How to access Stelara 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 Stelara (ustekinumab) from their treating dermatologist, rheumatologist, or gastroenterologist. Stelara is FDA-approved in the United States and developed by Janssen (Johnson & Johnson). It is a human IgG1κ monoclonal antibody that targets the shared p40 subunit of IL-12 and IL-23. In India, ustekinumab availability is evolving — biosimilars are entering the market, and originator supply through hospital pharmacies can be inconsistent. Where the originator product at the specific dose form is clinically required, named-patient import via CDSCO is the legitimate route.
This guide explains the pathway, what documentation your physician needs, typical costs and timing, and where Reserve Meds fits in.
The clinical situation
Stelara is administered as an IV infusion for Crohn's and UC induction, then subcutaneously (every 8 weeks) for maintenance; for psoriasis and PsA it is subcutaneous throughout. Dosing is weight-based for IBD induction. Your treating physician confirms diagnosis, activity score (PASI for psoriasis, endoscopic and clinical activity for IBD), TB and infection screening, and the monitoring plan per FDA labeling.
Is Stelara legally importable into India?
Yes — through the CDSCO / Drugs Controller General of India (DCGI) personal-use and hospital-sponsored named-patient import frameworks. The route permits a registered medical practitioner to request import of a medicine not locally registered for the specific indication or dose form, or where the originator product is clinically required, when the medicine is approved by a recognised reference authority (FDA qualifies), no clinically equivalent registered option fits, and chain of custody is documented.
How the pathway works, step by step
- Consultation with your treating physician. Diagnosis, activity documentation, and clinical rationale.
- Pre-treatment screening. TB, hepatitis, and infection screening per labeling.
- CDSCO application. The physician or hospital files the personal-use / named-patient application.
- US-side sourcing. Reserve Meds coordinates with our US-licensed specialty wholesale partner for originator Stelara.
- Cold-chain shipment. Stelara ships at 2–8°C with continuous temperature monitoring and chain-of-custody documentation end to end.
- Arrival and first dose. The hospital pharmacy releases product for IV induction (if IBD) or subcutaneous administration.
What documentation your physician needs
Your physician will typically need to provide:
- Clinical rationale letter confirming diagnosis, activity, prior therapies, and Stelara as the indicated treatment
- Verification of their Indian medical registration (NMC)
- Patient identifier and address for the import record
- Pre-treatment screening confirmation
- Planned induction and maintenance regimen
Reserve Meds provides a physician documentation kit that bundles the templates Indian customs and CDSCO reviewers expect to see for IL-12/23-class biologics.
Costs and timing
Stelara's US cash-pay reference price for a single 90 mg pre-filled syringe (common maintenance dose) sits in a broad indicative range of roughly USD 25,000–30,000; the IV induction vial is priced separately and depends on patient weight. International cold-chain logistics, customs clearance, CDSCO documentation handling, 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 first dose after cohort intake opens is approximately 14–28 days from the moment a complete application is submitted and customs processing begins. Maintenance doses ship on a rolling basis against the every-8-week schedule.
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: Indian IBD and psoriasis patients often have family abroad helping fund originator-biologic care. Our concierge case lead is set up to include every designated family member on coordination and document flow.
Reserve Meds's role
Reserve Meds is a US-based concierge coordinator for cross-border specialty medicine. For Stelara specifically, we provide:
- Sourcing. Through our US-licensed specialty wholesale partner, operating under DSCSA chain-of-custody.
- Documentation. Regulatory package for your physician and for CDSCO / customs review.
- Logistics. Cold-chain, temperature-monitored, internationally tracked shipment.
- Concierge case lead. A named point of contact.
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 physician.
Frequently asked
Is this legal in India? Yes, when executed through the CDSCO personal-use / named-patient framework with appropriate documentation.
What about biosimilars? If a locally available biosimilar is clinically appropriate and approved for your indication, your physician may recommend that instead — it is often the more practical option. Reserve Meds coordinates originator Stelara access when your physician specifically requests originator product.
Can the family abroad pay directly? Yes. Diaspora-supported invoicing is common; we issue invoicing that family members in the US, UAE, UK, Canada, and elsewhere can settle directly.
Will insurance cover this? Cash-pay is the default. Some Indian insurers and diaspora policies consider named-patient 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 are ready to enter intake for Stelara coordination in India.
Add me to the Stelara 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.