Consumption of systemic antibiotics in India in 2019
Summary: Background: Inappropriate use of antibiotics is a significant driver of antibiotic resistance in India. Largely unrestricted over-the-counter sales of most antibiotics, manufacturing and marketing of many fixed-dose combinations (FDC) and overlap in regulatory powers between national and s...
| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2022-09-01
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| Series: | The Lancet Regional Health - Southeast Asia |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2772368222000300 |
| _version_ | 1811214748754116608 |
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| author | Shaffi Fazaludeen Koya Senthil Ganesh Sakthivel Selvaraj Veronika J. Wirtz Sandro Galea Peter C. Rockers |
| author_facet | Shaffi Fazaludeen Koya Senthil Ganesh Sakthivel Selvaraj Veronika J. Wirtz Sandro Galea Peter C. Rockers |
| author_sort | Shaffi Fazaludeen Koya |
| collection | DOAJ |
| description | Summary: Background: Inappropriate use of antibiotics is a significant driver of antibiotic resistance in India. Largely unrestricted over-the-counter sales of most antibiotics, manufacturing and marketing of many fixed-dose combinations (FDC) and overlap in regulatory powers between national and state-level agencies complicate antibiotics availability, sales, and consumption in the country. Methods: We analyzed cross-sectional data from PharmaTrac, a nationally representative private-sector drug sales dataset gathered from a panel of 9000 stockists across India. We used the AWaRe (Access, Watch, Reserve) classification and the defined daily dose (DDD) metrics to calculate the per capita private-sector consumption of systemic antibiotics across different categories: FDCs vs single formulations; approved vs unapproved; and listed vs not listed in the national list of essential medicines (NLEM). Findings: The total DDDs consumed in 2019 was 5071 million (10.4 DDD/1000/day). Watch contributed 54.9% (2783 million) DDDs, while Access contributed 27.0% (1370 million). Formulations listed in the NLEM contributed 49.0% (2486 million DDDs); FDCs contributed 34.0% (1722 million), and unapproved formulations contributed 47.1% (2408 million DDDs). Watch antibiotics constituted 72.7% (1750 million DDDs) of unapproved products and combinations discouraged by the WHO constituted 48.7% (836 million DDDs) of FDCs. Interpretation: Although the per-capita private-sector consumption rate of antibiotics in India is relatively low compared to many countries, India consumes a large volume of broad-spectrum antibiotics that should ideally be used sparingly. This, together with significant share of FDCs from formulations outside NLEM and a large volume of antibiotics not approved by the central drug regulators, call for significant policy and regulatory reform. Funding: Not applicable. |
| first_indexed | 2024-04-12T06:09:54Z |
| format | Article |
| id | doaj.art-d212568d4b16440993b12db2d59c9350 |
| institution | Directory Open Access Journal |
| issn | 2772-3682 |
| language | English |
| last_indexed | 2024-04-12T06:09:54Z |
| publishDate | 2022-09-01 |
| publisher | Elsevier |
| record_format | Article |
| series | The Lancet Regional Health - Southeast Asia |
| spelling | doaj.art-d212568d4b16440993b12db2d59c93502022-12-22T03:44:45ZengElsevierThe Lancet Regional Health - Southeast Asia2772-36822022-09-014100025Consumption of systemic antibiotics in India in 2019Shaffi Fazaludeen Koya0Senthil Ganesh1Sakthivel Selvaraj2Veronika J. Wirtz3Sandro Galea4Peter C. Rockers5Boston University School of Public Health, Boston, MA, USA; Corresponding author at: Department of Epidemiology, Boston University School of Public Health, Boston, MA, USA.Public Health Foundation of India, New Delhi, Delhi, IndiaPublic Health Foundation of India, New Delhi, Delhi, IndiaBoston University School of Public Health, Boston, MA, USABoston University School of Public Health, Boston, MA, USABoston University School of Public Health, Boston, MA, USASummary: Background: Inappropriate use of antibiotics is a significant driver of antibiotic resistance in India. Largely unrestricted over-the-counter sales of most antibiotics, manufacturing and marketing of many fixed-dose combinations (FDC) and overlap in regulatory powers between national and state-level agencies complicate antibiotics availability, sales, and consumption in the country. Methods: We analyzed cross-sectional data from PharmaTrac, a nationally representative private-sector drug sales dataset gathered from a panel of 9000 stockists across India. We used the AWaRe (Access, Watch, Reserve) classification and the defined daily dose (DDD) metrics to calculate the per capita private-sector consumption of systemic antibiotics across different categories: FDCs vs single formulations; approved vs unapproved; and listed vs not listed in the national list of essential medicines (NLEM). Findings: The total DDDs consumed in 2019 was 5071 million (10.4 DDD/1000/day). Watch contributed 54.9% (2783 million) DDDs, while Access contributed 27.0% (1370 million). Formulations listed in the NLEM contributed 49.0% (2486 million DDDs); FDCs contributed 34.0% (1722 million), and unapproved formulations contributed 47.1% (2408 million DDDs). Watch antibiotics constituted 72.7% (1750 million DDDs) of unapproved products and combinations discouraged by the WHO constituted 48.7% (836 million DDDs) of FDCs. Interpretation: Although the per-capita private-sector consumption rate of antibiotics in India is relatively low compared to many countries, India consumes a large volume of broad-spectrum antibiotics that should ideally be used sparingly. This, together with significant share of FDCs from formulations outside NLEM and a large volume of antibiotics not approved by the central drug regulators, call for significant policy and regulatory reform. Funding: Not applicable.http://www.sciencedirect.com/science/article/pii/S2772368222000300AntibioticsDrug resistanceAntimicrobial stewardshipDrug combinationsDrug approvalFormulary |
| spellingShingle | Shaffi Fazaludeen Koya Senthil Ganesh Sakthivel Selvaraj Veronika J. Wirtz Sandro Galea Peter C. Rockers Consumption of systemic antibiotics in India in 2019 The Lancet Regional Health - Southeast Asia Antibiotics Drug resistance Antimicrobial stewardship Drug combinations Drug approval Formulary |
| title | Consumption of systemic antibiotics in India in 2019 |
| title_full | Consumption of systemic antibiotics in India in 2019 |
| title_fullStr | Consumption of systemic antibiotics in India in 2019 |
| title_full_unstemmed | Consumption of systemic antibiotics in India in 2019 |
| title_short | Consumption of systemic antibiotics in India in 2019 |
| title_sort | consumption of systemic antibiotics in india in 2019 |
| topic | Antibiotics Drug resistance Antimicrobial stewardship Drug combinations Drug approval Formulary |
| url | http://www.sciencedirect.com/science/article/pii/S2772368222000300 |
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