Mental health apps in India: regulatory landscape and future directions

Mental health apps (MHAs) are increasingly popular in India due to rising mental health awareness and app accessibility. Despite their benefits, like mood tracking, sleep tools and virtual therapy, MHAs lack regulatory oversight. India's framework, including the Central Drugs Standard Control O...

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Main Authors: M. I. Singh Sethi, Rakesh C. Kumar, Narayana Manjunatha, Channaveerachari Naveen Kumar, Suresh Bada Math
Format: Article
Language:English
Published: Cambridge University Press 2025-02-01
Series:BJPsych International
Subjects:
Online Access:https://www.cambridge.org/core/product/identifier/S2056474024000205/type/journal_article
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author M. I. Singh Sethi
Rakesh C. Kumar
Narayana Manjunatha
Channaveerachari Naveen Kumar
Suresh Bada Math
author_facet M. I. Singh Sethi
Rakesh C. Kumar
Narayana Manjunatha
Channaveerachari Naveen Kumar
Suresh Bada Math
author_sort M. I. Singh Sethi
collection DOAJ
description Mental health apps (MHAs) are increasingly popular in India due to rising mental health awareness and app accessibility. Despite their benefits, like mood tracking, sleep tools and virtual therapy, MHAs lack regulatory oversight. India's framework, including the Central Drugs Standard Control Organization (CDSCO) and Medical Device Rules 2017, does not cover standalone health apps, raising concerns about data privacy and accuracy. Establishing a centralised regulatory body with guidelines for MHAs is essential for user safety and efficacy. This paper examines the current regulatory landscape, compares international approaches and proposes a tiered regulatory framework to foster responsible innovation while safeguarding user interests in digital mental health services.
format Article
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institution Kabale University
issn 2056-4740
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language English
publishDate 2025-02-01
publisher Cambridge University Press
record_format Article
series BJPsych International
spelling doaj-art-026f3dc502524e07a66485ca13112d182025-01-30T12:42:54ZengCambridge University PressBJPsych International2056-47402058-62642025-02-01222510.1192/bji.2024.20Mental health apps in India: regulatory landscape and future directionsM. I. Singh Sethi0https://orcid.org/0000-0002-1567-541XRakesh C. Kumar1Narayana Manjunatha2Channaveerachari Naveen Kumar3Suresh Bada Math4Senior Resident, Tele Medicine Centre, NIMHANS Digital Academy, Department of Psychiatry, National Institute of Mental Health & Neurosciences (NIMHANS), Bangalore, IndiaAssistant Professor, Tele Medicine Centre, NIMHANS Digital Academy, Department of Psychiatry, National Institute of Mental Health & Neurosciences (NIMHANS), Bangalore, IndiaAdditional Professor, Tele Medicine Centre, NIMHANS Digital Academy, Department of Psychiatry, National Institute of Mental Health & Neurosciences (NIMHANS), Bangalore, IndiaHead of Community Psychiatry, Department of Psychiatry, National Institute of Mental Health & Neurosciences (NIMHANS), Bangalore, IndiaHead of Forensic Psychiatry & Tele Medicine Centre, I/C NIMHANS Digital Academy, Department of Psychiatry, National Institute of Mental Health & Neurosciences (NIMHANS), Bangalore, India.Mental health apps (MHAs) are increasingly popular in India due to rising mental health awareness and app accessibility. Despite their benefits, like mood tracking, sleep tools and virtual therapy, MHAs lack regulatory oversight. India's framework, including the Central Drugs Standard Control Organization (CDSCO) and Medical Device Rules 2017, does not cover standalone health apps, raising concerns about data privacy and accuracy. Establishing a centralised regulatory body with guidelines for MHAs is essential for user safety and efficacy. This paper examines the current regulatory landscape, compares international approaches and proposes a tiered regulatory framework to foster responsible innovation while safeguarding user interests in digital mental health services.https://www.cambridge.org/core/product/identifier/S2056474024000205/type/journal_articleMental health apps (MHAs)regulatory frameworkdigital healthdata privacymobile health (mHealth)
spellingShingle M. I. Singh Sethi
Rakesh C. Kumar
Narayana Manjunatha
Channaveerachari Naveen Kumar
Suresh Bada Math
Mental health apps in India: regulatory landscape and future directions
BJPsych International
Mental health apps (MHAs)
regulatory framework
digital health
data privacy
mobile health (mHealth)
title Mental health apps in India: regulatory landscape and future directions
title_full Mental health apps in India: regulatory landscape and future directions
title_fullStr Mental health apps in India: regulatory landscape and future directions
title_full_unstemmed Mental health apps in India: regulatory landscape and future directions
title_short Mental health apps in India: regulatory landscape and future directions
title_sort mental health apps in india regulatory landscape and future directions
topic Mental health apps (MHAs)
regulatory framework
digital health
data privacy
mobile health (mHealth)
url https://www.cambridge.org/core/product/identifier/S2056474024000205/type/journal_article
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