An evaluation of drug lag for new drugs approved by the Indian regulator relative to the United States, European Union, and Japanese regulatory agencies: A 15-year analysis (2004–2018)

Background: The approval process of every drug regulatory agency differs, and hence, the time required for the approval of a new drug varies. This results in a drug lag and India is no exception to this phenomenon. A drug lag precludes Indian patients from accessing new medicines at the same time as...

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Main Authors: Mahanjit Konwar, Mitesh R Maurya, Tushar B Nishandar, Urmila M Thatte, Nithya J Gogtay
Format: Article
Language:English
Published: Wolters Kluwer Medknow Publications 2021-01-01
Series:Perspectives in Clinical Research
Subjects:
Online Access:http://www.picronline.org/article.asp?issn=2229-3485;year=2021;volume=12;issue=3;spage=159;epage=164;aulast=
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spelling doaj-de40117a3ad14aa2a08b245957de6f1f2021-07-27T04:49:35ZengWolters Kluwer Medknow PublicationsPerspectives in Clinical Research2229-34852021-01-0112315916410.4103/picr.PICR_99_19An evaluation of drug lag for new drugs approved by the Indian regulator relative to the United States, European Union, and Japanese regulatory agencies: A 15-year analysis (2004–2018)Mahanjit KonwarMitesh R MauryaTushar B NishandarUrmila M ThatteNithya J GogtayBackground: The approval process of every drug regulatory agency differs, and hence, the time required for the approval of a new drug varies. This results in a drug lag and India is no exception to this phenomenon. A drug lag precludes Indian patients from accessing new medicines at the same time as they are approved elsewhere. Against this backdrop, we assessed the absolute and relative drug lags of the Indian regulator relative to three regulators in mature markets, namely United States (US), European Union (EU), and Japan. Methods: International nonproprietary names were used to identify new drugs. Their dates of approval (2004-2018) from the online database of four regulatory agencies were identified. Both absolute and relative drug lags were calculated for India as compared to US, EU, and Japan as well for all the agencies relative to the Indian regulator. Results: We identified a total of 453, 473, 424, and 472 new drugs approved over the study period in India, US, EU, and Japan, respectively. The absolute drug lag of Central Drugs Standard Control Organization (CDSCO) was 19 and 18 relative to the US Food and Drug Administration (FDA) and Japan Pharmaceuticals and Medical Devices Agency (PMDA), respectively. The relative drug lag for the CDSCO vis-a-vis the US FDA, European Medicines Agency, and PMDA was 43.2 (2.1–1287.8), 25.6 (0.03–1310.5), and 30.3 (1.2–1242) months, respectively. Conclusion: Our study shows a significant drug lag between India and other three developed nations (US, EU, and Japan). However, in some therapeutic areas, Indian regulator has proactively approved new drugs much before other agencies. The New Drugs and Clinical Trials Rule of 2019 has brought hope for reduction in drug lag in the near future.http://www.picronline.org/article.asp?issn=2229-3485;year=2021;volume=12;issue=3;spage=159;epage=164;aulast=absolute drug lagcentral drugs standard control organizationeuropean medicines agencypharmaceuticals and medical devices agencyrelative drug lagunited states food and drug administration
collection DOAJ
language English
format Article
sources DOAJ
author Mahanjit Konwar
Mitesh R Maurya
Tushar B Nishandar
Urmila M Thatte
Nithya J Gogtay
spellingShingle Mahanjit Konwar
Mitesh R Maurya
Tushar B Nishandar
Urmila M Thatte
Nithya J Gogtay
An evaluation of drug lag for new drugs approved by the Indian regulator relative to the United States, European Union, and Japanese regulatory agencies: A 15-year analysis (2004–2018)
Perspectives in Clinical Research
absolute drug lag
central drugs standard control organization
european medicines agency
pharmaceuticals and medical devices agency
relative drug lag
united states food and drug administration
author_facet Mahanjit Konwar
Mitesh R Maurya
Tushar B Nishandar
Urmila M Thatte
Nithya J Gogtay
author_sort Mahanjit Konwar
title An evaluation of drug lag for new drugs approved by the Indian regulator relative to the United States, European Union, and Japanese regulatory agencies: A 15-year analysis (2004–2018)
title_short An evaluation of drug lag for new drugs approved by the Indian regulator relative to the United States, European Union, and Japanese regulatory agencies: A 15-year analysis (2004–2018)
title_full An evaluation of drug lag for new drugs approved by the Indian regulator relative to the United States, European Union, and Japanese regulatory agencies: A 15-year analysis (2004–2018)
title_fullStr An evaluation of drug lag for new drugs approved by the Indian regulator relative to the United States, European Union, and Japanese regulatory agencies: A 15-year analysis (2004–2018)
title_full_unstemmed An evaluation of drug lag for new drugs approved by the Indian regulator relative to the United States, European Union, and Japanese regulatory agencies: A 15-year analysis (2004–2018)
title_sort evaluation of drug lag for new drugs approved by the indian regulator relative to the united states, european union, and japanese regulatory agencies: a 15-year analysis (2004–2018)
publisher Wolters Kluwer Medknow Publications
series Perspectives in Clinical Research
issn 2229-3485
publishDate 2021-01-01
description Background: The approval process of every drug regulatory agency differs, and hence, the time required for the approval of a new drug varies. This results in a drug lag and India is no exception to this phenomenon. A drug lag precludes Indian patients from accessing new medicines at the same time as they are approved elsewhere. Against this backdrop, we assessed the absolute and relative drug lags of the Indian regulator relative to three regulators in mature markets, namely United States (US), European Union (EU), and Japan. Methods: International nonproprietary names were used to identify new drugs. Their dates of approval (2004-2018) from the online database of four regulatory agencies were identified. Both absolute and relative drug lags were calculated for India as compared to US, EU, and Japan as well for all the agencies relative to the Indian regulator. Results: We identified a total of 453, 473, 424, and 472 new drugs approved over the study period in India, US, EU, and Japan, respectively. The absolute drug lag of Central Drugs Standard Control Organization (CDSCO) was 19 and 18 relative to the US Food and Drug Administration (FDA) and Japan Pharmaceuticals and Medical Devices Agency (PMDA), respectively. The relative drug lag for the CDSCO vis-a-vis the US FDA, European Medicines Agency, and PMDA was 43.2 (2.1–1287.8), 25.6 (0.03–1310.5), and 30.3 (1.2–1242) months, respectively. Conclusion: Our study shows a significant drug lag between India and other three developed nations (US, EU, and Japan). However, in some therapeutic areas, Indian regulator has proactively approved new drugs much before other agencies. The New Drugs and Clinical Trials Rule of 2019 has brought hope for reduction in drug lag in the near future.
topic absolute drug lag
central drugs standard control organization
european medicines agency
pharmaceuticals and medical devices agency
relative drug lag
united states food and drug administration
url http://www.picronline.org/article.asp?issn=2229-3485;year=2021;volume=12;issue=3;spage=159;epage=164;aulast=
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