A Review of Herbal Regulations and Approval Process in India and Europe
Abstract
The main suppliers of herbal plants and medications are India and Europe. People prefer using plants and herbs as remedies over synthetic ones since they have fewer adverse effects. In India, AYUSH, CDSCO (Central Drugs Standard Control Organization), AND D&C Act 1940 & 1945(amendment) all control herbal medications. In India, AYUSH systems have been developed to house almost 8000 herbal medications. While in Europe, the European Medicines Agency (EMA) and the Herbal Medicinal Products Committee (HMPC) are in charge of overseeing herbal medications. The regulation of herbal goods in India and Europe is the subject of this essay.
Keywords:
Herbal Regulations, Herbal medicine, Herbal food supplements, Drugs and Cosmetics Acts and Rules, AYUSH, CDSCO, WHO
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References
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http://www.gov.cn/xinwen/2019-05/02/content_5388253.htm. (In Chinese).
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https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20200928164311143.html.
26. Kumar V. Herbal medicines- overview on regulation in India and South Africa [Internet]. India: WJPR; 2017 Jul 24 [cited 2023 Sep. 21]. Available from:
https://tinyurl.com/4bbmn5cz.
27. Sharma s. Current Status of Herbal products [Internet]. JPBS; 2015 Oct-Dec 07 [cited 2023 Sep. 21]. Available from:
https://tinyurl.com/4jcsaydn.
28. CDSCO, Traditional drugs [Internet]. India: CDSCO; 2020 [cited 2023 Oct. 2]. Available from:
https://cdsco.gov.in/opencms/opencms/en/Home/.
29. Omprakash G, Madhuri C, Vijayendra S, Sachin B, Giram P, Mahesh JB. Phytopharmaceuticals: an emerging platform for innovation and development of new drugs from botanicals. J Drug Deliv Ther. 2019;9(3-s):1046-57.
30. General Guidelines for drug development of Ayurvedic formulations [Internet]. India: Ministry of AYUSH; 2023. Available from:
https://www.ayush.gov.in/docs/guideline-drugdevelopment.pdf.
31. Ministry of Ayush [Internet]. India: AYUSH; 2023 Oct 04. Available from:
https://www.ayush.gov.in/.
32. CDSCO, list of documents required for application for WHO-GMP/ CoPP FOR A.S.U. herbal drugs, May31 2018.
33. Ministry of Ayush [Internet]. India: AYUSH; 2021 Apr 14 [cited 2023 June 18]. Available from:
https://www.ayush.gov.in/.
34. Voluntary certification scheme for Ayush products [Internet]. India: Indian Register Quality Systems (IRQS); 2021 [cited 2023 Sep. 02]. Available from:
https://www.irqs.co.in/voluntary-certification-scheme-forayush-products/.
35. Ramadoss MSK, Koumaravelou K. Regulatory compliance of herbal medicines [Internet]. IJPRS; 2018 [cited 2023 Sep. 03]. Available from:
https://pharmascope.org/ijrps/article/view/1609/2192.
36. Good clinical practice guidelines [Internet]. India: Department of AYUSH; 2013 [cited 2023 Sep.03]. Available from:
https://main.ayush.gov.in/sites/default/files/5110899178-Final%20Book%2028-03-13_0.pdf.
37. Powerful Ayurvedic Herbs and Spices with Health Benefits, healthline [Internet]; 2021. healthline [cited 2023 Sep. 01]. Available from:
https://www.healthline.com/health/ayurvedic-herbs.
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https://www.dnaindia.com/ahmedabad/column-ayurveda-treatment-a-first-choice-need-for-more-science-2694121.
39. Herbal medicine [Internet]; 2020. Wikipedia. Wikipedia [cited 2023 Sep. 02]. Available from:
https://en.wikipedia.org/wiki/Herbal_medicine.
40. Jain SA, Agrawal R, Ahirwar RK D. Clinical trials of Herbal Products in India [Internet]. India: RJPT; 2008 [2023 Sep. 04]. Available from:
https://tinyurl.com/6rp7m2ca.
41. Chegu S, Nagabhushanam MV. A comprehensive study on regulation of herbal drugs in India, US and European union. Int J Drug Reg Affairs. 2021 Mar 19;9(1):78-86. doi: 10.22270/ijdra.v9i1.458.
42. 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 Aff. 2017 Dec 7;5(4):8-17.
43. Regulatory overview of traditional medicines. Regulatory guidance. Health Sciences Authority -Health Products Regulation Group. Science Authority. Sep 10. p. 2020; 2018 [Internet]. Singapore. Health [cited 2023 Sep. 02]. Available from:
https://www.hsa.gov.sg/traditional-medicines/regulatory-overview-of-traditional-medicines.
44. Financial express. Global Medicinal Plants Demand May Touch $5 Trillion By 2050[Internet].2004 Mar 29 [cited 2023 Sep. 04]. Available from:
https://www.financialexpress.com/archive/global-medicinal-plants-demand-may-touch-5-trillion-by-2050/102863/.
45. Yevale R, Khan N, Kalamkar P. Overview on “Regulations of herbal medicine” Innovation development and standardization of Novel Herbal Formulation. September.2018;6:24-25.
46. Giri RP, Dr. Gangawane AK, Dr. Giri SG. International Research Journal of Engineering and Technology (IRJET). Regul Herb Prod Used Med Around World Rev. 2018 Oct;05(10):2395-0056.
47. Alostad AH, Steinke DT, Schafheutle EI. 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. doi: 10.1007/s40290-018-0223-0, PMID 29456449.
48. World Health Organization. Legal status of traditional medicines and complimentary/alternative medicine: worldwide review. Switzerland: World Health Organization; 2001. p. 10-4.
49. Alonso-Castro AJ, Domínguez F, Maldonado-Miranda JJ, Castillo-Pérez LJ, Carranza-Álvarez C, Solano E et al. Use of medicinal plants by health professionals in Mexico. J Ethnopharmacol. 2017;198:81-6.
doi: 10.1016/j.jep.2016.12.038, PMID 28025163.
50. Kumar S, Mittal A, Babu D, Mittal A. Herbal medicines for diabetes management and its secondary complications. Curr Diabetes Rev. 2021;17(4):437-56.
doi: 10.2174/1573399816666201103143225, PMID 33143632.
51. Complementary and alternative medicine products and their regulation by the Food and Drug Administration [2023 Sep. 5]. Available from:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/complemenytary-and-alternativemedicine-products-and-their-regulation-food-and-drug-administration.
52. World Health Organization. Index of world pharmacopoeias and pharmacopoeial authorities [Internet]. WHO; 2021 [cited 2023 Sep. 11]. Available from:
https://www.who.int/publications/m/item/QAS-11.453-Rev.12.
2. Chattopadhyay N, Maurya R. Herbal medicines [Internet]. ScienceDirect; 2015 [cited 2023 May. 20]. Available from: https://www.sciencedirect.com/topics/agricultural-andbiological-sciences/herbal-medicines.
3. Sharma S. Current status of herbal product: regulatory overview. J Pharm Bioallied Sci. 2015; 7(4):293-6.
doi: 10.4103/0975-7406.168030, PMID 26681886.
4. Anupama S, Vikas AS, Vandana K, Anil B. Current status of regulations for herbal medicine in Europe, USA and India. J Nat Conscientia. 2011;2(3):406-22.
5. Nitin V. Herbal medicines: regulation and practice in Europe, United States and India. Int J Herb Med. 2013;1(4):1-5.
6. Ganesh G, Ramachandran A, Suresh KR, Senthil V, Baviya PR. Nutraceuticals – A regulatory review. Int J Drug Regul Aff. 2015;3(2):22-9.
7. Singh A, Kalaivani M, Chaudhary P, Srivastava S, Kumar Goyal R, Gupta SK. Opportunities and challenges in development of phytopharmaceutical drug in India- A SWOT analysis. J Young Pharm. 2019;11(3):322-7.
doi: 10.5530/jyp.2019.11.66.
8. European medicines agency [Internet]. EMEA; 2021 [cited 2023 Feb. 01]. Available from:
https://www.ema.europa.eu/en/human-regulatory/herbal-products/herbal-medicines-regulatory-scientific-support.
9. Australian Government Department of Health. North Sydney [Internet]. Therapeutic Goods Administration; 2014. [cited on 2023 Apr 29]. Available from:
http://tga.gov.au/.
10. 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.
11. Health Canada. Ottawa: natural health products [Internet]. drugs and health products; 2013. [cited on 2023 Apr 29]. Available from:
http://www.hc sc.gc.ca/dhp mps/prodnatur/index eng.php
12. Official Journal of the European Union: Directive. 31st March, 2004. [Internet]. European community; 2004/24:136:0085:0090. [cited on 2023 Apr 29]. Available from: http://www.eur lex.europa.eu/LexUriServ/LexUriServ.
13. United States Government, United States Census Bureau. [Internet]. census.gov [cited 2023 Jun 22]. Available from: https://www.census.gov/quickfacts/fact/table/US/PST045221.
14. Bailey RL. Current regulatory guidelines and resources to support research of dietary supplements in the United States. Crit Rev Food Sci Nutr. 2020;60(2):298-309.
doi: 10.1080/10408398.2018.1524364, PMID 30421981.
15. Wu KM, Dou J, Ghantous H, Chen S, Bigger A, Birnkrant D. Current regulatory perspectives on genotoxicity testing for botanical drug product development in the USA.bRegul Toxicol Pharmacol. 2010;56(1):1-3.
doi: 10.1016/j.yrtph.2009.09.012, PMID 19782117
16. 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 Aff. 2017 Dec 7 [cited 2023 Sep. 02];5(4):8-17.
17. Verma N. IJHM: Herbal Medicines: Regulation and Practice in Europe, United States and India.2021;1(4):8-9.
18. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the community code relating to medicinal products for human use [Internet]. edctp; 2001 Nov [cited 2023 Mar 20]. Available from:
http://www.edctp.org/fileadmin/documents/ethics/DIRECTIVE_200183EC_OF_THE_EUROPEAN_PARLIAMENT. Google Scholar.
19. Directive 2004/24/EC of the European Parliament and of the Council [Internet]. Eurlex; 2004 [cited 2023 Sep. 20]. Available from:
http://Eurlex.europa.eu/LexUriServ/LexUriServ.do?Uri=OJ:L:2004:136:0085:0090.
20. Rojas P, Jung-Cook H, Ruiz-Sánchez E, Rojas-Tomé IS, Rojas C, López-Ramírez AM et al. Historical aspects of herbal use and comparison of current regulations of herbal products between Mexico, Canada and the United States of America. Int J Environ Res Public Health. 2022;19(23):15690.
doi: 10.3390/ijerph192315690, PMID 36497761.
21. Government of Canada. Crown-indigenous relations and northern affairs Canada. A history of treaty-making in Canada [Internet]. [cited 2023 Sep. 10]. Available from:
https://www.rcaanc-cirnac.gc.ca/eng/1314977704533/1544620451420.
22. Azhar HA lostad. Douglas TSteinke,EllenI. Schafheutle. Pharm Med. 2018;32:39-49.
23. Liang Z, Lai Y, Li M, Shi J, Lei CI, Hu H et al. Applying regulatory science in traditional Chinese medicines for improving public safety and facilitating innovation in China: A scoping review and regulatory implications. Chin Med. 2021;16(1):23.
doi: 10.1186/s13020-021-00433-2, PMID 33593397.
24. The Center People’s Government of the PRC. NMPA has initiated the action plan on regulatory science in China [Internet]. 2022 [cited 2023 Oct 10]. Available from:
http://www.gov.cn/xinwen/2019-05/02/content_5388253.htm. (In Chinese).
25. National medical products administration of China. Requirements for registration, categories and application documents of traditional Chinese medicine; national medical products administration of China: Beijing [Internet]. China; 2020 [cited 2023 Oct. 12]. Available from:
https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20200928164311143.html.
26. Kumar V. Herbal medicines- overview on regulation in India and South Africa [Internet]. India: WJPR; 2017 Jul 24 [cited 2023 Sep. 21]. Available from:
https://tinyurl.com/4bbmn5cz.
27. Sharma s. Current Status of Herbal products [Internet]. JPBS; 2015 Oct-Dec 07 [cited 2023 Sep. 21]. Available from:
https://tinyurl.com/4jcsaydn.
28. CDSCO, Traditional drugs [Internet]. India: CDSCO; 2020 [cited 2023 Oct. 2]. Available from:
https://cdsco.gov.in/opencms/opencms/en/Home/.
29. Omprakash G, Madhuri C, Vijayendra S, Sachin B, Giram P, Mahesh JB. Phytopharmaceuticals: an emerging platform for innovation and development of new drugs from botanicals. J Drug Deliv Ther. 2019;9(3-s):1046-57.
30. General Guidelines for drug development of Ayurvedic formulations [Internet]. India: Ministry of AYUSH; 2023. Available from:
https://www.ayush.gov.in/docs/guideline-drugdevelopment.pdf.
31. Ministry of Ayush [Internet]. India: AYUSH; 2023 Oct 04. Available from:
https://www.ayush.gov.in/.
32. CDSCO, list of documents required for application for WHO-GMP/ CoPP FOR A.S.U. herbal drugs, May31 2018.
33. Ministry of Ayush [Internet]. India: AYUSH; 2021 Apr 14 [cited 2023 June 18]. Available from:
https://www.ayush.gov.in/.
34. Voluntary certification scheme for Ayush products [Internet]. India: Indian Register Quality Systems (IRQS); 2021 [cited 2023 Sep. 02]. Available from:
https://www.irqs.co.in/voluntary-certification-scheme-forayush-products/.
35. Ramadoss MSK, Koumaravelou K. Regulatory compliance of herbal medicines [Internet]. IJPRS; 2018 [cited 2023 Sep. 03]. Available from:
https://pharmascope.org/ijrps/article/view/1609/2192.
36. Good clinical practice guidelines [Internet]. India: Department of AYUSH; 2013 [cited 2023 Sep.03]. Available from:
https://main.ayush.gov.in/sites/default/files/5110899178-Final%20Book%2028-03-13_0.pdf.
37. Powerful Ayurvedic Herbs and Spices with Health Benefits, healthline [Internet]; 2021. healthline [cited 2023 Sep. 01]. Available from:
https://www.healthline.com/health/ayurvedic-herbs.
38. Ayurveda treatment a first choice: need for more science [Internet]; 2020. DNA India [cited 2023 Sep. 02]. Available from:
https://www.dnaindia.com/ahmedabad/column-ayurveda-treatment-a-first-choice-need-for-more-science-2694121.
39. Herbal medicine [Internet]; 2020. Wikipedia. Wikipedia [cited 2023 Sep. 02]. Available from:
https://en.wikipedia.org/wiki/Herbal_medicine.
40. Jain SA, Agrawal R, Ahirwar RK D. Clinical trials of Herbal Products in India [Internet]. India: RJPT; 2008 [2023 Sep. 04]. Available from:
https://tinyurl.com/6rp7m2ca.
41. Chegu S, Nagabhushanam MV. A comprehensive study on regulation of herbal drugs in India, US and European union. Int J Drug Reg Affairs. 2021 Mar 19;9(1):78-86. doi: 10.22270/ijdra.v9i1.458.
42. 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 Aff. 2017 Dec 7;5(4):8-17.
43. Regulatory overview of traditional medicines. Regulatory guidance. Health Sciences Authority -Health Products Regulation Group. Science Authority. Sep 10. p. 2020; 2018 [Internet]. Singapore. Health [cited 2023 Sep. 02]. Available from:
https://www.hsa.gov.sg/traditional-medicines/regulatory-overview-of-traditional-medicines.
44. Financial express. Global Medicinal Plants Demand May Touch $5 Trillion By 2050[Internet].2004 Mar 29 [cited 2023 Sep. 04]. Available from:
https://www.financialexpress.com/archive/global-medicinal-plants-demand-may-touch-5-trillion-by-2050/102863/.
45. Yevale R, Khan N, Kalamkar P. Overview on “Regulations of herbal medicine” Innovation development and standardization of Novel Herbal Formulation. September.2018;6:24-25.
46. Giri RP, Dr. Gangawane AK, Dr. Giri SG. International Research Journal of Engineering and Technology (IRJET). Regul Herb Prod Used Med Around World Rev. 2018 Oct;05(10):2395-0056.
47. Alostad AH, Steinke DT, Schafheutle EI. 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. doi: 10.1007/s40290-018-0223-0, PMID 29456449.
48. World Health Organization. Legal status of traditional medicines and complimentary/alternative medicine: worldwide review. Switzerland: World Health Organization; 2001. p. 10-4.
49. Alonso-Castro AJ, Domínguez F, Maldonado-Miranda JJ, Castillo-Pérez LJ, Carranza-Álvarez C, Solano E et al. Use of medicinal plants by health professionals in Mexico. J Ethnopharmacol. 2017;198:81-6.
doi: 10.1016/j.jep.2016.12.038, PMID 28025163.
50. Kumar S, Mittal A, Babu D, Mittal A. Herbal medicines for diabetes management and its secondary complications. Curr Diabetes Rev. 2021;17(4):437-56.
doi: 10.2174/1573399816666201103143225, PMID 33143632.
51. Complementary and alternative medicine products and their regulation by the Food and Drug Administration [2023 Sep. 5]. Available from:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/complemenytary-and-alternativemedicine-products-and-their-regulation-food-and-drug-administration.
52. World Health Organization. Index of world pharmacopoeias and pharmacopoeial authorities [Internet]. WHO; 2021 [cited 2023 Sep. 11]. Available from:
https://www.who.int/publications/m/item/QAS-11.453-Rev.12.
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Sahane, M. B., and G. D. Basarkar. “A Review of Herbal Regulations and Approval Process in India and Europe”. International Journal of Drug Regulatory Affairs, Vol. 11, no. 4, Dec. 2023, pp. 25-33, doi:10.22270/ijdra.v11i4.629.
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