TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY

ISO 9001: 2015 CERTIFIED

PUBLIC NOTICE

EXISTENCE OF ONE BATCH OF FALSIFIED GENTRISONE
10G CREAM ON TANZANIAN MARKET

1. Tanzania Medicines and Medical Devices Authority (TMDA) is an executive agency under the Ministry of Health, Community Development, Gender, Elderly and Children which was established on 1st of July 2019 after the amendment of the Tanzania Food, Drugs and Cosmetics Act, Cap 219 done through the Finance Act of 2019.
2. TMDA has replaced Tanzania Food and Drugs Authority (TFDA) and it is now responsible for regulation of medicines, medical devices and diagnostics while the Tanzania Bureau of Standards (TBS) has assumed the responsibilities of regulating food and cosmetic products.
3. TMDA would like to notify the public that through its surveillance system it has encountered a falsified product by the name of Gentrisone 10g cream with labels purported to be manufactured by a company namely Shin Poong Pharm Co. Ltd, Republic of Korea and distributed by K&C Trading Co. Ltd of Dar es Salaam.
4. The falsified medicinal product has a fake batch number GNTRO X030 printed on labels with fake manufacturing date of 21. 04. 2019 and expiry date 20. 04. 2022 together with a registration number TAN00. 368 D07C SHI.
5. The falsified product closely imitates the genuine in many features and it is difficult to differentiate between the two.
6. The only notable difference is on the batch number and validity dates of which the manufacturer has also declined to have ever manufactured.
7. Laboratory investigations done on samples of the falsified product have confirmed that there are no active pharmaceutical ingredients (i.e Betamethasone diproprionate 0.64mg, Clotrimazole 10mg and Gentamycin Sulfate 1mg) on this product. And above all, the falsified product does not emanate the smell of the medicines that commonly comes out after opening of the tubes.
8. Following detection of this product, the TMDA has taken various steps to embrace recalling from the market a total of 4,188 tubes from regions (i.e. Mwanza - 1,814 tubes, Dar es Salaam – 931 tubes, Dodoma - 591 tubes, Tabora - 29 tubes, Arusha – 6 tubes and Mtwara - 817 tubes).
9. Since the intelligence and surveillance of this product was done in collaboration with the Police Force, culprits and one cyclist who were caught distributing the falsified product are under Police custody for further interrogation on the entire network.
10. With this public notice, the general public is instructed to scrutinize the tubes to look for the implicated batch (i.e. GNTRO X030) and return the same to the pharmacy where they had purchased.
11. All wholesalers who unknowingly bought this product are also directed to return the same to the distributor or TMDA for further guidance.
12. Nonetheless, it should be noted that only one batch (i.e. GNTRO X030) has been confirmed to be falsified and the rest of other batches that exist on the market are genuine and they can continue to be used for the treatment of skin infections to include itching, pruritus, eczema, dermatitis, skin burns and other fungal and bacterial skin infections, as the product has been registered for these types of conditions.
13. The regulation of quality, safety and efficacy is an ongoing process under the TMDA mandate and we are still vigilant and conducting regular post marketing surveillance activities to detect any other substandard and falsified products that might cross borders and reach our market.
14. The public is finally encouraged to report any suspected substandard or falsified medical product that they may encounter including all those who are engaged in the clandestine manufacturing, illegal smuggling and selling of such kind of products for regulatory actions to be taken by TMDA instantly.