II (formulations). Unani medicines are presented as classical or patent and proprietary formulations prepared using single ingredients or multiple ingredients of plant, animal, mineral, and/or metal origin. UPI Part I is published in six volumes comprising 298 monographs on Unani drugs derived from plants (single drugs). Part II is published in three volumes encompassing formulations, standard operating procedures, and quality standards for 150 classical formulations of Unani medicines, which are chosen from the National Formularies of Unani Medicine. The National Formulary of Unani Medicine is published in six parts comprising 1229 formulations of Unani medicines. Each monograph of the Pharmacopoeia provides specific analytical parameters and limits (standards) to ensure the quality of drugs or medicines. This communication reviews the UPI, the National Formulary of Unani Medicine, regulatory quality standards (parameters), and analytical techniques adopted for pharmacopeial standards of Unani drugs and medicines.

中文翻译：

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Unani药品质量控制的法规要求。

必须遵守药典标准，以确保药物的质量，安全性和有效性。在印度，同种疗法，阿育吠陀，悉达，乌纳尼和顺势疗法是公认的医学系统，属于不同法规的规定。《 1940年药品和化妆品法》的颁布及其中的规定为所有这些系统的药品提供了监管框架，并为监管质量标准规定了“药典和配方”。与许多其他国家不同，该法对每种药物系统都规定了独立的药典。印度的Unani药典（UPI）和国家Unani药典分别是质量标准和Unani药物生产的法规纲要。药典由第一部分（单一药物）和第二部分（配方）组成。Unani药物以使用植物，动物，矿物和/或金属来源的单一成分或多种成分制备的经典或专利和专有配方形式提供。UPI第I部分共分六卷出版，其中包括298部有关植物来源的Unani药物（单一药物）的专着。第二部分分三册出版，涵盖了150种经典的Unani药物配方，标准操作程序和质量标准，这些均选自《 Unani Medicine国家配方》。《乌纳尼医学国家处方》分六部分出版，包括1229种乌纳尼药物配方。每本药典专着都提供了特定的分析参数和限值（标准），以确保药物或药品的质量。本来文回顾了UPI，《乌纳尼医学国家处方》，监管质量标准（参数）以及乌纳尼药物和药物的药典标准采用的分析技术。