Named Patient Program

Named Patient Program India

Named Patient Support Program

The Named Patient Support pathway, also known as the Named Patient Program India, enables physicians to access unapproved medicines for individual patients with serious or life-threatening conditions when no suitable approved treatments are available. In some of the cases its on a compassionate basis through the Named Patient Import pathway.

We at Arkon solutions are committed to provide you with a comprehensive support system designed to empower patients throughout their treatment journey and beyond. Accessing critical care medicines can sometimes create unforeseen challenges due to multifactorial determinants impacting their availability and regulatory status of medicines including restrictions in scope of distribution network continuity, local regulatory registration limitations and transitional phases of life-cycle. This encompasses novel treatment entities pending requisite authorization as well as previously authorized formulations subjected to regulatory withdrawal, discontinuation or market suspension in your home country of a patient. Navigating these complexities is precisely where we can assist and provide potential avenues for access to medicines not available in India, unregistered medicines, and specialty medicines, through our Named Patient Program India service. We make sure to support the patients with right guidance and right resources at every stage, making the Named Patient Import process smooth, which makes them feel confident and assured.

Trusted Across Healthcare

Liable sourcing

Timely Updates

Optimized pricing

Scheduled delivery

Thermal stability

Pre and Post-delivery Support

Why Arkon Solutions?

Expertise

8 years of experience of our professionals in this domain, catered to the needs of proactive access provision of medicines for our customers setting a benchmark through a distinctive commitment to ethical regulatory governance.

Transparency

Ensure clear and transparent cost breakdowns, allowing care seekers and providers to understand the financial implications before proceeding.

International Network

An extensive network of vendors, pharmaceutical manufacturers, healthcare providers, and regulatory authorities, help us to navigate broadened access, faster execution and robustness.

Logistics

Maintain EU- GMP certified facilities, temperature control requirements (including cold chain integrity), navigating complex international customs and import regulations for unauthorized products and ensure timely delivery.

Adherence to SOP’s

Maintain consistent operational standards even in complex and demanding situations. We assure traceability for each specific unit of drug and gather documentation for the seamless import procedure.

Country-level Compliance

We ensure providing the requisite licensed documentation including COO and COA, thereby strengthening patient confidence in the supplied products.

Frequently Asked Questions

A Named Patient Import, sometimes referred to as compassionate use or early access programs is an approach that allows a doctor to obtain unapproved medicines for a specific named patient. These programs provide doctors and patients with a framework for the use of unapproved medicines, and also provides a legal and ethical framework for use, usually requiring approval by regulatory authorities, and the manufacturer of the drug.

Signed Prescription from a Licensed Physician:
Patient Medical Records/Report:
Letter of Medical Necessity (from Provider):
Completed Import Application:
Copy of the Patient Passport or National ID:
Proof of Address:
Manufacturer’s Information (if applicable):
Import License (if required):

For Patients: Access to Life-Saving Treatment, Personalized Treatment Plans, Better Quality of Life
For Physicians: Wider Treatment Options, A Way To Show Compassionate Care, Research and data collection, Improved Professional Image
For Pharmaceutical Companies: Real-World Data Early In The Market, Identify Possible Side Effects, Create More Patient Awareness And Adoption, Ethical Social Responsibility

Initial Inquiry & Determining Eligibility for Treatment (Physician Driven)
Documenting and Submitting requests (Physician Collaboration)
Informed Consent Document
Internal Review & Approval (Arkon’s Solutions)
Verification of patient eligibility
Medical Justification Confirmation
Review for Regulatory Compliance
Manufacturer Consultation and Approval
Obtaining all Import/Export Licenses and Permits
Medication to Patient & Patient monitoring (Physician Responsibility)
Ongoing Support and Documenting (Arkon’s Solution and Physician)
Assist with Documentation and Reporting

All medicines are sourced from authorized suppliers and shipped with appropriate temperature-controlled packaging, ensuring safe and secure access to medicines while adhering to all legal and regulatory frameworks—both national and international.

No, patients cannot order directly. Requests must come through licensed healthcare professionals.