A Comprehensive Study on Regulation of Herbal Drugs in India, US and European Union

  • Maddi V Nagabhushanam


The current investigation surveys the guidelines of natural medications in the India US and Europe and illuminates issues identified with their clinical preliminaries. Natural medications have been utilized for quite a while in various frameworks of wellbeing like Ayurveda, Yunani, Sidha and Homeopathy for treating number of infections. It is an exceptionally hard to perform clinical investigation on Hm’s medications in light of the fact that these medications are an unpredictable mix of dynamic fixings. It is subsequently hard to distinguish the fixing which is answerable for the remedial impact among different elements of Hm’s medications. The normalization of Hm’s medications is likewise a troublesome assignment. Notwithstanding every one of these issues are existing public interest has expanded towards natural medications in last two thirty years in light of their long history of treating the illness securely. The laws and guidelines for natural medications are distinctive in various nations. The WHO has expressed that every nation ought to have a framework to control Hm’s medications in their region. In Europe, the Committee on Herbal Medicinal Products (HMPC) was established in accordance with Regulation (EC) No 726/2004 and Directive 2004/24/EC, which introduced a simplified registration procedure for traditional herbal medicinal products in EU Member States. The primary obligation of HMPC is to assess and give approval for natural medications based on their wellbeing and adequacy. In US spices are delegated dietary enhancements after the presentation of the Dietary Supplement Health and Education Act (DSHEA) in1994. In US natural medications are sorted into two kinds, first is OTC Hm’s medications and medications which required NDA endorsement. In India the Department of AYUSH has made rules for quality improvement of natural substances. The current investigation audits the guidelines of herbal medications (Hm’s) in the India US and Europe illuminates issues identified with their clinical preliminaries.

Keywords: AYUSH, Ayurveda, Herbal medications (HMs), IMCC (Central Council of Indian Medicine), The Drugs and Cosmetics Act, FDA, WHO, CDSCO, Regulation, Clinical trials, Herbal drugs


Download data is not yet available.


1. Winslow LC, Kroll DJ. Herbs as medicines Archives of Internal Medicine. 1998, 158:2192-2199. DOI:10.1001/archinte.158.20.2192.
2. M Gossell-Willams, O R Simon. M E West. The past and present use of plants for medicines. Pubmed. 2006 Sep; 55(4):217-8.
3. De-Smet, PGAM. “The role of plant derived drugs and herbal medicines in healthcare drugs.1997; 54:801-840.
4. WHO technical report series. “Guidelines for the Assessment of Herbal Medicines”.1999;863:178-184.
5. Abhishek, K; Ashutosh, M and Sinha, BN .The Pharma Review. “Herbal drugs- present status and efforts to promote and regulate cultivation”. 2006; 6:73-77.
6. Harish P. Current Science. “Herbal drugs”. 2001; 81(1):15.
7. Coleman, LM and Fowler, LL and Williams ME. Journal of the American Geriatrics Society. “Use of unproven therapies by people with Alzheimer’s disease”. 1995;43:747-750.
8. World Health Organisation. Legal status of traditional medicines and complimentary/alternative medicine: worldwide review. Switzerland: World Health Organization; 2001.p. 10–4.
9. Wah C, Hock S, Yun T. Pharm Eng. Current scientific status and regulatory control of traditional/herbal medicinal products: globalization challenges. 2012;32(6):1–11.
10. Alostad A, Steinke D, Schafheutle E. International comparison of five herbal medicine registration systems to inform regulation development: United Kingdom, Germany, United States of America, United Arab Emirates and Kingdom of Bahrain. Pharm Med. 2018;32(1):39–49.
11. Ekor M. Front Pharmacol. The growing use of herbal medicines: issues relating to adverse reactions and challenges in monitoring safety. 2014;4:177.
12. Barnes J. Adverse drug reactions and pharmacovigilance of herbal medicines. Stephens’ detection and evaluation of adverse drug reactions: principles and practice. United Kingdom:Wiley. 2011.p. 645–83.
13. Kanan S, Abu-Yousef I, Gunasekar C, Abdo N, Narasimhan S. Detection and quantification of synthetic drugs in herbal slimming formula. Eur J Sci Res. 2009;34:348-57.
14. Naja F, Alameddine M, Itani L, Shoaib H, Hariri D, Talhouk S. Evid Based Complement Alternat Med . The use of complementary and alternative medicine among Lebanese adults: results from a national survey; 2015 [about 9 pages].
15. Saad B, Azaizeh H, Said O. Evid Based Complement Alternat Med. Tradition and perspectives of Arab herbal medicine: a review. 2005;2(4):475-9.
16. Sahoo N, Manchikanti P, Dey S. Herbal drugs: standards and regulation. Fitoterapia. 2010; 81(6):462-71.
17. Saxena A. How harmless are herbal remedies on human kidneys? Saudi J Kidney Dis Transpl. 2003; 14(2):205.
18. Chugh N, Bali S, Koul A. Integr Med Res.Integration of botanicals in contemporary medicine: road blocks, checkpoints and go-ahead signals. 2018;7(2):109-210.
19. Kasilo O, Trapsida J, Régional B. Regulation of traditional medicine in the World Health Organisation African region: African health monitor. Regional office for Africa: World Health Organisation; 2010.p. 25-31.
20. 't Hoen, Ellen. Developing regional guidelines on minimum requirements for the registration of herbal medicinal products. Report of a workshop, Abu Dhabi, United Arab Emirates: World Health Organization, Regional Office for the Eastern Mediterranean; 2003June 9.
21. Rudra Prasad Giri, Dr. Ajit K Gangawane, Dr. Sucheta Ghorai Giri. International Research Journal of Engineering and Technology (IRJET). Regulation on herbal product used as medicine around the world: a review. 2018 Oct; 05(10):2395-0056.
22. Regulatory overview of traditional medicines. Regulatory guidance. Health Sciences Authority - Health Products Regulation Group.2018. [Internet]. Singapore: Health Science Authority; 2020 Sept 10 [cited 2021 Feb. 02]. Available from:
23. Geneva, Switzerland. Convention on International Trade in 2014; 2014 Apr 29.
24. Zhang X. Regulatory Situation of Herbal Medicines a World Wide Review. who/TRM/1998;98.1:1-45
25. Yevale R, Khan N and Kalamkar P.Overview on “Regulations of herbal medicine” Innovation development and standardization of Novel Herbal Formulation. September. 2018; 6:24-25.
26. Anderson DM. Dorland WAN. Dorlands illustrated medical dictionary. English: 29. Ed. Philadelphia: WB Saunders Company; 2000.
27. Chang J. Journal of Alternative and Complementary Medicine .Scientific evaluation of traditional Chinese medicine under DSHEA: a conundrum. 1999;5:181-189.
28. CSPI reports: international functional foods: public health boon or 21st century quackery, Washington, D.C., International Association of Consumer Organizations [Internet]. 1999 [cited 2021 Feb. 02]. Available from:
http://www.cspinet.org/reports/functional_foods/in dex.htmlUTH
29. Drugs and cosmetics (first and second amendment) rules 2008. Ministry of Health and Family Welfare, Govt. of India; 2008
30. Director-General, Indian Council of Medical Research, New Delhi ICMR. Ethical guidelines for biomedical research on human participants. New Delhi:Published by: Director-General Indian Council of Medical Research New Delhi 110 029; 2006 Oct.
31. Alexander J. Pharmabiz .Qci entrusts 2 agencies as certification bodies for units making ayush products; 2010.
32. Financial express. Global Medicinal Plants Demand May Touch $5 Trillion By 2050 [Internet]. 2004 Mar 29 [cited 2021 Feb. 04]. Available from:
33. Adhami HR, Mesgarpour B, Farsam H. Herbal Gram. Herbal Medicine in Iran. 2007;74:35-43.
34. Nitin Verma. IJHM: Herbal Medicines: Regulation and Practice in Europe, United States and India. 2013;1(4):1-5
35. European union[Internet] [Internet]. eur-lex; 2004 Mar 31 [cited 2021 Feb. 01]. Available from:
https://eur-lex.europa.eu/LexUriServ/LexUriServ. do?uri=OJ:L:2004:136:0085:0090:en:PDF
36. Suhas Shankar Joshi, V. Balamuralidhara. A comparative study of regulatory requirements for herbal medicines in India and Europe. Drug Invention. 2020; 14 (5):687-691.
37. Sharma A, Kumar R, Mishra A, Gupta R. Revista Brasileira de Farmacognosia. Problems associated with clinical trials of Ayurvedic medicines. 2010;20(2):1-8.
38. Walker LG, Anderson J. Testing complementary and alternative therapies within a research protocol. Eur J Cancer. 1999; 35:1614–8.
39. Parveen A, Parveen B, Parveen R, Ahmad S. Journal of Pharmacy & Bioallied Sciences Challenges and guidelines for clinical trial of herbal drugs. 2016;7(4):329-33.
40. Tilburt JC, Kaptchuk TJ. Bulletin World Health Organ Herbal Medicine Research and Global Health: An ethical analysis. 2008;86(8):594-599.
41. Committee on the Framework for Evaluating the Safety of Dietary Supplements Food and Nutrition Board Board on Life Sciences. Dietary Supplements: A Framework for Evaluating Safety. Washington, DC: National Academies Press. United States of America: The National Academies Press 500 Fifth Street, N.W. Washington, DC 20001;2005
42. Director-General, Indian Council of Medical Research, New Delhi ICMR. Ethical guidelines for biomedical research on human participants. New Delhi: Published by: Director-General Indian Council of Medical Research New Delhi 110 029; 2006 Oct.
43. Budhwar V, Yadav S, Choudhary M, Nitesh. A comprehension study on Regulation of Herbal Drugs in USA, European Union and India. Int J Drug Reg Affairs [Internet]. 2017 Dec 7 [cited 2021 Feb 02]; 5(4):8-17. Available from:
44. European medicines agency [Internet].EMEA; 2021 [cited 2021 Feb. 01]. Available from:
45. Azhar HA lostad, Douglas T Steinke, Ellen I. Schafheutle. International Comparison of Five Herbal Medicine Registration Systems to Inform Regulation Development: United Kingdom, Germany, United States of America, United Arab Emirates and Kingdom of Bahrain. Pharm Med.2018;32:39–49
46. Powerful Ayurvedic Herbs and Spices with Health Benefits, healthline [Internet]. healthline; 2021 [cited 2021 Feb. 01]. Available from:
47. Ayurveda treatment a first choice: Need for more science [Internet]. DNAIndia; 2020 [cited 2021 Feb. 02]. Available from:
48. Herbal medicine [Internet]. Wikipedia; 2020 [cited 2021 Feb. 02]. Available from:
733 Views | 273 Downloads
How to Cite
Chegu, S., and M. V. Nagabhushanam. “A Comprehensive Study on Regulation of Herbal Drugs in India, US and European Union”. International Journal of Drug Regulatory Affairs, Vol. 9, no. 1, Mar. 2021, pp. 78-86, doi:10.22270/ijdra.v9i1.458.