Overview of Good Manufacturing Practices Requirements for Herbal Medicines in India and Europe
Abstract
Over the past three decades, the usage of herbal medicines and supplements has grown significantly, with at least 80% of people turning to them for some aspect of primary healthcare. Although the efficacy of many herbal products has been proved, therapies utilising these compounds have showed promising potential. Since safety is still a major concern when using herbal remedies, it is crucial that the proper regulatory agencies put in place the necessary safeguards to protect public health by ensuring that all herbal medications are secure and of high enough quality. In addition to outlining some significant difficulties in conducting an efficient safety review of herbal medicinal products, this review examines toxicity-related issues and significant safety concerns resulting from their use. Good Manufacturing Practices are designed to promote human health and, as a result, quality of life. Ensure the applicability of the principles offered and demonstrate the advantages resulting from this applicability in order to accomplish the objectives specified.
Downloads
References
https://ispe.org/initiatives/regulatory-resources/gmp
2. Drugs and Cosmetics Act, 1940 read with Schedule T - Good Manufacturing Practices for Ayurvedic, Siddha and Unani Medicines [Internet]. India: team lease regtech [cited 2023 Oct 6]. Available from:
https://www.teamleaseregtech.com/resources/acts/article/110/drugs-and-cosmetics-act-1940-read-with-schedule-t-good-manufacturing-p/#:~:text=What%20is%20Schedule%20T%20under,Ayurvedic%2C%20Siddha%20and%20Unani%20Medicines
3. Singh S, Shukla VK. Current regulations for Herbal Medicines in India. International Journal of Drug Regulatory Affairs [Internet]. 2021 Jun 15[cited 2023 Oct 9]; 9(2):30-34. Available from:
https://www.researchgate.net/publication/352665627_Current_regulations_for_Herbal_Medicines_in_India
4. Sharma S. Current status of herbal product: Regulatory overview [Internet]. Bethesda: National Library of Medicine; 2015 Oct-Dec[cited 2023 Oct 12].Available from:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4678984/#:~:text=Herbal%20drugs%20are%20regulated%20under,medicine%20are%20clearly%20laid%20down.
5. Herbal Medicine [Internet]. Bethesda: Medline Plus; 2017 Sep 17 [cited 2023 Oct 15]. Available from:
https://medlineplus.gov/herbalmedicine.html#:~:text=People%20use%20herbal%20medicines%20to,the%20testing%20that%20drugs%20do.
6. Chegu S, Nagabhushanam MV. A Comprehensive Study on Regulation of Herbal Drugs in India, US and European Union. International Journal of Drug Regulatory Affairs [Internet]. 2021 Mar 15 [cited 2023 Oct 17]; 9(1):78-86 Available from:
https://www.researchgate.net/publication/351640145_A_Comprehensive_Study_on_Regulation_of_Herbal_Drugs_in_India_US_and_European_Union
7. Ghotadki R.Global Herbal Medicine Market Overview[Internet]. Market Research Future; 2021 Feb [cited 2023 oct 17]. Available from:
https://www.marketresearchfuture.com/uploads/infographics/Herbal_Medicine_Market.jpg
8. Global Herbal Medicine Market Overview [Internet]. value market research; 2023 jun [cited2023 oct 17]. Available from: https://www.valuemarketresearch.com/dist/img/Global Herbal Medicine Market.png
9. WHO guidelines on good manufacturing practices (GMP) for herbal medicines [Internet]. WHO; 2007 Dec 21 [cited 2023 Oct 16]. Available from:
https://iris.who.int/bitstream/handle/10665/43672/9789241547161_eng.pdf?sequence=1
10. Section I WHO good manufacturing practices (GMP): updated supplementary guidelines for the manufacture of herbal medicines [Internet. WHO [cited 2023 Oct 17]. Available from:
https://gmpsop.com/RegulatoryReference/WHO/WHO_4-Supplementary_guidelines_on_GMP_for_the_manufacture_of_herbal_medicine.pdf
11. Kamli AS, Desai Shuchi MA, Comparative Study: Good Manufacturing Practice (GMP) Requirements for Herbal Products: INDIA & EUROPE International Journal of Pharmaceutical Sciences Review and Research. [Internet]. 2018 Sep 6 [cited 2023 Oct 18]; 15(21): 75-81. Available from:
https://globalresearchonline.net/journalcontents/v52-1/14.pdf
12. Verma N. Herbal Medicines: Regulation and Practice in Europe, United States and India. International Journal of Herbal Medicine [Internet]. 2013 Sep 16 [cited 2023 Oct 21]; 1 (4): 1-5. Available from:
https://www.florajournal.com/vol1issue4/nov2013/c27.1.pdf
13. Manufacture of Herbal Medicinal Products [Internet]. Belgium: European commission; 2008 Sep 1 [cited 2023 Oct 22] Available from:
https://www.gmp-compliance.org/guidelines/gmp-guideline/eu-gmp-annex-7-manufacture-of-herbal-medicinal-product
14. EudraLex - Volumes 4 - Good Manufacturing Practice (GMP) guidelines [Internet]. Belgium: European commission [cited 2023 Oct 23] Available from:
https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en
15. Tian-Tian He, Carolina Oi Lam Ung. Good manufacturing practice (GMP) regulation of herbal medicine in comparative research: China GMP, cGMP, WHO-GMP, PIC/S and EU-GMP. [Internet]. Science direct [cited 2023 Oct 24]. Available from:
https://www.google.com/url?sa=t&source=web&rct=j&opi=89978449&url=https://www.sciencedirect.com/science/article/abs/pii/S1876382015000050&ved=2ahUKEwiGuuSxzu2BAxX01zgGH-*Wj9DtgQFnoECBgQAQ&usg=AOvVaw0byCW_b3f2WLa4TXxBtLmj
16. Devi A. Regulatory Status of Herbal Drugs in India. International Journal of Applied Pharmaceutical Sciences and Research [Internet]. 2022 Jul-Sep [cited 2023 Oct 24]; 7 (3): 30-35. Available from:
https://www.sierrajournals.com/index.php/IJAPSR/article/download/1073/669
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
The International Journal of Drug Regulatory affairs require a formal written transfer of copyright from the author(s) for each article published. We therefore ask you to complete and return this form, retaining a copy for your records. Your cooperation is essential and appreciated. Any delay will result in a delay in publication.
I/we have read and agree with the terms and conditions stated Page 2 of this agreement and I/we hereby confirm the transfer of all copyrights in and relating to the above-named manuscript, in all forms and media, now or hereafter known, to the International Journal of Drug Regulatory affairs, effective from the date stated below. I/we acknowledge that the IJDRA is relying on this agreement in publishing the above-named manuscript. However, this agreement will be null and void if the manuscript is not published in the IJDRA.
Download link for COPYRIGHT FORM
