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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. Copyright © 2022 International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved.


Rashmi Shrivastava, Shalini Tewari, Charu Mehra Kamal, Niharika Trivedi, Manisha Varshney, Aakanksha Yadav, Anupkumar R Anvikar. National Control Laboratories in quality healthcare-a roadblock for substandard biopharmaceuticals. Biologicals : journal of the International Association of Biological Standardization. 2022 Apr;76:42-45

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PMID: 35221225

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