Camzyos access in India: the CDSCO Rule 36 pathway
How Indian patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) legally access Camzyos (mavacamten), the first-in-class cardiac myosin inhibitor, through the Central Drugs Standard Control Organization Rule 36 personal-import pathway when the locally available options (beta-blockers, calcium channel blockers, disopyramide) have not delivered adequate symptom control or have caused intolerable side effects.
Last reviewed 2026-05-16 by Reserve Meds clinical and regulatory team.
Quick orientation
Camzyos (mavacamten) is the first-in-class oral selective allosteric cardiac myosin inhibitor approved by the US Food and Drug Administration in April 2022 for adults with symptomatic New York Heart Association (NYHA) class II to III obstructive hypertrophic cardiomyopathy. Manufactured by Bristol-Myers Squibb, the medicine works by reducing actin-myosin cross-bridge formation, lowering excessive cardiac contractility, reducing left ventricular outflow tract obstruction, and improving exercise capacity and symptoms. The EXPLORER-HCM and VALOR-HCM pivotal trials demonstrated significant improvements in peak VO2, NYHA class, and a substantial reduction in the proportion of patients meeting criteria for invasive septal reduction therapy (surgical myectomy or alcohol septal ablation). The medicine is dispensed only through the Camzyos REMS program in the US due to the risk of heart failure from systolic dysfunction. Camzyos is not registered with India's CDSCO, and access for Indian patients runs through Rule 36 personal-import combined with rigorous local cardiology follow-up.
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How Camzyos reaches patients in India
Camzyos (mavacamten, cardiac myosin inhibitor, FDA-approved April 2022 for symptomatic obstructive hypertrophic cardiomyopathy in NYHA class II to III adults) is not visible on the CDSCO SUGAM registered-product database at cdscoonline.gov.in as of 2026-05-31. Indian patients access Camzyos through the patient-led personal-use pathway under Rules 36 and 36A of the Drugs and Cosmetics Rules 1945, by filing Form 12-A online through SUGAM at cdscoonline.gov.in/CDSCO/Drugs_Personal; CDSCO issues the import permit on Form 12-B, typically within one to two working days when documentation is complete per CDSCO public materials at cdsco.gov.in/consumer/Drugs-for-Personal-Use. A hospital-led alternative under CT Form-16 (New Drugs and Clinical Trials Rules 2019) is available where the treating institution imports for the named patient. The Camzyos-specific clinical justification must document obstructive HCM (peak LVOT gradient at least 50 mmHg by echocardiography), NYHA class II to III symptoms, baseline LVEF of 55% or greater, and CYP2C19 metaboliser-status starting-dose selection. The Form 12-A package includes the Indian prescribing cardiologist's National Medical Council registration, the patient's identity document, the prescription specifying drug, strength, dose, and treatment duration, and a written commitment to the FDA-label echocardiographic surveillance schedule (weeks 4, 8, 12, 24, then every 12 weeks). The Form 12-B permit is single-consignment; chronic therapy re-files per cycle.
Where Camzyos is dispensed in India
Camzyos requires HCM-experienced cardiology and serial echocardiography; the dispensing centres are advanced cardiology rather than oncology units. Indian tertiary cardiology nodes with structured HCM and cardiomyopathy services include the All India Institute of Medical Sciences (AIIMS) Cardiothoracic Sciences Centre in New Delhi at aiims.edu; the Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST) Department of Cardiology in Trivandrum, the national reference centre for inherited cardiovascular disease; the Asian Heart Institute in Mumbai; the Narayana Health City Cardiac Sciences hospitals in Bangalore; the Madras Medical Mission Institute of Cardiovascular Diseases in Chennai; Apollo Hospitals Department of Cardiology in Chennai, Hyderabad, and Delhi at apollohospitals.com; Medanta The Medicity Heart Institute in Gurugram; and Fortis Escorts Heart Institute in Delhi. SCTIMST and AIIMS publish HCM clinic schedules and inherited-cardiomyopathy genetics services. The Indian Cardiology Society HCM working group also publishes a list of HCM-focused centres which overlaps with the above. CYP2C19 phenotyping is broadly available in private-tertiary genetics labs and increasingly in public-tertiary genetic medicine departments at AIIMS and SCTIMST.
What Camzyos costs in India
The US reference WAC for Camzyos is approximately USD 7,800 to USD 8,500 per 30-day supply across 2.5 mg, 5 mg, 10 mg, and 15 mg strengths per Drugs@FDA at accessdata.fda.gov/scripts/cder/daf. Annual WAC at the labelled dose runs USD 90,000 to USD 100,000. No National Pharmaceutical Pricing Authority (NPPA) ceiling has been published for mavacamten on the NPPA database at nppaindia.nic.in as of 2026-05-31 (NPPA ceilings apply to scheduled formulations under the Drug Price Control Order; mavacamten is not currently listed). No public local-currency benchmark for Camzyos in INR is observed in Indian patient-organisation reporting or hospital-distributor channels as of 2026-05-31; do not estimate. Price snapshot: 2026-05-31. Cost layers: ambient-temperature international logistics into India (low to mid four-figure USD; Camzyos is a stable oral capsule), CDSCO Form 12-B permit fees (nominal), the dispensing hospital's cardiology consultation and serial-echocardiography fees (5 in the first year per the FDA REMS schedule), and the Reserve Meds concierge fee itemised separately.
Funding and access barriers for Camzyos in India
Symptomatic obstructive HCM has a population prevalence of approximately 1 in 500 globally and is well-recognised at Indian tertiary centres; the historical management pathway combines beta-blockers, non-dihydropyridine calcium channel blockers, disopyramide, and surgical septal myectomy or alcohol septal ablation. Camzyos is a first-in-class targeted disease-modifier without an Indian-registered equivalent. Public-sector funding routes: the National Policy for Rare Diseases 2021 lists certain inherited cardiomyopathies under Group 3 (high-cost chronic conditions), but the policy's INR 50 lakh per-patient cap historically funds therapies for ultra-rare lysosomal storage disease and similar; routine application to mavacamten through a designated Centre of Excellence is not a documented precedent. Ayushman Bharat PM-JAY (cap INR 5 lakh per family per year) does not cover this drug class meaningfully. The Health Minister's Cancer Patient Fund does not apply (HCM is not oncologic). State schemes (Tamil Nadu CMCHIS, Kerala KASP, Karnataka, Andhra Aarogyasri) do not list mavacamten. Major private insurers (Star Health, Niva Bupa, HDFC ERGO Health, Care Health, ManipalCigna; general insurers New India Assurance, ICICI Lombard, Bajaj Allianz, Tata AIG) typically exclude unregistered named-patient imports in retail policies; corporate group riders may cover with documented step-therapy failure. Crowdfunding via Ketto, Milaap, or ImpactGuru is a documented funding source for high-cost chronic therapies in India. The Form 12-B import-permit step is straightforward for the oral capsule; funding is the binding constraint.
Recent regulatory and access news for Camzyos
FDA expanded the Camzyos indication (June 2025) to non-obstructive HCM in adults based on the ODYSSEY-HCM trial; the expanded label is referenced at accessdata.fda.gov/scripts/cder/daf. FDA also modified the Camzyos REMS (June 2025) to reduce the LVEF echocardiogram monitoring burden in stable maintenance patients; the REMS update is at accessdata.fda.gov/scripts/cder/rems. CDSCO has not published a class-specific notification for cardiac myosin inhibitors on its Notifications feed at cdsco.gov.in/Notifications. The National Policy for Rare Diseases 2021 disease list at mohfw.gov.in NPRD 2021 is updated by the Health Minister's Committee on a rolling basis but as of 2026-05-31 has not added a class-specific entry for mavacamten-eligible HCM.
Where Reserve Meds fits in Camzyos cases
Reserve Meds is a US-based concierge coordinator. For Camzyos cases originating in India, we orchestrate US-side sourcing through DSCSA-compliant channels, build the Form 12A documentation packet your cardiologist submits, coordinate shipment to the receiving Indian importer, and assign a single named coordinator. We work with your local cardiology team to ensure the REMS-equivalent monitoring schedule is maintained. No prior Reserve Meds Camzyos case experience is logged yet at the India-origin profile.
Next step
If your Indian cardiologist is considering Camzyos for a symptomatic oHCM patient, the next step is a short intake request. We respond within 24 to 48 hours.
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