How to access Skyrizi from India — the named-patient import pathway, 2026
By Reserve Meds · Clinical & regulatory team · Last reviewed 2026-04-23
An Indian patient with moderate-to-severe plaque psoriasis, active psoriatic arthritis, moderately-to-severely active Crohn's disease, or moderately-to-severely active ulcerative colitis may receive a prescription for Skyrizi (risankizumab) from their treating dermatologist, rheumatologist, or gastroenterologist. Skyrizi is FDA-approved in the United States and manufactured by AbbVie. It is a humanised IgG1 monoclonal antibody that selectively targets the p19 subunit of interleukin-23, with a maintenance cadence measured in weeks rather than days. Access in India varies by state, by institution, and by indication; when locally available presentations do not match the prescribed regimen, a CDSCO personal-use import pathway remains legitimate for the patient whose physician has already prescribed the drug.
This guide explains the pathway, what documentation your physician needs, typical costs and timing, and where Reserve Meds fits in.
The clinical situation
Skyrizi is an injectable anti-IL-23p19 monoclonal antibody. Dosing is indication-specific. For plaque psoriasis and psoriatic arthritis, the typical regimen is 150 mg subcutaneously at week 0, week 4, and every 12 weeks thereafter. For Crohn's disease and ulcerative colitis, induction is given intravenously (commonly 600 mg at weeks 0, 4, and 8) followed by subcutaneous maintenance (often 360 mg every 8 weeks). The IL-23 class has a cleaner safety profile than the JAK class and does not carry an FDA boxed warning. Pre-treatment screening per FDA labeling includes tuberculosis evaluation, hepatitis B and C serology, and review of vaccination status (live vaccines are not recommended during therapy). India's high background TB prevalence makes careful pre-treatment TB evaluation especially important; your physician will document severity, prior therapy history, and the induction and maintenance plan.
Is Skyrizi legally importable into India?
Yes — through the Central Drugs Standard Control Organization (CDSCO) personal-use / named-patient import framework, coordinated with the treating hospital or prescribing physician. India has a long-standing personal-use import mechanism under the Drugs and Cosmetics Rules that supports access to medicines approved by reference authorities but not available locally in the specific presentation or indication.
The CDSCO pathway allows a qualified Indian physician to support import of a medicine when: (a) the medicine is approved by a recognised reference authority such as the US FDA or EMA, (b) no clinically equivalent locally available alternative is suitable for the patient, (c) the treating physician takes clinical responsibility and a valid prescription is in hand, and (d) chain of custody is documented from the US source to the patient or dispensing facility. Quantities imported are typically bounded by a defined treatment duration.
How the pathway works, step by step
- Consultation with your treating physician. The prescribing decision is clinical. Your physician documents the indication, severity, prior therapy history, and rationale for Skyrizi.
- Baseline screening. TB evaluation (with careful attention given Indian epidemiology), viral hepatitis, and vaccination review are completed and documented.
- CDSCO personal-use documentation. Your physician writes a prescription and supporting letter; Reserve Meds's regulatory team packages the import documentation.
- US-side sourcing. Reserve Meds coordinates with our US-licensed specialty wholesale partner to secure product from AbbVie's authorised distribution under DSCSA chain-of-custody.
- Cold-chain shipment. Skyrizi requires refrigerated transport (2 to 8 degrees Celsius) with temperature-excursion monitoring and customs documentation.
- Arrival and first administration. Product reaches the dispensing facility or patient against the physician's prescription, and administration proceeds on the planned induction and maintenance schedule.
What documentation your physician needs
Your physician will typically need to provide:
- A clinical rationale letter confirming the indication, severity scoring, prior therapy history (including any biologic exposure), and Skyrizi as the indicated treatment
- Verification of their Indian medical registration (NMC / state council)
- A patient identifier on the prescription
- Documented pre-treatment screening (TB with Indian context, hepatitis) and vaccination review
- The planned induction and maintenance schedule and the presentation required (150 mg SC; 600 mg IV induction; 360 mg SC maintenance)
- Identification of the administering facility for IV induction where applicable
Reserve Meds provides a physician documentation kit that bundles the templates typical for CDSCO personal-use imports of IL-23 biologics, including cold-chain handling documentation.
Typical costs and indicative timing
Reserve Meds gives you a drug-only reference range plus a transparent delivered quote at intake. As an illustrative composite case, the US cash-pay reference range for a Skyrizi 150 mg psoriasis maintenance dose sits in an indicative 2026 band of roughly USD 18,000 to 21,000 per dose, with IV induction for Crohn's or UC running higher per session. International cold-chain logistics, CDSCO documentation, Indian customs clearance, and concierge coordination add incremental cost. The delivered quote we issue at intake itemises each line so nothing is hidden.
Indicative timing — not a guarantee — for first dose after cohort intake opens is approximately 7 to 14 days from the moment a complete documentation package is finalised, assuming customs clears on first pass. Subsequent maintenance doses are scheduled against the physician's cadence.
Reserve Meds is in pre-launch; service availability is limited to our first cohort. All timelines are indicative, not guarantees. If your clinical situation is time-sensitive, flag that when you join the waitlist and we will triage accordingly.
Where Reserve Meds fits in
Reserve Meds is a US-based concierge coordinator for cross-border specialty medicine. For Skyrizi specifically, we provide:
- Sourcing. Through our US-licensed specialty wholesale partner, operating under DSCSA chain-of-custody from manufacturer to export.
- Documentation. CDSCO-oriented personal-use package tailored for your physician and for Indian customs.
- Cold-chain logistics. Temperature-controlled, internationally tracked shipment with excursion monitoring to your dispensing pharmacy or administering facility.
- Concierge case lead. A named point of contact for your family and your physician across the full case arc.
We are a coordinator — not the prescriber, not the dispensing pharmacy. All clinical decisions remain with your treating physician, and dispensing sits with the licensed pharmacy of record.
FAQ
Is this legal in India?
Yes, when executed through the CDSCO personal-use / named-patient framework with a valid prescription, appropriate clinical rationale, and complete customs documentation.
Why is TB screening emphasised?
India has higher background TB prevalence than many reference-authority jurisdictions. IL-23 inhibition is not expected to reactivate latent TB at the rates seen with TNF inhibitors, but pre-treatment evaluation remains part of standard labeling and is especially important in the Indian context.
How does Skyrizi compare to other IL-23 inhibitors available or importable in India?
Skyrizi, Tremfya, Ilumya, and Omvoh all target IL-23p19 but differ in dosing cadence, indication set, and trial evidence. Your physician will choose based on indication, prior therapy, and response expectations.
Can the SC presentation be self-administered at home?
The 150 mg SC presentation is designed for administration after training; your physician decides whether in-clinic or at-home administration is appropriate for your case.
Will private insurance cover this?
Cash-pay is the default posture. Some Indian private insurers reimburse specialty imports on a case-by-case basis; we supply documentation so you can submit, but we do not process insurance claims directly.
Join the 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 Skyrizi coordination in India.
Add me to the Skyrizi waitlistThis guide is educational, not medical advice. Reserve Meds is a US-based concierge coordinator; we are not the prescriber and not the dispensing pharmacy. All clinical decisions remain with the treating physician.