DNA-testing: from research to regulation

The use of DNA-testing for the herbal industry has been a hotly debated issue for several years [1]. During this time the methodologies have advanced, different approaches have been advocated and strengths and weaknesses highlighted. In 2016 the British Pharmacopoeia became the first to publish a DNA-based method for the identification of herbal drugs. This was intentionally placed in a non-mandatory section of the publication and focused on the provision of a ‘reference sequence’ for each herbal drug. The Chinese Pharmacopoeia has published ITS2 sequences for herbal drugs, and species-specific assays are being investigated by the US Pharmacopoeia. Examples of these techniques and their properties are described.

Harmonisation between the different global stakeholders would be a distinct advantage to the industry and facilitate compliance across the board; it is imperative that the methods proposed are transparent and accessible.

Through examples, the various issues that arise in the complex and varied supply chains for medicinal plants are described, arriving at the conclusion that DNA-based methods are a powerful piece of the puzzle for Quality Assurance but that this must be seen as part of a larger picture, along with phytochemical and other methods.

• References

• 1 Sgamma T, Lockie-Williams C, Kreuzer M. et al. DNA Barcoding for Industrial Quality Assurance. >Planta Med 2017; 83: 1117-1129.