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...
Main Authors: | , , , , |
---|---|
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= |
id |
doaj-de40117a3ad14aa2a08b245957de6f1f |
---|---|
record_format |
Article |
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= |
work_keys_str_mv |
AT mahanjitkonwar anevaluationofdruglagfornewdrugsapprovedbytheindianregulatorrelativetotheunitedstateseuropeanunionandjapaneseregulatoryagenciesa15yearanalysis20042018 AT miteshrmaurya anevaluationofdruglagfornewdrugsapprovedbytheindianregulatorrelativetotheunitedstateseuropeanunionandjapaneseregulatoryagenciesa15yearanalysis20042018 AT tusharbnishandar anevaluationofdruglagfornewdrugsapprovedbytheindianregulatorrelativetotheunitedstateseuropeanunionandjapaneseregulatoryagenciesa15yearanalysis20042018 AT urmilamthatte anevaluationofdruglagfornewdrugsapprovedbytheindianregulatorrelativetotheunitedstateseuropeanunionandjapaneseregulatoryagenciesa15yearanalysis20042018 AT nithyajgogtay anevaluationofdruglagfornewdrugsapprovedbytheindianregulatorrelativetotheunitedstateseuropeanunionandjapaneseregulatoryagenciesa15yearanalysis20042018 AT mahanjitkonwar evaluationofdruglagfornewdrugsapprovedbytheindianregulatorrelativetotheunitedstateseuropeanunionandjapaneseregulatoryagenciesa15yearanalysis20042018 AT miteshrmaurya evaluationofdruglagfornewdrugsapprovedbytheindianregulatorrelativetotheunitedstateseuropeanunionandjapaneseregulatoryagenciesa15yearanalysis20042018 AT tusharbnishandar evaluationofdruglagfornewdrugsapprovedbytheindianregulatorrelativetotheunitedstateseuropeanunionandjapaneseregulatoryagenciesa15yearanalysis20042018 AT urmilamthatte evaluationofdruglagfornewdrugsapprovedbytheindianregulatorrelativetotheunitedstateseuropeanunionandjapaneseregulatoryagenciesa15yearanalysis20042018 AT nithyajgogtay evaluationofdruglagfornewdrugsapprovedbytheindianregulatorrelativetotheunitedstateseuropeanunionandjapaneseregulatoryagenciesa15yearanalysis20042018 |
_version_ |
1721280001293156352 |