NAMED PATIENT SUPPLY AND UNLICENSED DRUGS

Named patient supply refers to a process by which a licensed healthcare professional can request an unlicensed medicine on behalf of a specific patient who has a clinical need for it. The unlicensed medicine can be supplied only for the named patient, and not for general use.

Unlicensed drugs are medications that have not been granted a license for use in a particular country or region. These drugs may be used in certain circumstances when there is no licensed alternative available or when a licensed drug is not suitable for a specific patient. In such cases, healthcare professionals may request the unlicensed drug through the named patient supply process.

It’s important to note that the use of unlicensed drugs is subject to strict regulations and must be carefully monitored by the prescribing healthcare professional. Patients should be fully informed about the use of unlicensed drugs and any potential risks associated with them.

Named Patient Import Service

The Named Patient Import (NPI) service is a mechanism used by pharmaceutical companies to provide access to unapproved or unavailable drugs to patients with specific medical needs.

Under the NPI service, Indian pharma network can import and supply medicinal products that are not licensed in a country or are not commercially available in the country. This service is typically used for patients who have exhausted all available treatment options and have a life-threatening or seriously debilitating condition.

The NPI service is subject to strict regulations, and the importation of unlicensed medicines is only permitted in certain circumstances. The pharmaceutical company must apply for a license from the relevant regulatory authority and meet specific criteria, such as demonstrating that the medicine is necessary and that there are no suitable alternatives available.

The NPI service is generally not available to individual patients or healthcare providers but is typically facilitated by specialist companies that manage the importation and supply of unlicensed medicines. These companies work closely with pharmaceutical companies and regulatory authorities to ensure that the process is legal, safe, and effective for patients in need.