Swagat Tripathy, PN Murthy, BP Patra, Vikram, Sumit Sanduria, Harish Dureja
Swagat Tripathy1*, PN Murthy2, BP Patra3, Vikram4, Sumit Sanduria4 , Harish Dureja4*
1Dr. Reddy’s. Laboratories, Hyderabad, Telangana, India – 500034.
2Royal College of Pharmacy and Health Sciences, Berhampur, India – 760002.
3XIMB, Xavier Square, Jayadev Vihar, Bhubaneswar, Odisha, India – 751013.
4Department of Pharmaceutical Sciences, Maharshi Dayanand University, Rohtak, India – 124001.
Volume - 15,
Issue - 5,
Year - 2022
Herbal Medicine Products (HMPs) are ever-present and demand still keeps on the rise, despite of fact that modern medicines are well developed. So, regulative intervention and attempts by various regulatory bodies across the globe to ensure the safety, quality, and efficacy of HMPs have been a real-time challenge. While Allopathic medicines principally depict chemical substances, and those interactions had been well-known, validated also, proper regulatory standard then relevant measures are put into action. HMPs, instead by and large consisting numerous ingredients holding multifaceted combinations along with plant constituents then frequently likewise comprise of roughly anonymous complexes, therefore, building affecting regulatory framework toward measure affecting worth about those drugs is more tricky. So, through this manuscript efforts have been made to summarize definitions, basis of formulating policies and measures pertaining on registration and regulation of herbal medicinal products (HMPs) for both regulated and emerging markets i.e., United States, India, China, Japan, and Europe.
Cite this article:
Swagat Tripathy, PN Murthy, BP Patra, Vikram, Sumit Sanduria, Harish Dureja. Strategic archetype of Herbal Medicine Product (HMP) in Regulated and Emerging Market. Research Journal of Pharmacy and Technology. 2022; 15(5):1973-0. doi: 10.52711/0974-360X.2022.00328
Swagat Tripathy, PN Murthy, BP Patra, Vikram, Sumit Sanduria, Harish Dureja. Strategic archetype of Herbal Medicine Product (HMP) in Regulated and Emerging Market. Research Journal of Pharmacy and Technology. 2022; 15(5):1973-0. doi: 10.52711/0974-360X.2022.00328 Available on: https://rjptonline.org/AbstractView.aspx?PID=2022-15-5-10
1. Vinod Matole, Yogesh Thorat, Shrishail Ghurghure, Suyash Ingle, Avinash Birajdar, Gajanand Nangare, Moulavi Safwan, Saili Madur, Smeeta Patil, Zainab Bagalkote, Aishwarya Sakhare. A Brief Review on Herbal Medicines. Research Journal of Pharmacognosy and Phytochemistry. 2021; 13(2):101-2. doi:10.52711/0975-4385.2021.00016
2. Sanat Sharma, Raj Sharma, Harminder Singh , Bithika Nelkumar. History of Medicine – Herbal Medicine Scenario: A Review. Research J. Pharmacology and Pharmacodynamics. 2011; 3(2): 45-47.
3. Verma N. Herbal medicines: regulation and practice in Europe, United States and India. International Journal of Herbal Medicine. 2013; 1(4):1-5.
4. Anita S. Wanjari, Dinesh S. Wanjari. An Overview on Herbal Medicine. Res. J. Pharmacognosy and Phytochem. 2019; 11(1): 14- 17. doi: 10.5958/0975-4385.2019.00003.7
5. P. Jaya Preethi. Herbal Medicine for Diabetes Mellitus: A Review. Asian J. Pharm. 2013; 3(2): 57-70.
6. Mohd. Yaqub Khan, Irfan Aziz, Bipin Bihari, Hemant Kumar, Maryada Roy, Vikas Kumar Verma. A Review- Phytomedicines Used in Treatment of Diabetes. Asian J. Pharm. 2014; 4(3): 135-154.
7. Samir Derouiche. Current Review on Herbal Pharmaceutical improve immune responses against COVID-19 infection. Res. J. Pharma. Dosage Forms and Tech.2020; 12(3):181-184. doi:10.5958/0975-4377.2020.00031.2
8. Darekar A. B. , Zope Janhavi S. , Saudagar R. B.. Current Scenario of Global and Indian Pharmaceutical Marketing and Management. Asian J. Res. Pharm. Sci. 2016; 6(2): 95-100. doi:10.5958/2231-5659.2016.00013.8
9. Parveen A, Parveen B, Parveen R, Ahmad S. Challenges and guidelines for clinical trial of herbal drugs. Journal of pharmacy and bioallied sciences. 2015; 7(4): 329.doi: 10.4103/0975-7406.168035
10. Liu FX, Salmon JW. Herbal medicine regulation in China, Germany, and the United States. Integrative Medicine. 2010; 9(5):54-61.
11. Patel KS, Chaitanya MVLN, Reddy YP, Ahmed MG, Peraman R, Bharath GS. Current regulatory perspective of herbal drugs. Indo American Journal of Pharmaceutical Sciences. 2019;06(05): 9547-9551.doi:10.5281/zenodo.2783990
12. Budhwar V, Yadav S, Choudhary M, Nitesh. A comprehension study on regulation of herbal drugs in USA, European Union and India. International Journal of Drug Regulatory Affairs. 2017; 5(4): 8-17.doi:10.22270/ijdra. v5i4.205
13. Herbal medicines: overview on regulations in India and Europe. Available on: https://www.researchgate.net/publication/318661060_herbal_medicines_overview_on_regulations_in_india_and_europe.
14. Keshri S. (2021). Market Analysis on Traditional Medicine-2020 [Ebook] (7th ed., p.2). Tokyo, Japan. Available on: https://herbal-medicine.imedpub.com/conference-announcement-on-7th-asian-herbal-and-traditional-medicine-summit.pdf
15. Global HPMC Market Report and Forecast 2021-2026. Available on: https://www.expertmarketresearch.com/reports/hpmc-market.
16. Swati Rawat, Akhilesh Gupta. Regulatory Requirements for Drug Development and Approval in United States: A Review. Asian J. Pharm. 2011; 1(1) : 01-06.
17. Cornell Law School. 21 U.S. Code § 321 - Definitions; generally, | U.S. Code | US Law | LII / Legal. Information Institute. Published 2019. Available on: https://www.law.cornell.edu/uscode/text/21/321.
18. U.S. Food and Drug Administration. Botanical Drug Development - Guidance for industry. US Department of Health and Human Services. Available on: https://www.fda.gov/downloads/Drugs/Guidances/UCM458484.pdf.
19. Food and Drug Administration (FDA). CFR Code of Federal Regulations Title 21. Available on: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=170.3&SearchTerm=170.3.
20. 21 CFR § 330.10 - Procedures for classifying OTC drugs as generally recognized as safe and effective and not misbranded, and for establishing monographs. | CFR | US Law | LII / Legal Information Institute. Available on: https://www.law.cornell.edu/cfr/text/21/330.10.
21. Hmpc. European Medicines Agency. Committee on Herbal Medicinal Products (HMPC). 14/04. Published online 2008:2008-2010. Available on: https://www.ema.europa.eu/en/committees/committee-herbal-medicinal-products-hmpc.
22. EMA. European Medicines Agency. Herbal products - European Union monographs and list entries. Published online 2016:3-6. Available on: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001132.jspandmid=WC0b01ac0580033809.
23. Williamson G, Coppens P, Serra-Majem L, Dew T. Review of the efficacy of green tea, isoflavones and aloe vera supplements based on randomised controlled trials. Food and function. 2011; 2(12):753-9. doi: 10.1039/c1fo10101c
24. Vishal P, Patel NM, Patel PM. Review on quality safety and legislation for herbal products. International Journal of Research in Ayurveda and Pharmacy (IJRAP). 2011; 2(5):1486-9.
25. Anquez TC. The Legal and Regulatory framework of herbal medicinal products in the European Union: A focus on the traditional herbal medicine’s category. Drug Information Journal. 2011; 45(1): 15-23.doi:10.1177/009286151104500102
26. Somekawa L, Maegawa H, Tsukada S, Nakamura T. Establishment of application guidance for OTC non-Kampo crude drug extract products in Japan. Journal of intercultural ethno pharmacology. 2017; 6(3): 333.doi:10.5455/jice.20170713091550
27. Maegawa H, Nakamura T, Saito K. Regulation of traditional herbal medicinal products in Japan. Journal of ethno pharmacology. 2014; 158: 511-515.doi: 10.1016/j.jep.2014.07.012
28. Yuan H, Ma Q, Ye L, Piao G. The traditional medicine and modern medicine from natural products. Molecules. 2016; 21(5): 559-565.doi:10.3390/molecules21050559
29. Saharan VA. Current status of regulations for herbal medicines in Europe, United States and India. J Nat Conscientia. 2011; 2(3):406.
30. Sen S, Chakraborty R. Revival, modernization and integration of Indian traditional herbal medicine in clinical practice: Importance, challenges and future. Journal of traditional and complementary medicine. 2017; 7(2): 234-244.doi: 10.1016/j.jtcme.2016.05.006
31. Nooreen Z, Rai VK, Yadav NP. Phyto pharmaceuticals: A new class of drug in India. Ann. Phytomed. 2018; 7(1):27-37.
32. Chegu S, MV Nagabhushanam. A Comprehensive Study on Regulation of Herbal Drugs in India, US and European Union. International Journal of Drug Regulatory Affairs. 2021; 9(1): 78-86.doi:10.22270/ijdra. v9i1.458.
33. Kumar V. Herbal Medicines: Overview on regulations in India and South Africa. World Journal of Pharmaceutical Research. 2017. 13; 6(8): 690-8.doi:10.20959/wjpr20178-9091
34. Geng, S., LIU, X. and Beachy, R., 2015. New Food Safety Law of China and the Special issue on food safety in China. Journal of Integrative Agriculture, 14(11), pp.2136-2141.doi: 10.1016/S2095- 3119(15)61164-9
35. Robinson N. Integrative medicine—traditional Chinese medicine, a model. Chinese Journal of Integrative Medicine. 2011;17(1): 21-5.doi:10.1007/s11655-011-0602-9
36. NIH. National Medical Products Administration. Clinreghs. 2018; 7:1-20. Available on: http://english.nmpa.gov.cn/
37. Thakkar S, Anklam E, Xu A, Ulberth F, Li J, Li B, Hugas M, Sarma N, Crerar S, Swift S, Hakamatsuka T. Regulatory landscape of dietary supplements and herbal medicines from a global perspective. Regulatory Toxicology and Pharmacology. 2020; 114: 104647.doi: 10.1016/j.yrtph.2020.104647
38. Drug Registration and Market Approval Process in China | Credevo Articles. Available on: https://credevo.com/articles/2021/02/25/china-drug-registration-process/
39. Kamalraj Raji, Vijey Aanandhi M. Regulatory Filing In Us and Eu: A Comparative View. Research J. Pharm. and Tech. 2017; 10(1): 286-292. doi;10.5958/0974-360X.2017.00059.2
40. Swati Rawat, Akhilesh Gupta. Regulatory Requirements for Drug Development and Approval in United States: A Review. Asian J. Pharm. 2011; 1(1): 01-06.