How to access Mayzent from India — the named-patient import pathway, 2026

By Reserve Meds · Clinical & regulatory team · Last reviewed 2026-04-24

An Indian patient with active secondary-progressive multiple sclerosis (SPMS) — the progressive form characterised by ongoing inflammatory activity layered on accumulating disability — may receive a prescription for Mayzent (siponimod) from their treating neurologist. Mayzent is FDA-approved and developed by Novartis. It is an oral S1P1/S1P5 receptor modulator that remains one of the few agents carrying a specific labelled indication for active SPMS. In India, Mayzent is not routinely registered for domestic dispensing, and access is typically coordinated through the named-patient import pathway under the Central Drugs Standard Control Organisation (CDSCO) framework.

This guide explains the pathway, documentation your physician prepares, typical timing and cost bands, and where Reserve Meds fits in.

The clinical situation

Mayzent is a selective S1P1/S1P5 receptor modulator taken orally once daily. Dose titration (0.25 mg escalation over five days to the maintenance 2 mg daily for most patients) is used at initiation to manage the first-dose cardiac-conduction signal characteristic of the class. Mayzent is unusual among MS therapies in that dosing depends on CYP2C9 genotype — patients with CYP2C93/3 genotype should not receive Mayzent, and 1/3 or 2/3 genotypes require a reduced maintenance dose. Genotyping before starting is therefore part of standard initiation.

Eligibility requires a confirmed active SPMS diagnosis and a clinical rationale. Before starting, your neurologist will establish CYP2C9 genotype, baseline ECG, cardiac review, complete blood count with lymphocyte count, baseline liver function tests, varicella serology, and ophthalmologic baseline (macular oedema risk). Live vaccines are avoided during therapy. Ongoing monitoring includes LFTs, lymphocyte count, and skin/ophthalmology surveillance.

Is Mayzent legally importable into India?

Yes — through the CDSCO personal-import / named-patient framework administered under the Drugs and Cosmetics Rules. The mechanism permits import of an unregistered medicine for a specific named patient when (a) the medicine is approved by a recognised reference authority such as the US FDA, (b) no clinically equivalent registered alternative is suitable for the patient, (c) a qualified Indian physician accepts clinical responsibility, and (d) chain of custody is documented. SPMS has limited registered options in India, which is why named-patient imports are frequently used for Mayzent.

How the pathway works, step by step

1. Consultation with your treating neurologist. Confirmation of active SPMS, MRI review, prior DMT history, and clinical rationale.
2. CYP2C9 genotyping. Required before prescribing; determines eligibility and maintenance dose.
3. Baseline workup. ECG, cardiac review, CBC with lymphocyte count, LFTs, varicella serology, ophthalmology baseline.
4. CDSCO named-patient application. The physician or hospital pharmacy files the application including clinical rationale, patient reference, genotype, titration plan, and chain-of-custody commitment.
5. US-side sourcing. Reserve Meds coordinates with our US-licensed specialty wholesale partner to secure Mayzent from authorised distribution under DSCSA.
6. Ambient shipment. Mayzent ships under controlled ambient conditions with chain-of-custody documentation.
7. Arrival and first dose. The dispensing pharmacy releases the titration pack; first-dose cardiac monitoring is arranged per your neurologist's protocol.

What documentation your physician needs

• Clinical rationale letter confirming active SPMS and Mayzent as the indicated therapy
• Verification of Indian medical registration (NMC / state council)
• CYP2C9 genotype result
• Baseline ECG report and cardiac review
• CBC with lymphocyte count and LFTs
• Varicella serology
• Ophthalmology baseline
• Planned titration schedule and monitoring plan

Reserve Meds provides a physician documentation kit bundling templates CDSCO reviewers expect for S1P-modulator SPMS named-patient imports.

Typical costs and indicative timing

Mayzent's US cash-pay reference cost sits in an indicative 2026 annual range of roughly USD 100,000–120,000 at the 2 mg maintenance dose. International logistics, CDSCO documentation handling, and concierge coordination add incremental cost. Reserve Meds issues a transparent quote at the start of intake. These figures are indicative drug-only reference pricing, not guaranteed.

Indicative timing — not guaranteed — for first dispense after cohort intake opens is approximately 7–14 days from the moment a complete CDSCO application is submitted and CYP2C9 genotype result is in hand. Monthly refills are generally faster once the pathway is established.

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

• Sourcing. Through our US-licensed specialty wholesale partner under DSCSA chain-of-custody.
• Documentation. Regulatory package for your physician and CDSCO review.
• Logistics. Ambient-controlled shipment to your prescribing hospital pharmacy.
• Concierge case lead. A named point of contact coordinating monthly 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 named-patient / personal-import framework with appropriate documentation. See our trust and compliance page.

Why CYP2C9 genotyping? Mayzent is metabolised through CYP2C9; patients with certain genotypes have higher exposure and require a reduced dose, and some genotypes preclude use entirely. Genotyping is standard of care before initiation.

Why first-dose cardiac monitoring? S1P-modulator therapy can cause first-dose bradycardia and conduction effects; the titration is designed to manage this, and some patients require observed first-dose monitoring depending on cardiac history.

How does Mayzent compare with Zeposia or Ponvory? All are S1P modulators; Mayzent carries a specific active-SPMS indication and requires CYP2C9 genotyping. Your neurologist selects based on MS phenotype, genotype, and comorbidity profile.

Will private insurance cover this? Cash-pay is the default. Some Indian private insurers consider case by case; 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 Mayzent coordination in India.

Add me to the Mayzent 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.

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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: 2026-04-24.