Alhemo access in India: the CDSCO Rule 36 named-patient pathway
How families in India legally obtain Alhemo (concizumab-mtci) for hemophilia A or B prophylaxis (with or without inhibitors) from US-source supply through CDSCO personal importation, with validated 2 to 8 degree Celsius cold-chain and daily subcutaneous dosing logistics built into the case plan.
Last reviewed 2026-05-12 by Reserve Meds clinical and regulatory team.
Quick orientation
Alhemo (concizumab-mtci) is a humanized IgG4 monoclonal antibody from Novo Nordisk that targets tissue factor pathway inhibitor (TFPI), restoring factor Xa generation in patients whose intrinsic coagulation cascade is broken by an absence of factor VIII or factor IX activity. It is supplied as a single-patient prefilled pen for once-daily subcutaneous injection. The US Food and Drug Administration first approved Alhemo on 20 December 2024 for routine prophylaxis in adult and pediatric patients 12 years of age and older with hemophilia A or B with inhibitors, and the label has since expanded to include hemophilia A or B without inhibitors. Alhemo is not registered with the CDSCO as of this review. Indian patients with the relevant hematology indication reach Alhemo through the Central Drugs Standard Control Organization (CDSCO) personal importation framework under Rule 36 of the Drugs and Cosmetics Rules 1945, with the Form 12A application and Form 12B permit issued by the office of the Drugs Controller General of India (DCGI). Reserve Meds coordinates the US-side specialty pharmacy sourcing, validated 2 to 8 degree Celsius cold-chain logistics with temperature monitoring through to handoff, and the documentation kit your treating hematologist needs to file.
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How Alhemo reaches patients in India
Alhemo (concizumab-mtci, a humanised IgG4 monoclonal antibody targeting tissue factor pathway inhibitor, FDA-approved 20 December 2024 for routine prophylaxis in patients 12 years and older with haemophilia A or B with FVIII or FIX inhibitors, label at accessdata.fda.gov) is not listed on the Central Drugs Standard Control Organization SUGAM approved-product search at cdscoonline.gov.in as of 2026-06-01. Patients obtain Alhemo 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. Applications run through the SUGAM portal at cdscoonline.gov.in/CDSCO/Drugs_Personal. The CDSCO public guidance describes priority processing of Form 12-B within one to two working days when documentation is complete. Where a hospital files on a named patient's behalf, the 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 is the institutional channel, rules text at cdsco.gov.in/Acts-and-rules/New-Drugs. The prescription must come from a registered medical practitioner with a current National Medical Commission registration number, paired with a treating physician's case summary and a pro-forma invoice. Quantity per permit is read conventionally as up to a three-month supply.
Where Alhemo is dispensed in India
Alhemo is a refrigerated 2 to 8 degree Celsius prefilled pen administered as a once-daily subcutaneous injection. Dispensing routes through haemophilia treatment centres and tertiary haematology services with refrigerated-biologic handling, family pen-training, and inhibitor-monitoring infrastructure. Christian Medical College Vellore Department of Haematology operates the largest haemophilia care registry in South Asia and is a primary referral node, at clin.cmcvellore.ac.in. The All India Institute of Medical Sciences New Delhi Department of Haematology and Bone Marrow Transplantation, at aiims.edu, is the apex public-sector node. The Postgraduate Institute of Medical Education and Research Chandigarh runs an established haematology service. Tata Memorial Hospital and ACTREC Mumbai, at tmc.gov.in, host adult and paediatric haematology with BMT. State Hemophilia Society chapters maintain bleed and inhibitor registries that feed directly into the clinical justification letter. Among private tertiary nodes, Apollo Hospitals Chennai, Delhi, Hyderabad, and Bangalore, Kokilaben Dhirubhai Ambani Hospital Mumbai, Fortis Memorial Research Institute Gurugram, and Medanta The Medicity Gurugram routinely handle named-patient imports of refrigerated haematology biologics. Sanjay Gandhi Postgraduate Institute of Medical Sciences Lucknow carries the eastern Uttar Pradesh case load. The dispensing facility must hold a drug licence covering refrigerated biologics.
What Alhemo costs in India
Per published US pricing references and Novo Nordisk disclosures, Alhemo list pricing is approximately USD 10,088 per 60 mg / 1.5 mL pen, USD 25,209 per 150 mg / 1.5 mL pen, and USD 50,411 per 300 mg / 3 mL pen, sourced from manufacturer disclosures and the FDA label dose section at accessdata.fda.gov label. Dosing is weight-based at a 1 mg/kg loading dose on Day 1 followed by 0.2 mg/kg subcutaneous once daily from Day 2, with a plasma-concentration check at approximately 4 weeks driving titration to 0.25 mg/kg or 0.15 mg/kg per label thresholds. For a 70 kg adult, the daily 0.2 mg/kg maintenance dose is 14 mg, translating to roughly 420 mg per month at steady state. No public local-currency benchmark for Alhemo 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 drug cost include international validated 2 to 8 degree Celsius cold-chain freight (typically four-figure USD per shipment depending on city of destination and pen count), CDSCO permit and customs handling (nominal relative to drug cost), the dispensing facility's biologic-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.
Funding and access barriers for Alhemo in India
The National Policy for Rare Diseases 2021 lists haemophilia 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 shorter-course interventions. Indefinite prophylactic dosing of a 2 to 8 degree Celsius biologic on a daily subcutaneous cadence does not fit the one-time-treatment ceiling structure naturally. State haemophilia programmes vary; Karnataka, Maharashtra, Tamil Nadu, and Kerala have historically provided factor concentrate through state Hemophilia Society partnerships but coverage of unregistered subcutaneous prophylactic biologics is not the norm. Ayushman Bharat Pradhan Mantri Jan Arogya Yojana at INR 5 lakh per family per year hospitalisation cover does not extend to chronic outpatient prophylactic biologics outside its listed package set. Indian private health insurers including Star Health, Niva Bupa, HDFC ERGO Health, Care Health, and ManipalCigna assess unregistered named-patient imports case by case and most retail policies sub-limit or exclude unregistered drugs. The dominant funding pattern for an Alhemo case is family self-pay, often supplemented by diaspora remittance, crowdfunding through Ketto, Milaap, and ImpactGuru, and the Novo Nordisk Haemophilia Foundation patient-access initiatives where applicable. Customs handling for refrigerated biologics is the operational complication beyond funding; CDSCO documentation completeness governs the speed of clearance at Delhi, Mumbai, Bengaluru, Chennai, and Hyderabad airports.
Recent regulatory and access news for Alhemo
The CDSCO Notifications feed at cdsco.gov.in/Notifications has not posted a concizumab-specific 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; no haemophilia-specific reclassification altering Alhemo eligibility has been published in the most recent roster. On the manufacturer side, Novo Nordisk has continued regional rollout of concizumab through 2025 and 2026 quarterly disclosures with EMA approval published in the EPAR at ema.europa.eu Alhemo EPAR; the US label expansion in 2025 broadened the indication beyond inhibitor cohorts. India-specific CDSCO filings have not appeared on the SUGAM approved-product search at cdscoonline.gov.in as of the snapshot date.
Where Reserve Meds fits in Alhemo cases
Reserve Meds is a US-based concierge coordinator. We do not replace your hematologist, do not replace CDSCO or the DCGI, and do not replace the dispensing hospital pharmacy or the licensed specialty importer. What we do is orchestrate the US-side specialty pharmacy sourcing under DSCSA serialization with full pedigree, validated 2 to 8 degree Celsius cold-chain logistics with temperature monitoring through to handoff, and the documentation kit your treating hematologist needs for the Form 12A filing. No prior Reserve Meds case experience exists for Alhemo as of this review, so standard NPP coordination applies with particular attention to the once-daily subcutaneous cadence (which leaves no buffer for prolonged customs delays), the thrombosis risk surveillance the prescribing hematologist holds, the 4-week plasma-concentration milestone that drives the dose-titration decision, and family training on the prefilled pen and injection-site rotation. A single named coordinator carries the case from intake through indefinite chronic prophylaxis dosing.
Next step
If an Indian patient with hemophilia A or B has a treating hematologist considering Alhemo prophylaxis, start your case at the portal. We will respond within 24 to 48 hours with a documentation kit for your hematologist and an indicative cost range scaled to the patient's current weight.
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This guide is informational, not medical or legal advice. The named-patient framework requires a licensed Indian physician's clinical judgment; Reserve Meds is the coordinator, not the prescriber.