Named Patient Exemption

Official source: CDSCO; AYUSH Ministry

Named Patient Exemption and Compassionate Use are substantially similar pathways under CDSCO regulations. Both permit use of an unlicensed medical device for a specific identified patient (or small group of patients) when no licensed equivalent is available in India and the patient has a serious or life-threatening condition. The terms are often used interchangeably, though some applications may distinguish between single-patient use and broader compassionate access scenarios. 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.

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.