Estimating Herbal Product Authentication and Adulteration in India Using a Vouchered, DNA-Based Biological Reference Material Library.
India is considered the 'medicinal garden' of the world, with 8000 medicinal plants of which 960 are commercial species that are traded nationally and globally. Although scientific studies estimate herbal product adulteration as 42-66 % in North America, India does not have any published marketplace studies and subsequent estimates of adulteration in an industry facing considerable supply demands.



The goal of this project is to provide an initial assessment of herbal product authentication and adulteration in the marketplace in India by (1) developing a biological reference material (BRM) herbal DNA library for Indian herbal species using DNA barcode regions (ITS2 and rbcL) in order to facilitate accurate species resolution when testing the herbal products; and (2) assessing herbal product identification using our BRM library; and (3) comparing the use of our BRM library to identify herbal products with that of GenBank.



A BRM herbal DNA library consisting of 187 herbal species was prepared to authenticate the herbal products within India. Ninty-three herbal products representing ten different companies were procured from local stores located at Coimbatore, India. These samples were subjected to blind testing for authenticity using the DNA barcode regions rbcL and ITS2.



The results indicate that 40 % of the products tested are authentic, and 60 % of the products may be adulterated (i.e. contained species of plants not listed on the product labels). The adulterated samples included contamination (50 %), substitution (10 %) and fillers (6 %). Our BRM library provided a 100 % Basic Local Alignment Search Tool (BLAST) match for all species, whereas the GenBank match was 64 %.



Our findings suggest that most Indian herbal medicinal products are essentially mixed with one or a few other herbs that could lessen the therapeutic activity of the main ingredients. We do not recommend the use of GenBank to identify herbal products because the use of this non-curated and/or vouchered database will result in inaccurate species identification. These DNA-based tools provide a scientific foundation for herbal pharmacovigilance to ensure the safety and efficacy of natural drugs. This study provides curated BRMs that will underpin innovations in molecular diagnostic biotechnology, which will soon provide more robust estimates of adulteration and commercial tools that will strengthen due diligence in quality assurance within the herbal industry.
Plant Genetic Engineering Laboratory, Department of Biotechnology, Bharathiar University, Marudhamalai Road, Coimbatore, Tamil Nadu, 641 046, India.|Department of Integrative Biology, Office 208, Centre for Biodiversity Genomics, Biodiversity Institute of Ontario (BIO), University of Guelph, Guelph, Ontario, N1G 2W1, Canada.
Dhivya
D
Shanmughanandhan
Department of Integrative Biology, Office 208, Centre for Biodiversity Genomics, Biodiversity Institute of Ontario (BIO), University of Guelph, Guelph, Ontario, N1G 2W1, Canada.
Subramanyam
S
Ragupathy
Department of Integrative Biology, Office 208, Centre for Biodiversity Genomics, Biodiversity Institute of Ontario (BIO), University of Guelph, Guelph, Ontario, N1G 2W1, Canada. snewmast@uoguelph.ca.
Steven G
SG
Newmaster
Plant Genetic Engineering Laboratory, Department of Biotechnology, Bharathiar University, Marudhamalai Road, Coimbatore, Tamil Nadu, 641 046, India.
Saravanan
S
Mohanasundaram
Plant Genetic Engineering Laboratory, Department of Biotechnology, Bharathiar University, Marudhamalai Road, Coimbatore, Tamil Nadu, 641 046, India. rsathish@buc.edu.in.
Ramalingam
R
Sathishkumar
D058893:DNA Barcoding, Taxonomic; D004340:Drug Contamination; D006801:Humans; D007194:India; D008517:Phytotherapy / Q000592:standards*; D010946:Plants, Medicinal / Q000235:genetics*; D011786:Quality Control; D012016:Reference Values
Phytochem Anal. 2013 Jan-Feb;24(1):1-24
22678654
Front Pharmacol. 2014 Jan 10;4:177
24454289
J Altern Complement Med. 2013 Dec;19(12):957-63
23829812
PLoS One. 2010 Jan 07;5(1):e8613
20062805
Mol Ecol. 2012 Apr;21(8):1794-805
22486820
Proc Biol Sci. 2003 Feb 7;270(1512):313-21
12614582
Toxins (Basel). 2011 Apr;3(4):398-408
22069715
PLoS One. 2010 Oct 01;5(10):null
20957043
JAMA. 2003 Sep 17;290(11):1505-9
13129992
Rev Environ Contam Toxicol. 1997;152:1-55
9297984
Chin Med. 2007 Sep 05;2:9
17803808
JAMA. 2004 Dec 15;292(23):2868-73
15598918
Genomics Proteomics Bioinformatics. 2012 Dec;10(6):364-7
23317705
Mol Biol Evol. 2013 Dec;30(12):2725-9
24132122
Sci Rep. 2011;1:42
22355561
Drug Saf. 2015 Jul;38(7):611-20
26076652
Chemosphere. 2003 Sep;52(9):1361-71
12867165
Annu Rev Food Sci Technol. 2011;2:467-83
22129392
Planta Med. 2010 Mar;76(5):495-7
19844865
PLoS One. 2008 Jul 30;3(7):e2802
18665273
PLoS One. 2011;6(5):e19254
21637336
Indian J Pharm Sci. 2010 Sep;72(5):546-56
21694984
Food Chem Toxicol. 2013 Dec;62:609-21
24075916
J AOAC Int. 2012 Jul-Aug;95(4):1023-34
22970567
Mol Ecol Resour. 2009 May;9 Suppl s1:130-9
21564972
BMC Med. 2013 Oct 11;11:222
24120035
J Ethnopharmacol. 2010 Jul 20;130(2):208-15
20435119
Trends Pharmacol Sci. 2002 Mar;23(3):136-9
11879681
Eur J Clin Pharmacol. 2013 Mar;69(3):295-307
22843016
PLoS One. 2012;7(6):e39459
22761800
Genet Mol Res. 2014 Apr 16;13(2):2959-68
24782130
Int J Legal Med. 2015 Jul;129(4):693-700
25425095
Proc Natl Acad Sci U S A. 2011 Dec 6;108(49):19641-6
22100737
Anc Sci Life. 2013 Oct;33(2):139-40
25284949
Philos Trans R Soc Lond B Biol Sci. 2005 Oct 29;360(1462):1889-95
16214746
J Ayurveda Integr Med. 2010 Jan;1(1):33-9
21829299
Planta Med. 2008 May;74(6):603-23
18449847
Pharmacogn Rev. 2014 Jul;8(16):73-80
25125878