Named Patient Program – Fast Global Access to Unapproved & Critical Medicines

GNH India delivers global Named Patient Supply services, helping patients and healthcare providers access unapproved, unavailable, or life-saving medicines through fully compliant Named Patient Programs across international markets from global sources to those who need them most.

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  • A ISO 9001:2015 certified and WHO-GSDP compliant company.
Healthcare professional delivering temperature-controlled Named Patient Supply medicines worldwide – GNH India

What Is Named Patient Supply?

Named patient supply (NPS) is a regulated pharmaceutical program that enables patients to access medications that are not yet approved, available, or registered in their country. Also known as a named patient program, compassionate use, or expanded access program, this service provides a legal pathway for obtaining unlicensed medicines for individual patients with serious medical conditions.

Under a named patient basis:

  • A licensed physician requests the medicine for a specific patient
  • The treatment is justified by medical necessity
  • The medicine is legally sourced from a country where it is approved or available

Named Patient Programs are widely used for rare diseases, oncology, orphan drugs, and compassionate use therapies, enabling timely treatment when standard options are unavailable.

At GNH India, we partner with leading global manufacturers and health authorities to secure these critical therapies on a patient-by-patient basis. We support this process end-to-end, ensuring the medicine is sourced from legitimate manufacturers and supplied in full compliance with Indian and international regulations.

How It Works – The Named Patient Supply Process

Our end-to-end Named Patient Supply service is designed to be transparent, efficient, and patient-centric, ensuring compliant global access to unapproved or hard-to-find medicines through a structured Named Patient Program.

Initial Consultation:

The process begins when the patient or treating physician shares the relevant medical details, including diagnosis, treatment history, and a valid prescription. This information allows our team to understand the clinical need and confirm whether the request qualifies under a named patient basis.

Regulatory Assessment:

Once the request is received, our regulatory experts review the case and prepare the required documentation in accordance with applicable Named Patient Program regulations. We ensure that all submissions align with the regulatory requirements of the destination country and relevant health authorities.

Manufacturer Coordination:

After regulatory feasibility is confirmed, we coordinate with approved global manufacturers or authorized suppliers to source the prescribed medicine. This includes confirming availability, reserving the required batch, and ensuring the medicine meets quality and authenticity standards.

Import–Export & Compliance Clearance:

Our logistics and compliance teams manage the complete import-export process, including securing permits, customs clearance, and GDP-compliant handling. Where required, temperature-controlled and cold-chain logistics are arranged to maintain product integrity.

Secure Delivery:

The medicine is shipped using validated global logistics partners and delivered securely to the designated hospital pharmacy, clinic, or authorized healthcare facility, ensuring safe and timely arrival.

Ongoing Support & Pharmacovigilance:

Post-delivery, GNH India continues to support the Named Patient Supply by assisting with pharmacovigilance reporting, regulatory follow-ups, and coordination for repeat or continuation supplies if needed.

Why Choose GNH India as Your Named Patient Supplier?

  • 20+ Years of Global Experience in pharmaceutical distribution and regulatory affairs, supporting complex Named Patient Program requirements worldwide.
  • Proven Expertise in Named Patient Programs, including compassionate use and early access pathways, enabling compliant access to critical named patient medicines.
  • Dedicated Regulatory Affairs Specialists who manage documentation and approvals under country-specific regulations.
  • Global Network of Vetted Manufacturers and authorized suppliers, ensuring quality, authenticity, and reliable sourcing under a named patient basis.
  • End-to-End Cold-Chain & GDP-Compliant Logistics for safe handling and global delivery of temperature-sensitive named patient medicines.
  • 24/7 Customer Support & Pharmacovigilance services, providing continuous assistance before and after named patient supply delivery.
  • Fully Compliant Operations aligned with CDSCO, EMA, FDA, and other international health authorities, ensuring ethical and regulatory adherence at every step.

Regulatory recognitions

Quality You Can Trust

Our internationally recognized certifications underscore our commitment to safety, quality, and excellence in pharmaceutical distribution.

SGS GDP Compliant

GSDP Compliant from SGS

URS ISO 9001

URS ISO 9001 Certification

FDA Maharashtra

Licensed by FDA Maharashtra

IEC DGFT

IEC License issued by DGFT

Pharmexcil

Pharmexcil Member / RCMC

FIEO

FIEO Member Certification

Frequently Asked Questions

Everything You Need to Know

Named Patient Supply (NPS) is a regulatory mechanism that allows physicians to prescribe and import unlicensed or unapproved medicines for individual patients with serious conditions when no locally approved treatment alternatives exist. Also known as compassionate use, early access, or expanded access programs, NPS bridges the gap between pharmaceutical innovation and patient access globally.

Yes, Named Patient Supply is legal and regulated by health authorities worldwide. Countries including the USA (FDA Expanded Access), UK (MHRA Named Patient Supply), EU (EMA Compassionate Use), and India (CDSCO import permissions) have established frameworks to allow licensed physicians to import medicines for specific named patients when medically necessary.

Patients diagnosed with serious, debilitating, or life-threatening conditions who have exhausted all locally approved treatment options are eligible. A licensed physician must prescribe the medicine and certify medical necessity. The patient should not be eligible for or enrolled in relevant clinical trials offering the same treatment.

Medicines available through NPS include: unlicensed drugs not yet approved in the patient's country, orphan drugs for rare diseases, medicines experiencing local shortages, discontinued medications still available elsewhere, specialty biologics and biosimilars, investigational drugs approved in other jurisdictions, and temperature-sensitive medicines like vaccines.

Typical timeline is 14-21 days from initial inquiry to medicine delivery. This includes: 24-48 hours for quotation, 7-10 days for product procurement after payment, 2-3 days for export documentation, and 3-7 days for international shipping. Urgent cases can be expedited with advance coordination.

Essential documents include: valid physician prescription on letterhead with medical license number, import permit/license (e.g., Form 12A for India), patient ID proof (passport/national ID), medical diagnosis records, patient consent/authorization, and country-specific regulatory documents. GNH India assists with all documentation requirements.

Yes, most countries require an import permit or license for controlled pharmaceutical imports. In India, Form 12A from the Drug Controller is mandatory. Requirements vary by country—GNH India provides guidance on obtaining necessary permits for each destination and can facilitate the application process.

While patients can initiate the inquiry, a valid prescription from a licensed physician is mandatory. Most regulatory authorities require the prescribing physician to be the official requester. Patients work with their treating doctor, who prescribes the medicine and authorizes the import through GNH India.

Named Patient Supply typically refers to importing commercially available medicines approved in one country for use in another country where they're not yet licensed. Compassionate Use often involves access to investigational drugs still in clinical trials for groups of patients. However, terms are sometimes used interchangeably depending on regional regulations.

Yes, GNH India provides Named Patient Supply services to 180+ countries worldwide, including North America, Europe, Middle East, Asia Pacific, Africa, and Latin America. We maintain regulatory compliance expertise for diverse jurisdictions and coordinate with local health authorities as required.

Yes, GNH India specializes in temperature-controlled pharmaceutical logistics. We supply biologics, vaccines, insulin, and other temperature-sensitive medicines using validated cold chain packaging, real-time temperature monitoring, and GDP-compliant handling throughout transit to maintain product integrity.

GNH India sources medicines exclusively from WHO-GMP certified manufacturers and authorized distributors. Every product undergoes: manufacturer credential verification, batch certificate validation, cold chain integrity testing, QA inspection before dispatch, and full traceability documentation. We are ISO 9001:2015 and WHO-GSDP certified, ensuring international quality standards.