How to access Ultomiris from India — the named-patient import pathway, 2026
By Reserve Meds · Clinical & regulatory team · Last reviewed 2026-04-23
An Indian patient with paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), generalised myasthenia gravis (gMG), or neuromyelitis optica spectrum disorder (NMOSD) may receive a prescription for Ultomiris (ravulizumab-cwvz) from their treating haematologist, nephrologist, or neurologist. Ultomiris is FDA-approved in the United States and manufactured by Alexion (AstraZeneca Rare Disease). It is a long-acting terminal complement C5 inhibitor — a next-generation successor to Soliris (eculizumab) that offers every-eight-week maintenance dosing versus Soliris's biweekly schedule, a meaningful quality-of-life improvement for patients on chronic complement inhibition. In India, Ultomiris is not yet broadly registered for routine dispensing through hospital pharmacies, which is why your physician may be navigating a named-patient import pathway with you.
This guide explains the legal pathway, what documentation your physician needs, typical costs and timing, and where Reserve Meds fits in.
The clinical situation
Ultomiris is administered as an IV infusion with a weight-based loading dose followed by maintenance dosing every eight weeks (every four weeks in paediatric patients under 20 kg). It carries a US boxed warning regarding life-threatening meningococcal infections, which is why meningococcal vaccination (or appropriate antibiotic prophylaxis if vaccination is not feasible in time) is a gating step before therapy begins, as is enrolment in the US REMS program. Internationally, equivalent manufacturer risk-minimisation measures apply. Your treating physician confirms diagnosis (flow cytometry for PNH; clinical and complement/ADAMTS13 criteria for aHUS; AChR-antibody serology for gMG; AQP4-IgG for NMOSD), vaccination status, and the infusion plan per FDA labeling.
Is Ultomiris legally importable into India?
Yes — through the Central Drugs Standard Control Organization (CDSCO) named-patient / personal-use import framework. The pathway allows an Indian-licensed physician (or the patient directly, with physician prescription) to request import of a medicine not locally registered when: (a) the medicine is approved by a recognised reference authority (FDA qualifies), (b) no clinically equivalent registered alternative fits, (c) the physician takes clinical responsibility, and (d) the imported quantity is proportionate to a defined treatment period.
For ravulizumab specifically, international access respects the manufacturer's controlled-distribution program and the physician-registration expectations tied to the meningococcal-infection risk profile.
How the pathway works, step by step
- Consultation with your treating physician. Diagnosis confirmation, clinical rationale, and meningococcal vaccination review.
- Meningococcal vaccination / prophylaxis. Vaccination at least 2 weeks before first dose, or antibiotic cover per labeling.
- CDSCO named-patient / personal-use application. Your physician or hospital pharmacy files the application.
- US-side sourcing. Reserve Meds coordinates with our US-licensed specialty wholesale partner, aligned with the manufacturer's controlled-distribution model.
- Cold-chain shipment. Ultomiris ships at 2–8°C with continuous temperature monitoring.
- Arrival, induction, and maintenance dosing. The infusion facility administers on the induction-then-eight-weekly schedule.
What documentation your physician needs
Your physician will typically need to provide:
- Clinical rationale letter confirming indication, diagnostic evidence, prior therapies (including any prior Soliris exposure), and Ultomiris as the indicated treatment
- Verification of Indian medical licence
- Patient identifier
- Meningococcal vaccination documentation or prophylaxis plan
- Planned induction and eight-weekly maintenance regimen
Reserve Meds provides a physician documentation kit that bundles the templates CDSCO reviewers expect to see for complement inhibitors, including the meningococcal-infection risk-minimisation block.
Costs and timing
Ultomiris's US cash-pay reference price sits in a broad indicative range — annualised treatment costs for PNH or aHUS are typically quoted in the USD 400,000–500,000 range in US list pricing, driven by loading plus every-eight-week maintenance. International cold-chain logistics, CDSCO documentation, and concierge coordination add incremental cost. Reserve Meds issues a full transparent quote at the start of intake. These ranges are indicative, not guaranteed.
Indicative timing — not guaranteed — for the first dose after cohort intake opens is approximately 14–28 days from the moment a complete application is submitted (vaccination lead time may extend this).
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.
Reserve Meds's role
Reserve Meds is a US-based concierge coordinator for cross-border specialty medicine. For Ultomiris specifically, we provide:
- Sourcing. Through our US-licensed specialty wholesale partner, operating under DSCSA chain-of-custody and aligned with the manufacturer's controlled-distribution program.
- Documentation. Regulatory package for your physician and for CDSCO review, including the meningococcal-risk-minimisation block.
- Logistics. Cold-chain, temperature-monitored shipment.
- Concierge case lead. A named point of contact.
What we do not do: We are not the prescriber. We do not practise medicine. We are not the dispensing pharmacy. All clinical decisions remain with your treating physician.
Frequently asked
Is this legal in India? Yes, when executed through the CDSCO named-patient / personal-use framework with appropriate documentation and respect for the manufacturer's controlled-distribution expectations. India's pathway is well-established for rare-disease biologics not yet locally registered.
What about the meningococcal warning? It is load-bearing. Vaccination at least 2 weeks before first dose, or antibiotic prophylaxis per labeling, is non-negotiable. Your physician coordinates this before treatment starts.
Ultomiris vs Soliris — which is right for me? Both are C5 inhibitors from the same family. Ultomiris is the longer-half-life successor, dosed every eight weeks versus Soliris's biweekly schedule. For most chronic PNH and aHUS patients, Ultomiris's reduced infusion burden is a meaningful quality-of-life advantage. Your physician decides based on clinical profile, prior Soliris exposure, and logistics.
Will private insurance cover this? Cash-pay is the default. Some Indian private insurers reimburse named-patient imports for ultra-rare-disease therapies on escalated review; we supply documentation for your submission but do not process insurance 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 are ready to enter intake for Ultomiris coordination in India.
Add me to the Ultomiris 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.
Clinical & regulatory review: Reserve Meds clinical team and AI regulatory-counsel review pipeline. Last medically reviewed: 2026-04-23.