Skyrizi access in India

Quick orientation

Skyrizi is AbbVie's biologic risankizumab-rzaa, a humanized IgG1 monoclonal antibody that binds the p19 subunit of interleukin-23 and blocks IL-23 from engaging its receptor. The US FDA has approved it across four indications: moderate to severe plaque psoriasis in adults, active psoriatic arthritis in adults, moderately to severely active Crohn's disease in adults, and moderately to severely active ulcerative colitis in adults. India families seek Skyrizi when CDSCO has registered the molecule for plaque psoriasis but the treating gastroenterologist or rheumatologist is prescribing for Crohn's disease, ulcerative colitis, or psoriatic arthritis, where local labelling and stocking have not caught up to the FDA-approved indication set. The legal route is the Central Drugs Standard Control Organization (CDSCO) personal importation framework under Rule 36 of the Drugs and Cosmetics Rules 1945, using Form 12A application and Form 12B permit. Reserve Meds coordinates US-side sourcing, the documentation kit, validated cold-chain logistics, and a single named coordinator for the case.

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Why patients in India need Skyrizi via NPP

India's CDSCO has approved risankizumab for plaque psoriasis. Inflammatory bowel disease and psoriatic arthritis indications are not uniformly registered locally, which is the most frequent driver of named-patient demand from Indian gastroenterology and rheumatology programs. The country module describes three structural patterns of access gap: registered but not stocked, registered for one indication but prescribed for another, and not registered locally at all. Skyrizi sits in the middle pattern for most India patients today.

The drug module documents the cross-border demand pattern in specific terms. A patient in India with moderate to severe Crohn's disease whose local market carries Skyrizi for plaque psoriasis only has no local IBD label. A patient with ulcerative colitis is seeking access to the June 2024 UC indication before the local AbbVie affiliate completes the Indian regulatory and reimbursement filings. A patient with prior anti-TNF or ustekinumab exposure whose gastroenterologist has documented that IL-23p19 selective blockade is the next-line option may find the local market has not yet listed Skyrizi for that step in the algorithm. None of these cases is off-label use. Each is a request for access to an FDA-approved and globally registered indication that the Indian market has not caught up to. India's domestic biosimilar landscape is strong for adalimumab and ustekinumab, but no biosimilar to risankizumab is available in India today, so the only path to the molecule the prescribing specialist has named is the originator AbbVie product.

The CDSCO Rule 36 personal importation pathway for Skyrizi

The legal foundation for personal import of a small quantity of medicine into India is Rule 36 of the Drugs and Cosmetics Rules 1945. Rule 36 permits import of small quantities of a drug, whose import would otherwise be prohibited under Section 10 of the Drugs and Cosmetics Act 1940, for the exclusive personal use of a named patient.

The mechanism is documented and accessible. Form 12A is the application for a permit to import a small quantity of a drug for personal use under the second proviso to Rule 36. Form 12B is the permit itself, issued by the office of the Drugs Controller General of India (DCGI) at FDA Bhawan, Kotla Road, New Delhi, or by a designated CDSCO Port Office. The application is accompanied by a prescription from a Registered Medical Practitioner (RMP) showing the RMP's National Medical Commission (NMC) registration number and the quantity required for treatment. The quantity of any single drug imported shall not exceed one hundred average doses per application.

CDSCO's published guidance states the Form 12B permit is issued on a priority basis, typically within one to two days for routine applications where the documentation is complete. In practice, families and hospitals plan for a two to four week window from physician decision to dispensed medicine, because the bulk of the elapsed time is upstream documentation assembly and downstream international logistics rather than the regulator's stamp.

For Skyrizi specifically, the clinical justification letter centers on four angles. First, the documented FDA-approved indication being prescribed: plaque psoriasis with PASI or BSA severity score, psoriatic arthritis with joint count and CRP, Crohn's disease with disease activity index and prior therapy summary, or ulcerative colitis with Mayo score and biologic history. Second, tuberculosis screening status, which is mandatory before initiation given India's TB burden and is detailed below in the physician section. Third, prior biologic exposure and rationale for IL-23p19 selective blockade as the next step in the patient's specific treatment algorithm. Fourth, the dosing plan with the specific presentation requested (150 mg subcutaneous for psoriasis and PsA; 600 mg IV induction at week 0, 4, 8 for Crohn's; 1200 mg IV induction at week 0, 4, 8 for UC; followed by 360 mg or 180 mg SC maintenance every 8 weeks). A complete CDSCO application also includes the treating physician's NMC registration number, the patient identifier and supporting records, product details (brand Skyrizi, INN risankizumab-rzaa, manufacturer AbbVie, strength, quantity, batch where available), the dispensing facility's drug licence, and a chain-of-custody plan that preserves the 2 to 8 degrees Celsius envelope from the US source to the Indian dispensing pharmacy or infusion centre.

Where Skyrizi gets dispensed in India

India's tertiary specialty hospital network handles named-patient cold-chain biologics and IV-induction infusions as established workflow. Institutions with established import pharmacy desks and infusion capability include the All India Institute of Medical Sciences (AIIMS) in New Delhi (apex public-sector institution, a designated Centre of Excellence under the National Policy for Rare Diseases), Apollo Hospitals (Chennai flagship, plus Delhi, Bangalore, Hyderabad, Kolkata), Fortis Memorial Research Institute in Gurgaon and the broader Fortis network, Medanta in Gurgaon, Kokilaben Dhirubhai Ambani Hospital in Mumbai, MGM Healthcare in Chennai, Christian Medical College (CMC) in Vellore, and Manipal Hospitals in Bangalore.

For Skyrizi, the most relevant clinical departments are dermatology for plaque psoriasis, rheumatology for psoriatic arthritis, and gastroenterology for Crohn's disease and ulcerative colitis. Crohn's and UC induction require infusion-centre capacity for the 600 mg or 1200 mg IV doses at week 0, 4, and 8. Subcutaneous maintenance (150 mg via prefilled pen or syringe for psoriasis and PsA; 180 mg or 360 mg via on-body injector for IBD) can be administered at home after training. If the treating specialist is at a smaller institution without an import pharmacy desk or infusion centre, the practical route is to work with one of the centres above or with a CDSCO-licensed specialty importer in Mumbai, Delhi, or Bangalore that handles the filing and chain-of-custody documentation on behalf of the smaller hospital.

Real cost picture for Skyrizi in India

US wholesale acquisition cost for Skyrizi is approximately USD 23,838 per single dose as of early 2026, per AbbVie disclosure. For plaque psoriasis at 150 mg every 12 weeks after induction, annual gross WAC runs in the USD 90,000 to USD 100,000-plus range per patient-year. For Crohn's disease and ulcerative colitis the IV induction phase plus SC maintenance produces a first-year gross cost materially higher than the psoriasis steady state, driven by the 600 mg and 1200 mg IV induction doses. International logistics for cold-chain biologic shipment to India typically adds USD 400 to USD 1,500 per consignment depending on validated packout, temperature logger configuration, and lane. Regulatory documentation handling, Indian customs handling at the destination airport, and the Reserve Meds concierge fee are separate transparent line items.

India invoices land in INR with the rupee floating against the dollar; in May 2026 USD/INR is in the 94 to 95 range. India's Union Budget 2026-27 expanded customs duty exemptions on life-saving medicines and GST on most life-saving medicines is 5%; biologic immunology agents generally fall under the standard medicines bracket and the specific HSN code is confirmed at the documentation stage. None of Star Health, HDFC ERGO, ICICI Lombard, or Niva Bupa reimburse a Rule 36 personal import as a standard line item; the default posture is cash-pay, with documentation structured so the family can pursue reimbursement after the fact if the plan allows.

Typical timeline for Skyrizi in India

For Skyrizi, total elapsed time from the prescribing specialist's decision to the first administered dose typically runs three to five weeks. The Form 12B permit issues in one to two days on routine documentation per CDSCO's published priority track. The bulk of the timeline is documentation assembly with the treating specialist (TB screen, indication justification, prior therapy summary, dosing plan), US-side sourcing alignment with AbbVie's Skyrizi Complete specialty pharmacy channel, validated cold-chain packout, international shipment, customs review of the Form 12B permit and cold-chain logger records at the port of entry, and dispensing pharmacy or infusion centre receipt under its drug licence. Cold-chain shipments add two to three days versus ambient on the international logistics leg because of the validated packout and the lane discipline required to keep the 2 to 8 degrees Celsius envelope intact through customs. Crohn's and ulcerative colitis cases starting on IV induction add destination-side scheduling at the infusion centre for the week 0, 4, and 8 doses, which is normally booked while the permit is in process.

What your physician needs to provide

The treating Registered Medical Practitioner in India with a valid NMC registration number assembles the clinical package that travels with the Form 12A application. For Skyrizi that package includes: the patient's diagnosis and the FDA-approved indication being prescribed (plaque psoriasis, psoriatic arthritis, Crohn's disease, or ulcerative colitis); severity assessment appropriate to the indication (PASI or BSA for psoriasis, joint count and CRP for PsA, CDAI or HBI plus CRP and fecal calprotectin for Crohn's, Mayo score plus endoscopic findings for UC); the documented tuberculosis screen result (interferon-gamma release assay or tuberculin skin test) and treatment of latent TB before initiation if positive, which is mandatory per the FDA label and especially salient in India given the high TB burden; hepatitis B screening; prior biologic exposure and the clinical rationale for IL-23p19 selective blockade as the appropriate next step in the patient's algorithm; the dosing plan with specific presentation (150 mg SC for psoriasis and PsA, 600 mg IV induction then 360 mg SC every 8 weeks for Crohn's, 1200 mg IV induction then 180 mg or 360 mg SC every 8 weeks for UC); the avoidance of live vaccines during treatment; and the prescription with NMC registration number. The Reserve Meds documentation kit references each of these elements so the package does not loop back through CDSCO for missing data.

Common questions about Skyrizi in India

Will Star Health, HDFC ERGO, ICICI Lombard, or Niva Bupa cover Skyrizi imported under Rule 36?
Each plan handles named-patient imports case by case. None of the major private insurers reimburse a Rule 36 personal import as a standard line item. Some have reimbursed full or partial drug cost where the underlying molecule is on their formulary and the import route was a stocking workaround. Cash-pay is the default posture; Reserve Meds provides the documentation so the family or hospital can pursue reimbursement after the fact if the plan allows.

Will my CGHS or ESIC entitlement cover this?
CGHS provides for life-saving medicines not in the standard formulary to be considered by an Expert Committee under Special DG (DGHS), case by case. Drugs not approved by DCGI for use in India face a stricter Expert Committee review. ESIC's formulary is narrower. Neither scheme is structured for routine personal-import reimbursement of an immunology biologic; check eligibility before assuming coverage.

Can a private gastroenterology or dermatology specialist sign the prescription?
Yes. Any Registered Medical Practitioner with a valid NMC registration number can support a Form 12A application. Specialists at AIIMS, Apollo, Fortis, Medanta, Kokilaben, MGM, CMC Vellore, and Manipal sign these letters routinely as part of institutional workflow.

What is the safety profile?
The most commonly reported adverse reactions in the pivotal trials were upper respiratory infections, headache, fatigue, injection site reactions, and tinea infections. Serious infection, hypersensitivity reactions including anaphylaxis, and reactivation of latent tuberculosis are labeled risks. TB screening before initiation is mandatory and especially salient in India. Live vaccines should be avoided during treatment.

What is the monitoring requirement?
Screening for latent and active tuberculosis is required before initiating Skyrizi, with treatment of latent TB before starting therapy. Patients are monitored for signs and symptoms of active TB throughout treatment. Routine lab monitoring is less intensive than with anti-TNF agents, but baseline labs and ongoing clinical assessment for infection are standard. Adverse event reporting in India runs through the Pharmacovigilance Programme of India (PvPI) coordinated by the Indian Pharmacopoeia Commission; the reporting obligation stays with the prescribing physician.

How does Skyrizi compare to ustekinumab or other alternatives?
In the IL-23 p19 inhibitor class, guselkumab (Tremfya) and tildrakizumab (Ilumya) are the main competitors. In the broader IL-12/23 class, ustekinumab (Stelara, with multiple Indian biosimilars now available) is a long-established alternative. For IBD specifically, vedolizumab and anti-TNF agents (infliximab, adalimumab including Indian biosimilars Exemptia and Adfrar) sit in adjacent treatment algorithms. The choice rests with the prescribing specialist; Reserve Meds coordinates the drug the specialist has named and does not direct substitution.

Where Reserve Meds fits in Skyrizi cases

Reserve Meds is a US-based concierge coordinator. We do not replace the treating specialist, we do not replace CDSCO, and we do not replace the hospital pharmacy or the infusion centre. For Skyrizi cases destined for India, we orchestrate US-side sourcing of the originator AbbVie product matching the specific presentation prescribed (150 mg SC pen or syringe, 600 mg IV induction vial for Crohn's, 1200 mg IV induction vial for UC, or the 180 mg or 360 mg SC maintenance presentation), the documentation kit the physician needs to file under Rule 36, validated cold-chain international logistics with continuous temperature monitoring through customs handoff at Delhi, Mumbai, Bangalore, Chennai, or Hyderabad, and a single named coordinator who carries the case from first contact through dispensed medicine and into the reporting period. The IV induction formulation requires destination-side infusion-centre arrangement before the consignment moves, which is part of the coordination scope.

Next step

If you are a family member, a treating physician, or a hospital pharmacy considering Skyrizi for an India case under Rule 36, the request route is a short intake on the Reserve Meds portal. We respond within 24 to 48 hours with eligibility and the documentation kit for your specialist.

Start a Skyrizi India request

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