Fake Drugs On The Market – FDA Warns
The Food and Drugs Authority (FDA) is warning the general public to be wary of fake medicines imported into the country from India and being circulated in the various markets through two leading chemical firms; Osons Chemists Limited and Roxin Ghana Limited.
Osons Chemist, according to the FDA in a statement signed and released in Accra yesterday by its Chief Executive Officer, Dr. Stephen K. Opuni , imported and distributed substandard MIMET (Ergometrine) Tablets, manufactured in India by MISSION VIVACARE, 54-B, DRUG HOUSE, PROCTER ROAD, MUMBAI, INDIA.
According to the statement, samples purchased from the market in a joint FDA/United States Pharmacopeia (USP) product quality and monitoring exercise and tested at the FDB’s laboratory proved to be of very low potency.
MIMET (Ergometrine) Tablets, the statement noted, are used to control minor irregular bleeding from the uterus.
Roxin Ghana Limited, on the other hand, according to the FDA, put on the market a counterfeit antibiotic, Rox-Clav 652 Tablets also manufactured in India by RONAK EXIM PVT LIMITED, GENDIGATE, BARODA-1, GUJARAT.
Rox-Clav 652 Tablets, as registered by FDA, the statement noted, contains a combination of Amoxicillin and Clavulanic Acid but samples of the tablet purchased from the market and tested were found to contain no Clavulnic acid, thus, making the product a counterfeit one.
“A combination of Amoxicillin and Clavulanic Acid is used in the treatment of severe infections, therefore, the absence of the Clavulanic acid makes the product dangerous because if such a counterfeit medicine is administered to a patient, it can lead to serious complications with fatal consequences,” argued the statement on the Rox-Clav 652 Tablet.
Mr. Opuni has, therefore, advised against the patronage of the counterfeit Rox-Clav with the following features:
Batch No: BRT115
Manufacturing Date: 08/11
Expiry Date: 07/13
Manufactured by: Ronak Exim PVT LTD
Packaging: 14 Tablets in green and white packet
Osons Chemist, the statement noted, is currently assisting the FDA in its investigations, whilst the importer of the counterfeit Rox-Clav Tablet has been arrested and is assisting the police in their investigation.
Furthermore, the FDA said it has revoked the registration of all medicines registered with it by Roxin Ghana Limited while also revoking the registration of medicines manufactured by Mission Vivacare Limited and Roxin EXIM Pvt Limited.
“The FDA will not permit any medicines to be imported from these companies into Ghana until a Good Manufacturing Practice Audit has been conducted and their facilities found to be of good standard for the manufacturing of safe and quality medicines,” noted Mr. Opuni in the statement
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