Quality and safety control of COVID-19 herbal medicine
MM, MwanzaThere are two principal legislation that provide a legal framework for control of the quality, efficacy and safety of traditional and alternative medicine in Tanzania. The two legislations are Tanzania Medicines and Medical Devices Act [Cap.219 R.E 2021] and the regulations made under it, and the Traditional and Alternative Medicine Act, 2002. The Tanzania Medicines and Medical Devices Act establishes the Tanzania Medicines and Medical Devices Authority (TMDA) which is the regulatory authority vested with power to control safety, efficacy and quality of herbal drugs, medicines and medical devices. Section 3 of the Act defines the herbal drug as “labelled preparation in pharmaceutical dosage which contains as active ingredients one or more substances of natural origin that are derived from plants”. TMDA therefore regulates safety, efficacy and quality of traditional medicines that are labelled and are in a form of pharmaceutical dosage.
In regulating herbal drugs, the Act requires local manufacturers, suppliers or distributors of herbal drugs to be registered with TMDA before the herbal drug is distributed for use by the population. In addition to that, the law demands that the premises in which the herbal drug is stored, manufactured, supplied or sold also be registered by TMDA. Further, any advertisement, packaging and labelling of traditional medicine requires approval of TMDA.
If the traditional medicine is not labelled and not in pharmaceutical dosage, its quality, efficacy and safety is regulated by the Traditional and Alternative Health Practice Council which is established under the Traditional and Alternative Medicine Act, 2002.
All in all, we confirm that traditional medicines that are locally produced or distributed to fight the COVID-19 pandemic are regulated by TMDA and the Traditional and Alternative Health Practice Council, depending on the nature of the herbal medicine whether it is labeled and in a form of pharmaceutical dosage or not.