MitoGENE – Legal Context

Enabling Global Access, Within Regulatory Frameworks

Why MitoGENE Is Qualified to Support Named Patient Access

At MitoGENE, we specialize in facilitating access to life-saving medications not yet commercially available in India. We operate strictly within the legal provisions of the Indian Drugs and Cosmetics Rules, 1945, and parallel international frameworks.

We serve as a reliable access partner—not a pharmacy or importer—but a facilitator helping hospitals, clinicians, and patients obtain documentation and connect with audited, globally licensed suppliers.

What Makes It Legal?

Under the Named Patient Import provision of the Indian regulatory system (Rule 36 and Rule 122A), patients can legally import small quantities of unapproved medicines for personal use, provided the following conditions are met:

  • The medicine is not approved or available in India but is approved in another country (e.g., US FDA, EMA).
  • The patient suffers from a life-threatening or serious illness, such as advanced cancer, rare genetic disease, or drug-resistant infection.
  • A valid prescription is issued by the treating physician.
  • The drug is used strictly for personal treatment, not for commercial sale.
  • Necessary import documentation is in place (e.g., Form 12B, prescription, justification letter).

We assist in preparing these documents—but we do not directly apply for import licenses or handle customs clearance.

📄Want to learn more about Rule 36 and Named Patient Import? [View D&C Rules – India]

Our Commitment to Medicine Authenticity

At MitoGENE, we source medicines only from GDP-compliant, WHO-GMP certified partners across Europe, North America, and other regulated markets. Every product is:

  • Supplied sealed and labeled by the original manufacturer
  • Accompanied by documentation such as COA (Certificate of Analysis), COO (Country of Origin), and batch information
  • Procured via licensed wholesalers or distributors that have been audited and qualified for quality, regulatory compliance, and stock integrity

We believe in transparency and safety—our sourcing partners undergo rigorous checks to ensure every medicine is authentic and traceable.

Why Choose MitoGENE

  • GDP-Compliant Suppliers
  • Regulatory Document Support (Form 12B, Prescription Guidelines, Justification Templates)
  • Cold Chain Coordination (if needed)
  • No Commercial Sale—Strictly Patient-Specific Use
  • Fair, Negotiated Pricing

Bridging Global Innovation & Local Access

Our goal is to reduce the time, complexity, and cost of accessing critical medications when no alternatives are available locally. We work hand-in-hand with healthcare providers, helping them navigate regulatory hurdles so patients can receive the treatments they need—ethically and legally.

📧 For guidance on NPP medicines or to begin the document support process, contact:
📩 info@mitogene.org | 📞+91-9941034386