How to access Evrysdi from India — the named-patient import pathway, 2026
By Reserve Meds · Clinical & regulatory team · Last reviewed 2026-04-23
An Indian patient — infant, child, or adult — with spinal muscular atrophy (SMA) confirmed by biallelic SMN1 mutations may receive a prescription for Evrysdi (risdiplam) from their treating neurologist. Evrysdi is FDA-approved, developed by Roche and Genentech in collaboration with PTC Therapeutics and the SMA Foundation, and is an oral, once-daily small-molecule SMN2 splicing modifier. Because Evrysdi is oral and does not require intrathecal administration or an infusion facility, the access pathway is logistically simpler than Spinraza or Zolgensma — but still requires CDSCO named-patient coordination for imported supply.
This guide explains the legal pathway, what your physician needs to provide, typical timelines, and where Reserve Meds fits in.
The clinical situation
Evrysdi is a once-daily liquid formulation taken orally (or via gastrostomy tube where appropriate). It acts by modifying SMN2 pre-mRNA splicing to increase full-length SMN protein. Dosing is weight-based with paediatric and adult regimens. Eligibility anchors to SMN1 biallelic mutation confirmation and clinical or pre-symptomatic SMA. Baseline assessment is modest compared with gene-therapy or intrathecal regimens, and ongoing monitoring is primarily clinical motor-function and routine safety follow-up. Your neurology team will confirm genotype and plan the monitoring cadence.
Is Evrysdi legally importable into India?
Yes — via the Central Drugs Standard Control Organisation (CDSCO) Personal Use / Named-Patient import framework. The mechanism 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, (c) the physician accepts clinical responsibility, and (d) chain of custody through a licensed importer is documented. CDSCO personal-use approvals support multi-month dispensation with renewed applications aligned to the refill calendar.
How the pathway works, step by step
- Consultation with your neurologist. SMN1 confirmation, clinical SMA type, weight documentation, baseline functional assessment, clinical rationale letter.
- Weight-based dosing plan. Paediatric and adult dosing depends on patient weight; the prescribing neurologist confirms the regimen.
- 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 Evrysdi from the manufacturer's authorised distribution chain under DSCSA.
- Controlled shipment. Evrysdi ships with appropriate refrigerated logistics and full chain-of-custody documentation to the importer of record.
- Initiation and ongoing refill cadence. Your team initiates daily dosing, monitors motor function and routine safety, and plans refill cycles.
What documentation your physician needs
- Clinical rationale letter confirming SMA diagnosis, SMN1 biallelic status, clinical SMA type, weight, and Evrysdi as the indicated therapy
- Verification of NMC / MCI registration
- SMN1 molecular-testing report
- Weight-based dosing plan
- Multi-month refill schedule
Reserve Meds provides a physician documentation kit bundling the CDSCO templates reviewers expect to see for SMA named-patient files.
Costs and timing
Evrysdi's US cash-pay reference cost is weight-based. In an indicative 2026 range, annual cost for a paediatric patient sits near USD 100,000–340,000 depending on weight, and for an adult patient near USD 340,000. 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: many Indian SMA families struggle with the logistics of repeated intrathecal Spinraza administration in families with difficult travel to tertiary neurology centres. Oral Evrysdi removes that travel burden and is often the practical choice — where clinically appropriate per your neurologist.
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 review, keyed to the SMA rationale.
- Logistics. Refrigerated shipment to the nominated pharmacy with importer-of-record handling.
- Concierge case lead. A named point of contact supporting the multi-year daily-dosing treatment horizon and ongoing refill cycles.
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 neurologist. We operate on a waitlist basis during our pre-launch phase.
Frequently asked
How does Evrysdi compare with Spinraza? Evrysdi is daily oral; Spinraza is every-four-month intrathecal. Both address the SMN pathway. Your neurologist selects based on anatomy, caregiver preference, and clinical picture.
My child has had Zolgensma — are they still candidates for Evrysdi? Sequential therapy is not a contraindication. Your neurologist decides.
How is the liquid taken? A weight-based oral daily dose; families use the supplied dispensing syringe, or a gastrostomy tube where appropriate.
Will insurance or philanthropy cover this? Cash-pay is the default for named-patient imports. Some Indian private insurers and SMA philanthropic programmes consider case-by-case support; we supply documentation but do not manage funding 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 Evrysdi coordination.
Add me to the Evrysdi 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.