TANZANIA is seeking partnerships with multinational firms to ensure local development of drugs. The move follows years of doing without local drug development due to lack of capacity, accredited standards and required infrastructure.
It also comes following the discovery of a plant by a group of researchers in Mahale National Park in Kigoma Region that could be used in breast cancer treatment.
The discovery was a culmination of a series of 40 years of research that might lead to the production of new drugs for hard-to-treat breast cancers.
The medicine is extracted from the plants, christened centratherum anthelminticu, found in the national park. In various interviews yesterday, various experts said there was no existing infrastructure for local drug development as it is also a capital intensive process.
But the Director of Life Sciences of the Commission for Science and Technology (COSTECH), Dr Flora Tibazarwa, told the 'Daily News' that the commission was working on how to get requisite partnerships. "Drug development is also most non existent in Tanzania because of capacity.
Costech is pushing for this. It is due to lack of infrastructure, standards and capital involved," he said. The Public Relations Officer with Ifakara Health Institute, Mr David Mbulumi, said they have not been doing research into Non- Communicable Diseases but the new strategy was to start the research by 2015.
A pharmacist and Production Manager at a drug manufacturing plant, Mansoor Daya Chemicals, Ms Rehema Kasaizi told the 'Daily News' in Dar es Salaam yesterday that translating such findings as the recent one in Kigoma into medical drug reality is a long process that could take over 10 years.
"What we use here are generics. Global pharmaceuticals have to make feasibility studies to see if they can develop such a research finding further or not. It's a long process in a capital intensive industry," she said. Ms Kasaizi noted that in new drug/ medicine development, they are patent (20 years) protected when they are approved for marketing.
"This means that only the developer/manufacturer has the right to market the drug exclusively. Once the patent expires, other drug manufacturers can develop the drug, which will be known as a generic drug (what is done mainly in African pharmaceutical companies).
Generic drugs are way cheaper than the brand name drugs," she observed. On drug discovery and development, she said they identify new molecules including from traditional remedies. Many tests are done on these molecules to determine if they have beneficial effects against diseases.
Studies are done to determine the best way it should be used as a tablet/injection/solution/suspension. She said pre-clinical studies are done to determine the drug's harmful effects/toxicity in humans. These studies are done in the laboratory (test tube studies) and on animals such as rats.
This stage gives insight into whether the drug should be tested in humans. "Clinical studies/trials are done in humans to determine how the drug is going to interact with the human body.
These studies should be designed well to determine which people qualify to take part, how many they should be, for how long the study should run. These studies are divided into phases depending on how many people will participate," she said.
On TFDA approval, she noted that with the information obtained from the drug's early tests, Pre-clinical research and clinical trials; the developer may then apply for a review from the regulatory bodies like TFDA in Tanzania's case. "This body will thoroughly review this information and decide on whether to give approval," she explained.
The recent finding of medicine is extracted from the plants, christened centratherum anthelminticu, found in the national park, which is in Kigoma Region.
"Vernodalin exhibits antimalarial and anti-bacterial activities and is a constituent of Vernonia amygdalina (Compositae), a plant ingested by wild chimpanzees, sometimes suffering from parasite related diseases in the Mahale Mountains National Park, Tanzania," the researchers noted.
According to the researchers, only two studies have so far been done on anti-cancer effect of vernodalin, "which demonstrated cytotoxic activity on melanoma and ovarian cancer cell lines and human arcinoma of the nasopharynx (KB)".