AIIMS, Kalyani
All India Institute of Medical Sciences
Clinical validation study conducted at AIIMS Kalyani — one of India's premier public medical institutions — establishing the clinical evidence base for NIBRA-CS®.
Clinical Evidence
A Published, Peer-Reviewed Randomized Controlled Trial
A factorial randomized controlled trial of 120 elderly patients with type 2 diabetes tested four approaches: standard care alone, standard care plus a medication adherence device (MedpeR®), standard care plus a clinical pharmacological review, and standard care plus both combined. The trial ran May–December 2023 and was published in the Journal of Diabetology in October–December 2024.
Standard care alone (control)
70.0%
Adherence rate
MedpeR® + standard care
73.1%
Adherence rate
Clinical pharmacological review + standard care
75.3%
Adherence rate
MedpeR® + clinical pharmacological review combined
82.1%
Highest-performing arm
Citation
Samajdar SS, Tripathi R, Mukherjee S, Biswas K, Joshi SR, Sarkar S, Tripathi SK, Saboo B. Improving medication adherence in geriatric T2DM patients: A factorial randomized controlled trial. Journal of Diabetology 2024;15:389–94.
DOI: 10.4103/jod.jod_85_24 · CTRI Registration: CTRI/2023/10/058703 · Ethics approval: HREC-AARC/33 · Published by Wolters Kluwer / Medknow
📄 Read Full Article →This was a pilot-scale study (30 patients per arm). The authors themselves note that future research should assess diverse populations and long-term sustainability — a normal and expected next step for a trial at this stage, not a limitation specific to MedpeR®.
Also Discussed in Peer-Reviewed Literature
The following peer-reviewed reviews discuss MedpeR® as an example of innovative adherence technology within a broader survey of the field. These are literature reviews, not independent studies of MedpeR® — the RCT above remains the primary clinical evidence.
Medication Adherence in the Elderly: A Comprehensive Review
Samajdar SS, Tripathi R, Venkatraman S, Mukherjee S, Pal J, Tripathi SK, Joshi SR, Maheshwari A. National Journal of Pharmacology and Therapeutics 2024;2:143–7.
DOI: 10.4103/NJPT.NJPT_60_24 · Published by Wolters Kluwer / Medknow
📄 Read Full Article →Bridging the Gap: Innovative Strategies to Enhance Medication Adherence in Cardiovascular Disease Management
Samajdar SS, Joshi SR, Chakraborty S, Sarkar S, Banerjee S, Maheshwari A, Tewari A, Singh NK. Public Health Discourse, Vol. 1, Issue 1, Oct–Dec 2024.
Official journal of the Centre for Public Health and Hygiene Research (CPHHR)
📄 Read Full Article →Conference Abstracts
Ahead of the factorial RCT above, an earlier single-site pilot evaluation of MedpeR® (30 urban elderly patients, 2-arm design) was presented at two conferences. This pilot is a separate, smaller study from the published trial — presented here as part of the same ongoing research programme, not as additional evidence for the published results.
Advancing Medication Adherence in India: Validating MedpeR® — Your Personal Medicinal helpeR
ESPACOMP 2024 — 28th Annual Conference of the European Society for Patient Adherence, COMpliance and Persistence (Italy). Published in the ESPACOMP 2024 Official Conference Abstract Book (peer-reviewed proceedings).
📄 View Abstract (PDF) →Advancing Medication Adherence in India: Validating MedpeR® — A Novel Assistive Technology Focused on the Diabetic and Elderly
MIDCON 2025 — Annual Conference of RSSDI, West Bengal Chapter. Published in International Journal of Diabetes and Technology, Vol. 4, Supplement 2 (June 2025).
📄 View Abstract (PDF) →Regulatory & Intellectual Property
Formally Registered, Patented, and Protected
MedpeR® is manufactured under a registered medical device classification and holds granted patent, design, and trademark protection in India.
Medical Device Registration
CDSCO Class A — Non-Sterile, Non-Measuring Device
Registration No. Inovoc-Kolka-WB/M/MD/031883
Application No. MFG/Class A-NSNM/2026/031886
Central Drugs Standard Control Organisation, Ministry of Health, Government of India
📄 View Registration (PDF) →Utility Patent
Smart Personalized Electronic Pill Dispenser and Medication Monitoring Device and a System Thereof
Patent No. 568287 · Application No. 201931029876
Filed 24 July 2019 · Granted 1 July 2025 · 20-year term · The Patent Office, Government of India
📄 View Certificate (PDF) →Design Patent
Smart Medication Container
Design No. 421181-001 · Class 24-01
Registered 26 June 2024 · Issued 25 July 2024 · The Patent Office, Government of India
📄 View Certificate (PDF) →Registered Trademark
MedpeR® — Word & Logo Mark
Trade Mark No. 4899026 · Class 9 (application software, electronic components)
Registered 9 March 2021 · Trade Marks Registry, Mumbai
📄 View Certificate (PDF) →Clinical Validation
Validated Across Leading Institutions
NIBRA-CS® has been deployed and evaluated in paid clinical pilots at nationally recognised medical colleges and teaching hospitals.
800+
Patients Evaluated
5+
Institutions
Multi
Ethics Approvals
1st
Commercial Unit at RIMS
MMCH, Midnapore
Medinipur Medical College & Hospital
Paid clinical pilot successfully completed with 300+ patients tested — demonstrating real-world clinical throughput and institutional readiness at scale.
RIMS, Ranchi
Rajendra Institute of Medical Sciences
First commercial unit deployed at RIMS Ranchi. PHC-level screening integration currently underway — marking the transition from clinical validation to active institutional deployment.
JIMS, Budge Budge
Jagannath Gupta Institute of Medical Sciences
Clinical pilots conducted with institutional ethics approval, contributing multi-site validation data for the autonomic assessment protocol.
IIMC, Sonarpur
Institute for Indian Mother & Child Hospital
Clinical pilots conducted at IIMC, Sonarpur, extending the validation dataset across diverse patient populations in the greater Kolkata region.
Multi-Institutional Ethics Approval
Institutional Ethics Committee approvals secured across more than 5 distinct organisations — a prerequisite for rigorous clinical data and a signal of institutional trust.
Regulatory & Intellectual Property
Patented, Licensed, and Institutionally Backed
NIBRA-CS® holds granted patent protection and a CDSCO manufacturing licence, and its development has been supported by government grant funding and formal incubation.
Patent
Granted Patent Certificate
Granted patents protecting the core autonomic assessment methodology and device architecture.
📄 View Certificate (PDF) →Regulatory
CDSCO Manufacturing Licence — Class B (MD5)
Regulatory approval authorising manufacture and commercialization of the medical device in India.
📄 View Licence (PDF) →Grant
BIRAC / DBT Grant
Innovation grant from the Department of Biotechnology supporting clinical development of NIBRA-CS®.
📄 View Document (PDF) →Incubation
IIM Calcutta Innovation Park
Official incubation and innovation support through one of India's leading technology incubation centres.
📄 View Document (PDF) →