ZFDA main responsibility is stated in
the Zanzibar Health policy, 2011 and its mandate is stipulated in the Zanzibar
Food, Drugs and Cosmetics Act (ZFDCA), No. 2/2006 and it’s Amendment Act
No.3/2017. The act provides for the efficient and comprehensive regulation and
control of safety and quality of food, medicines, cosmetics, medical devices
and diagnostics in Zanzibar. Specific functions of ZFDA as prescribed in
section 4 of the ZFDCA include the following:-
- Regulate all matters relating to quality, safety of food, drug, herbal drug, cosmetics, medical devices, and diagnostics;
- Regulate in accordance with this Act, the importation, manufacture, labeling, marking or identification, storages, promotion, sell and distribution of food, drug, cosmetics, herbal drugs and medical devices or any materials or substances used in the manufacture of products regulated under this ZFDCA;
- Ensure that evidence of existing and new adverse events, interactions and information about pharmacovigilance of products being monitored globally, are analyzed and acted upon;
- Ensure that, clinical trials on drug, medical devices and herbal drugs are being conducted in accordance with prescribed standards;
- Foster co-operation between the Agency and other institutions or organizations and other stakeholders;
- Approve and register products regulated under this Act, manufactured within or imported into, and intended for use in Zanzibar;
- Examine, grant, issue, suspend, cancel and revoke certificates and licenses or permits issued under this Act;
- Appoint Inspectors and order inspection of any premises;
- Promote rational use of drugs, medical devices and herbal drug;
- Provide the public with unbiased information on products regulated under this Act;
- Regulate standards of quality in respect of products regulated under this Act, manufactured or intended to be manufactured or imported into or exported from Zanzibar;
- Maintain registers prescribed under this Act;
- Promote, monitor and ensure successful implementation of the provisions of this Act;
- Attend to and, where possible, take legal measures on complaints made by consumers against manufacturer, distributor, supplier, wholesaler and retailer of products regulated under this Act;
- Carry out such other functions as may be conferred upon the Board by any written law or as are incidental to the performance of its functions under this Act;
- Do such acts or take such measures as are, in the opinion of the Board, necessary or expedient for the prevention of health hazards to consumers which may result from the consumption or use of low or bad quality products regulated under this Act;
- To deregister the circulation of pharmaceutical due to substandard, counterfeiting, or changes in different standard treatment guidelines and policies;
- To prescribe guidelines on accepting donation of food, drugs, cosmetics, medical devices and herbal products;
- Control and where necessary take legal measures on improper disposal of products regulated under this Act;
- Conduct post marketing surveillance of safety and quality of medical products
