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13.02.2013 General News

Alert: Osons Chemists, Roxin Ghana import fake medicines from India

By Food and Drugs Authority
Alert: Osons Chemists, Roxin Ghana import fake medicines from India
LISTEN FEB 13, 2013

The Food and Drugs Authority (FDA) wishes to alert the general public about the circulation of fake medicines imported and put on the Ghanaian market by Osons Chemist Limited and Roxin Ghana Limited.

Osons Chemist Limited imported and distributed substandard MIMET (Ergometrine) Tablets, which is manufactured in India by MISSION VIVACARE, 54-B, DRUG HOUSE, PROCTER ROAD, MUMBAI, INDIA. Mimet Tablets purchased from the market during a joint FDA/United States Pharmacopeia (USP) product quality monitoring exercise and tested at the FDA laboratory were found to be of very low potency.

MIMET (Ergometrine) Tablets are used to control minor irregular bleeding from the uterus.

Roxin Ghana Limited, on the other hand, put on the market a counterfeit antibiotic, Rox-Clav 625 Tablets which is manufactured in India by RONAK EXIM PVT LTD, GENDIGATE, BARODA-1, GUJARAT.

Rox- Clav 625 Tablets, as registered by FDA, contains a combination of Amoxicillin and Clavulanic Acid but samples of the tablet purchased from the market and tested were found to contain no Clavulanic 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.

The general public is therefore advised against the patronage of the counterfeit Rox-Clav, which has 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

With regards to Mimet Tablets, samples submitted to the FDA for registration met all the quality requirements and therefore the product was registered but afterwards, samples taken from the market and analysed at the FDA laboratory were found to be substandard.

The importer of the substandard MIMET Tablets, Osons Chemist is 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 Food and Drugs Authority has revoked the registration of all medicines registered with it by Roxin Ghana Limited.

The Food and Drugs Authority has also revoked the registration of medicines manufactured by Mission Vivacare Limited and Roxin Exim Pvt Limited, manufacturers of the substandard and counterfeit medicines.

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.

Additionally, information from the general public on persons in any practice possible of endangering public health and safety with respect to FDA's mandate is most welcomed through any of the following contact numbers; 0244337235, 0246809509, 0244337252 or 0544863418.

DR. STEPHEN K. OPUNI
CHIEF EXECUTIVE

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