Will Star Health and HDFC ERGO cover this?

Each insurer assesses named-patient imports case by case. Some reimburse fully when Eylea 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 Eylea 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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Eylea access in India: the CDSCO named-patient pathway

How patients in the Republic of India legally obtain Eylea (aflibercept) 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 Eylea (aflibercept) for neovascular (wet) age-related macular degeneration, diabetic macular edema, diabetic retinopathy, retinal vein occlusion, and retinopathy of prematurity 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 Eylea reaches patients in India

Eylea (aflibercept, recombinant VEGF-A and placental growth factor decoy receptor, FDA-approved 2011 for neovascular age-related macular degeneration with subsequent expansions to diabetic macular oedema, diabetic retinopathy, retinal vein occlusion macular oedema, and retinopathy of prematurity; Eylea HD 8 mg approved 2023) is registered in India through Bayer's local affiliate and appears on CDSCO SUGAM at cdscoonline.gov.in for selected presentations. Where the prescribed presentation (Eylea HD 8 mg, prefilled syringe, or specific paediatric ROP dosing) is not locally stocked or where supply gaps occur, Indian patients access Eylea via Form 12-A personal-use import under Rules 36 and 36A of the Drugs and Cosmetics Rules 1945; the Form 12-B permit issues typically within one to two working days when documentation is complete per cdsco.gov.in/consumer/Drugs-for-Personal-Use. The Eylea-specific clinical justification must document the indication (nAMD, DME, DR, RVO macular oedema, or ROP), the dosing schedule per FDA label (monthly induction then maintenance, with HD 8 mg allowing extended intervals of 8 to 16 weeks), and the prescribing retina specialist's National Medical Council registration. Cold-chain handling (2 to 8 degrees Celsius) is documented; intravitreal injection environment requirements (sterile retina clinic or OT) are referenced in the supporting medical report.

Where Eylea is administered in India

Eylea is delivered as a sterile intravitreal injection in a retina-specialist clinic or operating theatre; the dispensing centres are ophthalmology rather than oncology. Indian tertiary ophthalmology and dedicated retina nodes include Sankara Nethralaya in Chennai, the L V Prasad Eye Institute network in Hyderabad, Bhubaneswar, Visakhapatnam, and Vijayawada at lvpei.org, the Aravind Eye Hospitals network across Tamil Nadu, the Dr Rajendra Prasad Centre for Ophthalmic Sciences at AIIMS New Delhi at aiims.edu, the Postgraduate Institute of Medical Education and Research (PGIMER) Chandigarh Advanced Eye Centre, the Narayana Nethralaya in Bangalore, and the Shankar Netralaya Sankara Eye Foundation centres. Public-tertiary ophthalmology at AIIMS and PGIMER, and the dedicated charitable and private-tertiary eye institutes (LVPEI, Aravind, Sankara Nethralaya, Narayana Nethralaya), carry the bulk of intravitreal anti-VEGF case load nationally. For paediatric retinopathy of prematurity, the LVPEI Retinopathy of Prematurity service and AIIMS Dr Rajendra Prasad Centre paediatric retina service are the primary tertiary nodes. Aravind and Sankara Nethralaya publish lead retina-specialist faculty.

What Eylea costs in India

The US reference WAC for Eylea 2 mg intravitreal injection is approximately USD 1,850 to USD 2,000 per single-dose vial; Eylea HD 8 mg is approximately USD 2,600 to USD 2,850 per single-dose vial per Drugs@FDA at accessdata.fda.gov/scripts/cder/daf. Annual cost depends on injection frequency: monthly induction for nAMD or DME typically requires 7 to 9 injections in year one followed by treat-and-extend, driving year-one US cost in the range of USD 13,000 to USD 18,000 per eye for Eylea 2 mg. Bayer India publishes a local MRP for the registered Eylea 2 mg presentation; reporting from Indian retina-specialist channels places the locally-procured INR price in the range of INR 28,000 to INR 40,000 per 2 mg vial depending on supplier window. NPPA at nppaindia.nic.in has placed aflibercept under selected DPCO ceiling reviews; check current ceiling at the NPPA database before quoting a single ruling price. Price snapshot: 2026-05-31. Cost layers: cold-chain logistics into India (low four-figure USD for the 2 mg vials, higher for HD 8 mg), CDSCO Form 12-B permit (nominal), the retina-clinic injection-procedure fee (typically INR 5,000 to INR 15,000 per injection in private tertiary), and Reserve Meds concierge fee itemised separately.

Funding and access barriers for Eylea in India

Intravitreal anti-VEGF therapy for nAMD, DME, DR, and RVO is high-volume in India, and locally-registered aflibercept plus ranibizumab plus brolucizumab plus the off-label-bevacizumab pathway means most Indian patients access an anti-VEGF therapy without invoking Form 12-A. The named-patient import lane is most often invoked for Eylea HD 8 mg (the extended-interval presentation not yet locally launched at scale) or for paediatric ROP dosing not locally stocked. Public-sector funding: Ayushman Bharat PM-JAY at pmjay.gov.in covers selected ophthalmology packages with capped per-procedure rates; intravitreal anti-VEGF series typically exceed the per-episode cap, leaving co-pay or self-pay residual. State schemes (Tamil Nadu CMCHIS, Kerala KASP, Karnataka, Andhra Aarogyasri) include retinopathy packages with state-specific drug ceilings. The Health Ministry's National Programme for Control of Blindness has historically supported community-screening DR programmes but does not consistently fund individual anti-VEGF cycles. Major private insurers (Star Health, Niva Bupa, HDFC ERGO Health, Care Health, ManipalCigna; New India Assurance, ICICI Lombard, Bajaj Allianz, Tata AIG) cover anti-VEGF with documented retina-specialist indication and prior authorisation. Pharma compassionate-access from Bayer India is available case-by-case. The cold-chain import-permit step for the 8 mg HD presentation is operationally straightforward at major Indian air-cargo hubs.

Recent regulatory and access news for Eylea

FDA approved (August 2023) Eylea HD 8 mg for nAMD, DME, and DR enabling extended dosing intervals of 8 to 16 weeks, summarised at accessdata.fda.gov/scripts/cder/daf. FDA approved (February 2023) Eylea 2 mg for ROP in preterm infants. EMA (CHMP) approved aflibercept 8 mg for similar indications in 2024. Locally, NPPA has continued periodic DPCO review of anti-VEGF formulations; check the current ceiling at nppaindia.nic.in. CDSCO Notifications at cdsco.gov.in/Notifications have not issued an Eylea-specific bulletin over the last 12 months as of 2026-05-31. The Indian Retina Specialists' Society treatment guidelines have been updated to include aflibercept 8 mg as an option for treatment-experienced nAMD and DME patients seeking extended-interval dosing.

Where Reserve Meds fits in Eylea 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 Eylea 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 Eylea 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.

Eylea is administered by intravitreal injection in a sterile clinic setting; named-patient files in India document the baseline OCT and FAF imaging, the FDA-labelled dosing schedule for the specific indication (wet AMD, DME, RVO, or DR), and the retinal specialist's intravitreal injection volume. Cold-chain (2 to 8 degrees Celsius) handling is required through the dispensing pharmacy with continuous temperature logging; the dispensing pharmacy releases the medicine for same-session injection at the clinic rather than for outpatient home storage.

Next step

If your Indian physician has prescribed Eylea 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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