Agamree access in India: the CDSCO Rule 36 named-patient pathway
How families in India legally obtain Agamree (vamorolone) for pediatric Duchenne muscular dystrophy from US or EU source supply through CDSCO personal importation, with weight-based dosing logistics and ambient-temperature handling built into the case plan.
Last reviewed 2026-05-12 by Reserve Meds clinical and regulatory team.
Ask about Agamree in India
Tell us the medicine and your country. We reply within one business day. On WhatsApp we usually reply the same day.
Quick orientation
Agamree (vamorolone) is a first-in-class dissociative steroidal anti-inflammatory drug developed as an alternative to prednisone and deflazacort in Duchenne muscular dystrophy (DMD). It is formulated as an oral suspension at 40 mg per millilitre and was approved by the US Food and Drug Administration on 26 October 2023 for DMD in patients 2 years of age and older, with European Commission approval following in December 2023 and a CHMP positive opinion to expand the EU label down to age 2 issued on 27 April 2026. Agamree may not be registered with CDSCO (we confirm its current CDSCO status for your case at intake), and Indian families with cash means reach it 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 or EU-side specialty sourcing through Catalyst Pathways or Santhera's local agent network, ambient-temperature logistics with no-freeze handling, and the documentation kit your pediatric neuromuscular specialist needs to file.
Case active and ready to skip the regulatory walkthrough? Ask about a medicine or WhatsApp us.
Reserved for you.
How Agamree reaches patients in India
Agamree (vamorolone oral suspension 40 mg/mL, FDA-approved 26 October 2023 for Duchenne muscular dystrophy in patients aged 2 years and older, per the FDA label at accessdata.fda.gov) does not appear on the Central Drugs Standard Control Organization SUGAM approved-product search at cdscoonline.gov.in as of 2026-06-01. Families access the drug under the Permission to Import Small Quantities of New Drug for Personal Use, 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, with the pathway page at cdsco.gov.in. 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 a hospital is the importer-of-record for a named patient under treatment, the parallel pathway is 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, rules text at cdsco.gov.in/Acts-and-rules/New-Drugs. Form 12-B is single-consignment; chronic-therapy families re-file Form 12-A per shipment cycle, conventionally up to a three-month supply per permit. A registered medical practitioner with current National Medical Commission registration must sign the prescription specifying drug name, strength, dosage form, and total quantity required, alongside a treating physician's medical justification or case summary and a pro-forma invoice from the foreign supplier.
Where Agamree is dispensed in India
Agamree is an oral suspension shaken before each dose and administered once daily with food, with weight-based dosing at 6 mg/kg/day in paediatric DMD patients. Dispensing nodes are paediatric neurology and neuromuscular clinics rather than infusion suites. The Indian Centres of Excellence under the National Policy for Rare Diseases 2021 framework, identified in the policy document at mohfw.gov.in NPRD 2021, host the most-frequent paediatric DMD case load. The dispensing facility must hold a valid drug licence covering imported unregistered medicines.
What Agamree costs in India
Medicine price: quote on request. Every case gets a written custom quote before you commit. Cost layers on top of drug cost include international ambient-temperature freight (Agamree does not require refrigeration but freezing must be avoided), CDSCO permit and customs processing, the dispensing hospital's drug-handling fee, and the Reserve Meds coordination fee itemised separately on every firm quote. Goods and Services Tax on life-saving medicines is set at 5 percent. The 3-month opened-bottle stability window at room temperature aligns reasonably well with quarterly shipping cadence for many weight bands; the weight-based recalculation cadence at every 3 to 6 months is a natural point to resize per-shipment volume.
Funding and access barriers for Agamree in India
Medicine price: quote on request. You get a written quote for your case before you commit. The cap is structured around one-time or short-course treatments and does not naturally align with the indefinite chronic dosing pattern of a corticosteroid-alternative agent. Medicine price: quote on request. You get a written quote for your case before you commit. private health insurers do not publish a standard rule for unregistered named-patient imports; IRDAI has not issued a uniform formulary rule for this category. India's out-of-pocket health expenditure share sits around 50 percent per the Ministry of Health and Family Welfare National Health Accounts series at nhsrcindia.org, and for unlicensed paediatric orphan imports the dominant funding pattern is family self-pay supplemented by diaspora remittance, crowdfunding through Ketto, Milaap, and ImpactGuru, and pharma compassionate-access programmes where the manufacturer operates one. Foreign Contribution (Regulation) Act 2010 considerations may apply if a foreign foundation or diaspora organisation is the named donor; a family paying directly is generally not engaged.
Recent regulatory and access news for Agamree
The CDSCO Notifications feed at cdsco.gov.in/Notifications remains the operational reference for any patient-facing change in the Form 12-A / 12-B regime; no drug-specific CDSCO notification for vamorolone over the last 12 months has been observed as of 2026-06-01. The Ministry of Health and Family Welfare has continued quarterly Health Minister's Committee updates on the National Policy for Rare Diseases list of approved Centres of Excellence and disease coverage, ministry page at mohfw.gov.in, with no Agamree-specific listing change observed in the most recent published roster. On the manufacturer side, Catalyst Pharmaceuticals and Santhera have continued regional rollout reporting for vamorolone through 2025 and 2026 quarterly disclosures; India-specific 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 Agamree cases
Reserve Meds is a US-based digital health company. We do not replace your pediatric neuromuscular specialist, 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 sourcing of Agamree through Catalyst Pathways' authorised specialty pharmacy network (or, where appropriate, EU-side sourcing through Santhera's local agents), ambient-temperature logistics with no-freeze handling and documented temperature logging through a bonded pharmaceutical 3PL, and the documentation kit your pediatric specialist needs for the Form 12A filing. Standard NPP coordination applies with particular attention to weight-based dose recalculation at every pediatric checkup, the 3-month opened-bottle stability window, family training on the calibrated oral dosing syringe and the shake-before-each-dose requirement, and multilingual support where Hindi or Arabic is the family's working language. A single point of contact carries the case from intake through the indefinite chronic dosing arc.
Next step
If an Indian child with confirmed DMD has a pediatric neuromuscular specialist considering Agamree, start your case at the portal. We will respond within one business day with a documentation kit for your specialist and a written quote scaled to the child's current weight.
Reserved for you.
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.