Lung Cancer – Availability and Access
Understanding Lung Cancer Treatment Access Through
Named Patient Programs
Lung cancer is one of the most serious health challenges globally. In India, it ranks as the fourth leading cause of cancer-related deaths. For patients diagnosed with advanced lung cancer, understanding what treatment options exist and how to access them can make a significant difference in their healthcare journey.
This content is for educational purposes only and is not medical advice. All information reflects current regulatory knowledge as of 2025. Patients should consult their oncologist regarding treatment options and eligibility.
A Named Patient Program is a regulated pathway that allows patients with serious or life-threatening conditions to access medications that may not yet be approved for general use in India. In India, NPP operations are governed by the Central Drugs Standard Control Organization (CDSCO) under the Drugs & Cosmetics Rules, 1945.
This program bridges the gap between patients who have exhausted standard treatment options and potentially beneficial medications available internationally, while maintaining strict safety standards.
How Does NPP Work?
To qualify for NPP, lung cancer patients typically must meet these criteria:
- Advanced or metastatic disease requiring urgent systemic intervention
- Exhaustion of suitable Indian-approved alternatives or inadequate response to standard treatments
- Medical evidence supporting potential benefit from the requested medication and it is approved in any other country especially USFDA or EMA
- Clear clinical justification by their treating physician
- Informed consent after understanding potential risks and benefits
Immunotherapy – Enhances body’s immune system to fight cancer cells.
Targeted Therapies for RET fusion-positive lung cancer:
For ALK-positive lung cancer:
For KRAS G12C-positive lung cancer:
For SCLC (small cell lung cancer):
Organizations like MitoGENE facilitate the NPP process by:
- Educating patients and physicians about NPP and eligibility
- Facilitating patients to get I2 B import permit for personal use from CDSCO
- Connecting patients with legitimate international medicine sources
- Ensuring regulatory compliance
- Providing documentation support for NPP applications
- Coordinating logistics for legal importation and delivery
By working with MitoGENE, patients access expertise and connections necessary to navigate NPP successfully.
Please Note: All clinical decisions, including whether a therapy is suitable, are made solely by the treating physician, and MitoGENE does not influence prescribing decisions or the medical judgment of physicians.
The Named Patient Program provides an important mechanism for patients with advanced lung cancer to access medications not yet widely available in India. For patients who have exhausted standard Indian treatment options, NPP may provide an opportunity to access promising medications available internationally.
MitoGENE’s expertise as an experienced NPP facilitator significantly simplifies this complex process, providing patients and physicians with knowledgeable guidance and logistical support.
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 any specific product and does not replace advice from qualified healthcare professionals.
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