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ISSN (Online): 2665-9794

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Review Article

Regulatory Pathways for Ayurvedic Formulations in India

Author(s): Mohit Sanduja, Rishabh Gaur, Anuj Kumar Sharma, Devender Pathak and Mayank Kulshreshtha*

Volume 5, 2024

Published on: 15 November, 2023

Article ID: e151123223576 Pages: 10

DOI: 10.2174/0126659786269462231102071205

Price: $65

Abstract

Ayurveda, a traditional system of medicine originating in India, focuses on teaching people how to live a healthy lifestyle. Ayurveda describes health as harmony between body, mind, emotions, and spirituality. It interprets illness as a symptom and result of disharmony. It is a system that is increasingly becoming an object of interest for people around the world. It is a way for healthy people looking for methods of prevention and patients looking for natural ways to heal. The regulatory requirements for its formulations have been a major challenge. Some regulations for Ayurveda are clubbed together with those of other systems of medicine, for example, Siddha, Unani, and Homeopathy due to their similarity, but the official books relevant to the Ayurvedic systems of medicine are separately compiled and conserved. Ayurveda does not prohibit anything, it does not act invasively or aggressively, and in the treatment of ailments it uses all naturally occurring bioactive substances, which, for example, in Western countries are associated with "functional food" or "dietary supplements". In order to increase the quality and reliability of Ayurvedic formulations, various councils and departments under these ministries have been laying the foundation of standards and protocols as per the demands of regulatory authorities. The direct or indirect connection among the different Ministries of India governing the regulations for the production, standardization, and development of Ayurvedic formulations has also been viewed. Improvement in quality parameters has a higher level of acceptance of ayurvedic formulations. It has amplified the market size of the ayurvedic pharmaceutical industry. The synchronisation of various regulations in India could emerge as a powerful tool in establishing a novel platform for the whole world in the manufacturing and development of ayurvedic formulations for the benefit of mankind.

[1]
Jaiswal, Y.S.; Williams, L.L. A glimpse of Ayurveda – The forgotten history and principles of Indian traditional medicine. J. Tradit. Complement. Med., 2017, 7(1), 50-53.
[http://dx.doi.org/10.1016/j.jtcme.2016.02.002] [PMID: 28053888]
[2]
Thakar, V.J. Historical development of basic concepts of Ayurveda from Veda up to Samhita. Ayu, 2010, 31(4), 400-402.
[http://dx.doi.org/10.4103/0974-8520.82024] [PMID: 22048529]
[3]
Parasuraman, S.; Thing, G.; Dhanaraj, S. Polyherbal formulation: Concept of ayurveda. Pharmacogn. Rev., 2014, 8(16), 73-80.
[http://dx.doi.org/10.4103/0973-7847.134229] [PMID: 25125878]
[4]
General Guidelines for Drug Development of Ayurvedic Formulations. CCRAS; Ministry of AYUSH: India, 2018.
[5]
Patwardhan, B. Bridging Ayurveda with evidence-based scientific approaches in medicine. EPMA J., 2014, 5(1), 19.
[http://dx.doi.org/10.1186/1878-5085-5-19] [PMID: 25395997]
[6]
Katoch, D.; Sharma, J.S.; Banerjee, S.; Biswas, R.; Das, B.; Goswami, D.; Harwansh, R.K.; Katiyar, C.K.; Mukherjee, P.K. 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]
[7]
Ayurveda Industry Vision 2022. Available from: http://ayurvedaindustry.com/pdf/Key-Recommendations-Ayurveda.pdf
[8]
Indian Ayurvedic Industry to Grow to $ 4.4 Billion: ET Bureau. Available from: https://economictimes.indiatimes.com/industry/healthcare/biotech/healthcare/indian-ayurvedic-industry-to-grow-to-4-4-billion-by-the-end-of-this year/articleshow/66694089.cms?from=mdr(Accessed on: 22/11/2022).
[9]
Ayurveda Industry in India 2019-2025. Statista Reports. Available from: https://www.statista.com/statistics/1252538/india-ayurveda-industry-market-value/(Accessed on: 23/09/2022).
[10]
Ayurvedic Medicine Market Size in 2022 as Fastest Growing Companies. Market Watch Press Release. 2022. Available from: https://www.marketwatch.com/press-release/ayurvedic-medicine-market-size-in-2022-by-fastest-growing-companies-patanjali-ayurved-limited-dabur-emami-group-with-top-countries-data-new-report-spreads-in-108-pages-2022-02-23(Accessed on: 25/09/2022).
[11]
Advertisement of Herbal Medicine as Magic Remedies. Press Information Bureau, Ayush. Available from: https://pib.gov.in/PressReleaseIframePage.aspx?PRID=1782667 (Accessed on: 12/10/2022).
[12]
Pandey, M.M.; Rastogi, S.; Rawat, A.K.S. Indian traditional ayurvedic system of medicine and nutritional supplementation. Evid. Based Complement. Alternat. Med., 2013, 2013, 1-12.
[http://dx.doi.org/10.1155/2013/376327] [PMID: 23864888]
[13]
Semwal, D.K.; Chauhan, A.; Kumar, A.; Aswal, S.; Semwal, R.B.; Kumar, A. Status of Indian medicinal plants in the International Union for Conservation of Nature and the future of Ayurvedic drugs: Shouldn’t think about Ayurvedic fundamentals? J. Integr. Med., 2019, 17(4), 238-243.
[http://dx.doi.org/10.1016/j.joim.2019.04.008] [PMID: 31076374]
[14]
Wangpan, T. Traditional use of plants as medicine and poison by Tagin and Galo Tribe of Arunachal Pradesh. J. Appl. Pharm. Sci., 2019, 9(9), 98-104.
[http://dx.doi.org/10.7324/JAPS.2019.90914]
[15]
Hussain, M.K. Botanical identification of Ayush - Ayurveda and unani drugs and it’s relevance in quality control. Research. J. Pharm. Teach., 2022, 15(11), 5177-5183.
[16]
Mangla, M.; Mukhtar, H.M.; Sanduja, M. Illustrated pharmacognostic standardization of ocimum kilimandscharicum. Res. J. Pharm. Technol., 2020, 13(11), 5139-5144.
[17]
Shekhar, A.D.; Yeola, G.H.; Kulkarni, P.N.; Khade, P.; Gaikwad, P. Preventive cardiology: Ayurveda View. Research. J. Pharm. Teach., 2022, 15(11), 5368-5372.
[18]
Kaushik, R.; Jain, J.; Mazumder, A. Chromatographic fingerprinting of sarasvata churna- an ayurvedic polyherbal formulation for epilepsy. J. Appl. Pharm. Sci., 2018, 8(04), 90-98.
[19]
Evidence Based Research Data of AYUSH Systems at Global Level via Ayush Portal. Ministry of AYUSH, India. Available from: https://ayushportal.nic.in/(Accessed on: 14/11/2022)
[20]
WHO establishes the global centre for traditional medicine in India. WHO News 2022. 2022. Available from: https://www.who.int/news/item/25-03-2022-who-establishes-the-global-centre-for-traditional-medicine-in-india(Accessed on: 27/09/2022).
[21]
Ministry of Health and Family Welfare, India. Available from: https://main.mohfw.gov.in/about-us/about-the-ministry(Accessed on: 03/10/2022).
[22]
The Drugs and Cosmetics Act, 1940 and Rules 1945. 2022.
[23]
Ayurvedic Products with Certificate of Pharmaceutical Product Granted, Ayush, CDSCO, India. Available from: https://cdsco.gov.in/opencms/opencms/en/Aayush/(Accessed on: 20/11/2022).
[24]
Tandon, N.; Yadav, S.S. Contributions of Indian Council of Medical Research (ICMR) in the Area of Medicinal Plants/Traditional Medicine. J. Ethnopharmacol., 2017, 197, 39-45.
[http://dx.doi.org/10.1016/j.jep.2016.07.064] [PMID: 27452657]
[25]
Priced Publications: Medicinal Plants: Indian Council of Medical Research, India. Available from: https://main.icmr.nic.in/priced-publications/1352(Accessed on: 24/10/2022).
[26]
Background: Ministry of AYUSH, India. Available from: https://main.ayush.gov.in/about-us/background(Accessed on: 06/11/2022).
[27]
General Guideline Series: Central Council for Research in Ayurvedic Sciences, India. Available from: http://www.ccras.nic.in/content/general-guideline-series(Accessed on: 05/11/2022).
[28]
Yadav, P.; Prajapati, P.K. Quality control parameters for medicinal plants, an overview. Asian J Biomed Pharm Sci., 2012, 2(5), 12-16.
[29]
Ayurveda Pharmacopoeial Publication. PCIM&H, India. Available from: https://pcimh.gov.in/show_content.php?lang=1&level=1&ls_id=56&lid=54(Accessed on: 1/11/2022).
[30]
Lohar, D.R. Protocol for Testing of Ayurvedic, Siddha and Unani Medicines; Pharmacopoeial Laboratory for Indian Medicines: Ghaziabad, India, 2008.
[31]
Kamath, M. A narrative study on extra pharmacopeial drugs used in ayurveda. Research. J. Pharm. Teach., 2020, 13(8), 3929-3932.
[32]
Mukherjee, P.K.; Nema, N.K.; Venkatesh, P.; Debnath, P.K. Changing scenario for promotion and development of Ayurveda – way forward. J. Ethnopharmacol., 2012, 143(2), 424-434.
[http://dx.doi.org/10.1016/j.jep.2012.07.036] [PMID: 22885133]
[33]
About Drug Control Cell: Ministry of AYUSH, India. Available from: http://www.e-aushadhi.gov.in/ayush/aboutus (Accessed on: 28/11/2022).
[34]
Essential Drug List: Ayurveda; Ministry of AYUSH: India, 2003.
[35]
Guidelines for Inspection of GMP Compliance by ASU Drug Industry; Ministry of AYUSH: India, 2014.
[36]
Good Clinical Practice Guidelines for Clinical Trials in Ayurveda, Siddha and Unani Medicine; Ministry of AYUSH: India, 2013.
[37]
Introduction of National Medicinal Plants Board, India. Available from: https://www.nmpb.nic.in/content/introduction(Accessed on: 7/10/2022).
[38]
CSIR Labs: Council of Scientific & Industrial Research, India. Available from: https://www.csir.res.in/csir-labs(Accessed on: 23/11/2022)
[39]
Act and Rules for Department of Commerce: Ministry of Trade and Commerce, India. Available from: https://commerce.gov.in/acts-and-schemes/(Accessed on: 04/07/2022).
[40]
Chaudhary, A.; Singh, N. Intellectual property rights and patents in perspective of Ayurveda. Ayu, 2012, 33(1), 20-26.
[http://dx.doi.org/10.4103/0974-8520.100298] [PMID: 23049179]
[41]
Intellectual Property: Protection and Enforcement. WTO Agreements 2021. 2021. Available from: https://www.wto.org/english/thewto_e/whatis_e/tif_e/agrm7_e.htm(Accessed on: 27/10/2021).
[42]
Swaminathan, S.; Shekhar, C.; Srivastava, S. Handbook on Intellectual Property Rights & Technology Transfer; Indian Council of Medical Research: India, 2017.
[43]
Role and Functions: Department for Promotion of Industry and Internal Trade, India. Available from: https://dpiit.gov.in/about-us/role-and-functions-dpiit(Accessed on: 24/11/2022).
[44]
Ghosh, P.; Palbag, S. TKDL: An answer to biopiracy in India. Int. Ayurvedic. Med. Journal., 2017, 5(11), 4180-4187.
[45]
About TKDL, Traditional Knowledge Digital Library, India. Available from: http://www.tkdl.res.in/tkdl/langdefault/common/Abouttkdl.asp?GL=Eng(Accessed on: 23/08/2022).
[46]
About Department of Consumer Affairs: Ministry of Consumer Affairs, Food & Public Distribution, India. Available from: https://consumeraffairs.nic.in/about-us/about-dca(Accessed on: 27/11/2022).
[47]
Origin of BIS. Bureau of Indian Standards, India. Available from: https://www.bis.gov.in/index.php/the-bureau/origin-of-bis/(Accessed on: 24/11/2022).
[48]
Published Standards: Bureau of Indian Standards, India. Available from: https://www.services.bis.gov.in/php/BIS_2.0/dgdashboard/Published_Standards(Accessed on: 24/11/2022).
[49]
Rate of GST on Goods: Central Board of Indirect Taxes and Customs, India. Available from: https://cbic-gst.gov.in/pdf/goods-rates-booklet-03July2017(Accessed on: 22/11/2022).
[50]
Seeks to Amend the Dutiable Goods falling within the Item No. of the Schedule to the Medical and Toilet Preparations (Excise Duties) Act, 1955. Central Board of Indirect Taxes and Customs, India. 1955. Available from: https://taxinformation.cbic.gov.in/view-pdf/1005203/ENG/Notifications(Accessed on: 06/11/2022).
[51]
Regulations of Health Insurance, 2016. IRDAI, India. 2016. Available from: https://www.irdai.gov.in/ADMINCMS/cms/NormalData_Layout.aspx?page=PageNo4133&mid=4.2.1(Accessed on 30/09/2022).
[52]
About Protection of Plant Varieties & Farmer’s Rights Authority. Ministry of Agriculture and Farmers Welfare, India. Available from: http://www.plantauthority.gov.in/index.htm(Accessed on: 22/08/2022).
[53]
About us: Directorate of Plant Protection Quarantine & Storage, India. Available from: http://ppqs.gov.in/about-us/about-department(Accessed on: 20/09/2022).
[54]
Departments comprises under Ministry of Chemicals and Fertilizers, India. Available from: https://www.mygov.in/group/ministry-chemicals-and-fertilizers/(Accessed on: 22/09/2022).
[55]
Committee for the Purpose of Control and Supervision of Experiments on Animals, India. Available from: https://cpcsea.nic.in/Auth/index.aspx# (Accessed on: 14/11/2022).
[56]
Revival of Ayurvedic Medicines. Press Information Bureau, Ayush. Available from: https://pib.gov.in/PressReleaseIframePage.aspx?PRID=1808150 (Accessed on: 26/10/2022).
[57]
Development of AYUSH Cluster: Ministry of Micro, Small & Medium Enterprises, India. Available from: https://msme.gov.in/sites/default/files/MSME_Schemes_English_0.pdf(Accessed on: 27/10/2022).
[58]
Department of Revenue: Narcotic Drugs & Psychotropic Substances. Ministry of Finance, India. Available from: https://dor.gov.in/narcotic-drugs-psychotropic(Accessed on: 09/09/2022).
[59]
Advisory on Granting Exemption to Industries Covered under the MSIHC Rules from the Provisions under the Poisons Act, 1919. Ministry of Home Affairs, India. 1919. Available from: https://www.mha.gov.in/sites/default/files/Advisory_19082021.pdf (Accessed on: 10/09/2022).
[60]
Ministry of Labour and Employment, India. Available from: https://labour.gov.in/about-ministry (Accessed on: 17/09/2022).

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