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{
    "id": 1339682,
    "url": "https://info.mzalendo.com/api/v0.1/hansard/entries/1339682/?format=api",
    "text_counter": 923,
    "type": "speech",
    "speaker_name": "Endebess, UDA",
    "speaker_title": "Hon. (Dr) Robert Pukose",
    "speaker": null,
    "content": "supply scheduled substances, and the sale of such substances, including through electronic or online means. Part VI of the Bill, which comprises clauses 47 and 48 provides for manufacture of medicinal substances upon issuance of a manufacturing license, which is renewable annually by the KDA, as well as compliance with good manufacturing practices. Part VII of the Bill, which comprises clauses 49 to 54 provides for regulation of therapeutic substances or therapeutic cosmetics. Some people apply cosmetics which might be harmful to their skin. This Part prohibits the sale of therapeutic cosmetics that contain substances that may injure the user's health due to lack of adherence to directions on the label, as well as preparation of therapeutic cosmetics under unsanitary conditions. Part VIII of the Bill, which comprises clauses 55 to 59 provides for regulation of medical devices. The Bill penalises the sale of adulterated and sub-standard medical devices, which have not been registered by the KDA. It further requires compliance with standards of manufacturing, labelling, packaging, sale or advertisement of medical devices. Part IX of the Bill, which comprises clauses 60 and 61 establishes the National Quality Control Laboratory, which is responsible for the examination and testing of drugs and any material substance from which drugs may be manufactured, processed or treated, and ensuring the quality control of drugs and medical devices. The National Quality Control Laboratory will be the quality control laboratory for the KDA. It will perform chemical, biological, biochemical, physiological and pharmacological analyses and other pharmaceutical evaluations. It will also be involved in conducting research, training and testing the quality of locally manufactured and imported medicines or medical substances, medical devices or therapeutic cosmetics on behalf of KDA. Part XII of the Bill, which comprises clauses 62 to 70 provides for standards of advertisement and labelling of health products and technologies. All advertisements must be authorised by KDA, especially those related to diseases listed in the Sixth Schedule to the Bill, including HIV/AIDS, leprosy, diabetes, pneumonia, as well as drugs and appliances for procuring abortions. You will often find people placing misleading advertisements on radio or even in print media that certain drugs cure gonorrhoea, leprosy, tuberculosis or HIV/AIDS. That should be controlled. Part XIII of the Bill, which comprises clauses 71 to 87, provides for administration and enforcement of the Act. The Bill makes provision for the general powers of the Cabinet Secretary on recommendations of the KDA to prohibit or control certain medicines or medical devices, and to request further information."
}