How to access Praluent from India — the named-patient import pathway, 2026
By Reserve Meds · Clinical & regulatory team · Last reviewed 2026-04-23
An Indian patient with established atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolaemia (HeFH) who is not at LDL-C goal on maximally tolerated statin therapy may receive a prescription for Praluent (alirocumab) from their treating cardiologist or lipidologist. Praluent is FDA-approved for LDL-C lowering and developed by Regeneron and Sanofi. In India, access to PCSK9 inhibitors through the local supply chain is uneven, and patients frequently navigate the named-patient / personal-use import pathway when their preferred brand or specific dose isn't reliably stocked.
This guide explains the pathway, documentation your physician prepares, typical timing and cost bands, and where Reserve Meds fits in.
The clinical situation
Praluent is a fully human monoclonal antibody against PCSK9, administered subcutaneously every two weeks (or every four weeks at the higher dose) via auto-injector or pre-filled syringe. Eligibility anchors to LDL-C history above goal despite maximally tolerated statin (with or without ezetimibe), documented ASCVD or HeFH, and patient willingness to self-administer. Your cardiologist will set a lipid follow-up cadence and injection-technique training pathway.
Is Praluent legally importable into India?
Yes — through the CDSCO / Drugs Controller General of India (DCGI) personal-use and hospital-sponsored named-patient import frameworks. India's personal-use import mechanism is regularly used for therapies where the patient's clinician has established a specific product choice and the local supply chain is inconsistent for that particular product or presentation. A registered medical practitioner (or the patient with physician documentation) may request import of an FDA-approved medicine where the locally registered supply does not meet the clinical need.
How the pathway works, step by step
- Consultation with your treating cardiologist or lipidologist. ASCVD / HeFH documentation, statin-history confirmation, lipid-panel history, and clinical rationale.
- Baseline assessment. Full lipid panel, hepatic and renal function, and injection-technique training plan.
- CDSCO personal-use / named-patient application. The physician or hospital files clinical rationale, patient identification, and product details.
- US-side sourcing. Reserve Meds coordinates with our US-licensed specialty wholesale partner to secure Praluent under DSCSA chain-of-custody.
- Cold-chain shipment. Praluent requires refrigerated handling; shipment follows validated cold-chain protocols with temperature logging and customs clearance support.
- Arrival and dispensing. The hospital pharmacy or licensed personal-use receiver releases the auto-injectors to the patient after clinic-based injection training.
What documentation your physician needs
- Clinical rationale letter confirming indication (ASCVD / HeFH), statin history, and Praluent as the indicated therapy
- Verification of Indian medical registration (NMC)
- Lipid-panel history documenting LDL-C above goal
- Patient identifier and address for the import record
- Planned dosing schedule (every 2 or 4 weeks) and follow-up LDL-C cadence
Reserve Meds provides a physician documentation kit bundling templates CDSCO reviewers and Indian customs expect for cardiology named-patient and personal-use imports.
Costs and timing
Praluent's US cash-pay reference cost sits in an indicative 2026 annual range of roughly USD 6,000–7,000. International logistics, customs clearance, CDSCO documentation handling, cold-chain shipment, and concierge coordination add incremental cost. Reserve Meds issues a transparent quote at the start of intake. These figures are indicative, not guaranteed.
Indicative timing — not guaranteed — for first dispense after cohort intake opens is approximately 14–28 days from the moment a complete application is submitted and customs processing begins.
Reserve Meds is in pre-launch. Fulfillment availability is limited to our first cohort, and all timelines published on this site are indicative. If your clinical situation is time-sensitive, flag that when you join the waitlist — we triage accordingly.
Reserve Meds's role
- Sourcing. Through our US-licensed specialty wholesale partner under DSCSA chain-of-custody.
- Documentation. Regulatory package for your physician and CDSCO / customs review.
- Logistics. Validated cold-chain shipment with customs clearance support.
- Concierge case lead. A named point of contact coordinating every-2-week (or monthly) refill cadence.
What we do not do: We are not the prescriber, do not practise medicine, and are not the dispensing pharmacy. All clinical decisions remain with your treating cardiologist. We operate on a waitlist basis during pre-launch.
Frequently asked
Is this legal in India? Yes, when executed through the CDSCO personal-use / named-patient framework with appropriate documentation. See our trust and compliance page.
Why not just use a locally available statin or ezetimibe? The pathway anchors on maximally tolerated statin therapy being insufficient — your cardiologist documents that trial. Praluent is not a first-line monotherapy replacement.
How does Praluent compare with Repatha or Leqvio? Praluent and Repatha are PCSK9 monoclonal antibodies dosed every 2–4 weeks; Leqvio is a PCSK9-targeting siRNA dosed every 6 months after loading. Your cardiologist selects based on adherence profile, dosing convenience, and payer considerations.
Will insurance cover this? Cash-pay is the default. Some Indian private insurers and diaspora policies consider case by case; we supply documentation but do not process claims directly.
Next step — join the first-cohort waitlist
Reserve Meds is opening to a limited first cohort in 2026. Add your case to the waitlist and our concierge case lead will reach out when we enter intake for Praluent coordination.
Add me to the Praluent waitlist> Examples and timings above are composite illustrations drawn from published sources and typical named-patient patterns. Your individual case is assessed by your physician and our clinical-regulatory team; Reserve Meds does not guarantee outcomes or timelines.
Reserve Meds is a US-based concierge coordinator for cross-border specialty medicine. We are in pre-launch; service availability is limited to our first cohort and published timelines are indicative, not guarantees. Cash-pay. Export-only (US → overseas). Composite case examples. Not medical advice.
Clinical & regulatory review: Reserve Meds clinical team and AI regulatory-counsel review pipeline. Last medically reviewed: 2026-04-23.