Global Access to Radicut: How the Named Patient Program Supports Patients

Introduction

Radicut® (Edaravone) is a medicine first developed in Japan to help patients recovering from acute ischemic stroke. It works by reducing harmful free radicals and has been used since 2001 to manage stroke-related neurological symptoms.¹

Because of its protective effect on nerve cells, Japanese doctors suggested that it might also help people with ALS/MND. This led to clinical trials by Mitsubishi Tanabe Pharma, the makers of Radicut.^1,2

^{Why RADICUT Access Is Limited Globally}

RADICUT represents one of the few disease modifying therapies for Amyotrophic Lateral Sclerosis (ALS), a progressive neurodegenerative disease.³

However, despite its potential, access to RADICUT remains highly variable worldwide for several reasons:

• Regulatory approvals are fragmented. Although Radicut has been approved for ALS in countries, many nations especially low‑ and middle-income countries (LMICs) — still do not have marketing authorization.²
• Cost and treatment burden. The traditional intravenous (IV) formulation requires repeated infusions (a 28‑day cycle with daily IV infusions for certain days). This makes long-term therapy expensive, logistically difficult, and inconvenient for patients — particularly those in regions with limited infusion infrastructure.^4,5
• Limited healthcare infrastructure & inequities. According to the International Alliance of ALS/MND Associations, global access to high-quality ALS care remains heavily skewed due to accessibility and limited healthcare infrastructure.⁶
• Access is also limited by several factors such as high out-of-pocket costs, lengthy regulatory procedures, lack of reimbursement, delayed diagnosis, low awareness of available treatments, and insufficient infrastructure to administer and monitor therapy.⁷

Because of these factors, many ALS patients remain without timely access to Radicut, despite its potential benefit.

The Role of the Named Patient Program in India

To help patients access medicines that are not yet available in India, programs like the Named Patient Program (NPP) play an important role. They allow patients to legally import drugs that are approved in other countries but not yet sold locally. In India, the Central Drugs Standard Control Organization (CDSCO) allows patients to bring in such medicines for personal use, provided a licensed doctor prescribes them and gives a medical justification.

How Patients Apply to Import Radicut

1.  Prescription from a licensed physician

• The process begins when a treating doctor issues a prescription for Radicut.
• The doctor also provides a medical justification explaining why the treatment is needed and why suitable alternatives are not available in India.

2. Patient documentation and consent

• The patient or caregiver gathers required documents such as Government ID proof, relevant medical records and test reports and signed consent letter stating the medicine is being imported for personal use

3. Submission of import application (Form 12A)

• The patient (or caregiver) submits the application to CDSCO using Form 12A, along with the prescription, justification, and supporting documents.
• This form formally requests permission to import the medicine for personal use.

4. Review by DCGI

• The Drug Controller General of India (DCGI) evaluates the application.
• The review ensures medical justification, safety considerations, and compliance with national guidelines.

5. Grant of import permit (Form 12B)

• If the application is approved, CDSCO issues an import authorization through Form 12B.
• This permit allows the patient to legally import Radicut into India from an authorized supplier.

Barriers in Cost, Regulation, and Awareness

High cost of therapy: High costs involved with this therapy makes it out of reach for many individuals outside high‑income settings.⁴

Administrative and regulatory burden: The import process requires doctor justification, regulatory approvals, import permits, documentation, paperwork — both for patient and doctor. Especially in countries with limited regulatory knowledge or cumbersome bureaucracy, delays or rejections may occur.⁹

Logistics and supply-chain issues: Importing a controlled medicine, involves complex logistics, secure shipping, customs clearance — all of which increase cost and risk of delay or loss.¹⁰

Awareness gap among physicians and patients: Doctors, patients and care givers may not be aware of the pathways or schemes, many may assume that lack of local registration means the drug is unavailable. ¹¹

^{How Rx4U Bridges the Access Gap}

This is where a platform like Rx4U becomes vital. By offering end-to-end support — from regulatory navigation to sourcing, import logistics, and patient/family guidance — Rx4U can help make RADICUT accessible for patients in India and other countries where commercial availability is lacking. As described on its website, Rx4U’s support includes regulatory compliance, sourcing authentic medications, logistic coordination, and patient support through the process.

Conclusion

RADICUT offers real hope for ALS patients, yet remains inaccessible in many low- and middle-income countries due to limited availability, regulatory hurdles, and weak infrastructure. The Named Patient Program (NPP), legally recognized in India and elsewhere, provides a compassionate, patient-specific pathway to access.

Platforms like Rx4U help bridge regulatory, logistical, and sourcing barriers, enabling global innovation to reach local patients. While cost and systemic inequities remain, emerging oral options, growing real-world evidence, and rising global interest in equitable access offer renewed hope.

FAQs

Q1: Is RADICUT (edaravone) a cure for ALS?
No. Edaravone is not a cure — it is intended to slow the progression of ALS by reducing oxidative stress in neurons.³

Q2: If the drug is not approved locally, is it legal to import it via NPP?
Yes — under the NPP regime, medicines approved elsewhere but not commercially available locally can be imported for personal use, provided there is a valid prescription, medical justification, and regulatory approval (e.g. by CDSCO in India). ⁹

Q3: How can Rx4U help patients seeking RADICUT?
Rx4U offers end-to-end support: regulatory navigation (import permits, documentation), sourcing genuine medicine from authorised distributors, logistic coordination including customs/ shipping and delivery, and patient support throughout the process to ensure safe, legal, and timely access¹²

References:

1. Kikuchi K, Miura N, Kawahara KI, et al. Edaravone (Radicut), a free radical scavenger, is a potentially useful addition to thrombolytic therapy in patients with acute ischemic stroke. Biomed Rep. 2013;1(1):7-12. doi:10.3892/br.2012.7
2. International Alliance of ALS/MND Associations. Radicava/Edaravone. Accessed December 08, 2025. https://www.als-mnd.org/support-for-pals-cals/approved-drugs/radicava-edaravone/
3. Bhandari R, Kuhad A, Kuhad A. Edaravone: a new hope for deadly amyotrophic lateral sclerosis. Drugs Today (Barc). 2018;54(6):349-360. doi:10.1358/dot.2018.54.6.2828189
4. Pharmacoeconomic Review Report: Edaravone (Radicava): (Mitsubishi Tanabe Pharma Corporation): Indication: For the treatment of Amyotrophic Lateral Sclerosis (ALS) [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2019 Apr. Executive Summary. Available from: https://www.ncbi.nlm.nih.gov/books/NBK542529
5. Clinical Review Report: Edaravone (Radicava): (Mitsubishi Tanabe Pharma Corporation): Indication: For the treatment of amyotrophic lateral sclerosis [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2019 Apr. Discussion. Available from: https://www.ncbi.nlm.nih.gov/books/NBK542357/
6. 2023 Fundamental Rights for People Living with ALS/MND & Caregivers of People Living with ALS/MND Survey Report. Accessed December 08, 2025. https://www.als-mnd.org/wp-content/uploads/2024/11/PALS-CALS-Report-Web.pdf?
7. Rare Diseases International. Global Access. Accessed December 08, 2025. https://www.rarediseasesinternational.org/access/?
8. Patil S. Early access programs: Benefits, challenges, and key considerations for successful implementation. Perspect Clin Res. 2016;7(1):4-8. doi:10.4103/2229-3485.173779
9. Central Drugs Standard Control Organisation. Procedures To Import Small Quantities of Drugs for Personal Use: Notice. Ministry of Health & Family Welfare, Government of India. February 19, 2015. Accessed December 08, 2025. https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadConsumer/ProcedureforpermissiontoImportSmallQuantitiesofDrugsForPersonalUse_link.pdf
10. Sykes C. Time- and Temperature-Controlled Transport: Supply Chain Challenges and Solutions. P T. 2018;43(3):154-170.
11. Rajasimha H. Tackling rare disease in India: each stakeholder of the healthcare and life sciences ecosystem should take responsibility for the millions suffering from rare diseases worldwide. Inside Precision Med. 2023;10(3):32‑)
12. Accessed December 08, 2025. https://rx4u.in/