Named Patient Exemption

Official source: CDSCO; AYUSH Ministry

Named Patient Exemption (also called Named Patient Use) permits use of an unlicensed medical device for a specific identified patient when no licensed equivalent is available in India and the patient has a serious or life-threatening condition. This differs from compassionate use in scope and approval pathway. Applications are submitted to CDSCO with patient-specific clinical justification, physician certification, and ethics committee approval where required. Each exemption applies to the identified patient only.