Plant-derived Hepatoprotective Drugs

Regulatory Affairs in Herbal Products

Author(s): Megha Jha*, Dolly Rani and Kavita Chahal

Pp: 115-133 (19)

DOI: 10.2174/9789815079845123010007

* (Excluding Mailing and Handling)


Various parameters/guidelines regulating the safety and efficacy of herbal pharmaceuticals, as well as their manufacturing and distribution, have been strongly implemented by regulatory bodies. To understand the pre-marketing requirements, the legislative status of herbal drugs/products was analyzed in this chapter for various countries in Southeast Asia, Africa, America, Europe, and Austria. Apart from the challenges of herb availability and conservation, it has been shown that there is a lack of harmony in the regulatory requirements for herbal products across the world. A critical evaluation was performed in order to detect the obstacles in the harmonization of herbal products. The worldwide trade and development of herbal products are being hampered by these issues. The herbal drug industry is inadequately regulated in most countries, and herbal medicines are often neither registered nor controlled. Quality compliance and assurance of the safety and efficacy of the marketed herbal drugs are major issues faced by developing as well as developed countries across the globe. The problem arises when herbal medication is utilized without legitimate permission, or in huge dosages, or in combination with other drugs for a longer period, or without discussion with a doctor, and produced properly. Taking these factors into account, the World Health Organization's International Drug Monitoring Program (WHO) has published standards for herbal assessment and quality control testing in order to improve the safety and efficacy of herbal-based therapeutics. This chapter covers the importance of regulatory affairs to be used in the processing of herbs and herbal products, and a comparative study of regulatory situations in different countries

Keywords: Compliance, Harmonization, Legislative, Legitimate, Quality control, Regulatory affairs, Therapeutics.

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