Intravenous Immunoglobulin Preparations: Quality Assurance Measures and Proposed Strategies for Improving its Safe and Judicious use in India

Author(s): Sudha V. Gopinath*, J.P. Prasad

Journal Name: Applied Clinical Research, Clinical Trials and Regulatory Affairs (Discontinued)
Continued as Applied Drug Research, Clinical Trials and Regulatory Affairs

Volume 5 , Issue 1 , 2018


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Abstract:

Immunoglobulins (IgG) derived from the human plasma are used as biotherapeutics primarily in the form of polyclonal IgG or as hyperimmune sera. Intravenous Immunoglobulin (IVIG) has been the driving force of the growth of plasma products industry. In India, the demand for IVIG has been growing on account of increased usage of IVIG in the treatment of primary immunodeficiency as well as for newer neurological indications. In order to assure patient safety, Government of India has devised and implemented regulations for import, manufacturing and marketing of these products. Regulatory provisions in India have basic common features such as review of data in marketing authorization application, inspection and licensing of manufacturing facilities, process and quality systems, control agency batch review and release of approved products. Nevertheless, there remains a room for considering additional safety requirements for the enhanced confidence in the safety of this plasma-derived product as well as research strategies for its judicious use that may provide additional options to address patient needs. This article gives an overview of the current quality assurance measures of plasma-derived IVIG in India and further strategies to improve its quality as well as judicious use.

Keywords: Immunoglobulin, IVIG, neurological indications, Alzheimer’s disease, human plasma, India.

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Article Details

VOLUME: 5
ISSUE: 1
Year: 2018
Published on: 13 March, 2018
Page: [42 - 52]
Pages: 11
DOI: 10.2174/2213476X05666180313124525
Price: $25

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