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Current Traditional Medicine

Editor-in-Chief

ISSN (Print): 2215-0838
ISSN (Online): 2215-0846

Review Article

Important Regulatory Guidelines on Natural Products

Author(s): Abhisar Sahu, Nimisha Srivastava*, Devashish Jena, Aayushee Singh, Satya Kumar and Iti Chauhan

Volume 10, Issue 6, 2024

Published on: 20 October, 2023

Article ID: e201023222452 Pages: 21

DOI: 10.2174/0122150838226206230922043839

Price: $65

Abstract

Ayurvedic cosmeceuticals are alluded to as products of various passable magnificence substances to shape the base in which one or more ayurvedic parts are utilized to give benefits and various ailments. The Drugs and Cosmetics Act of 1940 controls the approaches concerning the making, dealing, amassing, allotment, and importing of drugs in essentially a comparable manner to radiance care things in India. Quality control and assessment of Ayurvedic drugs must ensure the effectiveness of the drug. Given their crucial role, it involves evaluating their physical, chemical, and physiochemical qualities, as well as conducting in-vitro and in-vivo tests. Natural ingredients have consistently been our primary source of medicines, and dosage forms determine how drug molecules or plant components are delivered to the site of action within the body. Good agricultural and collection practices (GACP) rules have been given by the WHO (World Health Organization) for the differentiation and planning of regular items. There are primarily two legal regulatory bodies within the AYUSH (Ayurveda, Yoga and Naturopathy, Unani, Siddha, and Homeopathy) sector i.e., Central Council of Indian Medicine (CCIM) and the Central Council of Homeopathy.

Keywords: Cosmeceuticals, quality control, WHO, GACP, CCIM, drug & cosmetic act.

Graphical Abstract
[1]
Gulati K, Thokchom SK, Joshi JC, Ray A. Regulatory guidelines for nutraceuticals in India: An overview. Nutraceuticals 2021; 2021: 1273-80.
[2]
Ferreira L, Pires PC, Fonseca M, et al. Nanomaterials in cosmetics: An outlook for european regulatory requirements and a step forward in sustainability. Cosmetics 2023; 10(2): 53.
[http://dx.doi.org/10.3390/cosmetics10020053]
[3]
Verma N. Herbal medicines: Regulation and practice in Europe, United States and India. Int J Herb Med 2013; 1(4): 1-5.
[4]
Dwivedi M, Patwardhan K. An exploratory analysis of selected textbooks enlisted by the Central Council of Indian Medicine for the Bachelor of Ayurvedic Medicine and Surgery program. Annals Ayurvedic Med 2022; 11: 1.
[http://dx.doi.org/10.5455/AAM.81089]
[5]
Aayog NI. A Preliminary Report of the Committee on the Reform of the Indian Medicine Central Council Act 1970 and Homoeopathy Central Council Act. 1973.
[6]
Bharatendra K. Indian Medicine and Homoeopathy Pharmacy Central Council Draft Bill.
[7]
Gopalakrishnan C. Indian medicine and homeopathy pharmacy central council bill.
[8]
Dossett ML, Davis RB, Kaptchuk TJ, Yeh GY. Homeopathy use by US adults: results of a national survey. Am J Public Health 2016; 106(4): 743-5.
[http://dx.doi.org/10.2105/AJPH.2015.303025] [PMID: 26890179]
[9]
Singh P, Yadav RJ, Pandey A. Utilization of indigenous systems of medicine & homoeopathy in India. Indian J Med Res 2005; 122(2): 137-42.
[PMID: 16177471]
[10]
Kaur H, Chalia DS, Manchanda RK. Homeopathy in public health in India. Homeopathy 2019; 108(2): 76-87.
[http://dx.doi.org/10.1055/s-0038-1673710]
[11]
Acharya R, Narayanan RV, Mahajon B, Khanduri S, Srikanth N. Contributions to research and development by Central Council for Research in Ayurvedic Sciences (CCRAS): An appraisal. Int J Ayurveda Res 2022; 3(2): 86-101.
[http://dx.doi.org/10.4103/0974-7788.366603]
[12]
Null G, Carolyn DMD, Feldman M, Rasio D, Smith D. Ministry of Ayush has established the Central Council of Research in Ayurvedic Sciences.
[13]
Sharma BS, Singh S, Sharma BS, Khanduri S, Singh R, Maheswar T. Tribal health care research program: An overview of central council for research in ayurvedic sciences contributions. J Drug Res Ayurvedic Sci 2017; 2(2): 118-48.
[http://dx.doi.org/10.5005/jp-journals-10059-0013]
[14]
Srikanth N. Ayurveda: The knowledge source for systems medicine. J Drug Res Ayurvedic Sci 2021; 6(1): 1.
[15]
Patwardhan B, Vaidya AD. Ayurveda: Scientific research and publications. Curr Sci 2009; 97(8): 1117-21.
[16]
Katoch D, Sharma JS, Banerjee S, et al. Government policies and initiatives for development of Ayurveda. J Ethnopharmacol 2017; 197: 25-31.
[http://dx.doi.org/10.1016/j.jep.2016.08.018] [PMID: 27543425]
[17]
Chincholikar MB, Mahajon B, Tripathi AK. Ayurveda-based seasonal collection practices for selected medicinal plants: A scientific appraisal––book review. J Drug Res Ayurvedic Sci 2021; 6(3): 195.
[18]
Sharma R, Sharma BS. Safety and prescription trends of rasaushadhis critical appraisal of reported medical practices of Ayurveda herbomineral formulations from CCRAS experience: Book review. J Drug Res Ayurvedic Sci 2022; 7(2): 151.
[19]
Manohar R, Eranezhath S, Mahapatra A. R SM. P05.67. A narrative review of research on Ayurveda. BMC Complement Altern Med 2012; 12(S1): 427.
[http://dx.doi.org/10.1186/1472-6882-12-S1-P427]
[20]
Nishteswar K. Safeguarding Ayurvedic therapeutics: Need of the hour. Ayu 2013; 34(1): 4-5.
[http://dx.doi.org/10.4103/0974-8520.115433] [PMID: 24049397]
[21]
Chandra S, Narayana DB. Evaluation of drug standards, quality control, and trade in medicinal plants. J Res Ayurvedic Sci 2023; 7(1): 13.
[22]
Choudhari DD, Kulkarni YR. National Journal of Research in Ayurved Science. Natl J 2019; 7(7th)
[23]
Jain AK, Sharma BK. Developments in the field of ayurveda–past to present. Ayushdhara 2014; 1(2): 51-64.
[24]
Abraham J, Mathew F. Taste masking of paediatric formulation: A review on technologies, recent trends and regulatory aspects. Int J Pharm Pharm Sci 2014; 6(1): 12-9.
[25]
Kambham V. Regulatory aspects of pharmaceutical excipients in india and their qualification to use in pharmaceuticals. Upi J Bus Manag Comput Appl 2018; 30: 31-6.
[26]
Choudhury A, Singh PA, Bajwa N, Dash S, Bisht P. Pharmacovigilance of herbal medicines: Concerns and future prospects. J Ethnopharmacol 2023; 309: 116383.
[http://dx.doi.org/10.1016/j.jep.2023.116383] [PMID: 36918049]
[27]
Sharma S. Current status of herbal product: Regulatory overview. J Pharm Bioallied Sci 2015; 7(4): 293-6.
[http://dx.doi.org/10.4103/0975-7406.168030]
[28]
Hirudkar VN, Shivhare V. A review on ayurvedic cosmeceuticals and their mode of actions. J Drug Deliv Ther 2022; 12(6): 204-6.
[http://dx.doi.org/10.22270/jddt.v12i6.5664]
[29]
Vij D, Srivastava PK, Marde R, Mishra RK. Ayurveda and cosmeceuticals: A literary review. Int J Unani Integr Medicine 2019; 3(4): 29-32.
[http://dx.doi.org/10.33545/2616454X.2019.v3.i4a.104]
[30]
Jain A, Malviya N. Herbal cosmeceutical for skin care. Int J Pharm Life Sci 2018; 9(2)
[31]
Patil AS, Patil AV, Patil AH, Patil TA, Bhurat M, Barhate S. A review on: Standardization of herb in new era of cosmeceuticals: Herbal cosmetics. World J Pharm Res 2017; 6(12): 303-20.
[32]
Mandal SC, Mandal M. Quality, safety, and efficacy of herbal products through regulatory harmonization. Drug Inf J 2011; 45: 45-53.
[http://dx.doi.org/10.1177/009286151104500105]
[33]
Rathod S, Mali S, Shinde N, Aloorkar N. Cosmeceuticals and beauty care products: Current trends with future prospects. Res J Top Cosmet Sci 2020; 11(1): 45-51.
[http://dx.doi.org/10.5958/2321-5844.2020.00008.4]
[34]
Dhapte-Pawar V, Kadam S, Saptarsi S, Kenjale PP. Nanocosmeceuticals: Facets and aspects. Future Sci OA 2020; 6(10): FSO613.
[http://dx.doi.org/10.2144/fsoa-2019-0109] [PMID: 33312696]
[35]
Gupta V, Mohapatra S, Mishra H, et al. Nanotechnology in cosmetics and cosmeceuticals-A review of latest advancements. Gels 2022; 8(3): 173.
[http://dx.doi.org/10.3390/gels8030173] [PMID: 35323286]
[36]
Sharma N, Singh S, Kanojia N, Grewal AS, Arora S. Nanotechnology: A modern contraption in cosmetics and dermatology. Appl Clin Res Clin Trials Regul Aff 2018; 5(3): 147-58.
[http://dx.doi.org/10.2174/2213476X05666180528093905]
[37]
Comstock J. The future of cosmeceuticals. In: Cosmeceuticals Karger Publishers. 2021; 5: pp. 157-62.
[http://dx.doi.org/10.1159/000491860]
[38]
Ajazzuddin M, Jeswani G, Jha A. Nanocosmetics: Past, present and future trends. Recent Pat Nanomed 2015; 5(1): 3-11.
[http://dx.doi.org/10.2174/1877912305666150417232826]
[39]
Ahmad U, Ahmad Z, Khan A, Akhtar J, Singh S, Ahmad F. Strategies in development and delivery of nanotechnology based cosmetic products. Drug Res 2018; 68(10): 545-52.
[http://dx.doi.org/10.1055/a-0582-9372] [PMID: 29579762]
[40]
Latha MS, Martis J, Shobha V, et al. Sunscreening agents: A review. J Clin Aesthet Dermatol 2013; 6(1): 16-26.
[PMID: 23320122]
[42]
21CFR Parts 710, 720; FDA, bad reaction to cosmetics? Tell FDA.. 2020. www.fda.gov/ForConsumers/Consumer Updates/ucm241820.htmGoogle
[43]
European Commission. Brussels Nanotechnology Emerging Needs (2007) 2007. http://cordis.europa.eu/nanotechnology/src/pressroom_projects_nmp6.htmGoogle
[44]
Singh PA, Baldi A. Good agricultural practices: A prequisite approach for enhancing the quality of Indian herbal medicines. Biomed J 2018; 2: 4.
[45]
Ahmad S, Parveen A, Parveen B, Parveen R. Challenges and guidelines for clinical trial of herbal drugs. J Pharm Bioallied Sci 2015; 7(4): 329-33.
[http://dx.doi.org/10.4103/0975-7406.168035] [PMID: 26681895]
[46]
Metta AM, Kingumahanthi NL, Kalidindi VR, Juturi RK, Boddu V. Scope for harmonisation of herbal medicine regulations. Int J Pharm Sci Res 2021; 12(4): 2012-20.
[47]
Bogatcheva E, Hanrahan C, Nikonenko B, et al. Identification of SQ609 as a lead compound from a library of dipiperidines. Bioorg Med Chem Lett 2011; 21(18): 5353-7.
[http://dx.doi.org/10.1016/j.bmcl.2011.07.015] [PMID: 21807506]
[48]
Kayne S. Homeopathy in the 21st century, and comparisons with hahnemann. Homeopathy 2021; 110(4): 292-302.
[http://dx.doi.org/10.1055/s-0041-1727160] [PMID: 34500486]
[49]
Ajazuddin SS, Saraf S. Legal regulations of complementary and alternative medicines in different countries. Pharmacogn Rev 2012; 6(12): 154-60.
[http://dx.doi.org/10.4103/0973-7847.99950] [PMID: 23055642]
[50]
Li FS, Weng JK. Demystifying traditional herbal medicine with modern approach. Nat Plants 2017; 3(8): 17109.
[http://dx.doi.org/10.1038/nplants.2017.109] [PMID: 28758992]
[51]
Roy V. Time to sensitize medical graduates to the Indian Systems of Medicine and Homeopathy. Indian J Pharmacol 2015; 47(1): 1-3.
[http://dx.doi.org/10.4103/0253-7613.150301] [PMID: 25821302]
[52]
Sachan AK, Vishnoi G, Kumar R. Need of standardization of herbal medicines in Modern era. Int J Phytomed 2016; 8(3): 300-7.
[http://dx.doi.org/10.5138/09750185.1847]
[53]
Noone J, Blanchette CM. The value of self-medication: Summary of existing evidence. J Med Econ 2018; 21(2): 201-11.
[http://dx.doi.org/10.1080/13696998.2017.1390473] [PMID: 28994329]
[54]
Duran MI, Ballesteros-Ramírez R, Tellez A, et al. Safety evaluation in healthy colombian volunteers of P2Et extract obtained from caesalpinia spinosa: Design 3+3 phase I clinical trial. Evid Based Complement Alternat Med 2022; 2022: 1-11.
[http://dx.doi.org/10.1155/2022/7943001] [PMID: 35251213]
[55]
Regulatory situation of herbal medicines: A worldwide review. World Health Organization 1998.
[56]
Li S, Yingyi G, Chen L, Lijuan G, Oua S, Peng X. Food & Function. Energy 3(5.31): 3-50.
[57]
Traditional medicine in the WHO South-East Asia Region: review of progress 2014–2019.
[58]
National policy on traditional medicine and regulation of herbal medicines: Report of a WHO global survey. World Health Organization 2005.
[59]
Sirdeshpande M, Chaudhari K, Bomble R. Critical study on selection criteria of Vishaghna Mahakashaya drugs. Ayurline: Int J Res Indian Med 2021; 5(1)
[60]
Onodugo CD, Obiekezie SO, Owun JE. Evaluation of microbiological criteria and quality of packaged herbal medicinal products. WJARR 2023; 17(2): 522-37.
[http://dx.doi.org/10.30574/wjarr.2023.17.2.1345]
[61]
Good Clinical Practices, Guidelines for Clinical Trials on Ayurveda, Siddha, Unani Medicines and Other Traditional Medicines based on CDSCO Document on GCP Guidelines for Clinical Trials on Pharmaceutical Products Department of AYUSH Ministry of Health & Family Welfare, Government of India.
[62]
Lourith N, Kanlayavattanakul M. Introduction to cosmetic science and phytocosmetics. In: Phytocosmetics and Cosmetic Science. (1st ed.), CRC Press 2021.
[http://dx.doi.org/10.1201/9781003107385-1]
[63]
Kalouta K, Eleni P, Boukouvalas C, Vassilatou K, Krokida M. Dynamic mechanical analysis of novel cosmeceutical facial creams containing nano‐encapsulated natural plant and fruit extracts. J Cosmet Dermatol 2020; 19(5): 1146-54.
[http://dx.doi.org/10.1111/jocd.13133] [PMID: 31529673]
[64]
Sarkar PK, Das S, Prajapati PK. Ancient concept of metal pharmacology based on Ayurvedic literature. Anc Sci Life 2010; 29(4): 1-6.
[PMID: 22557360]
[65]
Wayal SR, Gurav SS. Bhallatakadi Ghrita: Development and evaluation with reference to Murcchana and Shata-Dhauta process. J Ayurveda Integr Med 2020; 11(3): 261-9.
[http://dx.doi.org/10.1016/j.jaim.2020.05.005] [PMID: 32690353]
[66]
Ojha R, Gupta AK, Pandey SK. Shelf life of ayurvedic dosage form: Present scenario & need to follow modern paradigm: Present scenario of shelf life of ayurvedic dosage forms. JAHM 2020; 8(6)
[67]
Oliva A, Fariña JB, Llabrés M. An improved methodology for data analysis in accelerated stability studies of peptide drugs: Practical considerations. Talanta 2012; 94: 158-66.
[http://dx.doi.org/10.1016/j.talanta.2012.03.011] [PMID: 22608429]
[68]
Theodoridis S, Drakou EG, Hickler T, Thines M, Nogues-Bravo D. Evaluating natural medicinal resources and their exposure to global change. Lancet Planet Health 2023; 7(2): e155-63.
[http://dx.doi.org/10.1016/S2542-5196(22)00317-5] [PMID: 36754471]
[69]
Joshi VK, Joshi A, Dhiman KS. The Ayurvedic Pharmacopoeia of India, development and perspectives. J Ethnopharmacol 2017; 197: 32-8.
[http://dx.doi.org/10.1016/j.jep.2016.07.030] [PMID: 27404231]

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