Cargando…

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...

Descripción completa

Detalles Bibliográficos
Autores principales: Jadaun, Gaurav Pratap Singh, Rastogi, Shruti, Kumar, Amit, Chauhan, Jaishiv, Sharma, Surendra Kumar, Kumar, Mukesh, Saini, Pawan Kumar, Tiwari, Ritu, Raghuvanshi, Rajeev Singh
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2023
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
_version_ 1785146794505666560
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
work_keys_str_mv AT jadaungauravpratapsingh ensuringthequalityofmedicinesinindiaanupdateonthedevelopmentmodernizationandharmonizationofdrugstandardsintheindianpharmacopoeia
AT rastogishruti ensuringthequalityofmedicinesinindiaanupdateonthedevelopmentmodernizationandharmonizationofdrugstandardsintheindianpharmacopoeia
AT kumaramit ensuringthequalityofmedicinesinindiaanupdateonthedevelopmentmodernizationandharmonizationofdrugstandardsintheindianpharmacopoeia
AT chauhanjaishiv ensuringthequalityofmedicinesinindiaanupdateonthedevelopmentmodernizationandharmonizationofdrugstandardsintheindianpharmacopoeia
AT sharmasurendrakumar ensuringthequalityofmedicinesinindiaanupdateonthedevelopmentmodernizationandharmonizationofdrugstandardsintheindianpharmacopoeia
AT kumarmukesh ensuringthequalityofmedicinesinindiaanupdateonthedevelopmentmodernizationandharmonizationofdrugstandardsintheindianpharmacopoeia
AT sainipawankumar ensuringthequalityofmedicinesinindiaanupdateonthedevelopmentmodernizationandharmonizationofdrugstandardsintheindianpharmacopoeia
AT tiwariritu ensuringthequalityofmedicinesinindiaanupdateonthedevelopmentmodernizationandharmonizationofdrugstandardsintheindianpharmacopoeia
AT raghuvanshirajeevsingh ensuringthequalityofmedicinesinindiaanupdateonthedevelopmentmodernizationandharmonizationofdrugstandardsintheindianpharmacopoeia