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Review
. 2023 Dec;31(12):101825.
doi: 10.1016/j.jsps.2023.101825. Epub 2023 Oct 17.

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

Gaurav Pratap Singh Jadaun  1 , Shruti Rastogi  1 , Amit Kumar  1 , Jaishiv Chauhan  1 , Surendra Kumar Sharma  1 , Mukesh Kumar  1 , Pawan Kumar Saini  1 , Ritu Tiwari  1 , Rajeev Singh Raghuvanshi  1
Affiliations
Review

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

Gaurav Pratap Singh Jadaun et al. Saudi Pharm J. 2023 Dec.

Abstract

India has a sparkling pharmaceutical sector that holds a distinguished place by producing and supplying high-quality 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.

Keywords: Active pharmaceutical ingredients; Finished pharmaceutical preparations; Indian pharmacopoeia; Monograph; Reference standards.

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Conflict of interest statement

The authors declare no conflict of interest. The views expressed in this article are the personal views of the authors. They shall not be understood or quoted as being made on behalf of or reflecting the position of the Indian Pharmacopoeia.

Figures

Fig. 1
Fig. 1
History of the publication of IP editions.
Fig. 2
Fig. 2
Monograph status in IP editions since 2007.
Fig. 3
Fig. 3
Status of monographs in IP 2022. a. Category-wise distribution of IP monographs; b. Newly added monographs; c. Revised monographs.
See this image and copyright information in PMC

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