Global Compassionate Use Programme Supply Partner
GNH India supports globally regulated compassionate use programmes by providing compliant pharmaceutical supply of unapproved, investigational, and hard-to-access medicines for patients with serious or life-threatening conditions across international markets.
As a licensed pharmaceutical supplier in India with WHO-GSDP compliant systems, we work alongside healthcare institutions, regulatory bodies, and clinical teams to facilitate timely, compliant sourcing and supply of medicines under compassionate use, expanded access, and early access frameworks worldwide.
Our compassionate use programme supply services are structured exclusively for healthcare institutions, licensed medical practitioners, and regulated clinical programmes — not for retail or direct-to-consumer pharmaceutical sales.
What Is a Compassionate Use Programme?
A compassionate use programme is a regulated mechanism that enables patients with serious, debilitating, or life-threatening conditions to access medicines that are not yet approved, licensed, or commercially available in their country, before full marketing authorisation is granted.
Also referred to as expanded access, early access programmes, or named patient programmes depending on the regulatory jurisdiction, compassionate use frameworks are established by health authorities worldwide to ensure no patient is denied access to potentially life-saving treatment due to regulatory timelines or local market unavailability.
These programmes support:
- Patients with rare or life-threatening conditions exhausting all approved treatment options
- Healthcare providers treating conditions with no licensed therapeutic alternatives
- Hospitals and institutions managing urgent, individual patient access requests
- Clinical research organisations bridging post-trial access gaps
- Government health bodies facilitating population-level early access initiatives
Unlike standard pharmaceutical supply, compassionate use programme supply requires strict adherence to:
- Country-specific regulatory authority approvals and notifications
- Medical necessity documentation and physician authorisation
- Regulatory frameworks such as FDA Expanded Access, EMA Article 83, MHRA Compassionate Use, and equivalent national pathways
- Compliant import, export, and cold chain handling protocols
- Pharmacovigilance and adverse event reporting obligations
As a trusted compassionate use programme supplier, GNH India supports healthcare institutions by delivering compliant, quality-assured, and traceable pharmaceutical supply aligned with international compassionate use frameworks across 180+ countries.
Our Scope & Capabilities
- Supply of unapproved and investigational medicines under compassionate use frameworks globally
- Support across FDA Expanded Access, EMA Article 83, MHRA Compassionate Use, and equivalent national pathways
- Licensed Pharmaceutical Wholesaler — State FDA Maharashtra
- WHO-GSDP Compliant Storage & Distribution
- ISO 9001:2015 Certified Quality Management System
- IEC Licence for Global Pharmaceutical Export
- Regulatory Documentation & Compliance Support
- Temperature-Controlled Warehousing & Validated Cold Chain Logistics
- Supply of Specialty, Orphan, Oncology & Rare Disease Medicines
- Pharmacovigilance Coordination & Batch Traceability Support
How It Works — Our Compassionate Use Programme Supply Process
Medical & Regulatory Eligibility Review
We assess the compassionate use request against applicable regulatory frameworks — including FDA Expanded Access (USA), EMA Article 83 (EU), MHRA Compassionate Use (UK), TGA SAS (Australia), CDSCO import provisions (India), and equivalent national authority pathways — to confirm regulatory feasibility before any supply commitment is made.
Verified Sourcing & Quality Assurance
All medicines supplied under our compassionate use programme are sourced exclusively from WHO-GMP certified manufacturers and authorised supply channels, ensuring full product authenticity, batch-level traceability, and regulatory documentation compliance prior to dispatch.
Regulatory Documentation Support
We assist healthcare institutions and clinical teams with preparation and organisation of required compassionate use documentation, including physician authorisation and medical necessity certification, manufacturer certificates of analysis and batch documentation, import/export licensing, country-specific regulatory application support, and pharmacovigilance frameworks.
WHO-GSDP Compliant Warehousing & Cold Chain Handling
All medicines are stored and handled in validated, temperature-controlled facilities with continuous monitoring — ensuring full product integrity for biologics, injectables, oncology medicines, and all temperature-sensitive compassionate use therapies.
Global Compliant Delivery & Ongoing Support
Our global logistics network supports structured, GDP-compliant delivery directly to authorised healthcare institutions with full shipment documentation, tracking visibility, and post-supply pharmacovigilance coordination for continuation or follow-up supply requirements.
Why Choose GNH India for Compassionate Use Programme Supply?
GNH India Pharmaceuticals Limited operates as a regulated, WHO-GSDP compliant pharmaceutical supplier with over 22 years of experience supporting complex international supply programmes — including compassionate use, expanded access, named patient, and early access frameworks across 180+ countries.
As a dedicated compassionate use programme supplier, we combine regulatory expertise, quality-assured global sourcing, and GDP-compliant logistics to ensure uninterrupted access to critical medicines for patients who need them most.
- WHO-GSDP Compliant Pharmaceutical Supply
- ISO 9001:2015 Certified Quality Management System
- Licensed by State FDA Maharashtra
- IEC Authorised Pharmaceutical Exporter
- Member — Pharmaexcil (Pharmaceuticals Export Promotion Council of India)
- Member — FIEO (Federation of Indian Export Organisations)
- 22+ Years of Global Pharmaceutical Supply Experience
- Supply Across FDA, EMA, MHRA, TGA & 180+ Country Regulatory Frameworks
- Dedicated Regulatory Documentation & Compliance Support Team
- End-to-End Cold Chain & Temperature-Controlled Logistics
We operate strictly as a regulated B2B and institutional pharmaceutical supply partner. We do not engage in retail or direct-to-consumer medicine sales.
Regulatory & Compliance Information
GNH India operates under the following compliance frameworks relevant to compassionate use programme supply:
Global Regulatory Frameworks Supported
IND-based and non-IND compassionate use pathways for individual and intermediate-size patient populations.
For medicinal products undergoing clinical trials or marketing authorisation review.
Named patient and hospital exemption supply of unlicensed medicines.
Category A, B, and C pathways for unapproved therapeutic goods.
Form 12A and special import provisions for unapproved medicines.
Across 180+ countries including ANVISA, SAHPRA, NMPA, MFDS, Swissmedic, and others.
GNH India Operational Compliance
- WHO Good Distribution Practices (WHO-GSDP)
- ISO 9001:2015 Certified Quality Management System
- State FDA Maharashtra Pharmaceutical Wholesale Licence
- Import Export Code — DGFT, Government of India
- Pharmaexcil Membership
- FIEO Membership
All sourcing, storage, and distribution activities adhere to Indian FDA regulations and applicable international pharmaceutical supply standards relevant to compassionate use programme frameworks.
Regulatory Recognitions
Quality You Can Trust
Our internationally recognised certifications underscore our commitment to safety, quality, and excellence in compassionate use programme pharmaceutical supply.
