Mental health apps in India: regulatory landscape and future directions
Open accessAbstract
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.
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
LLM-powered mental health applications are unregulated in the U.S.
“These applications of LLMs are unregulated in the U.S., whereas therapists and mental health care providers have strict training and clinical licensing requirements [39].”
From Expressing stigma and inappropriate responses prevents LLMs from safely replacing mental health providers. (2025) · cites this paper as [126]
In countries such as the U.S. and India, these apps are not regulated in practice.
“In countries such as the U.S. and India, these apps are not regulated in practice [39, 126].”
From Expressing stigma and inappropriate responses prevents LLMs from safely replacing mental health providers. (2025) · cites this paper as [126]
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
Cites
Cost estimation for the implementation of the Mental Healthcare Act 2017
Math, S., Gowda, G. S., Basavaraju, V., Manjunatha, N., Kumar, C., Enara, A., Gowda, M., & Thirthalli, J. (2019) · Indian Journal of Psychiatry · doi:10.4103/psychiatry.indianjpsychiatry_188_19 · Cited by 159 · see citing works
Self-citationActionable health app evaluation: translating expert frameworks into objective metrics
Lagan, S., Aquino, P. R., Emerson, M. R., Fortuna, K. L., Walker, R., & Torous, J. B. (2020) · npj Digital Medicine · doi:10.1038/s41746-020-00312-4 · Cited by 146 · see citing works
Health app policy: international comparison of nine countries’ approaches
Essén, A., Stern, A. D., Haase, C. B., Car, J., Greaves, F., Paparova, D., Vandeput, S., Wehrens, R., & Bates, D. W. (2022) · npj Digital Medicine · doi:10.1038/s41746-022-00573-1 · Cited by 131 · see citing works
Sinha Deb, K., Tuli, A., Sood, M., Chadda, R., Verma, R., Kumar, S., Ganesh, R., & Singh, P. (2018) · PLOS ONE · doi:10.1371/journal.pone.0203353 · Cited by 79 · see citing works
Mental Healthcare Act 2017 – Aspiration to action
Basavaraju, V., Math, S., Harihara, S., et al. (2019) · Indian Journal of Psychiatry · doi:10.4103/psychiatry.indianjpsychiatry_91_19 · Cited by 73 · see citing works
Self-citationThe Complexity of Mental Health App Privacy Policies: A Potential Barrier to Privacy
Powell, A., Singh, P., & Torous, J. (2018) · JMIR mHealth and uHealth · doi:10.2196/mhealth.9871 · Cited by 65 · see citing works
Menon, V., Rajan, T. M., & Sarkar, S. (2017) · Indian Journal of Psychological Medicine · doi:10.4103/0253-7176.198956 · Cited by 63 · see citing works
Johnson, J. A., Sanghvi, P., & Mehrotra, S. (2022) · Indian Journal of Psychological Medicine · doi:10.1177/02537176211034578 · Cited by 60 · see citing works
A review of medical device regulations in India, comparison with European Union and way-ahead
Manu, M., & Anand, G. (2021) · Perspectives in Clinical Research · doi:10.4103/picr.picr_222_20 · Cited by 52 · see citing works
A Review of Telemedicine Guidelines in the South-East Asia Region
Sharma, P., Sethi, M. I. S., Liem, A., Bhatti, H. B. S., Pandey, V., & Nair, A. (2023) · Telemedicine Reports · doi:10.1089/tmr.2023.0040 · Cited by 23 · see citing works
Singh, S., & Sagar, R. (2022) · Indian Journal of Psychological Medicine · doi:10.1177/02537176221082902 · Cited by 22 · see citing works
Protecting healthcare privacy: Analysis of data protection developments in India
Naithani, P. (2023) · Indian Journal of Medical Ethics · doi:10.20529/ijme.2023.078 · Cited by 11 · see citing works
The Vanguard of Psychiatry: Artificial Intelligence as a Catalyst for Change
Sethi, M. I. S., Kumar, C. N., & Math, S. B. (2023) · Journal of Psychiatry Spectrum · doi:10.4103/jopsys.jopsys_52_23 · Cited by 7 · see citing works
Self-citation
Flagged first, then by citations
Cited by
Sorted by citations
Moore, J., Grabb, D., Agnew, W., Klyman, K., Chancellor, S., Ong, D. C., & Haber, N. (2025) · Proceedings of the 2025 ACM Conference on Fairness, Accountability, and Transparency · doi:10.1145/3715275.3732039 · Cited by 204 · see citing works
- Authors
- Singh Sethi, M. I., Kumar, R. C., Manjunatha, N., Naveen Kumar, C., & Math, S. B.
- Affiliations
- National Institute of Mental Health and Neurosciences (IN)
- Corresponding author
- Math, Suresh Bada
- Venue
- BJPsych International
- Publisher
- Royal College of Psychiatrists
- Published
- 2024-10-10
- Volume
- 22
- Issue
- 1
- Pages
- 2-5
- ISSN
- 2056-4740 (ISSN-L)
- 2058-6264
- PMC
- PMC12022849
- OpenAlex
- W4403304550
- Cited by
- 10
- References
- 13
- Citations by year
- 2026: 3 · 2025: 7
- FWCI
- 3.97
- Type
- journal article
- Language
- en
- Open access
- diamond
- doi.org
- Locations
- BJPsych International (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Topics
- Social Sciences › Psychology › Applied Psychology › Digital Mental Health Interventions
- Health Sciences › Health Professions › General Health Professions › Mobile Health and mHealth Applications
- Health Sciences › Health Professions › Health Information Management › Healthcare Regulation
- Keywords
- mental health apps, digital mental health, regulatory oversight, India, CDSCO, data privacy, online therapy, responsible innovation
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
