STEP-BY-STEP GUIDE
How the Named Patient Program Works at MitoGENE
INTRODUCTION
For patients and physicians seeking to access an internationally approved medicine through the Named Patient Program, the pathway can seem complex. This comprehensive guide walks you through each stage—from initial inquiry to treatment initiation—demystifying the process and providing clear direction.
Overview: The NPP Pathway at MitoGENE
The NPP process involves multiple stakeholders working in coordination:
- The Patient: The individual requiring the medicine
- The Treating Physician: The licensed practitioner managing care and initiating NPP request
- MitoGENE: The facilitating organization coordinating the NPP process
- CDSCO: India’s drug regulator approving/denying NPP requests
- International Manufacturer: The company supplying the approved drug
- Logistics Partners: Managing importation and delivery.
Stage 1:
Initial Patient and
Physician Assessment
(Days 1-2)
Step 1: Initial Contact
with MitoGENE
Contact MitoGENE with:
- •Patient name and contact information
- •Treating physician credentials
- •Disease diagnosis and current treatment status
- •The specific medicine of interest
Step 2: MitoGENE
Conducts Preliminary
Assessment
MitoGENE verifies:
- •Is the requested medicine approved in any other countries like USA – FDA or Europe – EMA
- •Is it unapproved or unavailable in India?
- •Does the patient likely meet CDSCO eligibility criteria?
Timeline: 1 day
Stage 2:
Medical Documentation
Preparation (Days 1-2)
Step 3: Medical Documentation Gathering
Your physician must compile:
Prescription: Patients treating physician should provide a prescription mentioning the patient’s disease status, medicine required, dosage and quantity required.
Patient Consent and Authorization: Patient should sign a consent and Authorization form with MitoGENE.
MitoGENE’s Role: MitoGENE guides Form 12A completion and facilitates submission.
Timeline: 1 -2 days
Stage 3:
CDSCO Application
Submission and
approval (Days 2-3)
Step 4:
Form 12A and supporting documents are submitted to the Assistant Drug Controller (Import) at the appropriate port office.
MitoGENE’s Role: MitoGENE guides Form 12A completion and facilitates submission.
Timeline: 1 day
Stage 4:
Medicine Sourcing,
Payment through bank,
Customs Clearance,
and Delivery
(Days 2 – 10)
Step 5 – 9:
International Sourcing, Bank Payment, documentation and customs clearance, IGST Payment & Logistics Payment, Delivery
MitoGENE:
- •Procurement
- •Documentation & Custom clearance
- •Delivery
- •Make payment to the overseas supplier
- •Make payment to MitoGENE for IGST Payment and Logistics Payment at actuals
Patient / Patient Care giver
Timeline: 5-10 working days
Stage 5:
Ongoing Safety
Monitoring
(Throughout Treatment)
Step 10: Physician-Led
Medical Supervision
The NPP does not end with medicine delivery. Ongoing supervision is mandatory:
Physician Responsibilities:
- •Regular patient follow-up (typically every 2-4 weeks)
- •Assessment of treatment efficacy
- •Monitoring for adverse effects
- •Maintenance of comprehensive treatment records
- •Communication with CDSCO if significant safety concerns arise
Patient Responsibilities:
- •Adherence to prescribed treatment regimen
- •Honest reporting of side effects to physician
- •Attendance at scheduled follow-up appointments
Timeline Summary:
| Stage | Timeline | Key Actions |
|---|---|---|
| Initial Assessment | Day 1 | Patient/physician inquiry; MitoGENE feasibility review |
| Documentation | Days 1 – 2 | Physician compiles medical documents; MitoGENE guidance |
| CDSCO Application and approval | Days 2 – 3 | Form 12A preparation and submission and 12B approval |
| Medicine Sourcing & Payment | Days 2 – 3 | MitoGENE identifies suppliers; arranges Proforma Invoices and patient makes the payment |
| Logistics Arrangements | Days 5 – 7 | MitoGENE arrange for Logistics |
| Customs clearance, IGST Payment & Delivery | Days 7 – 15 | Custom clearance and delivery of medicine to physician/patient |
| Ongoing Monitoring | Throughout | Physician supervises patient treatment and safety |
Total Timeline: Approximately 10 to 15 days from inquiry to treatment initiation
Conclusion:
he NPP pathway, while involving multiple steps and regulatory touchpoints, is a clearly defined, transparent process that thousands of Indian patients have successfully navigated. Understanding each stage enables patients and physicians to approach NPP with confidence and clarity. MitoGENE’s role is to demystify this process, manage logistics, and ensure worthy patients gain timely access to medicines that international evidence suggests could help them.
Disclaimer:
MitoGENE facilitates patient-specific access to medicines under Named Patient Program permitted by CDSCO through Form 12B. The products mentioned are not approved for commercial sale in India. Access is strictly for personal use under physician supervision. Information provided on this website is sourced from publicly available references, and MitoGENE is not responsible for its completeness or accuracy. MitoGENE does not promote or sell unapproved drugs.
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