Tepkinly access in India: the CDSCO named-patient pathway
How India patients legally obtain Tepkinly (epcoritamab) when the locally registered indication, 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
Tepkinly (epcoritamab) is a CD3xCD20 bispecific T-cell engager developed by AbbVie and Genmab. It is approved by the US FDA for relapsed or refractory diffuse large B-cell lymphoma after 2+ prior lines, relapsed or refractory follicular lymphoma after 2+ prior lines (accelerated approval). The standard regimen is step-up dosing weeks 1-3 (0.16 mg, 0.8 mg, 48 mg), then 48 mg weekly through cycle 3, every 2 weeks cycles 4-9, every 4 weeks cycle 10+; subcutaneous. Tepkinly is available in the global pharmaceutical supply chain in subcutaneous injection. The drug may or may not be locally registered in India, and even when registered, a India family asking for Tepkinly is often asking for a precise version of it (specific indication, specific presentation, specific schedule) that the local market has not caught up to. Reserve Meds coordinates the US-side sourcing, the validated cold-chain logistics, and the documentation packet your physician needs.
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Why India patients need Tepkinly through the named-patient pathway
The Central Drugs Standard Control Organisation (CDSCO) administers personal-import permissions under Rule 36 of the New Drugs and Clinical Trials Rules, 2019, which carve out an avenue for an Indian patient with a treating physician's prescription to import a small quantity of an unregistered medicine for personal use. Applications are filed through the SUGAM portal at cdscoonline.gov.in. The pathway applies when the medicine is approved by a recognised regulator and a clinically suitable Indian-registered alternative is not available.
Several patterns drive these cases: indication lag against the FDA label, particularly for newer biomarker-defined regimens; CDSCO-registered local generics or biosimilars for older molecules but unregistered status for newer originator brands; payer denials by private insurers on specialty indications; and patient preference for the FDA-labeled originator product where biosimilar substitution does not match the prescribing physician's view. For Tepkinly specifically, the named-patient pathway exists to handle exactly the situations the local registered route cannot: a newer FDA indication that has not yet propagated to India labeling, a presentation or strength the local agent does not reliably carry, a payer denial that is uneconomic to appeal, or a biomarker-defined regimen where the prescriber's clinical judgement runs ahead of the local label's molecular language. In each pattern, the named-patient pathway is the mechanism that connects a India-licensed physician's clinical decision with US-sourced, FDA-labeled Tepkinly for a specific patient.
Tepkinly (FDA May 2023 for relapsed or refractory DLBCL post 2+ lines, follicular lymphoma accelerated approval June 2024) is the subcutaneous CD3xCD20 bispecific T-cell engager option in the haematologic-malignancy bispecific class. Local registration is generally limited, and centres comfortable with the step-up dosing CRS/ICANS monitoring profile drive the case mix.
The CDSCO named-patient pathway for Tepkinly
A complete application typically includes a clinical justification letter from the treating physician (diagnosis, severity or stage, prior therapies, biomarker results where relevant, why Tepkinly is appropriate, why the locally available alternative is not suitable for this case); the treating physician's India license verification (issued by Medical Council of India / National Medical Commission, with state council registration); an anonymised patient identifier where the regulator submission allows; full product details (brand name Tepkinly, generic epcoritamab, manufacturer AbbVie and Genmab, strength subcutaneous injection, quantity requested calibrated to the planned cycles or treatment duration); the destination dispensing facility name, license number, and pharmacy in charge; and a chain-of-custody plan describing how the medicine will move from the US manufacturer through the importer to the dispensing pharmacy, including cold-chain handling at 2 to 8 degrees Celsius from the US manufacturer through to the dispensing pharmacy.
For Tepkinly, the clinical justification typically rests on documentation of CD20 expression; CRS and ICANS monitoring during step-up where applicable, line of therapy and prior treatments, and a clear statement of why this medicine is the appropriate next step in this patient's care.
Approval timelines for routine cases are typically 10 to 25 business days from a complete filing. Complex cases (rare indication, paediatric application, larger multi-cycle quantities, gene therapy or cell therapy logistics, first-import scrutiny on a presentation new to the local route) can extend to 4 to 8 weeks. The CDSCO retains discretion on timing, and we do not promise specific durations.
Where Tepkinly gets dispensed in India
A small group of India institutions handle named-patient imports as established workflow, with in-house import pharmacy infrastructure and physicians experienced with the application set. Tertiary and major private hospitals that fit this profile include Tata Memorial Centre in Mumbai (national cancer referral), Apollo Hospitals network (Chennai, Bengaluru, Hyderabad, Delhi, Kolkata), Fortis Healthcare (Gurugram, Noida, Bengaluru, Mumbai), Max Healthcare in Delhi NCR, Medanta-The Medicity in Gurugram, AIIMS Delhi, Christian Medical College Vellore, Kokilaben Dhirubhai Ambani Hospital in Mumbai, Sir Ganga Ram Hospital, Manipal Hospitals (Bengaluru), Narayana Health (Bengaluru), and the larger corporate hospitals in Mumbai, Delhi NCR, Bengaluru, Hyderabad, Chennai, and Kolkata.
For physicians at smaller hospitals without internal import infrastructure, the common pattern is to route through a Mumbai, Delhi NCR, Bengaluru, Chennai, Hyderabad, and Kolkata-based specialty importer that holds a pharmaceutical establishment license and files the CDSCO application on the prescribing physician's behalf. The medicine then moves into the prescribing hospital's pharmacy under chain-of-custody documentation, where the patient receives the first dose under physician supervision; subsequent doses self-administered at home after injection training.
Real cost picture for Tepkinly in India
US WAC for Tepkinly is approximately USD 16,800 per vial, which translates to USD 200,000 to USD 240,000 first year. The Indian rupee floats; a working reference rate of approximately 83 INR to 1 USD applies for illustrative conversion, so the annual reference range converts accordingly when expressed in INR at US WAC equivalents.
International validated cold-chain logistics typically run USD 350 to USD 1,400 (approximately INR 29,000 to INR 116,000) per shipment depending on destination city, urgency, and pack size. India customs and CDSCO permit fees are nominal relative to drug cost. Reserve Meds' concierge fee is itemised separately on every firm quote.
On the insurance side, each India insurer assesses named-patient imports case by case. Local payer cover is administered through Star Health, HDFC ERGO, ICICI Lombard, Bajaj Allianz, Niva Bupa, Care Health, Aditya Birla Health, Tata AIG, Manipal Cigna, and the public Ayushman Bharat / PM-JAY scheme for eligible families; corporate group health is administered through the same private carriers. We do not promise coverage from any insurer. The US manufacturer copay programmes and patient assistance programs do not extend internationally; cross-border patients pay cash or rely on local payer coverage where it applies.
Clinical evidence behind Tepkinly
Tepkinly's pivotal EPCORE NHL-1 (relapsed/refractory DLBCL, ORR approximately 63% with high complete response rates) anchored the DLBCL accelerated approval. EPCORE FL-1 supports the follicular lymphoma expansion. The subcutaneous route distinguishes operational workflow from IV bispecifics.
Typical timeline for Tepkinly in India
CDSCO routine processing is typically 10 to 25 business days from a complete filing. For Tepkinly specifically, cold-chain shipment adds 2 to 3 days versus an ambient small molecule because validated thermal packaging, continuous temperature monitoring, and customs clearance scheduled to avoid extreme-heat exposure are non-negotiable. End-to-end, most cases complete within 3 to 6 weeks from first complete documentation to dispensing or first dose. For longer treatment courses, we coordinate cycle-by-cycle or quarterly resupply so the patient never approaches an empty pharmacy shelf.
What your physician needs to provide
For a India-licensed physician prescribing Tepkinly through the CDSCO pathway, the clinical justification letter is the cornerstone of the application. The letter typically documents the patient's diagnosis with relevant staging or severity language for the indication, the prior therapy history, the rationale for Tepkinly as the appropriate next step, and the precise FDA-labeled regimen (dose, route, frequency, expected duration). For Tepkinly specifically, the FDA-approved regimen is step-up dosing weeks 1-3 (0.16 mg, 0.8 mg, 48 mg), then 48 mg weekly through cycle 3, every 2 weeks cycles 4-9, every 4 weeks cycle 10+; subcutaneous.
For Tepkinly, the relevant molecular or laboratory documentation includes CD20 expression; CRS and ICANS monitoring during step-up. The letter references the test results that establish the patient's eligibility for the FDA-labeled indication. The treating physician's India license number, the dispensing facility license number, and the pharmacy in charge complete the package. Monitoring requirements relevant to Tepkinly (baseline labs, imaging cadence, adverse-event surveillance) are stated in the letter and operationalised by the prescribing physician's team.
Monitoring for Tepkinly: CRS and ICANS monitoring particularly during the step-up dosing (cycle 1 with doses on days 1, 8, 15), corticosteroid premedication for cycle-1 doses, tocilizumab availability, CBC, comprehensive metabolic panel, tumour lysis syndrome monitoring with high disease burden. Adverse-event profile: Cytokine release syndrome (boxed warning), ICANS, serious and opportunistic infections, neutropenia, tumour flare, hypersensitivity. CRS prophylaxis with corticosteroids during step-up is standard.
Common questions about Tepkinly in India
Will my insurer cover this? Each India insurer (Star Health, HDFC ERGO, ICICI Lombard, Bajaj Allianz, Niva Bupa, Care Health, Aditya Birla Health, Tata AIG, Manipal Cigna, and the public Ayushman Bharat / PM-JAY scheme for eligible families; corporate group health is administered through the same private carriers) assesses named-patient imports case by case. We supply the documentation set that allows your insurer to assess the case; the claim itself sits with you or your hospital.
Is Tepkinly already locally registered in India? Local registration status can shift over time; Tepkinly may already be on the India register for some indications but not others, or the registered presentation may not match what the prescriber needs. The CDSCO pathway exists precisely to bridge these gaps and is the cleanest legal route when the local supply chain does not match the prescription.
What about competitors? Alternatives in the same therapeutic class include glofitamab (Columvi), mosunetuzumab (Lunsumio), CD19 CAR-T (Yescarta, Breyanzi, Kymriah), polatuzumab + rituximab + bendamustine. Choice depends on the patient's full profile, prior therapy, biomarker status, and the prescriber's judgment. Reserve Meds coordinates whichever medicine the physician has prescribed.
How does the cold chain work? This medicine requires cold-chain handling at 2 to 8 degrees Celsius from manufacture through to dispensing. Reserve Meds uses validated thermal packaging with continuous temperature logging. Customs clearance is scheduled to avoid prolonged tarmac exposure. The cold chain is broken only at the dispensing pharmacy.
Will my US manufacturer assistance program help? US patient assistance programs (PAP), copay cards, and bridge programs from Merck, Pfizer, AstraZeneca, Lilly, Roche, Genentech, Novartis, AbbVie, Janssen, Gilead, Biogen, BMS, and other manufacturers are generally restricted to US residents with US prescriptions filled at US pharmacies. Cross-border patients pay cash or use local payer cover.
What if treatment is multi-year? For long-running treatment, we coordinate cycle-by-cycle or quarterly resupply through the same CDSCO pathway, with each shipment authorised against the same physician documentation set updated for the current cycle. Patients never need to navigate the supply chain themselves.
Where is the medicine actually administered? After the first physician-supervised dose, most patients self-administer at home using the prefilled syringe or autoinjector pen after a brief injection-technique training. Home refrigeration is required; we provide a patient onboarding kit.
What if my physician is at a smaller clinic that does not import directly? The standard pattern is to route through a Mumbai, Delhi NCR, Bengaluru, Chennai, Hyderabad, and Kolkata-based specialty importer that holds a pharmaceutical establishment license. The importer files the CDSCO application on behalf of the prescribing physician, takes delivery of the medicine, and transfers it under chain-of-custody to the prescribing facility's pharmacy.
Operational notes for the CDSCO workflow
Operationally, the CDSCO Rule 36 personal-import permission is filed through the SUGAM portal at cdscoonline.gov.in. The applicant is typically the patient or the patient's treating physician with hospital pharmacy support; common patterns include filings under the personal-use category for quantities consistent with the planned treatment duration. Common reasons for delay are missing import quantity justification against the dosing schedule, incomplete documentation of the unmet need versus locally registered alternatives, or chain-of-custody plans for cold-chain product that do not specify continuous temperature logging.
Where Reserve Meds fits in Tepkinly cases
Reserve Meds is a US-based concierge coordinator. We do not replace your prescribing physician, we do not replace the CDSCO, and we do not replace your dispensing pharmacy. For Tepkinly specifically, we orchestrate the US-side sourcing through a DSCSA-compliant specialty channel, build the documentation packet your physician submits, coordinate validated cold-chain logistics with appropriate temperature monitoring into India, plan cycle-by-cycle resupply across longer treatment courses, and assign a single named coordinator through the case. Standard NPP coordination under our cold-chain biologic playbook applies.
Next step
If your India physician has prescribed Tepkinly 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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