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Ensuring the quality of medicines in India: An update on the development, modernization, and harmonization of drug standards in the Indian Pharmacopoeia
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...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Elsevier
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10641554/ https://www.ncbi.nlm.nih.gov/pubmed/37965488 http://dx.doi.org/10.1016/j.jsps.2023.101825 |
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author | Jadaun, Gaurav Pratap Singh Rastogi, Shruti Kumar, Amit Chauhan, Jaishiv Sharma, Surendra Kumar Kumar, Mukesh Saini, Pawan Kumar Tiwari, Ritu Raghuvanshi, Rajeev Singh |
author_facet | Jadaun, Gaurav Pratap Singh Rastogi, Shruti Kumar, Amit Chauhan, Jaishiv Sharma, Surendra Kumar Kumar, Mukesh Saini, Pawan Kumar Tiwari, Ritu Raghuvanshi, Rajeev Singh |
author_sort | Jadaun, Gaurav Pratap Singh |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-10641554 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Elsevier |
record_format | MEDLINE/PubMed |
spelling | pubmed-106415542023-11-14 Ensuring the quality of medicines in India: An update on the development, modernization, and harmonization of drug standards in the Indian Pharmacopoeia Jadaun, Gaurav Pratap Singh Rastogi, Shruti Kumar, Amit Chauhan, Jaishiv Sharma, Surendra Kumar Kumar, Mukesh Saini, Pawan Kumar Tiwari, Ritu Raghuvanshi, Rajeev Singh Saudi Pharm J Review 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. Elsevier 2023-12 2023-10-17 /pmc/articles/PMC10641554/ /pubmed/37965488 http://dx.doi.org/10.1016/j.jsps.2023.101825 Text en © 2023 Published by Elsevier B.V. on behalf of King Saud University. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). |
spellingShingle | Review Jadaun, Gaurav Pratap Singh Rastogi, Shruti Kumar, Amit Chauhan, Jaishiv Sharma, Surendra Kumar Kumar, Mukesh Saini, Pawan Kumar Tiwari, Ritu Raghuvanshi, Rajeev Singh Ensuring the quality of medicines in India: An update on the development, modernization, and harmonization of drug standards in the Indian Pharmacopoeia |
title | Ensuring the quality of medicines in India: An update on the development, modernization, and harmonization of drug standards in the Indian Pharmacopoeia |
title_full | Ensuring the quality of medicines in India: An update on the development, modernization, and harmonization of drug standards in the Indian Pharmacopoeia |
title_fullStr | Ensuring the quality of medicines in India: An update on the development, modernization, and harmonization of drug standards in the Indian Pharmacopoeia |
title_full_unstemmed | Ensuring the quality of medicines in India: An update on the development, modernization, and harmonization of drug standards in the Indian Pharmacopoeia |
title_short | Ensuring the quality of medicines in India: An update on the development, modernization, and harmonization of drug standards in the Indian Pharmacopoeia |
title_sort | ensuring the quality of medicines in india: an update on the development, modernization, and harmonization of drug standards in the indian pharmacopoeia |
topic | Review |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10641554/ https://www.ncbi.nlm.nih.gov/pubmed/37965488 http://dx.doi.org/10.1016/j.jsps.2023.101825 |
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