Regimenly

Turns a tumour gene report into the options a patient can actually get in India

TL;DR Regimenly takes the tumour sequencing report an oncologist already has and adds an India-specific layer - which suggested drugs are approved here, roughly what they cost, which assistance schemes exist, and which registered Indian trials are recruiting. Hospitals and testing labs pay. It sells clarity on access, not a better treatment choice.

The problem

India had an estimated 14.6 lakh new cancer cases in 2022, with about 15.7 lakh projected for 2025[1]. More of these patients now get next-generation sequencing (NGS) reports, but the reports are all over the place. In a survey of 58 Indian oncologists, 71% said reporting varies from lab to lab and 72% did not know the reporting guidelines[2].

The sharper finding is this one - about 40% said they felt helpless when a report pointed to a therapy they could not get in India[2]. A report written for a US formulary leaves the doctor to do the access research alone, usually squeezed in between other patients.

The idea

What it does, in regulatory terms: information and access support for the treating oncologist, not diagnosis or treatment selection. Software that recommends therapy can count as a medical device under the Medical Devices Rules 2017, which explicitly cover software[3], so Regimenly must not rank treatments. Get a regulatory opinion before launch.

The oncologist or lab uploads the NGS report. Regimenly reads each actionable finding and builds a one-page access sheet covering whether the matched drug has Indian approval, typical price bands, manufacturer assistance programmes, and recruiting trials on the Clinical Trials Registry-India, where registration has been mandatory since 2009[4]. A pharmacist-curator checks every sheet before release, and AI only does the first-pass extraction.

The seed wanted to simulate each patient's pathways to pick the best drug, and I reframed it. Pathway simulation is unproven at the bedside, and an Indian precision-oncology firm already sells a patient-twin decision tool in India[5]. The unmet need the survey shows is access, not prediction.

Who pays

The patient benefits, but hospitals and NGS labs pay. A lab that bundles an India access sheet makes its report easier to act on than a rival's. Cancer hospitals running molecular tumour boards are the second buyer. I found no public price list for Indian NGS tests or report add-ons, so you'll have to discover the per-report fee in pilots.

Why now

Indian oncologists have now put the gap in writing. The 2023 survey found 98% wanted uniform NGS reporting and 93% an Indian data repository[2]. CTRI lists over 1.2 lakh registered trials[4], enough to make trial matching useful, and language models have made reading messy report PDFs cheap.

Market signal

There's no public figure for Indian NGS report volumes or spend on report interpretation. The firmest signals are the 14.6 lakh annual cancer cases[1] and the 40% of surveyed oncologists who struggle when a recommended drug is unavailable[2]. Treat the case count as a ceiling, since only a fraction of patients get sequenced.

Who's already doing this

One precision-oncology firm runs tissue and liquid profiling plus a patient-twin tool that supports molecular tumour boards[5]. Another tool, built with Tata Memorial's ACTREC, automates NGS interpretation[6]. Both start from the biology.

From what's published, none of them makes an India-specific access sheet that sits on top of any lab's report. That neutral, lab-agnostic layer is the gap.

How hard is it?

Difficulty Moderate (44/100)
Starting capital ₹60 L–1.1 Cr
Time to launch 6–9 months

The software is modest. The hard part is keeping drug approval, price and trial data current every single week, and that takes a pharmacist and an oncology adviser, not just code. Labs also guard their report format, so the first deal needs a lab willing to co-brand.

Licences and approvals

This is regulated territory. Software that recommends therapy can count as a medical device, so how you scope the product decides which rules apply.

  • Medical Devices Rules 2017, administered by CDSCO, which explicitly cover software[3]. Keep Regimenly to information and access support, and get a written regulatory opinion before launch.
  • DPDP Act 2023 compliance before launch, because tumour reports are personal health data. Collect consent through the lab or hospital and sign processing contracts[7].
  • CTRI. You only read the public Clinical Trials Registry-India, but quote trial IDs exactly and date-stamp each sheet[4].
  • Drug promotion. Take no per-drug payments from manufacturers, or the sheet becomes promotional [Requires validation].

Building this outside India? The categories above usually have a local equivalent, so check with your own regulator.

How AI can power this business

  • Report extraction. AI reads each NGS report and pulls the actionable findings into a structured list, which the pharmacist-curator then checks.
  • Approval and price lookups. Matched drugs are checked against an internal database of Indian approvals and price bands, so a curator isn't searching from scratch every time.
  • Trial matching. Findings are matched to recruiting CTRI trials by gene and cancer type, giving the curator a shortlist to verify.
  • Assistance scheme updates. Manufacturer programme pages are watched for changes, so stale sheets are flagged for review.

This product supports access, not treatment choice. AI must never rank drugs or suggest a therapy, and a human curator signs off every sheet before an oncologist sees it.

Want to work out the AI layer for Regimenly? Talk to Yash →

Biggest risks

  • Scope creep into advice. If sheets start ranking drugs, the product becomes regulated medical software with a clinical-evidence burden.
  • Stale data. One wrong approval status or price in front of a family will cost you the hospital's trust.
  • Labs build it themselves. Large NGS labs could add a basic access page once they see oncologists asking for it.

Our take

I like this for a founder with oncology pharmacy or medical affairs experience who genuinely enjoys careful, repetitive curation. If you're set on building a clever AI model then this will bore you. First prove that one lab will pay per report and that oncologists open the sheet in at least half of cases.

Questions founders ask

Plan for roughly ₹60 L–1.1 Cr, mostly on the curation team, the drug and trial database and a regulatory opinion.

Do I need a licence for cancer genomics software in India?

It depends on what it does. Software that recommends treatment can be a medical device under the Medical Devices Rules 2017, so keep it to information and access, and get a written opinion.

Can I start a genomic report access tool in another country?

Yes, but the access layer is local by nature. You'd rebuild the approval, price, assistance and trial data for that country and check how its regulator treats clinical software.

Download the kit

The free Regimenly validation kit has the line-by-line capital breakdown, the effort scoring, the medical-software and data-protection checklist, a 14-day validation sprint with pass/fail targets, a 90-day launch plan, 10 interview questions for oncologists and labs, and 5 assumptions to test. Download the kit →

Talk to Yash

Thinking about building Regimenly or something close to it? The make-or-break bit is staying on the right side of the medical-software line while still being useful to the oncologist, and I'm happy to help you draw that line. If you need a hand, you know where to find me. Talk to Yash →

Sources

  1. Sathishkumar et al., "Cancer incidence estimates for 2022 & projection for 2025", Indian Journal of Medical Research 156(4&5), 2023. https://ijmr.org.in/cancer-incidence-estimates-for-2022-projection-for-2025-result-from-national-cancer-registry-programme-india/
  2. Pathak et al., "A Survey on Unmet Need for Uniform Next-Generation Sequencing Reporting in India", Indian Journal of Medical and Paediatric Oncology 45(2), 2024. https://www.ijmpo.org/ejournals/topic/a-survey-on-unmet-need-for-uniform-next-generation-sequencing-reporting-in-india
  3. CDSCO, "Medical Device & Diagnostics", accessed 2026-10-21. https://cdsco.gov.in/opencms/opencms/en/Medical-Device-Diagnostics/Medical-Device-Diagnostics/
  4. ICMR-NIRDH, "Clinical Trials Registry-India", accessed 2026-10-21. https://ctri.nic.in/Clinicaltrials/login.php
  5. 4baseCare, official site, accessed 2026-10-21. https://www.4basecare.com/
  6. BioSpectrum, "4baseCare, Tata Memorial Centre to develop AI based clinical interpretation platform", 2021. https://www.biospectrumindia.com/article/pdf/17914
  7. PRS Legislative Research, "Digital Personal Data Protection Bill 2023", 2023-08. https://prsindia.org/billtrack/digital-personal-data-protection-bill-2023

For illustration only. Names are fictional and ideas hypothetical; sourced facts are real but may be out of date. Nothing here is legal, financial or professional advice, and Yash Khatri is not personally liable for any use of it. Read the full disclaimer.

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