Volume : 12, Issue : 10, October – 2025
Title:
STANDARDIZATION CHALLENGES AND STRATEGIES IN HERBAL FORMULATION
Authors :
Sakshi A. Deshkari*, Ankita S. Sarnaik, Dr. Swati P. Deshmukh
Abstract :
Herbs have been a surviving unit since we were born on this planet. Currently, they are the most probed topic in the food industry or pharmacotherapy due to their multidimensional approach where one herb targets various diseases and proffers a wide range of health benefits. Moreover, some herbal supplements are merchandised globally, and people are devouring these products blithely to extract additional benefits. But taking any herbal formulation under unsupervised conditions may be subject to herbal toxicity. Hence, providing safe herbal supplements is a daunting challenge for various reasons: availability of unstandardized, contaminated, adulterated, loosely available, and unlabelled products, scanty regulations, herb-herb, and herb-drug interaction, and many others. The present article is enriched with past and most recent literature on processing crude herbs, the necessity of standardization of herbal products, the health benefits of standardized herbal medicines, and the toxicity of herbal formulations. The literature has also discussed a case study linked to herbal products, the importance of the pharmacovigilance system, and the challenges associated with the safety monitoring of herbal medicines, as reliable data on these aspects is still lacking. Thus, more investigation is needed for in-depth clarity. This review may provide an instructive insight that no therapeutic agents are free of toxic effects and may be associated with risk and beneficial effects. The article might be helpful for herbal users or other health practitioners and may serve as a stepping stone to promote further research.
Cite This Article:
Please cite this article in press Sakshi Arvind Deshkari et al., Standardization Challenges And Strategies In Herbal Formulation, Indo Am. J. P. Sci, 2025; 12(10).
REFERENCES:
1. Chikezie PC, Ojiako OA (2015) Herbal Medicine: Yesterday, Today and Tomorrow.Altern Integr Med 4: 195. doi: 10.4172/2327-5162.1000195
2. Guidelines for the appropriate use of herbal medicine, Essential Medicines and Health Products Information Portal a World Health Organization resource.
3. Evidence-Based Complementary and Alternative Medicine Volume 2, Issue 4, Pages 465-473 http://dx.doi.org/10.1093/ecam/neh140.
4. Rasheed A, Reddy BS, Roja C. A Review on standardization of herbal formulation. Int J Phytother.2012;2:74-88
5. Houghton PJ. Establishing identification criteria for botanicals. Ther Innov Regul Sci. 1998;32:461-469
6. Patil PS, Rajani S. An advancement of analytical techniques in herbal research. J Adv Sci Res.2010;1:8-14
7. Calixto JB. Efficacy, safety, quality control, marketing and regulatory guidelines for herbal medicines (phytotherapeutic agents). Braz J Med Biol Res. 2002;33:179-189
8. World Health Organization & WHO Expert Committee on Specifications for Pharmaceutical Preparations. Fifty-second report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations. 2018.
9. World Health Organization. WHO guidelines on good agricultural and collection practices (GACP) for medicinal plants. World Health Organization 2003.
10. Liu S, Li F, Li Y, Li W, Xu J and Du H: A review of traditional and current methods used to potentially reduce toxicity of Aconitum roots in Traditional Chinese Medicine. Journal of Ethnopharmacology 2017; 207: 237-250.
11. World Health Organization, & WHO Expert Committee on Specifications for Pharmaceutical Preparations. Fifty-first report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations. 2017. WHO Technical Report Series, No. 1003, Annexure 1
12. Ved DK, Goraya GS. Demand and supply of medicinal plants in India. NMPB, New Delhi & FRLHT, Bangalore, India. 2007; 18(85):210-52 .World Health Organization. WHO good practices for pharmaceutical quality control laboratories. WHO technical report series. 2010; 957.
13. Solecki RS. Standardized product as well as the quality of the consumer information on the herbal remedy. Hanidar IV. Science1975; 190: 880-888.
14. Kokate C.K., Purohit A.P. & Gokhale S.B. Analytical Pharmacognosy. 30th edition. Pune: Nirali Publication; 2005.
15. Patwardhan B. Ayurveda the designer medicine: a review of ethnopharmacology and bioprospective research. Indian Drugs 2000;37: 2046-56.
16. Dr Rajesh Kumari et al. A review on the Standardization of herbal medicines. International Journal of Pharma Sciences and Research 2016; 7: 97-106.
17. Mosihuzzaman M, Choudhary MI. Protocols on Safety, Efficacy, Standardization, and Documentation of Herbal Medicine, Pure Appl. Chem. 2008; 80(10):2195–2230.
18. De Smet PAGM. Overview of herbal quality control. Drug Inform J. 1999;33:717-724.
19. De Smet PAGM. Health risks of herbal remedies: An update. Clin Pharmacol Ther. 2004:76:1-17.
20. Committee on Herbal Medicinal Products. Guideline on quality of herbal medicinal products/traditional herbal medicinal products. 2018.
21. Kumari R and Kotecha M: A review on the standardization of herbal medicines. International Journal of Pharma Sciences and Research, 7(2), 97-106.). A review on the standardization of herbal medicines. International Journal of Pharma Sciences and Research. 2016; 7(2): 97-106.
22. World Health Organization, & WHO Expert Committee on Specifications for Pharmaceutical Preparations. Fiftysecond report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations. 2018.
23. Chanda S. Importance of pharmacognostic study of medicinal plants: An overview. J Pharmacog & Phytochem, 2014; 2(5): 69-73.
24. Revathy SS, Rathinamala R, Murugesan M. Authentication methods for drugs used in Ayurveda, Siddha and Unani systems of medicine: an overview. Int J Pharm Sci & Res, 2012; 3(8): 2352-2361.
25. Patil SG, Wagh AS, Pawara RC, Ambore SM. Standard tools for evaluation of herbal drugs: an overview. The Pharma Innovation-Journal, 2013; 2(9): 60-65.
26. Evans, WT. Trease and Evans Pharmacognsoy. 2009; Elsevier Limited.
27. Gautam A, Kashyap SJ, Sharma PK, Garg VP, Visht S, Kumar N. Identificaion, evaluation and standardization of herbal drugs: an overview. Der Pharmacia Lettre, 2010; 2(6): 302-315.
28. Ahmad T, Singh SB, Pandey S. Phytochemical screening and physicochemical parameters of crude drugs: a brief review. Int J Pharm Res & Review, 2013; 2(12): 53-60.
29. Ahmad, I., M.S.A. Khan and S.S. Cameotra (2014). QualityAssessment of Herbal Drugs and Medicinal Plant Products
30. . Alamgir, M.N.A. (2017). Quality Control and Standardization of Herbal Drugs1(1): 453-495. Alhidary, A.I., Z. Rehman, R.U. Khan and M. Tahir (2017). Anti-aflatoxin activities of milk thistle (Silybum marianum) in broiler, 73.
31. Amponsah, K.I., A.Y. Mensah, A. Otoo, M.L.K. Mensah andJato Jonathan (2014). Pharmacognostic standardisation of Hilleria latifolia (Lam.) H. Walt. (Phytolaccaceae), 4(12):941-946
32. DR. Singh, N., Role of Markers in Standardization of HerbalMedicines.
33. Dubey, R., K. Dubey, S. Dwivedi, Y.K. Janapati, C. Sridhar andK.N. Jayaveera (2011). Standardization of leaves of Ziziphus nummularia Linn. – An effective herb for UTI infections,1(1): 5-7.
34. Ezekwesili, O.J.O., N.F. Onyemelukwe, P. Agwaga and I. Orji(2014). The bioload and aflatoxin content of herbal medicines from selected states in Nigeria, 11(3):143-147.
35. Nida N Mulla Sanjay K Bais Ranjeet C JadhavReview on Formulation and Evaluation of Acelofenac Tablet International Journal of Advanced Research in Science Communication and Technology Volume 3 Issue 1 January 2023 ISSN (online)2581-9429 P No589.
36. Shubhangi S Pawar Sanjay K Bais Akanksha Anil Nikate Evaluation of Formulations International Journal of Advanced Research in Science Communication and Technology Volume 3 Issue 1 January 2023 ISSN (online)2581-9429 P No344.
37. Windarsih, A.; Rohman, A.; Swasono, R.T. Application of H-NMR metabolite fingerprinting and chemometrics for the authentication of Curcuma longa adulterated with Curcuma manga. J. Appl. Pharm. Sci. 2018; 8:075–081. [Google Scholar].
38. Rohman, A.; Wijayanti, T.; Windarsih, A.; Riyanto, S. The authentication of Java turmeric (Curcuma xanthorrhiza) using thin layer chromatography and 1H-NMR based-metabolite fingerprinting coupled with multivariate analysis. Molecules, 2020;25:3928.
39. Windarsih, A.; Rohman, A.; Swasono, R.T. Application of 1H-NMR based metabolite fingerprinting and chemometrics for authentication of Curcuma longa adulterated with C. heyneana. J. Appl. Res. Med. Aromat. Plants, 2019;13:100203.
40. Gu, X.; Zhu, S.; Du, H.; Bai, C.; Duan, X.; Li, Y.; Hu, K. Comprehensive multi-component analysis for authentication and differentiation of 6 Dendrobium species by 2D NMR-based metabolomic profiling. Microchem. J. 2022;176:107225.




