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Access to certain medicines may require patient-specific import arrangements when not available through conventional channels in India. The Named Patient Program supports lawful import based on valid physician prescriptions, medical need, and regulatory requirements. Each request is handled with compliance, quality assurance, traceability, and patient safety for the identified patient only.
Medicine import into India is regulated under the Drugs and Cosmetics Act, 1940, Drugs and Cosmetics Rules, 1945, and CDSCO guidelines. Patient-specific access programs operate within this framework, requiring medical documentation and regulatory review. The Named Patient Program ensures compliant medicine access with strong focus on quality, safety, and compliance.
Providing complete and accurate documentation helps facilitate regulatory review and
patient-specific access requests.
Prescription from the treating physician for the requested treatment.
Relevant diagnosis details, treatment history, and supporting clinical information.
Additional documents may be required based on the medicine and patient circumstances.
Complete and accurate information supports regulatory review and import requirements.
Certain patient-specific medicine access requests may require regulatory review, authorization, or supporting documentation based on product, indication, and intended use. Requirements may vary by case. Our team collaborates with healthcare professionals, manufacturers, and regulatory stakeholders to support documentation and help facilitate a compliant and efficient medicine access process.
Medicines supplied under the Named Patient Program are intended solely for an identified patient based on a physician’s prescription and documented medical need. Quantities align with prescribed dosage, treatment duration, and clinical requirements. Each request is assessed individually to ensure compliance with applicable regulatory requirements and appropriate patient-specific medicine access.
Medicines supplied under the Named Patient Program are intended exclusively for the personal treatment of the patient identified in the prescription and supporting documents. They are not for resale, commercial distribution, institutional stockholding, or general market supply. This patient-specific approach ensures traceability, regulatory compliance, accountability, and patient safety throughout the supply process.
Patient safety is central to every stage of the access process. Medicines under the Named Patient Program are sourced through authorized pharmaceutical channels and managed under strict quality standards. Verification, traceability, and quality assurance are applied across sourcing, storage, transport, and delivery to ensure product authenticity, supply chain integrity, and compliant, safe medicine access.
