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Overview of herbal drugs: Regulatory perspective with special emphasis on global market
Pankaj Ramdas Khuspe1*, Phade Swapnil1, Inamdar Prajakta1, Kakade Sakshi1, Ingale Vaishnavi1, Magar Srushti1, Thavare Aishwarya1
Author Affiliation
1Shriram Shikshan Sanstha’s College of Pharmacy, Paniv, Maharashtra, India
Abstract
The market for herbal pharmaceuticals has grown significantly due to the growing demand for herbal medications worldwide, which is fueled by its perceived safety and natural source. However, regional differences in the regulatory frameworks governing these items provide difficulties for industry participants and impede the growth of the global market. This research offers a thorough analysis of the regulatory environment around herbal medications, looking at laws in important markets such as China, India, the US, and the EU. It draws attention to the intricate regulatory approval process and the necessity of international harmonization of safety, efficacy, and quality standards. Product quality and customer trust are frequently affected by differences in these regions' classification, licensing, and post-market surveillance regulations. The paper also discusses how new international regulatory initiatives, like the WHO's Traditional Medicine Strategy, are affecting the global standardization of herbal medication approval procedures. The paper also examines market trends, pointing to a growing demand for herbal treatments for the prevention of illness and the treatment of chronic conditions. Notwithstanding the strong market expansion, issues including product adulteration, a lack of therapeutic data, and restricted intellectual property rights still exist, calling for calculated regulatory changes to maintain consumer safety and market legitimacy. In addition to highlighting the significance of regulatory convergence, this report offers stakeholders practical advice on how to better manage the global herbal medication industry.
DOI: 10.18231/j.yjom.2024.022
Keywords: Herbal drugs, Regulatory frameworks, Global market, Quality standards, Consumer safety
Pages: 207-217
View: 15
Download: 36
DOI URL: https://doi.org/10.18231/j.yjom.2024.022
Publish Date: 15-12-2024
Full Text
Medicinal items made from plants and plant extracts are known as herbal pharmaceuticals, sometimes called herbal medicines or phytomedicines. These products have been used for centuries in traditional medical systems all over the world. In a broad sense, herbal medications are made from different plant parts, including leaves, roots, flowers, seeds, and bark, which are used for their medicinal properties and bioactive substances. These items serve as preventative or curative treatments for a variety of illnesses and come in a variety of forms, from unrefined botanical materials to more sophisticated forms including powders, tinctures, and capsules. The main characteristics that set herbal medications apart from traditional pharmaceuticals are their complex active component mixes and natural origin. Herbal medications often have several active ingredients, which makes their pharmacological actions complex but complementary to synthetic medications that only include one isolated chemical. The therapeutic adaptability and all-encompassing appeal of herbal medications in contemporary healthcare are greatly influenced by their multicomponent nature. 1–3
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