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Regulatory enforcement of the marketing of fixed-dose combinations in India: a case study of systemic antibiotics
BACKGROUND: In India, states have licensed the manufacture of large numbers of fixed-dose combination (FDC) drugs without the required prior approval of the central regulator. This paper describes two major regulatory initiatives to address the problem, which began in 2007 and 2013, and examines whe...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BioMed Central
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10636890/ https://www.ncbi.nlm.nih.gov/pubmed/37950272 http://dx.doi.org/10.1186/s40545-023-00644-y |
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author | Brhlikova, Petra Mehta, Aashna McGettigan, Patricia Pollock, Allyson M. Roderick, Peter Farooqui, Habib Hasan |
author_facet | Brhlikova, Petra Mehta, Aashna McGettigan, Patricia Pollock, Allyson M. Roderick, Peter Farooqui, Habib Hasan |
author_sort | Brhlikova, Petra |
collection | PubMed |
description | BACKGROUND: In India, states have licensed the manufacture of large numbers of fixed-dose combination (FDC) drugs without the required prior approval of the central regulator. This paper describes two major regulatory initiatives to address the problem, which began in 2007 and 2013, and examines whether they have been sufficient to remove centrally unapproved systemic antibiotic FDCs from the market. METHODS: Information was extracted from documents published by the central regulator and the ministry of health, including the National List of Essential Medicines (NLEM), and court judgments, and analysed alongside sales volume data for 2008–2020 using PharmaTrac market dataset. RESULTS: The regulatory initiatives permitted 68 formulations to be given de facto approvals (‘No Objection Certificates’) outside the statutory regime, banned 46 FDCs and restricted one FDC. Market data show that FDCs as a proportion of total antibiotic sales increased from 32.9 in 2008 to 37.3% in 2020. The total number of antibiotic FDC formulations on the market fell from 574 (2008) to 395 (2020). Formulations with a record of prior central approval increased from 86 (2008) to 94 (2020) and their share of the antibiotic FDC sales increased from 32.0 to 55.3%. In 2020, an additional 23 formulations had been permitted de facto approval, accounting for 10.6% of the antibiotic FDC sales. Even in 2020, most marketed formulations (70.4%, 278/395) were unapproved or banned, and comprised a 15.9% share of the antibiotic FDC sales. The share of NLEM-listed antibiotic FDC sales increased from 21.2 (2008) to 26.7% (2020). CONCLUSION: The initiatives had limited impact. Regulatory enforcement has been slow and weak, with many unapproved, and even banned, FDCs remaining on the market. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s40545-023-00644-y. |
format | Online Article Text |
id | pubmed-10636890 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-106368902023-11-11 Regulatory enforcement of the marketing of fixed-dose combinations in India: a case study of systemic antibiotics Brhlikova, Petra Mehta, Aashna McGettigan, Patricia Pollock, Allyson M. Roderick, Peter Farooqui, Habib Hasan J Pharm Policy Pract Research BACKGROUND: In India, states have licensed the manufacture of large numbers of fixed-dose combination (FDC) drugs without the required prior approval of the central regulator. This paper describes two major regulatory initiatives to address the problem, which began in 2007 and 2013, and examines whether they have been sufficient to remove centrally unapproved systemic antibiotic FDCs from the market. METHODS: Information was extracted from documents published by the central regulator and the ministry of health, including the National List of Essential Medicines (NLEM), and court judgments, and analysed alongside sales volume data for 2008–2020 using PharmaTrac market dataset. RESULTS: The regulatory initiatives permitted 68 formulations to be given de facto approvals (‘No Objection Certificates’) outside the statutory regime, banned 46 FDCs and restricted one FDC. Market data show that FDCs as a proportion of total antibiotic sales increased from 32.9 in 2008 to 37.3% in 2020. The total number of antibiotic FDC formulations on the market fell from 574 (2008) to 395 (2020). Formulations with a record of prior central approval increased from 86 (2008) to 94 (2020) and their share of the antibiotic FDC sales increased from 32.0 to 55.3%. In 2020, an additional 23 formulations had been permitted de facto approval, accounting for 10.6% of the antibiotic FDC sales. Even in 2020, most marketed formulations (70.4%, 278/395) were unapproved or banned, and comprised a 15.9% share of the antibiotic FDC sales. The share of NLEM-listed antibiotic FDC sales increased from 21.2 (2008) to 26.7% (2020). CONCLUSION: The initiatives had limited impact. Regulatory enforcement has been slow and weak, with many unapproved, and even banned, FDCs remaining on the market. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s40545-023-00644-y. BioMed Central 2023-11-10 /pmc/articles/PMC10636890/ /pubmed/37950272 http://dx.doi.org/10.1186/s40545-023-00644-y Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Research Brhlikova, Petra Mehta, Aashna McGettigan, Patricia Pollock, Allyson M. Roderick, Peter Farooqui, Habib Hasan Regulatory enforcement of the marketing of fixed-dose combinations in India: a case study of systemic antibiotics |
title | Regulatory enforcement of the marketing of fixed-dose combinations in India: a case study of systemic antibiotics |
title_full | Regulatory enforcement of the marketing of fixed-dose combinations in India: a case study of systemic antibiotics |
title_fullStr | Regulatory enforcement of the marketing of fixed-dose combinations in India: a case study of systemic antibiotics |
title_full_unstemmed | Regulatory enforcement of the marketing of fixed-dose combinations in India: a case study of systemic antibiotics |
title_short | Regulatory enforcement of the marketing of fixed-dose combinations in India: a case study of systemic antibiotics |
title_sort | regulatory enforcement of the marketing of fixed-dose combinations in india: a case study of systemic antibiotics |
topic | Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10636890/ https://www.ncbi.nlm.nih.gov/pubmed/37950272 http://dx.doi.org/10.1186/s40545-023-00644-y |
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