This review highlights the regulatory status of herbal medicines in India and in specific countries. The herbal medicines are being used in different system of medicines like the Ayurveda, siddha, homeopathy, unani and Chinese system of medicine. The regulatory authorities and WHO are making efforts to collaborate in order to for a harmonized herbal medicine regulation. The Drugs and Cosmetics Act 1940 and Rules 1945 consist of the regulatory guidance and guidelines for Ayurveda, Unani, Siddha medicine. The herbal medicines are being categorized as Complimentary medicines, Natural health products, Prescription medicines, over the counter medicines, Supplements, Traditional herbal medicines globally.
Cite this article:
Swathi. J, D. Nagasamy Venkatesh. A Review of Herbal Regulations in India and Worldwide. Research Journal of Pharmacy and Technology. 2022; 15(3):1348-2. doi: 10.52711/0974-360X.2022.00225
Swathi. J, D. Nagasamy Venkatesh. A Review of Herbal Regulations in India and Worldwide. Research Journal of Pharmacy and Technology. 2022; 15(3):1348-2. doi: 10.52711/0974-360X.2022.00225 Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2022-15-3-68
1. Paul C. Chikezie and Okey A. Ojiako. Herbal Medicine: Yesterday, Today and Tomorrow. Alternative and Integrative Medicine. 2015; 4(3): 2-5. Available from: URL:www.researchgate.net/publication/282837248.
2. Niharika Sahoo Bhattacharya. Recent developments in herbal drug standard in India. International Journal of Complementary and Alternative Medicine. 2019; 12(5): 186-188. Available from: URL: https://medcraveonline.com/.
3. Refaz Ahmad Dar, Mohd Shahnawaz, Parvaiz Hassan Qazi. General overview of medicinal plants: A review. The Journal of Phytopharmacology. 2017; 6(6): 349-351. Available from: URL: www.phytopharmjournal.com.
4. Stephen Bent. Herbal Medicine in the United States: Review of Efficacy, Safety and Regulation. J Gen Intern Med. 2008; 23(6):854–859. Available from: URL: www.ncbi.nlm.nih.gov/pmc/articles/PMC2517879.
5. Sanjay Sharma. Current status of herbal product: Regulatory Overview. J Pharm Bioall Sci 2015; 7(4):293-296. Available from: URL: http://www.jpbsonline.org.
6. Davyson de L. Moreira, et al. Traditional use and safety of herbal medicines. Rev Bras Farmacogn. 2014; 24: 248-257. Available from: URL: https://www.sciencedirect.com/science/article/pii/S0102695X1400012X.
7. Vijay Kumar. Herbal medicines: Overview on regulations in India and South Africa. World Journal of Pharmaceutical Research. 2017; 6(8): 690-698. Available from: URL: https://www.researchgate.net/publication/318815842.
8. Darshan Shankar and Bhushan Patwardhan. AYUSH for New India: Vision and strategy. Journal of Ayurveda and Integrative Medicine. 2017; 8: 137-139. Available from: URL: http://elsevier.com/locate/jaim.
9. Shrivastava Alankar, et al. Clinical trial of herbal drugs and products in India: Past and current status and critical issues. Research J. Pharm. and Tech. 2008; 1(2): 69-74.
10. World Health Organization (WHO). Quality control methods for medicinal plant materials. Geneva: WHO. 1998; 1-127. Available from: URL: https://www.who.int/.
11. World Health Organization (WHO). General guidelines for Methodologies on research and evaluation of Traditional medicines. Geneva: WHO. 2000; 1-80. Available from: URL: https://www.who.int/.
12. OECD guidelines for testing of chemicals: Acute oral toxicity-acute toxic class method. 2001. Pharmacopoeia Commission for Indian Medicine and Homoeopathy. Available from: URL: https://www.academia.edu/3780435/OECD_Guideline_for_Testing_of_Chemicals_Acute_Oral_Toxicity_Acute_Toxic_Class_Method.
13. Quality Control Manual for Ayurvedic, Siddha and Unani Medicine. India: Pharmacopoeial Laboratory for Indian Medicine. 2008. Available from: URL: https://www.researchgate.net/publication/224944102_Quality_control_manual_for_Ayurvedic siddha_and_Unani_Medicines.
14. Lavekar, Padhia EE, Pant P, et al. Laboratory Manual for the Analysis of Ayurveda and Siddha formulations. India: Central Council for Research in Ayurvedic Sciences. Ministry of AYUSH; 2010. Available from: URL: https://www.worldcat.org/title/laboratory-guide-for-the-analysis-of-ayurveda-and-siddha-formulations/oclc/660089454.
15. World Health Organization (WHO). Quality control methods for herbal materials. Geneva: WHO. 2011; 1–187. Available from: URL: https://www.who.int/.
16. GCP Guidelines for ASU Medicines. India: Ministry of AYUSH. 2013; 1–114. Available from: URL: https://www.jli.edu.in/blog/good-clinical-practice-gcp-guidelines-to-provide-new-direction-for-asu-trials/.
17. General Guidelines of Safety/Toxicity Evaluation of Ayurvedic Formulations (CCRAS, 2016). India: Central Council for Research in Ayurvedic Sciences. Ministry of AYUSH. 2018; 1–94.
18. General Guidelines For Drug Development Of Ayurvedic Formulations (CCRAS, 2016). India: Central Council for Research in Ayurvedic Sciences. Ministry of AYUSH. 2016; 1–123.
19. General Guidelines for Clinical Evaluation of Ayurvedic Interventions (CCRAS, 2016). India: Central Council for Research in Ayurvedic Sciences. Ministry of AYUSH. 201; 1–123.
20. Niharika Sahoo and Padmavati Manchikanti. Herbal Drug Regulation and Commercialization: An Indian Industry Perspective. The Journal of alternative and complementary medicine. 2013; 19(12): 957-963. Available from: URL: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3868382/.
21. Nitin Verma. Herbal Medicines: Regulation and Practice in Europe, United States and India. International Journal of Herbal Medicine 2013; 1 (4): 1-5. Available from: URL: www.florajournal.com.
22. Regulatory requirements for registration of Nutritional supplements and Herbal products in India: A case study. Journal of Analytical and Bioanalytical Techniques. 2011; 2(6): 6-53. Available from: URL: www.wjpr.net.
23. Ministry of AYUSH Official Website. Available from URL: https://www.ayush.gov.in/ .
24. Budhwar Vikaas, Yadav Sunita, et al. 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. Available from URL: https://www.researchgate.net/publication/235393678.
25. Chaduvu Ramakrishna, Jayachandra Reddy. P, Alagusundaram. M. Current Regulations for Herbal Products. International Journal of Advance Research, Ideas and Innovations in Technology. 2017; 3(3): 1597-1604. Available from URL: www.ijariit.com/manuscripts/v3i3/V3I3-1637.pdf.
26. Rudra Prasad Giri, et al. Regulation on herbal product used as medicine around the world: a review. International Research Journal of Engineering and Technology. 2018; 5(10): 217-223. Available from URL: https://www.irjet.net/archives/V5/i10/IRJET-V5I1037.pdf.
27. Malathi Seshasayee Konda Ramadoss and Kailasam Koumaravelou. Regulatory compliance of herbal medicines – A review. International journal of research in pharmaceutical sciences. 2019; 10(4): 3132-3135. Available from URL: www.irjet.net.
28. Ruiz-Poveda OMP. Regulation of Herbal (Traditional) Medicinal Products in the European Union. Pharmaceutical Regulatory Affairs: Open Access. 2015; 4(2): 1-5. Available from URL: www.pharmascope.org/ijrps.
29. Khushboo Mayurbhai Vora, et al. Regulatory Requirements for Registration of Herbal Medicinal Products in European Union and Australia. International Journal of Pharmaceutical Sciences Review and Research. 2015; 31(1): 147-153. Available from URL: https://www.hilarispublisher.com
30. Avdhesh Kumar, et al. Regulations And Challenges Of Herbal Medicines In Russia. International Journal of Ayurvedic and Herbal Medicine. 2016; 6(1): 2149-2161. Available from URL: www.globalresearchonline.net.
31. Ngcobo, M, et al. Recommendations for the development of regulatory guidelines for registration of traditional medicines in South Africa. Afr J Tradit Complement Altern Med. 2012; 9(1):59‐66. Available from URL: https://pubmed.ncbi.nlm.nih.gov/23983321/.
32. Rakesh K Sindhu and Parneet Kaur. Regulatory Requirements and stability testing of Ethnomedical Plant Products. Research J. Pharm. and Tech 2020; 13(3):1538-1542. Available from URL: https://rjptonline.org/.
33. Tripti Jain, et al. Regulatory Status of Traditional Medicines in Different Countries: An Overview. Research J. Pharm. and Tech. 2011; 4(7):1007-1015. Available from URL: https://rjptonline.org/.
34. Nishith. M.C, M.P. Venkatesh. Herbal Drug Regulatory Landscape: Key comparison between Russia and India. Research J. Pharm. and Tech. 2019; 12(12): 6153-6156. Available from URL: https://rjptonline.org/AbstractView.aspx?PID=2019-12-12-92.