Medicines are licensed by the regulatory authorities before they can be used in humans. The licensing of medicines ensures safety and efficacy for their approved indications. Licensing of drugs was made mandatory after the infamous incidences related to drug toxicity, for instance, the development of grey baby syndrome in neonates due to the use of chloramphenicol and the occurrence of phocomelia in the developing fetus due to the ingestion of thalidomide by the pregnant women.
Under particular circumstances, the physicians, after evaluating the risk-benefit ratio may need to prescribe certain drugs that may not have been approved by the regulatory authorities. Such type of drug prescription is known as the off-label use of the drug. An off-label prescription may refer to the use of a drug approved by the regulatory authorities for indications that fall outside the terms of the official…
