Bridging Drug Access Gaps: Named Patient Pathway
05:04:53 April 3, 2025
In an ideal world, every patient would have timely access to the medicines they need, regardless of where they live. But the reality is different. In many countries, including India, patients are often unable to access life-saving or life-enhancing treatments because those medicines are not yet approved, commercially launched, or available in the local market. This is where Named Patient Access Management steps in as a critical, compassionate, and compliant solution.
At Global Rare Meds, we specialize in managing access to these essential medicines through legal and ethical channels. By working closely with global pharmaceutical distributors and local healthcare professionals, we ensure patients in India can obtain critical treatments not available in the country—under strict regulatory provisions.
What is Named Patient Access?
Named Patient Access refers to the import of unapproved or unregistered medicines for an individual patient who has a serious or life-threatening condition and no viable treatment alternatives locally. This process is facilitated under regulatory provisions that allow such imports on a compassionate, case-by-case basis—most commonly through the Named Patient Programme (NPP).
Unlike commercial drug distribution, NPPs are not promotional or sales-driven. They are patient-specific, need-based, and carried out in full compliance with the local drug regulatory authority—in India, that’s the Central Drugs Standard Control Organization (CDSCO).
Who Can Benefit from a Named Patient Programme?
- Patients with rare diseases where no approved treatment exists in India
- Cancer patients requiring innovative, globally approved therapies
- Patients awaiting drug approval in India but needing immediate access
- Individuals who have exhausted all standard local therapies
How Global Rare Meds Supports Named Patient Access
While the NPP framework is legally permissible in India, navigating it can be complex. That’s where Global Rare Meds brings unmatched value.
We do not manufacture drugs, but we act as a trusted access partner—collaborating with licensed global distributors, pharmaceutical suppliers, and regulatory authorities to ensure that patients receive the medications they need quickly, safely, and lawfully.
Our End-to-End Support Includes:
✅ Regulatory Compliance
We assist in preparing the documentation required by CDSCO, including the doctor’s prescription, patient consent, medical justification, and import application.
✅ Global Drug Sourcing
We identify and coordinate with international medicine distributors and authorized suppliers to source the required drug, even if it’s niche or hard to find.
✅ Import & Logistics Management
We manage the import process, customs clearance, and delivery—ensuring secure, temperature-controlled handling where needed.
✅ Ethical Handling & Patient Privacy
We strictly follow standards related to patient confidentiality, pharmacovigilance, and data security in every interaction.
The Process: How Named Patient Access Works in India
1. Diagnosis & Prescription
A licensed doctor in India determines that the patient needs a drug unavailable locally and prescribes it.
2. Documentation & Justification
The prescribing doctor provides medical justification, prescription, and informed consent from the patient.
3. Application to CDSCO
An application is submitted to CDSCO under the “Form 12B” provision for importing unapproved drugs for personal use.
4. Drug Sourcing & Import
Once permission is granted, Global Rare Meds sources the drug from international partners and handles the import, storage, and safe delivery.
5. Patient Receives Treatment
The drug is delivered to the healthcare facility or treating physician, where the patient receives the medicine under supervision.
Therapy Areas Commonly Supported by NPPs
- Oncology (Cancer)
- Rare Diseases (e.g., Lysosomal Storage Disorders, DMD)
- Neurology (e.g., ALS, MS)
- Hematology (e.g., Hemophilia)
- Immunology
- Infectious Diseases
- Organ Transplantation (Immunosuppressive therapies)
Why Global Rare Meds?
We’re not just a logistics provider. We are a trusted access partner who understands the nuances of drug regulations, patient urgency, and ethical responsibility.
Our Key Strengths:
- Deep experience with Named Patient Imports in India
- Partnerships with global pharma distributors and authorized sources
- Knowledge of CDSCO regulatory pathways
- Ability to handle temperature-sensitive, time-critical shipments
- Transparent process with regular updates and dedicated support
Is Named Patient Access Legal in India?
Yes. Under the Drugs and Cosmetics Act, 1940, CDSCO allows the import of unapproved medicines for personal use upon a doctor’s prescription and subject to regulatory approval. These imports are not for commercial sale and are granted on compassionate grounds, strictly for individual patients.
Final Thoughts: A Lifeline When It Matters Most
Named Patient Access is not just a process—it’s a lifeline for patients and families fighting against time, disease, and uncertainty. At Global Rare Meds, we’re proud to be part of that journey—working behind the scenes to ensure that hope doesn’t run out just because a medicine isn’t locally available.
If you’re a healthcare provider looking to support your patient with access to critical medicines, or a patient or caregiver seeking guidance, reach out to Global Rare Meds. We’ll help navigate the process—from sourcing to safe delivery—with clarity, care, and compliance.
