How to access Krazati from India — the named-patient import pathway, 2026
By Reserve Meds · Clinical & regulatory team · Last reviewed 2026-04-23
An Indian patient with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumour carries a KRAS G12C mutation, and who has progressed on at least one prior systemic therapy, may receive a prescription for Krazati (adagrasib) from their treating medical oncologist. Krazati is FDA-approved, developed by Mirati Therapeutics (now part of Bristol Myers Squibb), and represents one of the two covalent KRAS G12C inhibitors available globally. In India, Krazati is not yet broadly registered for routine pharmacy dispensing, which is why your oncologist may be navigating a named-patient import pathway with you.
This guide explains the legal pathway, what your physician needs to provide, typical timelines, and where Reserve Meds fits in.
The clinical situation
Krazati is an oral, selective covalent inhibitor of KRAS G12C, an oncogenic driver mutation that has historically been considered undruggable. Eligibility anchors to a confirmed KRAS G12C alteration on validated molecular testing (tissue or plasma NGS), documented prior systemic therapy, and a performance status and organ-system profile consistent with FDA labelling. Dosing is typically 600 mg orally twice daily, continued until progression or unacceptable toxicity. Your oncologist will confirm the molecular result, plan the adverse-event monitoring cadence (notably QTc, hepatic panel, and GI tolerability), and document the clinical rationale.
Is Krazati legally importable into India?
Yes — via the Central Drugs Standard Control Organisation (CDSCO) Personal Use / Named-Patient import framework, which permits a treating physician to import a medicine not yet locally registered when (a) the medicine is approved by a recognised reference authority such as the US FDA, (b) no clinically equivalent alternative is routinely available for the patient, (c) the physician accepts clinical responsibility, and (d) chain of custody through a licensed importer is documented. CDSCO issues a personal-use license keyed to the individual patient and a specified quantity consistent with the dosing plan.
The pathway is well-established in India for advanced oncology where a molecular target defines eligibility and no registered equivalent is locally dispensed.
How the pathway works, step by step
- Consultation with your treating medical oncologist. KRAS G12C confirmation, prior-therapy documentation, performance-status assessment, and the clinical rationale letter.
- Molecular-testing confirmation. Tissue or plasma NGS report documenting KRAS G12C; this is the gating evidence for the named-patient file.
- CDSCO personal-use import application. Your physician or the importing licensed pharmacy files the dossier including rationale, patient reference, and dosing plan.
- US-side sourcing. Reserve Meds coordinates with our US-licensed specialty wholesale partner to secure Krazati from the manufacturer's authorised distribution chain under DSCSA.
- Controlled shipment. Krazati ships with standard temperature-controlled logistics and full chain-of-custody documentation to the importer of record.
- Arrival and initiation. Your oncology team dispenses, initiates therapy, and manages adverse events per FDA labelling.
What documentation your physician needs
- Clinical rationale letter confirming diagnosis, KRAS G12C molecular status, prior-therapy sequence, and Krazati as the indicated treatment
- Verification of the treating physician's Medical Council of India / NMC registration
- Molecular-testing report (NGS tissue or plasma)
- Patient identifier (anonymised reference where possible)
- Dosing and monitoring plan (QTc baseline and periodic ECG, hepatic panel, GI supportive care)
Reserve Meds provides a physician documentation kit that bundles the CDSCO templates reviewers expect to see, so a first-time applicant is not reinventing the file.
Costs and timing
Krazati's US cash-pay reference price sits in an indicative 2026 monthly range of roughly USD 19,000–22,000 for the 600 mg twice-daily regimen. International logistics, CDSCO documentation handling, importer-of-record fees, and concierge coordination add incremental cost. Reserve Meds issues a transparent quote at the start of intake. These figures are indicative, not guaranteed.
Indicative timing — not guaranteed — for first dispensation after cohort intake opens is approximately 14–28 days from the moment a complete CDSCO application is submitted.
Reserve Meds is in pre-launch. Fulfillment availability is limited to our first cohort, and all timelines published on this site are indicative. If your clinical situation is time-sensitive, flag that when you join the waitlist — we triage accordingly.
A culturally-aware note: Indian NSCLC families routinely travel between cities for molecular-test-directed oncology. Our coordination is built around the reality that the treating oncologist and the family may not be in the same metro as the importing pharmacy; documentation flows electronically and the physical shipment is directed to whichever tertiary pharmacy your oncologist nominates.
Reserve Meds's role
- Sourcing. Through our US-licensed specialty wholesale partner under DSCSA chain-of-custody.
- Documentation. Regulatory package for your physician and for CDSCO review, keyed to the KRAS G12C rationale.
- Logistics. Temperature-controlled shipment to the nominated hospital pharmacy with importer-of-record handling.
- Concierge case lead. A named point of contact for your family and your oncology team.
What we do not do: we are not the prescriber, we do not practise medicine, and we are not the dispensing pharmacy. All clinical decisions remain with your treating oncologist. We operate on a waitlist basis during our pre-launch phase.
Frequently asked
How is Krazati different from Lumakras? Both are covalent KRAS G12C inhibitors. They differ in pharmacokinetics, dosing schedule, and adverse-event profile. Your oncologist will select based on the clinical picture; either can be pursued through the named-patient pathway.
Does my tumour have to be tested locally? The NGS report can come from any credentialed laboratory — many Indian molecular pathology labs and international reference labs are accepted. Your oncologist will confirm.
What if I progress on Krazati? Your oncologist will reassess and may pursue repeat biopsy, alternative targeted therapy, or a clinical trial. Our role ends with the import coordination; clinical decisions remain with the oncology team.
Will insurance cover this? Cash-pay is the default for named-patient imports. Some Indian private insurers consider case-by-case reimbursement for molecular-directed oncology; we supply documentation but do not process claims directly.
Next step — join the first-cohort waitlist
Reserve Meds is opening to a limited first cohort in 2026. Add your case to the waitlist and our concierge case lead will reach out when we enter intake for Krazati coordination.
Add me to the Krazati waitlist> Examples and timings above are composite illustrations drawn from published sources and typical named-patient patterns. Your individual case is assessed by your physician and our clinical-regulatory team; Reserve Meds does not guarantee outcomes or timelines.
Reserve Meds is a US-based concierge coordinator for cross-border specialty medicine. We are in pre-launch; service availability is limited to our first cohort and published timelines are indicative, not guarantees. Cash-pay. Export-only (US → overseas). Composite case examples. Not medical advice.
Clinical & regulatory review: Reserve Meds clinical team and AI regulatory-counsel review pipeline. Last medically reviewed: 2026-04-23.