Will Star Health and HDFC ERGO cover this?

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

How patients in the Republic of India legally obtain Rezzayo (rezafungin) 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 Rezzayo (rezafungin) for candidemia and invasive candidiasis in adults with limited or no alternative treatment options 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 Rezzayo reaches patients in India

Rezzayo (rezafungin, a novel long-acting echinocandin, FDA-approved March 2023 for candidemia and invasive candidiasis in adults with limited or no alternative treatment options; once-weekly IV) is not visible on the CDSCO SUGAM registered-product database at cdscoonline.gov.in as of 2026-05-31. Access for Indian patients runs predominantly through the hospital-led pathway CT Form-16 under the New Drugs and Clinical Trials Rules 2019, because candidemia and invasive candidiasis are inpatient diagnoses requiring ICU or inpatient ID consultation; patient-led Form 12-A is procedurally available but operationally less common for acute infections. The Rezzayo-specific clinical justification must document: blood-culture or sterile-site-culture-confirmed Candida species (or strong clinical suspicion with documented inability to tolerate or contraindication to standard echinocandins or fluconazole), prior antifungal exposure where applicable, MIC susceptibility data where available, intent to leverage the once-weekly IV dosing schedule (typically a 400 mg loading dose followed by 200 mg weekly), and the ICU or inpatient ID team's care plan. CT Form-16 is processed through SUGAM with the institutional importer-of-record (the treating hospital) signing the application; CDSCO turnaround on hospital-led imports is typically rapid for documented urgent need.

Where Rezzayo is administered in India

Rezzayo is an acute hospital-administered IV antifungal; the dispensing setting is inpatient infectious diseases, ICU, or haematology-oncology with confirmed or strongly suspected candidemia or invasive candidiasis. Indian tertiary nodes with structured antimicrobial stewardship and access to advanced antifungals through institutional channels include AIIMS New Delhi Department of Microbiology and Department of Internal Medicine and Department of Medical Oncology BMT unit at aiims.edu; PGIMER Chandigarh Department of Medical Microbiology; CMC Vellore Department of Clinical Microbiology and Department of Infectious Diseases at clin.cmcvellore.ac.in; Tata Memorial Hospital Adult Haematolymphoid DMG and Critical Care service in Mumbai at tmc.gov.in; Apollo Hospitals critical care and infectious diseases services in Chennai, Hyderabad, and Delhi; Fortis Memorial Research Institute Department of Internal Medicine and ID in Gurugram; Medanta The Medicity Critical Care Institute in Gurugram; and Kokilaben Dhirubhai Ambani Hospital Critical Care in Mumbai. CMC Vellore Department of Clinical Microbiology runs one of South Asia's largest invasive-candidiasis case series and publishes a national Candida species and antifungal susceptibility profile.

What Rezzayo costs in India

The US reference WAC for Rezzayo is approximately USD 950 to USD 1,100 per 200 mg vial. The typical loading-then-weekly course (400 mg loading followed by 200 mg weekly for 2 to 6 weeks depending on response and duration of fungaemia) drives a per-course US cost in the range of USD 5,000 to USD 12,000 per Drugs@FDA at accessdata.fda.gov/scripts/cder/daf. No public local-currency benchmark for Rezzayo in INR is observed on the NPPA database at nppaindia.nic.in or in Indian hospital-procurement reporting as of 2026-05-31 (the drug is not commercially launched locally); do not estimate. Price snapshot: 2026-05-31. Cost layers: cold-chain logistics into India (mid four-figure USD for refrigerated lanes), CDSCO CT Form-16 institutional import (nominal), ICU or inpatient hospitalisation costs which dominate the total cost picture for invasive candidiasis, and Reserve Meds concierge fee itemised separately. Note the cost comparison: micafungin and anidulafungin (older echinocandins, available in India) have substantially lower per-course costs than rezafungin; the Rezzayo case turns on the once-weekly IV dosing advantage where central-venous-access or daily-dosing is the bottleneck.

Funding and access barriers for Rezzayo in India

Candidemia is a substantial nosocomial-infection problem in Indian tertiary ICUs; CMC Vellore and AIIMS have published Candida species shifts toward non-albicans and azole-resistant species (Candida auris notably). Older echinocandins (micafungin, anidulafungin, caspofungin) are first-line per IDSA guidelines and are available in India; rezafungin's positioning is for adults with limited or no alternative treatment options, including cases where daily IV dosing is the operational constraint. Public-sector funding: AIIMS, PGIMER, and CMC Vellore institutional formularies adjudicate non-listed antifungals on case-by-case clinical-microbiology committee review. Ayushman Bharat PM-JAY ICU and infection packages do not consistently list rezafungin by name. State schemes typically do not include rezafungin. Private insurance covers hospitalisation but the drug-specific cost recovery depends on policy. Mundipharma (the global rezafungin licensee through Cidara Therapeutics' partnership for ex-North America markets) operates compassionate-access on case-by-case clinical need; the European launch is more advanced than the Indian. The CDSCO CT Form-16 hospital-led import is straightforward where the treating institution documents urgent clinical need and the inability to tolerate or use first-line echinocandins.

Recent regulatory and access news for Rezzayo

EMA (CHMP) issued a positive opinion for rezafungin in invasive candidiasis in late 2023; the European Commission approved the marketing authorisation. The EMA EPAR is at ema.europa.eu/medicines/Rezzayo. Phase 3 ReSPECT-EU and ReSTORE results supporting the FDA approval are referenced in the FDA approval letter at accessdata.fda.gov/scripts/cder/daf. No CDSCO bulletin on rezafungin has been observed over the last 12 months as of 2026-05-31; the drug is not currently listed on the SUGAM portal. IDSA guidelines on candidiasis (2016, with subsequent updates) have not been refreshed to incorporate rezafungin as a primary recommendation but list it as an option for treatment-experienced or echinocandin-restricted cases.

Where Reserve Meds fits in Rezzayo 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 Rezzayo 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 Rezzayo 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.

Rezzayo's once-weekly dosing simplifies extended outpatient antifungal courses; the named-patient case typically supports outpatient continuation after inpatient initiation. Indian specialty referral concentrates these cases at the major academic medical centres and oncology networks.

Next step

If your Indian physician has prescribed Rezzayo 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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