TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY
ISO 9001: 2015 CERTIFIED
EXISTENCE OF ONE BATCH OF FALSIFIED GENTRISONE
10G CREAM ON TANZANIAN MARKET
- 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.
- 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.
- 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
- 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.
- The falsified product closely imitates the genuine in many features and it is
difficult to differentiate between the two.
- The only notable difference is on the batch number and validity dates of which
the manufacturer has also declined to have ever manufactured.
- 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
- 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).
- 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.
- 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.
- All wholesalers who unknowingly bought this product are also directed to
return the same to the distributor or TMDA for further guidance.
- 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.
- 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.
- 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.
Acting Director General,
Tanzania Medicines and Medical Devices Authority (TMDA),
Mwanza Street, Block T, Plot No.6,
P. O. Box 1253, Dodoma Or
P. O. Box 77150, Dar es Salaam
Phone: +255 22 2452108/2450512/2450751
Fax: +255 22 2450793