Precious Fella Makafui, a Ghanaian actress and influencer, was arrested on 22nd May, 2024 for the sale of unregistered drug products. The arrest was effected at the instance of the Pharmacy Council of Ghana-the body charged with the regulation of the sale and distribution of medicines.
What triggered Fella’s arrest is her open and overt peddling of products promising remedies for fibroid obesity etc and it would seem these products – whether categorized as drugs or cosmetics – require statutory approval by the Food and Drugs Authority (FDA)
The law in relation to the sale and advertisement of drugs and related products.
Under Section 80(1) of The Public Health Act, 2012 (Act 851) the enabling act of the FDA, the FDA shall inter alia enforce standards for the sale of food, herbal medicinal products, cosmetics, drugs, medical devices and household chemical substances.
The Pharmacy Council, established by Section 78(1) of the Health Professions Regulatory Bodies Act, 2013 (Act 857), ensures and secures the highest standards in the practice of the sale and distribution of medicines in the country. Together, these two statutory bodies assist in achieving food and drug safety.
Relating to the FDA, Section 118 of Act 851 states that a person shall not manufacture, prepare, import, export, distribute, sell, supply or exhibit for sale a drug, herbal medicinal product, cosmetic, medical device or household chemical substance unless the article has been registered by the FDA.
In other words, no drug, herbal medicinal product, cosmetic or any of the above listed items shall be manufactured, sold, imported, supplied etc if it has not been approved by the FDA. It follows that, if the FDA has not approved a medicinal or related product/article, no individual or organization can import, export, manufacture, distribute or sell same.
Further, under Section 118(4), the FDA may also approve registration of the above stated items subject to conditions it may impose where a person makes an application for registration and the FDA conducts the necessary investigation and is satisfied that the product is suitable for its intended purpose. This provision empowers the regulator to register products only after the necessary investigations have been carried out.
Worthy of note is the fact that a person shall not manufacture a drug, herbal medicinal product unless the manufacturing operation is carried on or is supervised by a pharmacist or a qualified person approved by the FDA as having specialist knowledge in the article to be manufactured and the manufacture will be carried out in conditions specified in the guidelines of the FDA per Section 115 of Act 851. Thus, drugs and other medicinal products must be manufactured under the auspices and supervision of a pharmacist or an individual approved by the FDA and the conditions under which manufacturing occurs must satisfy the guidelines of the FDA.
Still, the FDA MUST AUTHORISE advertisement of a drug, a herbal medicinal product, cosmetic, medical device or household chemical substance. Of crucial importance is the fact that, while subsection (1) of section 114 of Act 851 allows certain advertisements to be made provided they’ve been approved by the FDA, a person shall however not advertise a drug, a herbal medicinal product, medical device or cosmetic for the treatment or cure for diseases specified in the Fifth Schedule, and the diseases specified in the Fifth Schedule include but are not limited to infertility, alcoholism, deafness, heart disease, fibroid, obesity, epilepsy or fits, diseases of the reproductive organ among others.
Accordingly, an individual shall not advertise the above stated products unless the FDA has approved such an advertisement. Note that for certain diseases such as infertility, fibroid among others, advertisements of products for curing same are barred.
What is the likely punishment?
An individual who does not follow through on the above requirements breaches the law and if found guilty is liable on summary conviction to a fine of not less than 7,500 penalty units and not more than 15,000 penalty units or to a term of imprisonment of not less than 15 years and not more than 25 years or both.
The actress has however been granted bail pending further investigations. Stay tuned.
Ibrahim Zulaiha a student at MountCrest University, Faculty of Law contributed to research
