How to access Enhertu from India, the named-patient import pathway, 2026
By Reserve Meds · Clinical & regulatory team · Last reviewed 2026-04-23
An Indian patient with HER2-positive or HER2-low metastatic breast cancer, or HER2-positive advanced gastric cancer, or HER2-mutant non-small cell lung cancer, may receive a prescription for Enhertu (trastuzumab deruxtecan, T-DXd) from their treating oncologist. Enhertu is FDA-approved, developed by AstraZeneca and Daiichi Sankyo, and is increasingly a standard option across HER2-driven advanced solid tumours. In India, access may depend on hospital formulary decisions, supply timing, and, for patients and families overseas supporting care at home, the named-patient import route under the Central Drugs Standard Control Organisation (CDSCO) framework.
This guide explains the pathway, what documentation your physician needs, typical timing and costs, and where Reserve Meds fits in.
Ask about Enhertu in India
Tell us the medicine and your country. We reply within one business day. On WhatsApp we usually reply the same day.
The clinical situation
Enhertu is an antibody-drug conjugate combining a HER2-targeted antibody with a topoisomerase I inhibitor payload. It is administered as an intravenous infusion every three weeks in an outpatient oncology setting. Eligibility is determined by HER2 status on tumour biopsy via IHC or in-situ hybridisation, and by prior line history per FDA labeling. Pivotal studies have shown extended progression-free survival in HER2-positive and HER2-low metastatic breast cancer cohorts relative to prior standards. Your oncologist will confirm HER2 expression, prior therapy, and baseline lung imaging, interstitial lung disease monitoring is a standing consideration on T-DXd.
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Is Enhertu legally importable into India?
Yes, through the CDSCO / Drugs Controller General of India (DCGI) personal-use import framework, and through hospital-sponsored named-patient pathways where the treating facility takes responsibility for administration. India's import mechanism permits a registered medical practitioner to request import of a medicine that is not locally registered, or whose local supply does not meet the patient's specific clinical need, when the medicine is approved by a recognised reference authority (FDA qualifies), no clinically equivalent registered option is suitable, and chain of custody is documented.
For families in the diaspora supporting care at home, the pathway is well-trodden: many Indian tertiary oncology centres in Mumbai, Delhi, Bangalore, Chennai, Hyderabad, and Kolkata have navigated named-patient and personal-use imports for advanced biologics for years.
How the pathway works, step by step
- Consultation with your treating oncologist. The decision to prescribe Enhertu is a clinical one, supported by HER2 testing and a written rationale.
- Hospital coordination. The treating hospital's pharmacy and medical records department confirm receipt, storage, and administration capacity.
- CDSCO personal-use / named-patient application. The physician or hospital files the application with the required clinical rationale, patient identification, and product details.
- US-side sourcing. Reserve Meds coordinates with our US-licensed pharmaceutical wholesale partner to secure product from authorised distribution.
- Cold-chain shipment. The product ships with continuous temperature monitoring and chain-of-custody documentation end to end.
- Arrival and first infusion. The hospital pharmacy receives the product and releases doses to the oncology day-unit for administration on your cycle schedule.
What documentation your physician needs
Your physician will typically need to provide:
- A clinical rationale letter confirming HER2 status, diagnosis, prior therapies, and Enhertu as the indicated treatment
- Verification of their Indian medical registration (MCI / NMC)
- Identification of the administering infusion facility
- Patient identifier and address for the import record
- Planned dosing cycle (typically 5.4 mg/kg every three weeks, with baseline and follow-up imaging)
Reserve Meds provides a physician documentation kit that bundles the templates Indian customs and CDSCO reviewers expect to see, including the ILD surveillance plan that is a standing monitoring element for T-DXd.
Costs and timing
The cost of Enhertu is set per 100 mg vial. Medicine price: quote on request. You get a written quote for your case before you commit. International cold-chain logistics, customs clearance, CDSCO documentation handling, and coordination add incremental cost. Reserve Meds issues a full transparent quote at the start of intake.
We give you a written timeline estimate for your case before you commit. Subsequent cycles ship on a rolling basis against your infusion calendar.
If your clinical situation is time-sensitive, tell us at intake. We triage accordingly.
A culturally-aware note: many Indian families make cancer treatment decisions together, across generations and often across continents. Our case lead is set up to include whichever family members the patient designates, a son in New Jersey, a daughter-in-law in Dubai, a son-in-law in London, on coordination calls and document flow.
Reserve Meds's role
Reserve Meds is a US-based digital health company that coordinates access to cross-border specialty medicine. For Enhertu specifically, we provide:
- Sourcing. Through our US-licensed pharmaceutical wholesale partner, operating under DSCSA chain-of-custody.
- Documentation. Regulatory package for your physician and for CDSCO / customs review.
- Logistics. Cold-chain, temperature-monitored, internationally tracked shipment coordination.
- Dedicated case lead. A named point of contact for the patient's family wherever they are based.
What we do not do: we are not the prescriber, we do not practise medicine, and we are not the dispensing pharmacy. All clinical decisions remain with your treating oncologist.
Frequently asked
Is this legal in India? Yes, when executed through the CDSCO personal-use / named-patient framework with appropriate documentation. Cross-border named-patient and personal-use imports are routine mechanisms in Indian oncology. See our trust and compliance page.
My mother has HER2-low disease, does Enhertu apply? Enhertu's FDA label was expanded to include HER2-low metastatic breast cancer based on pivotal study data. Your oncologist will confirm whether the HER2-low indication fits her specific case.
Can the family abroad pay directly? Yes. Cross-border payment to the US coordinator is common for diaspora-supported care, and we issue invoicing that family members in the US, UK, UAE, Canada, and Australia can settle directly.
Will local Indian biosimilars or alternatives do the same thing? Enhertu is a novel antibody-drug conjugate, not a trastuzumab biosimilar; the two are clinically distinct. Your oncologist will explain sequencing and why T-DXd is being chosen.
What about insurance? Cash-pay is the default. Some Indian private insurers and diaspora insurance policies consider named-patient imports case by case; we supply documentation for your submission but do not process insurance claims directly.
Next step
For Enhertu coordination in India, start your case at the portal or message us on WhatsApp. We reply within one business day. On WhatsApp we usually reply the same day.
Composite case examples. This content is for general information and does not constitute medical advice.
Reviewed by the Reserve Meds clinical operations team. Last reviewed: 2026-04-23.
Frequently asked questions
How can I get Enhertu in India if it is not approved or available there?
Reserve Meds coordinates US-sourced Enhertu for patients in India through a legal named-patient pathway, working with your treating doctor. Your treating physician provides the prescription and clinical justification; Reserve Meds prepares the named-patient documentation for India and arranges DSCSA-compliant US sourcing and delivery to your physician or hospital pharmacy.
Can I access Enhertu in India through a named-patient import?
Often, yes. Named-patient access (sometimes called personal import) is the legal route we use for FDA-approved medicines such as Enhertu. It is different from compassionate use, which covers investigational medicines through the manufacturer's own program; we do not supply investigational medicines. Eligibility and paperwork depend on the regulator in India, and Reserve Meds maps the specific pathway for each market it coordinates.
Do I need a prescription to access Enhertu in India through Reserve Meds?
Yes. Reserve Meds is not a pharmacy and does not prescribe. A valid prescription and clinical justification from your treating physician are required, and all clinical decisions remain with your physician.
How does Reserve Meds deliver Enhertu to a patient in India?
Medicines are supplied through a US-licensed pharmaceutical wholesale partner, and Reserve Meds coordinates delivery of Enhertu to your treating physician or hospital pharmacy in India, with appropriate handling for the product.
How long does it take, and what does Enhertu in India cost through Reserve Meds?
After a short intake, the clinical team responds within one business day with case-specific feasibility, an indicative timeline, and a formal written quote. Cost depends on the destination, the prescribed regimen, and the duration of therapy, and is confirmed in writing before anything proceeds.
How do I start a request for Enhertu in India?
Submit a 60-second intake through the Reserve Meds patient portal, or message our team on WhatsApp. We reply within one business day. On WhatsApp we usually reply the same day.