The Food and Drugs Authority (FDA) with the assistance of the Police Drug Enforcement Unit of the Ghana Police CID, has seized a total of 431 bottles of two unregistered herbal medicinal products namely, COVID-CURE (1) and COVID-CURE (2), purported to treat COVID-19, as it violates Section 118(1) of the Public Health Act, 2012 (Act 851), which states
"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 Authority".
The unregistered products, which were being manufactured by Dr. Abdellah Herbal Home at Kojo Ashong, a village near Amasaman, have been falsely labeled to bear forged FDA registration number:'FDB/TMP03709' on both products and also have March 2020 and March 2021 as their manufacturing and expiry dates respectively.
This breaches Section 113(1) of the Public Health Act 2012, (Act 851), which states,
"A person commits an offence if that person labels, packages, sells or advertises a drug, a herbal medicinal product, cosmetic, medical device or household chemical substance
(a) in contravention of Regulations or Guidelines made under this Part, or
(b) in a manner, that is false, misleading or deceptive or misbranded as regards its character, constitution, value, potency, quality, composition, merits or safety."
Additionally, FDA's visit to the manufacturing premises revealed that the products were being manufactured under unhygienic conditions, which is in contravention of Section 115 (1b) of the Public Health Act 2012, (Act 851), which states
"A person shall not manufacture a drug, herbal medicinal product, cosmetic, medical device or household chemical substance for sale unless
(b) the conditions under which the manufacture is to be carried on are as specified in the Guidelines of the Authority to ensure that the article will be of good quality and safe to use".
Moreover, results of Laboratory analysis on the product conducted at the FDA's ISO 17025-2017 Accredited Laboratory revealed that the products do not meet the requirements of Total Aerobic Microbial Count and Total Yeast and Moulds Counts as per the British Pharmacopeia specifications, which makes the products unsafe for use.
The quality, safety and efficacy of these products CANNOT be guaranteed by the FDA since the products have not been registered by the Authority.
The FDA wishes to reiterate that it has not registered any product for the treatment or cure for COVID-19 and therefore cautions the general public against patronizing such products.
Manufacturers, producers and distributers are to ensure that products have been duly approved by the FDA before putting such on the market.
Meanwhile, the police have arrested Dr. Abdellah, the Director of Dr. Abdellah Herbal Home and his Research Assistant, Dr. Abdul Samad Bin Musa, who are assisting the Police with investigations into the matter.
The FDA wishes to emphasize that the protection of the general public is its prime objective and all activities are designed to provide continuous assurance of safety of all foods, medicines, cosmetics, household chemicals and medical devices.
DELESE A. A. DARKO (MRS)
(Chief Executive Officer)
The FDA exists to protect public health by assuring the safety, efficacy and security of human and veterinary drugs, food, biological products, cosmetics, medical devices, household chemical substances, tobacco and the conduct of clinical trials in the country.