National Control Laboratories in quality healthcare-a roadblock for substandard biopharmaceuticals.

Biological Products Delivery of Health Care Humans Laboratories
Biopharmaceuticals National Control Laboratories National Regulatory Authority Not of Standard Quality Quality evaluation Substandard drugs

Journal

Biologicals : journal of the International Association of Biological Standardization
ISSN: 1095-8320
Titre abrégé: Biologicals
Pays: England
ID NLM: 9004494

Informations de publication

Date de publication:
Apr 2022
Historique:
received: 07 09 2021
revised: 02 12 2021
accepted: 15 02 2022
pubmed: 1 3 2022
medline: 11 5 2022
entrez: 28 2 2022
Statut: ppublish

Résumé

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.

Identifiants

DOI: 10.1016/j.biologicals.2022.02.002 PMID: 35221225
pubmed: 35221225
pii: S1045-1056(22)00016-1
doi: 10.1016/j.biologicals.2022.02.002
pii:
doi:

Substances chimiques

Biological Products 0

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

42-45

Informations de copyright

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

Auteurs

Rashmi Shrivastava (R)

National Institute of Biologicals, Ministry of Health and Family Welfare, Plot No. A-32, Sector-62, Institutional Area, NOIDA, 201 309, U.P., India.

Shalini Tewari (S)

National Institute of Biologicals, Ministry of Health and Family Welfare, Plot No. A-32, Sector-62, Institutional Area, NOIDA, 201 309, U.P., India. Electronic address: stewari69@gmail.com.

Charu Mehra Kamal (CM)

National Institute of Biologicals, Ministry of Health and Family Welfare, Plot No. A-32, Sector-62, Institutional Area, NOIDA, 201 309, U.P., India.

Niharika Trivedi (N)

National Institute of Biologicals, Ministry of Health and Family Welfare, Plot No. A-32, Sector-62, Institutional Area, NOIDA, 201 309, U.P., India.

Manisha Varshney (M)

National Institute of Biologicals, Ministry of Health and Family Welfare, Plot No. A-32, Sector-62, Institutional Area, NOIDA, 201 309, U.P., India.

Aakanksha Yadav (A)

National Institute of Biologicals, Ministry of Health and Family Welfare, Plot No. A-32, Sector-62, Institutional Area, NOIDA, 201 309, U.P., India.

Anupkumar R Anvikar (AR)

National Institute of Biologicals, Ministry of Health and Family Welfare, Plot No. A-32, Sector-62, Institutional Area, NOIDA, 201 309, U.P., India.

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Classifications MeSH

questionsmedicales.fr › Mélanges complexes › Produits biologiques › National Control Laboratories in quality...
questionsmedicales.fr › Qualité, accès, évaluation des soins de santé › Prestations des soins de santé › National Control Laboratories in quality...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › National Control Laboratories in quality...
questionsmedicales.fr › Établissements, main d'oeuvre et services de soins de santé › Établissements de santé › Laboratoires › National Control Laboratories in quality...