Title: STATUS OF TRADITIONAL MEDICINE REGISTRATION IN TANZANIA MAINLAND
Authors: Marko Hingi¹ , Ndahani Msigwa¹ , Eleonorah Erio¹ , Patrick Seme¹ , Ayoub Konah4 , Sigfrid Makoi¹ , Lucy Mziray² , Liggyle Vumilia² , Ruth R. Suza¹ , Rose S.Muhangwa5 , Paulo P. Mhame² , Edmund J. Kayombo³
1. Traditional and Alternative Health Practice Council, Ministry of Health, Community Development, Gender, Elderly and Children. P,o.Box 743, Dodoma, Tanzania.
2. Traditional Medicine Section, Ministry of Health, Community Development, Gender, Elderly and Children. P.o.Box 743, Dodoma, Tanzania.
3. Institute of Traditional Medicine, Muhimbili University of Health and Allied Sciences, P.o.Box 65001, Dar es Salaam, Tanzania.
4. Health Laboratory Practitioners Council, Ministry of Health, Community Development, Gender, Elderly and Children. P.o.Box 743, Dodoma, Tanzania.
5. World Health Organization. P.o.Box 9292, Dar es Salaam, Tanzania.
Background: In Recent years there have been an increase of Traditional Medicine utilisation in Tanzania. The safety of traditional medicine products (medicines) has been of less concern by general public. Traditional and Alternative Health Practice Council is a professional body responsible for regulating and monitoring both practice and products (traditional medicines) in Tanzania. In order to serve the interest of the profession, the Council introduced mechanism of observing the safety of the traditional medicines used in the practice of traditional medicine in the Country.
Methods: In 2017, the council introduced procedures regarding safety observations to all marketed traditional medicines and started to register traditional medicines based on safety laid down criteria. For traditional medicines to be registered it requires to pass through different government agencies for plant identification, toxins including aflatoxins, heavy mental and microorganism contamination screening under appropriate laboratory techniques and finally medicines registration committee approves and council issue a traditional medicines certificate of registration.
Results: In 2017 to May 2019, a total number of 23 applications of traditional medicines were filled and scrutinized. All applications of traditional medicines were assessed by the registration committee. 13 applications which were 56.5 percent were approved by the committee and hence registered. 10 applications which were 43.5 percent were not approved by the committee and hence not registered. The reasons for failure to register were mainly due to contaminations of either fungus causing aflatoxins or other microbiology and mycology contaminations. Among the prevailing microbiological and mycology contaminants were Staphylococcus spp (10%), Escherichia coli (15%), Total Plate Count (20%), Aerobic Bacteria (35%) and fungi/molds (20%). The result shows that many of the manufacturing facilities does not observe cleanliness during the processing from harvesting, drying, grinding and
other manufacturing procedures, thus causing such enormous contaminations.
Conclusion: The existing of microbial contaminations explains the status of the understanding during the manufacturing process. Therefore there is a need to provide education to traditional health practitioners; traditional medicine manufactures to adhere to basic good manufacturing process of their traditional medicines as well as the
importance of submitting their samples for contamination screening to relevant laboratories before submitting their products for registrations. Lastly, the importance of educating the population on the need for the community to emphasize the safety for the registered traditional medicines in the market.