Assistant Professor (Clinical Research), Department of Community Medicine, Himalayan Institute of Medical Sciences, Swami Rama Himalayan University, Swami Ram Nagar, Jolly Grant, Dehradun, India
*Corresponding Author: Assistant Professor (Clinical Research), Department of Community Medicine, Himalayan Institute of Medical Sciences, Swami Rama Himalayan University, Swami Ram Nagar, Jolly Grant, Dehradun, India.
Received: May 13, 2022 Published: August 01, 2022
After the completion of the clinical trials, a pharmaceutical product is only allowed to market. They can only “prescribed by a physician, dispensed by a pharmacist and used by a patient, after marketing authorization is given for a specific indication(s). All medication should be sold with a summary of product characteristics (SmPC)” in it. All “SmPC must contain all the information about the indications of medicinal product, its dosages, route of administration, who cannot use it (Children or pregnant women). All of the indications and guidelines included in the SmPC and summarised in their package insert are referred to as label drugs. Meanwhile, ‘Off-label usage' refers to the “use of a pharmaceutical “product for any indication, patient category, mode of administration, dosage, or treatment regimen”” not stated in the SmPC. When a doctor prescribes you a prescription that the US Food and Drug Administration (FDA) has approved to treat a condition other than yours, this is known as off-label prescribing. This is a common and legal practise. Today, one out of every five medications is for an off-label usage. Even if the indication hasn't been approved by regulatory bodies, a practitioner has the ability to prescribe any licenced medicine for any indication. Pharmaceutical companies are not allowed to market non-approved indications in most nations' prescribing information and promotional materials .
Citation: Nikku Yadav. “Snapshot of Off-Lable Use of Drugs: Perspectives and Practices in India". Acta Scientific Pharmacology 3.9 (2022): 01-02.
Copyright: © 2022 Nikku Yadav. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.