Ensuring the quality of medicines in India: An update on the development, modernization, and harmonization of drug standards in the Indian Pharmacopoeia

被引:0
|
作者
Jadaun, Gaurav Pratap Singh [1 ]
Rastogi, Shruti [1 ]
Kumar, Amit [1 ]
Chauhan, Jaishiv [1 ]
Sharma, Surendra Kumar [1 ]
Kumar, Mukesh [1 ]
Saini, Pawan Kumar [1 ]
Tiwari, Ritu [1 ]
Raghuvanshi, Rajeev Singh [1 ]
机构
[1] Govt India, Indian Pharmacopoeia Commiss, Minist Hlth & Family Welf, Sect 23,Raj Nagar, Ghaziabad 201002, India
关键词
Active pharmaceutical ingredients; Finished pharmaceutical preparations; Indian pharmacopoeia; Monograph; Reference standards;
D O I
10.1016/j.jsps.2023.101825
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
India has a sparkling pharmaceutical sector that holds a distinguished place by producing and supplying highquality and affordable medicines across the globe. Ensuring the quality and safety of the marketed medicinal products is one of the most important components of the drug regulatory framework and assessment of the quality of medicines is usually achieved by referring to the public standards of the official Pharmacopoeia. In India, the Indian Pharmacopoeia (IP) is published at regular intervals to fulfill the requirements of the Drugs and Cosmetics Act, 1940 to ensure the quality of medicines being manufactured and/or marketed in India. The present article aims to provide an overview of the history of the IP, its standards-setting process, and the current status of monographs in the 9th edition of the IP 2022. Special focus is placed on the newly added and upgraded general chapters and monographs within the IP 2022. There are a total of 223 general chapters and 3152 drug monographs available under various categories in the IP 2022. This study also highlights a total of 92 new drug monograph additions and 412 monograph revisions in the IP 2022. It is anticipated that the standards laid down in the IP 2022 will play an imperative role in delivering quality medicines to patients within and outside India.
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页数:7
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