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{
    "id": 1336972,
    "url": "https://info.mzalendo.com/api/v0.1/hansard/entries/1336972/?format=api",
    "text_counter": 184,
    "type": "speech",
    "speaker_name": "Seme, ODM",
    "speaker_title": "Hon. (Dr) James Nyikal",
    "speaker": null,
    "content": "Medicines will be regulated separately from professionals which is a major shift from what we have been doing before. In the past, we have regulated veterinary and human medicines together. That has been controversial. There was a feeling that they should be separated. If you look carefully, the chemical molecules of veterinary and human medicines are the same. The molecules in the antibiotics we use are similar to those used by animals. We should address the issue of whether we should split them or not. The other important issue that we are taking a new look at is that of the control laboratory. Currently, the National Quality Control Laboratory is part and parcel of the PPB, yet it has a board of its own. I call it a “kangaroo board” because it is a board within another board, which raises many problems. We need to look at those issues because they are ground- breaking and change-making. I support the Bill because it creates an Authority which will look into issues of licensing, regulation, advertising, and more importantly, manufacturing of medicines and medical devices. Can we locally produce medicines? Regulation of manufacturing is more complex because you are producing the products yourself, therefore, you have to be a lot more careful. The Fourth Schedule of the Bill creates scientific advisory committees that will deal with all these issues. One of the committees that we will create is the National Food Safety Committee. We should look into the amount of chemicals that are used in food. There are also the Human Medicines Committee, the Veterinary Medicines Committee, and the Medical Devices Committee. As I said, medical devices cover a wide area. They cover things like blood- giving sets, X-rays, Magnetic Resonance Imaging (MRIs), and other very complex machines. They all have to be regulated. In addition, we also need to look at how to manage the National Quality Control Laboratory, which will guide on registration and licensing of drugs. The Bill addresses those very important issues. We have to regulate the trade aspect. As much as these are health and medical issues that deal with human life, there is also a trade element because of business interests, which has to be regulated. We have pharmacies all over the country which charge different prices for medicines. That has to be looked at. Medicine wholesalers are also a major part of the regulation system. We should look at that carefully and ensure that it is taken care of. There is also the scheduling drugs so that we know which drugs are used where and by who. We have to look into that complex issue. More importantly, is the issue of international trade. If we get into international trade, particularly the production of medicine, we must abide by good manufacturing practices. The World Health Organisation (WHO) guidelines provide the levels of manufacturing. If one manufactures drugs for a large population, and not just Kenya or East Africa, you have to consider Maturity Level 3 (ML3). That must come out clearly in the Bill. We have to consider how we relate as a country. We have different levels of professionals in the pharmaceutical sector. We have pharmaceutical technologists, who hold diplomas. Pharmacists are at a degree level. We must be very clear and set out proper guidelines on who does what. That must be reflected in the Bill."
}