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.
Ask about Rezzayo in India
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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 how to get a written quote.
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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.
What Rezzayo costs in India
Medicine price: quote on request. You get a written quote for your case before you commit. Micafungin and anidulafungin (older echinocandins, available in India) remain options; 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. 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. 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 digital health company. 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 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 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 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.
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 reply within one business day, then send a documentation checklist to your doctor.
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