Alyftrek access in India: the CDSCO named-patient pathway
How India patients legally obtain Alyftrek (vanzacaftor / tezacaftor / deutivacaftor) when the locally registered indication, stocked presentation, or payer coverage does not match what the prescribing physician has written.
Last reviewed 2026-05-16 by Reserve Meds clinical and regulatory team.
Quick orientation
Patients in India access Alyftrek (vanzacaftor-tezacaftor-deutivacaftor) for cystic fibrosis with responsive mutations through the CDSCO Rule 36 personal-import authorisation, a federal mechanism that allows a treating Indian physician 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 Alyftrek reaches patients in India
Alyftrek (vanzacaftor / tezacaftor / deutivacaftor, a next-generation oral CFTR triple combination from Vertex Pharmaceuticals, FDA-approved 20 December 2024 for cystic fibrosis in patients aged 6 years and older with at least one F508del mutation or another responsive CFTR mutation, label resource at accessdata.fda.gov) is not visible on the Central Drugs Standard Control Organization SUGAM approved-product search at cdscoonline.gov.in as of 2026-06-01. India patients access the medicine under the Permission to Import Small Quantities of New Drug for Personal Use, the statutory Form 12-B Permit applied for via Form 12-A under Rules 36 and 36A of the Drugs and Cosmetics Rules 1945, read with the New Drugs and Clinical Trials Rules 2019, pathway page at cdsco.gov.in/Drugs-for-Personal-Use. Applications are filed online via the SUGAM portal at cdscoonline.gov.in/CDSCO/Drugs_Personal. CDSCO public materials describe Form 12-B issuance within one to two working days when documentation is complete, an administrative target rather than a gazetted SLA. When a tertiary CF centre files on behalf of an admitted named patient, the parallel Import Licence for Personal Use in CT Form-16 under the Second Schedule and Table-1 of the New Drugs and Clinical Trials Rules 2019 applies, rules text at cdsco.gov.in/Acts-and-rules/New-Drugs. The application requires a registered medical practitioner's prescription with National Medical Commission registration number, drug strength and quantity, and the patient's case summary. Form 12-B permits are single-consignment; chronic-therapy families re-file at each shipment cycle.
Where Alyftrek is dispensed in India
Alyftrek is an oral once-daily tablet taken with fat-containing food and dispensed in outpatient CF specialty clinic settings with sweat-chloride monitoring, lung function (ppFEV1) surveillance, hepatic enzyme baseline and routine LFTs, and paediatric ophthalmology screening. Indian centres with established CF clinics and the genetic-testing access needed to confirm CFTR mutation status include the Postgraduate Institute of Medical Education and Research Chandigarh paediatric pulmonology service; the All India Institute of Medical Sciences New Delhi Department of Paediatrics, at aiims.edu; Christian Medical College Vellore Paediatric Pulmonology, at clin.cmcvellore.ac.in; King Edward Memorial Hospital Mumbai with paediatric pulmonology and CF support; Sir Ganga Ram Hospital Delhi; and Sanjay Gandhi Postgraduate Institute of Medical Sciences Lucknow. Private tertiary nodes routinely handling CFTR-modulator imports include Apollo Hospitals Chennai, Delhi, Hyderabad, and Bangalore; Kokilaben Dhirubhai Ambani Hospital Mumbai; Fortis Memorial Research Institute Gurugram; Medanta The Medicity Gurugram; Manipal Hospitals Bangalore; and Narayana Health Bangalore. The Cystic Fibrosis Foundation of India operates an informal national network through these centres. The dispensing facility must hold a drug licence covering imported unregistered medicines.
What Alyftrek costs in India
The US wholesale acquisition cost for Alyftrek is approximately USD 31,500 per 30-day supply, with annual cost in the range of approximately USD 370,000 per year for the standard once-daily adult dose at the labelled regimen, sourced from Vertex Pharmaceuticals investor materials and Drugs@FDA at accessdata.fda.gov. Paediatric patients aged 6 to less than 12 years receive weight-banded dosing per the FDA-approved label. No public local-currency benchmark for Alyftrek in INR is observed on the National Pharmaceutical Pricing Authority ceiling-price database at nppaindia.nic.in as of 2026-06-01, consistent with the drug not being CDSCO-registered; do not estimate. Price snapshot: 2026-06-01. Cost layers stacked on drug cost include international ambient or refrigerated freight depending on the lane (Alyftrek tablets are stable at controlled room temperature per the FDA label), CDSCO permit and customs handling (nominal relative to drug cost), the dispensing facility's drug-handling fee, and the Reserve Meds concierge fee itemised separately on every firm quote. Goods and Services Tax on life-saving medicines is 5 percent. Re-supply cadence is quarterly for many families after the first cycle is stable.
Funding and access barriers for Alyftrek in India
The National Policy for Rare Diseases 2021 lists cystic fibrosis under its rare-disease groupings; the central financial-assistance ceiling of INR 50 lakh per patient under the Rashtriya Arogya Nidhi umbrella scheme at mohfw.gov.in RAN applies to designated Centres of Excellence, with the policy text at mohfw.gov.in NPRD 2021. The cap is structured around one-time or short-course treatments and is not naturally aligned with indefinite CFTR-modulator dosing at originator pricing. Ayushman Bharat Pradhan Mantri Jan Arogya Yojana at INR 5 lakh per family per year hospitalisation cover does not cover chronic outpatient CFTR modulators outside listed packages. Indian private health insurers including Star Health, Niva Bupa, HDFC ERGO Health, Care Health, ManipalCigna, ICICI Lombard, Bajaj Allianz, and Tata AIG assess unregistered named-patient imports case by case; IRDAI has not issued a uniform rule for this category. The dominant funding pattern for an Alyftrek case is family self-pay supplemented by diaspora remittance, crowdfunding through Ketto, Milaap, and ImpactGuru, and the Vertex GPS (Guidance & Patient Support) compassionate-access programme where the company operates one in the patient's home country. CFTR-modulator access in India has been the subject of patient-advocacy lobbying and Delhi High Court petitions; the Cystic Fibrosis Society of India tracks developments. Foreign Contribution (Regulation) Act 2010 considerations may apply where a foreign foundation is the named donor.
Recent regulatory and access news for Alyftrek
The CDSCO Notifications feed at cdsco.gov.in/Notifications has not published an Alyftrek-specific notification over the last 12 months as of 2026-06-01. The Ministry of Health and Family Welfare continues quarterly Health Minister's Committee updates on the NPRD 2021 Centres of Excellence and disease coverage at mohfw.gov.in, with no Alyftrek-specific reclassification observed in the most recent roster. Indian patient-advocacy organisations including the Cystic Fibrosis Society of India have continued advocacy for broader CFTR-modulator access through 2025 and 2026, with public reporting of compassionate-access negotiations between Vertex and Indian institutions. India-specific Alyftrek registration filings have not appeared on the SUGAM approved-product search at cdscoonline.gov.in as of the snapshot date.
Where Reserve Meds fits in Alyftrek cases
Reserve Meds is a US-based concierge coordinator. We do not replace your Indian specialist, we do not replace the CDSCO, and we do not replace your dispensing pharmacy. For Alyftrek specifically, we orchestrate the US-side sourcing through a DSCSA-compliant specialty channel, build the documentation packet your physician submits, coordinate logistics into India, and assign a single named coordinator through the case. The pharmacist-of-record review, prescription validation, biomarker confirmation, and physician sign-off are the recurring operational fundamentals for this drug.
Next step
If your Indian physician has prescribed Alyftrek 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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