Praluent access in India: the CDSCO Rule 36 named-patient pathway

Last reviewed 2026-05-12 by Reserve Meds clinical and regulatory team.

Quick orientation

Praluent is the Regeneron and Sanofi monoclonal antibody approved by the US FDA in July 2015 as the first PCSK9 inhibitor on the US market. The label covers adults with heterozygous familial hypercholesterolemia, established atherosclerotic cardiovascular disease, and (since 2019) cardiovascular risk reduction across the same population. Praluent has been registered with the SFDA and MOHAP via local agents across the GCC, but the PCSK9 inhibitor class has limited routine availability in India and is most often sourced through CDSCO named-patient import authorisation under Rule 36 of the Drugs and Cosmetics Rules 1945. Indian cardiology and lipid clinics increasingly identify familial hypercholesterolemia in younger patients with premature coronary disease, and patient demand for PCSK9 therapy has grown faster than local stocking. Reserve Meds operates as a legitimate cross-border named-patient channel for families whose treating physician has decided Praluent is the right next step.

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Why patients in India reach for Praluent through NPP

India has the largest tertiary specialty hospital network of any Reserve Meds priority country, and Indian manufacturers supply a significant share of the world's generic medicines. For US originator specialty biologics like Praluent, three patterns of access gap recur. A drug can be registered with CDSCO but the specific brand, strength, or pack size is not stocked in the dispensing pharmacy on the day therapy is meant to start. A drug can be registered for one indication and prescribed for another FDA-approved use that is not on the Indian label. A drug can be FDA-approved in the United States but not registered locally at all. For Praluent the dominant pattern is the first: PCSK9 inhibitors as a class have limited routine stocking in Indian retail pharmacy channels, and patients referred to start therapy frequently find that no inventory is locally available and that reorder lead times stretch weeks.

Familial hypercholesterolemia is the demand driver. India's clinical genetics and lipidology community has grown more active over the last five years, and cascade screening for FH in families with premature coronary events is becoming standard practice at tertiary cardiology centres. The Lipid Association of India guidelines recommend PCSK9 inhibitor therapy as add-on to maximally tolerated statin and ezetimibe in adults with heterozygous FH whose LDL-C remains above goal, in homozygous FH, and in established cardiovascular disease with inadequate LDL response. The pediatric label for FH detection-driven cascades is a growing area of advocacy. Praluent and Repatha are both class members; selection in practice is driven by prescriber familiarity, prior patient tolerability, dosing-frequency preference (Praluent's 300 mg every-4-weeks option is preferred by some patients), and local availability on the day the prescription is written. Reserve Meds frames Praluent cases as a documented cross-border channel under the CDSCO Rule 36 framework rather than a workaround.

The CDSCO named-patient pathway for Praluent

The legal foundation for personal import of unregistered medicines into India is Rule 36 of the Drugs and Cosmetics Rules 1945. Rule 36 permits import of small quantities of a drug, whose import would otherwise be prohibited under Section 10 of the Drugs and Cosmetics Act 1940, for the exclusive personal use of a named patient. Form 12A is the application for the permit. Form 12B is the permit itself, issued by the office of the Drugs Controller General of India (DCGI) at FDA Bhawan, Kotla Road, New Delhi, or by designated CDSCO Port Offices. The application is accompanied by a prescription from a Registered Medical Practitioner (RMP) showing the RMP's National Medical Commission registration number and the quantity required for treatment. The quantity of any single drug imported shall not exceed one hundred average doses per application.

For Praluent the clinical-justification angle is genotype, biomarker, and statin-failure documentation rather than off-label use. A complete CDSCO application typically includes:

• A clinical justification letter naming the diagnosis (heterozygous FH, homozygous FH, or established ASCVD), the genetic testing result where available (LDLR, APOB, or PCSK9 gain-of-function variants for FH), the baseline LDL-C, the maximally tolerated statin regimen and any ezetimibe trial, and the on-therapy LDL-C above goal that drives the PCSK9 add-on decision
• The treating physician's NMC registration number and a copy of state council registration where required
• A patient identifier and supporting medical records, including the lipid panel, cardiac imaging or coronary event documentation, and the FH genetic-testing report where applicable
• Product details: Praluent (alirocumab), 75 mg, 150 mg, or 300 mg pre-filled pen, manufacturer Regeneron, pack size, quantity (not to exceed one hundred average doses per application, which for a once-monthly 300 mg patient comfortably covers an annual supply)
• The dispensing facility's drug licence (hospital pharmacy or specialty importer's wholesale licence)
• A chain-of-custody plan from the US specialty-pharmacy source to the dispensing pharmacy in India, including continuous 2-to-8-degree cold-chain documentation

CDSCO's published guidance states the Form 12B permit issues on a priority basis, typically within one to two days for routine applications where the documentation is complete. In practice families plan for a two to four week window from physician decision to dispensed medicine, because the bulk of the elapsed time is upstream documentation assembly and downstream international logistics rather than the regulator stamp.

Where Praluent gets dispensed in India

Praluent is a refrigerated biologic supplied as single-dose pre-filled pens for subcutaneous self-injection. The dispensing footprint is the cardiology, lipidology, and internal medicine pharmacy desks at tertiary specialty institutions, plus CDSCO-licensed specialty importers that maintain validated cold-chain receiving infrastructure. Institutions that file named-patient imports as established practice include the All India Institute of Medical Sciences (AIIMS) in New Delhi, Apollo Hospitals (Chennai flagship, with Delhi, Bangalore, Hyderabad, and Kolkata), Fortis Memorial Research Institute in Gurgaon and the Fortis Mulund, Bangalore, and Kolkata sites, Medanta in Gurgaon, Kokilaben Dhirubhai Ambani Hospital in Mumbai, MGM Healthcare in Chennai, Christian Medical College (CMC) in Vellore, and Manipal Hospitals in Bangalore. Tata Memorial Centre in Mumbai is a cancer-anchored institution and handles biologic imports for oncology cardio-vascular comorbidities through the same import-pharmacy workflow.

For lipid-clinic cases the natural homes are the preventive cardiology and lipid services at AIIMS Delhi, the cardiology services at Apollo Chennai, Apollo Delhi, Medanta Gurgaon, and Kokilaben Mumbai, and the cardiology and clinical genetics services at CMC Vellore. Families in tier 2 cities without a local lipid clinic typically route to one of these centres for the prescription and clinical justification letter, then work with a CDSCO-licensed specialty importer in Mumbai, Delhi, or Bangalore that files the Form 12A and handles chain-of-custody documentation. The importer carries the CDSCO relationship and the cold-chain customs broker relationship.

Real cost picture for Praluent in India

US wholesale acquisition cost for Praluent was reset by Sanofi and Regeneron in February 2019 to approximately USD 5,850 per year for both the 75 mg and 150 mg strengths, a 60 percent reduction from the prior list. The order-of-magnitude reference for NPP sourcing is therefore approximately USD 5,800 to USD 6,500 per year at US list, before specialty pharmacy markup, cold-chain logistics, customs handling, and the Reserve Meds coordination fee. Firm quotes are issued only after document review.

The Indian rupee floats against the US dollar. In May 2026 the USD/INR rate sits in the 94 to 95 range, with the rupee having weakened modestly against the dollar over the prior twelve months. Annual drug acquisition at US WAC translates to roughly INR 5.5 lakh to INR 6.2 lakh per year at the prevailing rate. International cold-chain logistics for Praluent runs in the typical Reserve Meds biologic lane, approximately USD 400 to USD 1,500 per shipment (roughly INR 38,000 to INR 1.4 lakh), depending on the destination port and shipment cadence. India's Union Budget 2026-27 expanded the list of life-saving drugs and rare-disease drugs eligible for customs duty exemption, and the specific HSN code and exemption status for any Praluent shipment is confirmed at the documentation stage. GST on most life-saving medicines is 5%.

On the insurance side, Star Health, HDFC ERGO, ICICI Lombard, and Niva Bupa each handle named-patient imports case by case. None of the major private insurers reimburse a Rule 36 personal import as a standard line item, though some have reimbursed full or partial drug cost where the underlying medicine is on their formulary. CGHS provides for life-saving drugs not in the standard formulary to be considered by an Expert Committee under Special DG (DGHS) case by case, with stricter constraints on drugs not approved by the DCGI. Cash-pay is the default posture. The all-in delivered cost for a year of Praluent in India typically sits in the high-five-figure USD range, materially below the cost stack of a single cardiovascular event.

Typical timeline for Praluent in India

For an established Praluent candidate with a clean lipid-clinic letter, documented statin and ezetimibe history, and a tertiary-centre prescription, the typical end-to-end cycle is 2 to 4 weeks. CDSCO published guidance puts the Form 12B priority window at 1 to 2 days for complete routine documentation. US-side sourcing through the Regeneron specialty-pharmacy network adds roughly 1 to 2 weeks. International cold-chain transit and Indian customs clearance under the import permit at Delhi, Mumbai, Bangalore, Chennai, or Hyderabad airport adds another 3 to 7 days, with continuous temperature monitoring at 2 to 8 degrees Celsius across the customs handoff. Cold-chain biologic shipments add 2 to 3 days versus ambient products due to packout and validation requirements. First-time imports through a smaller importer can extend the front end. Timelines are presented as typical ranges and not as promises; specific dates are confirmed at firm-quote issuance.

What your physician needs to provide

The clinical justification letter for Praluent is the centrepiece of the CDSCO package. For this product the letter typically includes:

• The patient's confirmed diagnosis: heterozygous familial hypercholesterolemia, homozygous familial hypercholesterolemia, or established atherosclerotic cardiovascular disease requiring additional LDL-C lowering
• The genetic-testing report where available (LDLR, APOB, or PCSK9 gain-of-function variants for FH), the family-history pattern of premature coronary disease, and the Dutch Lipid Clinic Network or Simon Broome criteria score where calculated
• Prior lipid-lowering therapy history: maximally tolerated statin (drug, dose, duration, intolerance documentation if applicable), ezetimibe trial, bempedoic acid where used, and the on-therapy LDL-C above goal
• The dosing plan: 75 mg subcutaneously every 2 weeks or 300 mg every 4 weeks as starting regimen, with up-titration to 150 mg every 2 weeks based on 4-to-8-week LDL-C response; for HoFH and HeFH patients undergoing LDL apheresis, 150 mg every 2 weeks
• The injection-training plan and site-rotation guidance (thigh, abdomen, upper arm)
• The monitoring plan: LDL-C at 4 to 8 weeks after initiation or dose change to assess response; assessment for injection-site reactions and hypersensitivity at each visit; no routine hepatic or hematologic monitoring required by the label
• The PvPI adverse-event reporting plan as part of the Pharmacovigilance Programme of India obligation

The treating physician's NMC registration number must appear on the prescription. State-council registration is required for practice in a particular state. Specialty physicians at AIIMS, Apollo, Fortis, Medanta, Kokilaben, MGM, CMC Vellore, and Manipal routinely sign these letters as part of established institutional workflow.

Common questions about Praluent in India

Will Star Health, HDFC ERGO, ICICI Lombard, or Niva Bupa cover Praluent? Each plan handles named-patient imports case by case. None of the major private insurers reimburse a Rule 36 personal import as a standard line item. Some have reimbursed full or partial drug cost when the underlying medicine is on their formulary; for Praluent that is the narrower case since PCSK9 inhibitor class members are inconsistently stocked. Reserve Meds supplies the documentation set that lets the insurer assess the case. Cash-pay is the default posture.

Will CGHS or ESIC cover Praluent? CGHS provides for life-saving medicines not in the standard formulary to be considered by an Expert Committee under Special DG (DGHS), case by case. ESIC's formulary is narrower and not structured for routine personal-import reimbursement. Check eligibility with your CGHS Wellness Centre or the ESIC dispensary before assuming coverage.

Why Praluent versus Repatha? Both products achieve substantial LDL-C reduction and both have cardiovascular outcomes evidence (ODYSSEY OUTCOMES for Praluent, FOURIER for Repatha). Selection in practice is driven by prescriber familiarity, local stocking, patient tolerability of one versus the other, dosing-frequency preference, and pricing dynamics. Reserve Meds does not promote one over the other; the named-patient pathway supports either based on the prescription written.

Is there a pediatric option? The Praluent label covers HeFH including pediatric patients aged 8 years and older. The FH detection movement in India, supported by clinical genetics services at tertiary cardiology centres, has expanded pediatric screening in families with premature coronary events. Pediatric dosing is weight-based and follows the package insert.

What is the safety profile? The most common adverse reactions in clinical trials were injection-site reactions, nasopharyngitis, and influenza-like symptoms. Hypersensitivity reactions have been reported, including rare cases requiring discontinuation. The product carries no boxed warning.

Is the cold chain genuinely manageable? Yes. Reserve Meds routes Praluent through 3PL partners with validated 2-to-8-degree cold-chain packout, continuous temperature monitoring, and excursion documentation across the customs handoff. The product permits a single excursion up to 25 degrees Celsius for up to 30 days, which provides a buffer against routine transit variability but does not relax the underlying cold-chain requirement.

Where Reserve Meds fits in Praluent cases

Reserve Meds is a US-based concierge coordinator. We do not replace your treating physician, do not replace CDSCO, and do not replace the dispensing pharmacy or the licensed importer. For Praluent specifically we orchestrate the US-side sourcing through Regeneron specialty-pharmacy partners, the regulatory documentation kit your physician needs for Form 12A (FH genotype reference, statin and ezetimibe failure documentation template, dosing reference by indication, monitoring plan summary, PvPI reporting reference), validated cold-chain international logistics under chain-of-custody at 2 to 8 degrees Celsius, and a single named coordinator who carries the family from intake through delivery and into the reporting period. Documented FH genotype or established ASCVD with statin and ezetimibe history is the standard intake artefact. We do not coordinate off-label use, and we will decline intake for prescriptions outside the FDA-approved indications.

Next step

If your cardiologist or lipidologist has decided Praluent is the right next step and local stocking is the bottleneck, the Rule 36 personal-import pathway through CDSCO is the route. Join the waitlist below and we will confirm eligibility within 24 to 48 hours and route the documentation kit to your physician.

Join the Praluent waitlist

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