Comparative Account of Quality Management and Regulatory Aspects of Products with Health Claims: Existing Approaches and Future Challenges for Probiotics and Herbal Products

Author(s): Malika Arora, Ashish Baldi.

Journal Name: Applied Clinical Research, Clinical Trials and Regulatory Affairs

Volume 2 , Issue 3 , 2015

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Graphical Abstract:


Background: Quality, the basic requirement, is meeting stated as well as implied needs of customer. It holds paramount significance when it is specifically related with health care products especially drugs and other related products. These traditional therapies are being explored today for its overwhelming roles in health care sector. However, lot many consequences are associated with traditional medicine with respect to their efficacy, safety and quality.

Methods: For the present article, literature has been reviewed in context to current approaches, used for quality control of pharmaceuticals, probiotics and herbal across the globe.

Results: This review has been compiled to discuss various factors associated with safety concern of selected health care products. It highlights various concerned factors associated with effective monitoring of the safety of traditional medicines including herbal products and live microorganisms i.e. probiotics and nutraceuticals in comparison to widely accepted pharmaceuticals.

Conclusion: Safety is supposed to be the major concern regarding health claiming products hence relevant regulatory regimes should be enforced to deliver quality as per demand of the consumer.

Keywords: Drugs, herbal drugs, nutraceuticals, pharmaceuticals, probiotics.

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Article Details

Year: 2015
Page: [123 - 132]
Pages: 10
DOI: 10.2174/2213476X02666151103213351
Price: $58

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PDF: 31