How to access Keytruda from India, the named-patient import pathway for formulary gaps, 2026
By Reserve Meds · Clinical & regulatory team · Last reviewed 2026-04-23
An Indian patient with an FDA-approved oncology indication where local registration or supply does not meet the need may receive a prescription for Keytruda (pembrolizumab) from their treating medical oncologist. Keytruda is FDA-approved, developed by Merck (MSD), and is a human monoclonal antibody against the PD-1 immune checkpoint that blocks the shared PD-1 / PD-L1 axis. Local registration and distribution in India vary by indication and by city; where your specific indication, age band, or supply need is not met locally, a named-patient import pathway may be appropriate.
This guide explains the legal pathway, what your physician needs to provide, typical timelines, and where Reserve Meds fits in.
The clinical situation
Keytruda is administered as an intravenous infusion in an outpatient oncology center, with a loading dose followed by every-three-weeks (200 mg) or every-six-weeks (400 mg) maintenance depending on indication and protocol. Eligibility is a clinical decision by your treating physician based on disease severity, response to standard therapies, and indication-specific criteria. Keytruda works upstream of the PD-1 / PD-L1 immune-checkpoint axis.
Is Keytruda legally importable into India?
Yes, through the Central Drugs Standard Control Organisation (CDSCO) personal-import and named-patient import framework, when the requested indication, presentation, or supply is not met through the locally available channel for a specific patient.
The named-patient / personal-import mechanism allows an Indian-licensed physician or the patient (with physician prescription) to import a medicine or specific presentation not locally satisfied when: (a) the medicine is approved by a recognised reference authority (FDA qualifies), (b) no locally available alternative pathway meets this patient's clinical need, (c) the physician takes clinical responsibility, and (d) the importing party documents chain of custody. CDSCO reviews the application.
How the pathway works, step by step
- Consultation with your treating physician. Clinical rationale documented, including indication, age/weight, prior therapy, and the reason local supply does not meet the need.
- Import authorisation application. Your physician or the importing pharmacy files the CDSCO personal-import / named-patient documentation.
- US-side sourcing. Reserve Meds coordinates with our US-licensed specialty wholesale partner under DSCSA chain-of-custody.
- Cold-chain shipment. Temperature-controlled transport with documented chain of custody.
- Arrival and administration. IV infusion per your physician's protocol; administration is in an outpatient oncology infusion center; not a self-administered drug.
- Ongoing coordination. Reserve Meds supports re-supply cadence aligned to every-three-weeks or every-six-weeks dosing.
What documentation your physician needs
Your physician will typically need to provide:
- Clinical rationale letter confirming diagnosis, prior therapies, and Keytruda as the indicated therapy
- Verification of their Indian medical licence
- Patient identifier (anonymised reference where possible)
- Prescription with specified loading and maintenance dose
- Explanation of why local channel does not meet the need (formulary-gap justification)
Reserve Meds provides a physician documentation kit that bundles the templates CDSCO reviewers expect.
Costs and timing
Keytruda's US cash-pay list price runs in an indicative 2026 drug-only range (delivered quote issued at intake) of roughly USD 10,000-12,000 per single 200 mg dose at the every-three-weeks adult schedule, with 6-weekly 400 mg an alternative. Shipment, cold-chain logistics, and concierge coordination add incremental cost; Reserve Meds issues a transparent quote at the start of intake. Some Indian patients compare the US cash-pay total-cost-delivered with what a locally distributed presentation would cost plus the supply-gap delay; we provide the data for that comparison at intake.
Indicative timeline for the first shipment after cohort intake opens is 10-21 days from the moment a complete application is submitted to CDSCO. Re-supply is generally faster once the pathway is established.
Fulfillment availability is limited to our first cohort, and all timelines published on this site are indicative. If your clinical situation is time-sensitive, tell us at intake. We triage accordingly.
Reserve Meds's role
Reserve Meds is a US-based concierge coordinator for cross-border specialty medicine. For Keytruda specifically, we provide:
- Sourcing. Through our US-licensed specialty wholesale partner, operating under DSCSA chain-of-custody.
- Documentation. Regulatory documentation package for your physician and for CDSCO review.
- Logistics. Cold-chain and temperature-monitored shipment coordination.
- Concierge case lead. A named point of contact throughout the coordination.
What we do not do: We are not the prescriber. We do not practice medicine. We are not the dispensing pharmacy. All clinical decisions remain with your treating physician. We are in pre-launch and operate on a waitlist basis. If Keytruda is already available to you locally for your indication and age, stay on the local channel.
Frequently asked
Is this legal? Yes, when executed through the CDSCO personal-import / named-patient framework. See our trust and compliance page.
My local supply has been inconsistent, can you bridge? We can coordinate a bridge supply while your local channel stabilises, provided your physician documents the rationale.
Can a child receive Keytruda through this pathway? Pediatric use is within the FDA label for select indications including pediatric Hodgkin lymphoma and select solid tumors with MSI-H/dMMR status. Your treating oncologist determines suitability.
Is Keytruda self-administered? After training by your clinical team, administration is performed in an outpatient infusion center.
Will insurance cover any of this? Cash-pay is the default for named-patient imports. Some Indian private insurers and corporate health plans reimburse on case-by-case approval; we supply documentation for your submission.
Next step
Composite case examples. This content is for general information and does not constitute medical advice.
Clinical & regulatory review: Reserve Meds clinical team and AI regulatory-counsel review pipeline. Last medically reviewed: 2026-04-23.