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.
Ask about Bylvay in India
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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 how to get a written quote.
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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. We give you a written timeline estimate for your case before you commit. 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.
What Bylvay costs in India
Medicine price: quote on request. Every case gets a written custom quote before you commit. Dosing is weight-based per the FDA label; smaller children consume proportionally fewer capsules or pellets per day. 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, the paediatric hepatology dispensing facility's drug-handling fee, and the Reserve Meds coordination 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
Indefinite paediatric Bylvay dosing on an open-ended cholestatic-pruritus indication does not fit the one-time-treatment structure naturally. Medicine price: quote on request. You get a written quote for your case before you commit. private health insurers 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 digital health company. 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 supply through a US-licensed pharmaceutical wholesale partner, 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 give you one point of contact 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 case 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 reply within one business day, then send a documentation checklist to your doctor.
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