Will Star Health, HDFC ERGO, and ICICI Lombard and Niva Bupa and Bajaj Allianz cover this?

Each insurer assesses named-patient imports case by case. Some reimburse fully when Bylvay is on their formulary even if not currently stocked, some reimburse a percentage subject to copay, and many require pre-authorisation. We supply the documentation set that allows your insurer to assess the case; the claim itself sits with you or your hospital.

Is the FDA-approved indication recognised by CDSCO?

The CDSCO named-patient pathway exists precisely to permit access when the local registration or stocking lags the FDA label. The application documents the FDA indication, the reference-authority approval, and the local gap; CDSCO review focuses on the clinical justification rather than re-litigating the FDA decision.

My physician is licensed in one emirate / state / province and the hospital is in another. Is that fine?

Any Indian-licensed physician practicing in good standing in the jurisdiction of the dispensing facility has signing authority on the clinical justification letter. The State Medical Council and the CDSCO Zonal Office verifies the active license; the CDSCO application records both the prescribing physician and the dispensing facility.

Can I receive Bylvay at home?

The dispensing facility must be Indian-licensed. The hospital outpatient or specialty pharmacy releases the medicine to you after final verification, and you then administer or self-administer at home where the FDA label permits, after the dispensing pharmacy's training. The cold-chain or controlled-storage handoff ends at the dispensing pharmacy; home storage and any handling protocol are part of your patient onboarding kit.

What about competitors or alternative therapies in the same class?

Choice of therapy depends on the patient's full phenotype, prior therapy, and the prescriber's judgment. Reserve Meds coordinates whichever medicine the physician has prescribed; we do not substitute, advise on substitution, or promote one brand over another.

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Bylvay access in India: the CDSCO named-patient pathway

How patients in the Republic of India legally obtain Bylvay (odevixibat) when the locally registered indication, stocked presentation, or payer coverage does not match what the prescribing physician has written.

Last reviewed 2026-05-12 by Reserve Meds clinical and regulatory team.

Quick orientation

Patients in India access Bylvay (odevixibat) for pruritus in patients 3 months of age and older with progressive familial intrahepatic cholestasis (PFIC) and pruritus in patients 12 months of age and older with Alagille syndrome through the CDSCO named-patient pathway, a Central Drugs Standard Control Organisation-administered mechanism that allows an Indian-licensed physician at a registered facility to import the FDA-labelled product for a specific named patient. This page details the documentation, approval timeline, and real cost in INR.

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How Bylvay reaches patients in India

Bylvay (odevixibat, a minimally absorbed ileal bile-acid transporter inhibitor from Ipsen / Albireo, FDA-approved 20 July 2021 for pruritus in patients aged 3 months and older with progressive familial intrahepatic cholestasis, with a subsequent 2023 expansion to pruritus in patients aged 12 months and older with Alagille syndrome, label resource at accessdata.fda.gov) is not visible on the Central Drugs Standard Control Organization SUGAM approved-product search at cdscoonline.gov.in as of 2026-06-01. Families access the medicine under the Permission to Import Small Quantities of New Drug for Personal Use, the statutory Form 12-B Permit applied for via Form 12-A under Rules 36 and 36A of the Drugs and Cosmetics Rules 1945 read with the New Drugs and Clinical Trials Rules 2019, pathway page at cdsco.gov.in/Drugs-for-Personal-Use. Applications are filed online through the SUGAM portal at cdscoonline.gov.in/CDSCO/Drugs_Personal. CDSCO public materials describe Form 12-B issuance within one to two working days when documentation is complete. Where the paediatric hepatology service is the importer-of-record for an admitted named child, the parallel Import Licence for Personal Use in CT Form-16 under the Second Schedule and Table-1 of the New Drugs and Clinical Trials Rules 2019 applies, rules text at cdsco.gov.in/Acts-and-rules/New-Drugs. The prescribing paediatric hepatologist or gastroenterologist's National Medical Commission registration number, the child's diagnosis with serum bile acid measurement, weight-based dose calculation per the FDA label, and a pro-forma invoice support the file. Form 12-B permits are single-consignment per shipment cycle.

Where Bylvay is dispensed in India

Bylvay is supplied as oral capsules or oral pellets administered once daily on an empty stomach for chronic cholestatic pruritus in paediatric patients with PFIC or Alagille syndrome. Dispensing routes through paediatric hepatology services with growth, fat-soluble vitamin (A, D, E, K), serum bile acid, and pruritus severity-scale tracking at each visit. Indian Centres of Excellence under the National Policy for Rare Diseases 2021, identified in the policy document at mohfw.gov.in NPRD 2021, host the paediatric cholestasis case load. Centres relevant to a Bylvay case include the All India Institute of Medical Sciences New Delhi Department of Paediatric Gastroenterology and Hepatology and the Centre for Genetics and Inherited Metabolic Disorders, at aiims.edu; Sanjay Gandhi Postgraduate Institute of Medical Sciences Lucknow Paediatric Hepatology service, with a long history of paediatric liver care; Christian Medical College Vellore Paediatric Gastroenterology and Clinical Genetics, at clin.cmcvellore.ac.in; the Postgraduate Institute of Medical Education and Research Chandigarh Paediatric Hepatology unit; the Institute of Liver and Biliary Sciences Delhi (ILBS), a national autonomous liver-disease institute at ilbs.in; and the Institute of Postgraduate Medical Education and Research / SSKM Hospital Kolkata. Among private tertiary nodes, Apollo Hospitals Chennai and Delhi (with active paediatric liver transplant programmes), Kokilaben Dhirubhai Ambani Hospital Mumbai, and Medanta The Medicity Gurugram routinely handle paediatric cholestasis cases.

What Bylvay costs in India

The US wholesale acquisition cost for Bylvay is reported in the range of approximately USD 354,200 to USD 415,800 per year at the standard FDA-labelled once-daily regimen for chronic paediatric cholestatic pruritus, sourced from Ipsen / Albireo investor materials and Drugs@FDA at accessdata.fda.gov. Dosing is weight-based per the FDA label; smaller children consume proportionally fewer capsules or pellets per day. No public local-currency benchmark for Bylvay in INR is observed on the National Pharmaceutical Pricing Authority ceiling-price database at nppaindia.nic.in as of 2026-06-01, consistent with the drug not being CDSCO-registered; do not estimate. Price snapshot: 2026-06-01. Cost layers stacked on the drug cost include international ambient freight (Bylvay is a stable oral solid at controlled room temperature per the FDA label), CDSCO permit and customs processing (nominal relative to drug cost), the paediatric hepatology dispensing facility's drug-handling fee, and the Reserve Meds concierge fee itemised separately on every firm quote. Goods and Services Tax on life-saving medicines sits at 5 percent. Re-supply cadence is typically quarterly once the dose is stabilised.

Funding and access barriers for Bylvay in India

The National Policy for Rare Diseases 2021 lists progressive familial intrahepatic cholestasis and Alagille syndrome under its rare-disease groupings. The central financial-assistance ceiling of INR 50 lakh per patient under the Rashtriya Arogya Nidhi umbrella scheme at mohfw.gov.in RAN applies to designated Centres of Excellence and is structured around one-time or short-course treatment. Indefinite paediatric Bylvay dosing on an open-ended cholestatic-pruritus indication does not fit the one-time-treatment structure naturally, though NPRD coordinators at the CoEs have applied the ceiling flexibly for chronic paediatric rare-disease therapies. Ayushman Bharat Pradhan Mantri Jan Arogya Yojana at INR 5 lakh per family per year hospitalisation cover does not extend to chronic outpatient paediatric cholestasis therapy. Indian private health insurers including Star Health, Niva Bupa, HDFC ERGO Health, Care Health, ManipalCigna, ICICI Lombard, and Bajaj Allianz assess unregistered named-patient imports case by case; IRDAI has not issued a uniform rule. The dominant funding pattern is family self-pay supplemented by diaspora remittance, crowdfunding through Ketto, Milaap, and ImpactGuru, and Ipsen patient-access mechanisms where the company operates one. State paediatric liver transplant programmes have historically been the touchpoint for severe-cholestasis families, and several paediatric hepatology services run charity programmes that may co-fund medication for the lowest-income families.

Recent regulatory and access news for Bylvay

The CDSCO Notifications feed at cdsco.gov.in/Notifications has not posted an odevixibat-specific Indian notification over the last 12 months as of 2026-06-01. The Ministry of Health and Family Welfare continues quarterly Health Minister's Committee updates on the NPRD 2021 Centres of Excellence and disease coverage at mohfw.gov.in; no PFIC- or Alagille-syndrome-specific reclassification altering Bylvay eligibility has been observed in the most recent published roster. On the manufacturer side, Ipsen has continued regional reporting of Bylvay rollout through 2025 and 2026 disclosures with EMA review published in the EPAR at ema.europa.eu. India-specific Bylvay registration filings have not appeared on the SUGAM approved-product search at cdscoonline.gov.in as of the snapshot date.

Where Reserve Meds fits in Bylvay cases

Reserve Meds is a US-based concierge coordinator. We do not replace your treating physician, we do not replace CDSCO, and we do not replace your dispensing pharmacy. For Bylvay specifically, we orchestrate the US-side sourcing through a DSCSA-compliant specialty channel, build the documentation packet your physician submits, coordinate validated logistics (cold-chain with continuous temperature logging where the FDA label requires it) into India, and assign a single named coordinator through the case. Standard named-patient coordination under our specialty playbook applies. Presentation selection, dose-band confirmation, and patient onboarding for self-administration where applicable are the recurring operational fundamentals we expect for this drug.

Operationally, a typical Bylvay case runs across four parallel tracks. The clinical track is the physician's: justification letter, dosing plan, monitoring schedule, and the next patient-facing follow-up. The regulatory track is the CDSCO application packaged by the importer; we provide the documentation template, the dispensing facility license check, and the chain-of-custody attestation. The logistics track is the US-side sourcing and the validated international shipment with continuous temperature logging and customs broker coordination. The patient-experience track is the named coordinator who keeps everyone aligned on dates, addresses dispensing-pharmacy questions, and confirms the medicine has been received and stored correctly. The four tracks are run in parallel rather than in series; that is the operational difference between a 3-week and a 9-week case.

Bylvay is dosed orally once daily (capsules or oral pellets) at paediatric hepatology centres; growth, fat-soluble vitamin status, and serum bile acid trends are tracked at each visit.

Next step

If your Indian physician has prescribed Bylvay and you are weighing the cross-border route, the next step is a short intake. We confirm eligibility within 24 to 48 hours and send a documentation kit to your physician.

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