Abstract：
Substandard or spurious drugs are a global problem with respect to Health and Economic burden. The impact is higher when medicines are from the category of life-saving drugs, essential medicines or high cost targeted medical treatment. Biopharmaceuticals are one such class of drugs where Quality testing plays a pivotal role to stop substandard drugs from reaching the patient. This study of 17,451 samples has highlighted the trend of occurrence of substandard biologicals (2.34%) over a decade (2011-2021) and the importance of continuous and complete evaluation of such Biopharmaceuticals. More such National Control Laboratories (NCL) should be involved in cross-checking the quality of the increasing number of biopharmaceuticals present in the market which are released only on the basis of the onsite inspection and dossier reviews. This will help the Regulators to ensure the readiness for testing the newer biologicals, devise effective policies for better health care initiatives and keep the substandard biopharmaceuticals at bay.
摘要：
就健康和经济负担而言，不合格或虚假药物是一个全球性问题。当药物来自救命药物类别时，影响更大，基本药物或高成本的针对性医疗。生物制药是一类这样的药物，其中质量测试在阻止不合格药物到达患者方面起着关键作用。这项对17,451个样本的研究强调了十年（2011-2021年）中不合格生物制品（2.34％）的发生趋势以及对此类生物制药进行连续和完整评估的重要性。更多这样的国家控制实验室（NCL）应参与交叉检查市场上越来越多的生物制药的质量，这些生物制药仅在现场检查和档案审查的基础上发布。这将有助于监管机构确保测试较新的生物制品的准备，制定有效的政策，以改善医疗保健计划，并阻止不合格的生物制药。
