The Ministry of Health has proposed strict measures through the Kenya Drugs Authority Bill, 2022.
The bill, which has already been presented to the Parliamentary Health Committee, outlines a series of regulations aimed at ensuring the safety and efficacy of herbal medicinal products in the country.
Under the proposed legislation, any individual found in violation of the stipulated measures will be committing an offense and may face penalties that include a fine not exceeding Ksh100,000, imprisonment for up to one year, or both.
The bill defines herbal medicine as any plant-derived material or preparations claiming therapeutic or other health benefits, whether for humans or animals. These herbal medicines may contain raw or processed ingredients derived from one or more plants, as well as materials of inorganic or animal origin.
“A person shall not sell any therapeutic cosmetic that contains any substance that may cause injury to the health of the user when used,” a key provision in the bill states.
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The liability for herbalists is contingent on the proper use of the product according to the instructions provided on the label or as prescribed by common methods of use.
Furthermore, the Ministry of Health’s proposal includes strict regulations against selling herbal medicine that contains any filth or injurious foreign matter, as well as products prepared, preserved, packed, or stored under unsanitary conditions.
Additionally, herbal drugs that bear a resemblance to therapeutic cosmetics of the prescribed standard will be considered an offense, potentially leading to legal consequences.
The introduction of the Kenya Drugs Authority, as outlined in the proposed bill, is anticipated to serve as the primary regulatory body for drugs and chemical substances in Kenya. The authority will also oversee the regulation of medical devices and other health technologies, in alignment with the principles and objectives of the devolved government for drug safety regulation.
If the Kenya Drugs Authority Bill, 2022, is passed into law, it will significantly impact the herbal medicine market, emphasizing the importance of adhering to stringent quality and safety standards in the interest of public health.
