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Microbiological acceptance criteria, specifications of herbal drugs and herbal drug preparations in various pharmacopoeias: a global scenario

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Abstract

Purpose

A pharmacopoeia is a compendium of guidelines and criteria for drug quality. It was established by a national or regional entity and has legal significance. This applies to administration of drugs in a particular nation or region.

Method

In this study, the differences and similarities of microbiological acceptance criteria, specifications for microbial enumeration of herbal drugs and herbal drug preparations in 14 national and international pharmacopeias were investigated.

Results

It was found that 12 pharmacopeias have given separate microbial limits for total aerobic microbial count (TAMC) and total yeast and mold count (TYMC), and a list of specified microorganisms for which acceptance criteria are defined. However, similarities were noticed in Ph.Eur, Ph. Helv and, BP. Salmonella, and Escherichia coli are the most common pathogens specified for herbal preparations in which boiling water is added prior to use and for internal use in all Pharmacopoeias because they serve as indicators of potential contamination.

Conclusion

From this study, it can be concluded that the differences in microbial limit tests and their acceptance criteria as specified in the various pharmacopoeias need to be harmonized. It will become a more convenient option for global drug manufacturers to import/export herbal drugs, and this would also eliminate the burden of performing various analytical methods and comply with different microbial acceptance criteria set by various pharmacopoeias. The comparative data obtained from this study will be used to develop strategies for revisions of pharmacopoeias in a harmonized manner with respect to microbiological acceptance criteria, specifications for microbial enumeration of herbal drugs and herbal drug preparations.

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Abbreviations

Ph.Eur:

European Pharmacopoeia

BP:

British Pharmacopeia

Ph. Helv:

Swiss Pharmacopoeia

JP:

Japanese Pharmacopoeia

IP:

Indian Pharmacopoeia

USP:

United States Pharmacopeia

WHO:

The World Health Organization

TGO100:

Therapeutic Goods (Microbiological Standards for Medicines) Order 2018

Pharmacopoeia.ru:

Russia State Pharmacopoeia

THP:

Thai Herbal Pharmacopoeia

API:

Ayurvedic Pharmacopoeia of India

Ph. Int.:

International Pharmacopoeia

IHP:

International Herbal Pharmacopoeia

ICH:

International Council for Harmonization

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Acknowledgements

The authors warmly acknowledge the administration of Pharmacopoeia Commission for Indian Medicine & Homoeopathy, Ministry of Ayush, Govt. of India for providing support and resources for writing this review article.

Funding

No funding was received for conducting this study.

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Authors and Affiliations

  1. Pharmacopoeia Commission for Indian Medicine & Homoeopathy, Ministry of Ayush, Ghaziabad, 201002, UP, India

    Ramesh Munukuntla, Akhilesh Tiwari, Ravi Shankar Yadav, A. Jayanthy, Subhash Chandra Verma & Raman Mohan Singh

  2. Department of Environmental Biotechnology, Faculty of Environmental and Energy Engineering, Silesian University of Technology, ul. Akademicka 2A, Gliwice, 44-100, Poland

    Ravi Shankar Yadav

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  1. Ramesh Munukuntla
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  2. Akhilesh Tiwari
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Contributions

RM: made substantial contributions to conception of idea, analysis of data and manuscript writing with the help of AK and RSY. JA, SCV and RMS: supervision, feedback and given approval for publication.

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Correspondence to Ramesh Munukuntla.

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Munukuntla, R., Tiwari, A., Yadav, R.S. et al. Microbiological acceptance criteria, specifications of herbal drugs and herbal drug preparations in various pharmacopoeias: a global scenario. DARU J Pharm Sci (2024). https://doi.org/10.1007/s40199-024-00510-5

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