Vyvgart access in India: the CDSCO Rule 36 named-patient pathway

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

Quick orientation

Vyvgart is the argenx-developed FcRn antagonist approved by the US FDA in December 2021 for adults with anti-AChR antibody positive generalized myasthenia gravis (gMG). The label has since been expanded to cover gMG regardless of antibody serostatus, and the subcutaneous Vyvgart Hytrulo formulation received FDA approval in June 2024 for chronic inflammatory demyelinating polyneuropathy (CIDP) in adults. Vyvgart is the first-in-class FcRn antagonist, opening a new mechanistic category that targets the recycling of pathogenic IgG antibodies rather than depleting B cells or blocking complement. Local registration status with CDSCO is verified at the time of each individual case, and access for Indian patients typically runs through Rule 36 of the Drugs and Cosmetics Rules 1945. For patients on chronic intravenous immunoglobulin (IVIG) or plasma exchange (PLEX) where Indian immunoglobulin supply is inconsistent and the per-cycle cost is substantial, Vyvgart can be a meaningful alternative when the treating neurologist decides it is the right step.

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Why patients in India reach for Vyvgart through NPP

India has the largest tertiary specialty hospital network of any Reserve Meds priority country, and Indian manufacturers supply a significant share of the world's generic medicines. For US originator specialty biologics like Vyvgart, three patterns of access gap recur. A drug can be registered with CDSCO but the specific brand, strength, or pack size is not stocked in the dispensing pharmacy on the day therapy is meant to start. A drug can be registered for one indication and prescribed for another FDA-approved use that is not on the Indian label. A drug can be FDA-approved in the United States but not registered locally at all. For Vyvgart the dominant pattern is the third, with country-level registration uneven across MENA and South Asia and reimbursement and stocking in India lagging behind US and EU regulatory approval.

The clinical demand driver in India is the IVIG and PLEX alternative case. Patients with gMG who are intolerant of, or losing response to, chronic intravenous immunoglobulin (IVIG) or plasma exchange (PLEX) often have no equivalent FcRn-antagonist option available locally. The mechanistic difference matters: FcRn antagonism produces a more targeted reduction in pathogenic IgG (approximately 60 to 70 percent at the nadir following a 4-week cycle) without the volume-loading, infusion-reaction risk, and intermittent supply burden of repeat IVIG cycles. Indian immunoglobulin supply is variable, and the per-cycle cost of IVIG or PLEX at a tertiary neurology centre is substantial, particularly for chronic users. For CIDP the same logic holds, with the subcutaneous Vyvgart Hytrulo formulation offering continuous weekly dosing that contrasts with the relapse-pattern of repeat IVIG cycles. Reserve Meds frames Vyvgart cases as a documented cross-border channel under the CDSCO Rule 36 framework rather than a workaround.

The CDSCO named-patient pathway for Vyvgart

The legal foundation for personal import of unregistered medicines 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. Form 12A is the application for the permit. 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 designated CDSCO Port Offices. The application is accompanied by a prescription from a Registered Medical Practitioner (RMP) showing the RMP's 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.

For institutional Compassionate Use of drugs not approved for marketing in India at all, the parallel pathway is the Compassionate Use application route to the DCGI by a government hospital, a registered medical practitioner, a pharmaceutical company, or the patient. This route applies when the drug is approved by a recognised reference authority (FDA, EMA, MHRA, Health Canada, PMDA) for a life-threatening condition, a serious permanent disability, or an unmet medical need. AIIMS and other tertiary institutions have established workflow for this route.

For Vyvgart the clinical-justification angle is antibody-status documentation and prior-line failure of IVIG or PLEX. A complete CDSCO application typically includes:

• A clinical justification letter naming the diagnosis (generalized myasthenia gravis, with anti-AChR antibody status documented; or CIDP with neurophysiology and clinical criteria documented), the patient's MG-ADL and QMG scores at baseline, the prior IVIG and/or PLEX history (cycles, response, tolerability, adverse events), and the documented reason this product is required
• The treating physician's NMC registration number and a copy of state council registration where required
• A patient identifier and supporting medical records, including the anti-AChR antibody assay result (where available, though the label now covers seronegative gMG), neurophysiology for CIDP cases, and prior therapy documentation
• Product details: Vyvgart (efgartigimod alfa-fcab) 400 mg per 20 mL single-dose IV vial, or Vyvgart Hytrulo (efgartigimod alfa with hyaluronidase) 1,008 mg subcutaneous prefilled syringe, manufacturer argenx SE, quantity (not to exceed one hundred average doses per application; for an IV gMG cycle of 4 weekly infusions, a single cycle's vial count fits comfortably within the limit)
• The dispensing facility's drug licence (hospital pharmacy or specialty importer's wholesale licence), and the infusion-suite capability for the IV formulation
• A chain-of-custody plan from the US specialty-pharmacy source to the dispensing pharmacy in India, including continuous 2-to-8-degree cold-chain documentation

CDSCO's published guidance states the Form 12B permit issues on a priority basis, typically within one to two days for routine applications where the documentation is complete. In practice families plan for a two to four week window from physician decision to dispensed medicine.

Where Vyvgart gets dispensed in India

Vyvgart is a refrigerated biologic. The IV formulation is administered in hospital infusion suites or specialised neurology infusion centres; the subcutaneous Hytrulo formulation can be administered at home after training, though the cold-chain receipt and storage requirements still apply. The dispensing footprint is the neurology infusion services and the specialty importer network. Institutions that file named-patient imports and operate infusion infrastructure include the All India Institute of Medical Sciences (AIIMS) in New Delhi, Apollo Hospitals (Chennai flagship, with Delhi, Bangalore, Hyderabad, and Kolkata), Fortis Memorial Research Institute in Gurgaon and the Fortis Mulund, Bangalore, and Kolkata sites, 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 neurology cases the natural homes are the neurology and neuromuscular disorders services at AIIMS Delhi, Apollo Chennai, Apollo Delhi, Medanta Gurgaon, and CMC Vellore, all of which manage chronic IVIG and PLEX programmes and can integrate Vyvgart cycles into established infusion workflow. Families in tier 2 cities typically route to one of these centres for the prescription and clinical justification letter, then work with a CDSCO-licensed specialty importer in Mumbai, Delhi, or Bangalore that files the Form 12A and handles the cold-chain documentation. The Hytrulo subcutaneous presentation simplifies last-mile handling because it does not require infusion-suite reconstitution, although it retains the 2-to-8-degree storage requirement.

Real cost picture for Vyvgart in India

US WAC for Vyvgart IV is reported by published health-economics analyses in the range of approximately USD 63,000 to USD 95,000 per 4-week treatment cycle, driven by patient weight (which determines vial count). Annualised across the typical 4 to 5 cycles per year, this translates to approximately USD 300,000 to USD 450,000 per patient per year for gMG. Vyvgart Hytrulo pricing is set at parity to the IV product on a per-cycle basis. Individual 20 mL IV vials are reported at approximately USD 6,000 to USD 6,200 in published price guides. Reserve Meds quotes firm pricing only after receiving final manufacturer or specialty-pharmacy procurement confirmation for the specific patient case.

The Indian rupee floats against the US dollar. In May 2026 the USD/INR rate sits in the 94 to 95 range. A single 4-week Vyvgart cycle at US WAC translates to roughly INR 59 lakh to INR 89 lakh at the prevailing rate; annualised across 4 to 5 cycles, the cost stack reaches the INR 2.8 crore to INR 4.2 crore range. International cold-chain logistics adds USD 800 to USD 2,000 per shipment (approximately INR 76,000 to INR 1.9 lakh) for the IV vials, with the Hytrulo presentation at the lower end because of reduced packout volume. India's Union Budget 2026-27 expanded the list of life-saving drugs eligible for customs duty exemption, and the specific HSN code and exemption status are confirmed at the documentation stage. GST on most life-saving medicines is 5%.

The cost stack reframes the comparison against chronic IVIG, which itself runs in the high-five-figure to low-six-figure USD range per year in India when fully accounted (drug acquisition, infusion-suite charges, monitoring, and adverse-event management). Vyvgart is not cheap, but it is the only mechanism-of-action alternative in its class and the comparator is rarely a free option. Star Health, HDFC ERGO, ICICI Lombard, and Niva Bupa each handle named-patient imports case by case; none reimburse a Rule 36 personal import as a standard line item. CGHS coverage flows through the Special DG (DGHS) Expert Committee route, with stricter constraints on US-only-approved products. The National Policy for Rare Diseases 2021 ceiling of INR 50 lakh per patient for rare diseases requiring one-time treatment may apply to specific cases through a Centre of Excellence application.

Typical timeline for Vyvgart in India

For an established Vyvgart candidate with a clean neurology letter, documented anti-AChR status, and prior IVIG or PLEX history, the typical end-to-end cycle from first inquiry to first infusion is 3 to 5 weeks. CDSCO published guidance puts the Form 12B priority window at 1 to 2 days for complete routine documentation. US-side specialty-pharmacy sourcing through argenx-aligned distribution adds 1 to 2 weeks. International cold-chain transit and Indian customs clearance under the import permit at Delhi, Mumbai, Bangalore, Chennai, or Hyderabad airport adds 3 to 7 days, with continuous temperature monitoring at 2 to 8 degrees Celsius. Cold-chain biologic shipments add 2 to 3 days versus ambient products. Infusion-suite scheduling at the receiving centre adds a few days. Timelines are presented as typical ranges and not as promises; specific dates are confirmed at firm-quote issuance.

What your physician needs to provide

The clinical justification letter for Vyvgart is the centrepiece of the CDSCO package. For this product the letter typically includes:

• The patient's confirmed diagnosis (gMG with anti-AChR antibody status documented, or seronegative gMG per the expanded label; or CIDP with EFNS/PNS clinical and neurophysiology criteria documented)
• Disease severity at baseline: MG-ADL and QMG scores for gMG, INCAT/RODS or grip-strength measures for CIDP
• Prior treatment history: anticholinesterase therapy (pyridostigmine), corticosteroids, steroid-sparing immunosuppressants (azathioprine, mycophenolate, methotrexate), IVIG cycles (number, dose, response, tolerability), and plasma exchange (frequency, response, complications)
• The dosing plan: for gMG IV, 10 mg/kg weekly for 4 consecutive weeks per cycle (capped at 1,200 mg for patients 120 kg or more), with subsequent cycles initiated no sooner than 50 days from the start of the previous cycle, averaging 4 to 5 cycles per year; for gMG Hytrulo, fixed-dose 1,008 mg subcutaneously weekly for 4 weeks per cycle; for CIDP Hytrulo, 1,008 mg weekly continuous maintenance
• The monitoring plan: infection surveillance during and between cycles (because FcRn antagonism reduces total IgG by 60 to 70 percent at nadir), MG-ADL and QMG reassessment, vaccination-status review before initiation
• The PvPI adverse-event reporting plan as part of the Pharmacovigilance Programme of India obligation

The treating physician's NMC registration number must appear on the prescription. State-council registration is required for practice in a particular state.

Common questions about Vyvgart in India

Will Star Health, HDFC ERGO, ICICI Lombard, or Niva Bupa cover Vyvgart? 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. Cash-pay is the default posture, with the documentation kit structured to support a post-fact reimbursement application if the plan allows.

Will CGHS or ESIC cover Vyvgart? 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. ESIC's formulary is narrower and not structured for routine personal-import reimbursement. The National Policy for Rare Diseases 2021 may apply to specific cases at a Centre of Excellence.

Why Vyvgart versus IVIG or PLEX? Vyvgart offers targeted IgG reduction with a defined cycle structure rather than the volume-loading and plasma-volume considerations of IVIG and PLEX. Indian immunoglobulin supply is variable, which adds operational risk to chronic IVIG. Clinical decision-making between these options is a physician-led discussion that weighs patient-specific factors. Reserve Meds does not direct this decision.

Is there a competitor in the FcRn class? Rozanolixizumab (Rystiggo) is another FcRn antagonist approved for gMG. Complement inhibitors such as eculizumab (Soliris) and ravulizumab (Ultomiris) are approved for anti-AChR antibody positive gMG and address a different node in the same pathway. Reserve Meds does not promote one over the other; the named-patient pathway supports whichever product the treating neurologist prescribes.

Can the subcutaneous formulation be self-administered? Yes, after appropriate training. A prefilled-syringe presentation of Vyvgart Hytrulo supports self-injection at home, with cold-chain storage and the same once-weekly dosing schedule.

What is the safety profile? The ADAPT phase 3 trial in gMG reported a safety profile comparable to placebo across the treatment period. Common adverse reactions per labelling include upper respiratory tract infections, urinary tract infections, and headache. Infusion-related reactions and injection-site reactions (for the subcutaneous formulation) are documented. Because FcRn antagonism reduces total circulating IgG, infection risk is a class consideration and warrants clinician monitoring.

Where Reserve Meds fits in Vyvgart cases

Reserve Meds is a US-based concierge coordinator. We do not replace your neurologist, do not replace CDSCO, and do not replace the dispensing pharmacy or the licensed importer. For Vyvgart specifically we orchestrate the US-side sourcing through argenx-aligned specialty-pharmacy partners, the regulatory documentation kit your physician needs for Form 12A (anti-AChR status reference, prior IVIG/PLEX failure documentation template, cycle-based dosing reference, infection monitoring plan, PvPI reporting reference), validated cold-chain international logistics under chain-of-custody at 2 to 8 degrees Celsius, and a single named coordinator who carries the case from intake through each cycle's infusion and into the reporting period. Weight-based dose calculation, infusion-suite or home-administration capability confirmation, and current vaccination-status review are mandatory intake artefacts.

Next step

If your neurologist has decided Vyvgart is the right next step and local stocking or registration is the bottleneck, the Rule 36 personal-import pathway through CDSCO is the route. Join the waitlist below and we will confirm eligibility within 24 to 48 hours and route the documentation kit to your physician.

Join the Vyvgart waitlist

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