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

Keywords: Herbal drugs, Regulatory frameworks, Global market, Quality standards, Consumer safety

DOI: 10.63475/j.yjom.2024.022

DOI URL: https://doi.org/10.63475/j.yjom.2024.022

Publish Date: 15-12-2024

Pages: 207 - 217

Views: 15

Downloads: 34

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.