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Herbal drugs: standards and regulation.
Niharika Sahoo1, Padmavati Manchikanti, Satyahari Dey
1Rajiv Gandhi School of Intellectual Property Law, IIT Kharagpur, Kharagpur 721302, West Bengal, India. g_bagetta@virgilio.it
Fitoterapia
|February 17, 2010
Summary
Herbal drug safety requires better standardization and quality control. This study explores the evolution of technical standards and regulatory guidelines for commercializing herbal medicines.
Area of Science:
- Pharmacognosy and Phytochemistry
- Regulatory Science
- Traditional Medicine
Background:
- Herbal drugs have a long history of use for health ailments.
- Concerns exist regarding the safety and efficacy of herbal medicines due to potential adverse reactions.
- Lack of standardized methods for isolation, identification, and quality control poses challenges.
Purpose of the Study:
- To investigate the historical development of technical standards in herbal drug manufacturing.
- To examine the evolution of regulatory guidelines for the commercialization of herbal drugs.
- To highlight the need for global consensus on standardization and quality control.
Main Methods:
- Literature review of technical standards development.
- Analysis of regulatory guideline evolution across different countries and medicine systems.
- Comparative study of standardization and quality control approaches.
Main Results:
- Significant variations exist in standardization and quality control methods globally.
- Regulatory frameworks for herbal drugs are not uniform internationally.
- The development of effective marker systems for herbal components is crucial.
Conclusions:
- Standardization, stability, and quality control of herbal drugs are challenging but feasible.
- Harmonized international regulations and technical standards are essential for safe commercialization.
- Further research is needed to develop robust identification and quality assurance systems for herbal medicines.
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