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.
Ask about Eylea 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
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 how to get a written quote.
Case active and ready to skip the regulatory walkthrough? Ask about a medicine or WhatsApp us.
Reserved for you.
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) may be registered in India (we confirm its current CDSCO status for your case at intake) 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.
What Eylea costs in India
Medicine price: quote on request. You get a written quote for your case before you commit. 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.
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; any amount above the cap is co-pay or self-pay. 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 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 digital health company. 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 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 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 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.
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 reply within one business day, then send a documentation checklist to your doctor.
Reserved for you.