How to access Onpattro from India — the named-patient import pathway, 2026
By Reserve Meds · Clinical & regulatory team · Last reviewed 2026-04-23
An Indian patient (or diaspora family supporting a relative in India) diagnosed with hereditary transthyretin-mediated amyloidosis (hATTR) with polyneuropathy may receive a prescription for Onpattro (patisiran) from their treating neurologist. Onpattro is FDA-approved for this indication and developed by Alnylam Pharmaceuticals. In India, Onpattro is not routinely available through the local supply chain for this indication, so patients are typically routed through the named-patient / personal-use import pathway.
This guide explains the legal pathway, documentation your physician prepares, typical timing and cost bands, and where Reserve Meds fits in.
The clinical situation
Onpattro is a lipid-nanoparticle-encapsulated siRNA that silences hepatic TTR production, administered by intravenous infusion every three weeks. Eligibility requires genetic confirmation of a pathogenic TTR variant, symptomatic polyneuropathy, and cardiac workup to characterise any ATTR-CM overlap. Your neurologist will establish baseline neuropathy impairment score, NIS+7, polyneuropathy disability score, and quality-of-life measures. Onpattro infusion requires a premedication regimen (corticosteroid, antihistamine, acetaminophen) and a clinic with infusion capability; many Indian tertiary centres can accommodate.
Is Onpattro legally importable into India?
Yes — through the CDSCO / Drugs Controller General of India (DCGI) personal-use and hospital-sponsored named-patient import frameworks. India has a well-established personal-use import mechanism regularly used for rare-disease therapies, including those without a locally registered alternative. A registered medical practitioner — or the patient on personal-use grounds with physician documentation — may request import of a medicine approved by a recognised reference authority where no clinically equivalent registered alternative exists. hATTR polyneuropathy has limited disease-specific registered options in India.
How the pathway works, step by step
- Consultation with your treating neurologist. TTR genetic report, neuropathy scoring, and a clinical rationale documenting the absence of locally registered alternatives.
- Baseline assessment. NIS+7, polyneuropathy disability score, cardiac workup (ECG, echocardiogram, NT-proBNP), and infusion-centre identification.
- CDSCO personal-use / named-patient application. The physician or hospital files clinical rationale, genetic report, patient identification, and product details.
- US-side sourcing. Reserve Meds coordinates with our US-licensed specialty wholesale partner to secure Onpattro from authorised distribution under DSCSA.
- Cold-chain shipment. Onpattro is a refrigerated product; shipment follows validated cold-chain protocols with temperature logging and customs clearance support.
- Arrival and infusion. The hospital pharmacy receives the vial; the infusion centre administers the dose with the on-label premedication regimen.
What documentation your physician needs
- Clinical rationale letter confirming hATTR polyneuropathy and Onpattro as the indicated therapy
- Verification of Indian medical registration (NMC)
- TTR genetic test result
- Baseline NIS+7 and polyneuropathy disability score
- Cardiac assessment for ATTR-CM overlap
- Planned infusion schedule (every 3 weeks) and premedication plan
Reserve Meds provides a physician documentation kit bundling templates CDSCO reviewers and Indian customs expect to see for rare-disease named-patient imports.
Costs and timing
Onpattro's US cash-pay reference cost sits in an indicative 2026 annual range of roughly USD 450,000–475,000 (dosed every three weeks). International logistics, customs clearance, CDSCO documentation handling, cold-chain shipment, 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 dispense after cohort intake opens is approximately 14–28 days from the moment a complete application is submitted and customs processing begins.
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: hATTR is an autosomal-dominant hereditary disease, and Indian families commonly take shared responsibility for long-term care decisions across generations and continents. Our concierge coordinates with whichever family members — a parent in Chennai, a sibling in New Jersey, a cousin in Dubai — the patient designates.
Reserve Meds's role
- Sourcing. Through our US-licensed specialty wholesale partner under DSCSA chain-of-custody.
- Documentation. Regulatory package for your physician and CDSCO / customs review.
- Logistics. Validated cold-chain shipment with customs clearance support.
- Concierge case lead. A named point of contact for long-term infusion-cycle refills.
What we do not do: We are not the prescriber, do not practise medicine, and are not the dispensing pharmacy. All clinical decisions remain with your treating neurologist. We operate on a waitlist basis during pre-launch.
Frequently asked
Is this legal in India? Yes, when executed through the CDSCO personal-use / named-patient framework with appropriate documentation. See our trust and compliance page.
Does my centre need infusion capability? Yes — Onpattro is IV-infused with on-label premedication. Your neurologist will confirm the infusion-capable centre before intake.
Can diaspora family pay directly? Yes. Cross-border payment is common; we issue invoicing that family in the US, UK, UAE, Canada, and Australia can settle directly.
Will insurance cover this? Cash-pay is the default. Some Indian private insurers and diaspora policies consider rare-disease imports case by case; 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 enter intake for Onpattro coordination in India.
Add me to the Onpattro 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.