Named Patient Program

Named Patient Program India

Named Patient Support Program

A Named Patient Program (NPP) provides a pathway for eligible patients to access medicines that may not be approved, registered, or commercially available in India, when an appropriate treatment option is not available through routine channels. Access is generally coordinated with the treating physician and is subject to applicable prescription, regulatory, and import requirements.

Named Patient Import (NPI) may be considered for individual patients who require specific medicines that are not routinely available in India. Depending on the medicine, its regulatory status, and the patient’s medical requirement, the applicable process may involve medical documentation, prescription requirements, regulatory permissions, and import documentation.

Arkon Solutions LLP provides support throughout the Named Patient Import process, including medicine sourcing coordination, documentation, regulatory coordination, international logistics, and delivery coordination, based on the specific medicine and patient requirement. Our team works with the relevant healthcare professionals and stakeholders to help navigate the requirements associated with accessing medicines that may not be commercially available or registered in India.

Trusted Across Healthcare

Liable sourcing

Timely Updates

Optimized pricing

Scheduled delivery

Thermal stability

Pre and Post-delivery Support

Why Arkon Solutions?

Expertise

8 years of experience of our professionals in this domain, catered to the needs of proactive access provision of medicines for our customers setting a benchmark through a distinctive commitment to ethical regulatory governance.

Transparency

Ensure clear and transparent cost breakdowns, allowing care seekers and providers to understand the financial implications before proceeding.

International Network

An extensive network of vendors, pharmaceutical manufacturers, healthcare providers, and regulatory authorities, help us to navigate broadened access, faster execution and robustness.

Logistics

Maintain EU- GMP certified facilities, temperature control requirements (including cold chain integrity), navigating complex international customs and import regulations for unauthorized products and ensure timely delivery.

Adherence to SOP’s

Maintain consistent operational standards even in complex and demanding situations. We assure traceability for each specific unit of drug and gather documentation for the seamless import procedure.

Country-level Compliance

We ensure providing the requisite licensed documentation including COO and COA, thereby strengthening patient confidence in the supplied products.

Frequently Asked Questions

A Named Patient Program (NPP) is a patient-specific access pathway that may allow eligible patients to access medicines that are not approved, registered, or commercially available in India, subject to applicable regulatory requirements. The process is generally supported by a valid prescription and medical documentation from the treating physician.

A medicine that is not approved or commercially available in India may be accessed through a patient-specific import pathway when the applicable medical, documentation, and regulatory requirements are fulfilled. Arkon Solutions LLP can assess the medicine requirement, availability, sourcing options, and applicable requirements for the individual request.

Certain unapproved or unregistered medicines may be imported for individual patient use subject to applicable Indian regulations and required permissions or documentation. The specific requirements depend on the medicine, quantity, intended use, and patient circumstances.

Documents commonly required may include a valid prescription from the treating physician, patient medical records or medical justification, patient identification, and import-related documentation. Additional documents or permissions may be required depending on the medicine and individual case.

A prescription establishes that the medicine has been prescribed for a specific patient by a registered medical practitioner. For certain personal-use imports, the applicable CDSCO process requires supporting prescription documentation indicating the medicine and quantity required for treatment.

Regulatory requirements for patient-specific medicine imports depend on the medicine, its regulatory status, quantity, intended use, and individual patient circumstances. Depending on the case, specific applications, permissions, prescriptions, and supporting documents may be required.

The timeline varies depending on medicine availability, documentation, regulatory requirements, sourcing, customs procedures, and logistics. After reviewing the specific medicine and supporting documents, an estimated timeline can be provided for the individual request.

Specialty medicines used in oncology and rare disease treatment may be considered for patient-specific import when they are unavailable through conventional channels and the applicable medical and regulatory requirements are fulfilled. Each medicine request is assessed individually.

To check the availability of a specific medicine, the treating healthcare professional or authorized representative can provide the medicine name, strength, dosage form, prescription, and relevant patient information. Arkon Solutions can then assess availability, sourcing options, documentation, regulatory requirements, and the next steps.

Arkon Solutions LLP supports patient-specific medicine import by coordinating medicine sourcing, prescription and document review, regulatory requirements, import documentation, international logistics, customs coordination, and delivery for eligible requests. Each medicine request is assessed individually based on availability, patient requirements, and applicable Indian regulations.