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Medicines under the Named Patient Program are supplied on a patient-specific basis and require a valid prescription from the treating physician. This ensures clinical appropriateness and supports regulatory compliance. All prescriptions and supporting documents are reviewed, and where necessary, the prescribing healthcare professional may be contacted for verification or clarification.
To help ensure timely processing, the prescription should contain the following information:
The prescribing physician's full name, contact details, professional registration number, and official clinic, hospital, or healthcare institution letterhead.
The patient's full name, date of birth, diagnosis, and other identifying information required for patient-specific access and regulatory review.
The prescribed medicine name, strength, dosage form, prescribed dose, treatment duration, quantity required, and relevant treatment instructions, where applicable.
The date of issue, physician's signature, and official stamp or seal, where applicable.
Medicines supplied through the Named Patient Program are imported on a patient-specific basis and may require supporting documentation in accordance with applicable regulatory requirements. The prescribing physician may be requested to provide clinical justification confirming the medical need for the requested treatment and its intended use for the patient.
Additional documentation may include a medical summary, diagnosis details, treatment history, and confirmation of the prescribed dosage and treatment duration. Accurate and complete documentation helps facilitate regulatory review, supports import authorization procedures, and ensures compliance with patient-specific access requirements.
In India, patient-specific imports are governed by the applicable provisions of the Drugs and Cosmetics Act, 1940 and related regulatory requirements administered by the Central Drugs Standard Control Organization (CDSCO). Depending on the medicine and patient circumstances, additional documentation or approvals may be required to support the lawful import of medicines that are not otherwise commercially available in the country.
The prescription should include: