TSE and BSE anti quality agents

TSE and BSE . TSE (Transmissible spongiform encephalopathy) and BSE(Bovine spongiform encephalopathy) could be called as anti quality agents in pharmaceuticals because the risk is never zero to understand this we will give a deep look into the matter .

BSE(Bovine spongiform encephalopathy) – BSE is basically the disease of cattle also known as mad cow disease in which the brain looks spongy and pores could be clearly seen in brain under microscope

TSE (Transmissible spongiform encephalopathy) – As the name indicates transmissible it is transmitted from cattle to humans via prions

Prions are the form of proteins commonly present in cells but in diseased case these prions show surprisingly new characteristics they form  folds and resists temperature , radiation ,freezing thus forming a stable disease causing protein . yet there is no effective treatment for the disease so prevention is must .

TSE is not caused from air contamination or any casual contact but it can be transmitted from infected fluid , blood contact .

Symptoms of TSE include loss in memory , jerking of organs , lack of coordination in organs as well as psychiatric issues

TSE/BSE a headache to regulatory authorities .

many regulations have been forwarded to control like TSE and BSE certificates requirements but as we know it is not possible to manufacture medicines with total elimination of animal products . and there is risk of disease with animal products so there is long way down for pharmaceuticals both the way  .

However many initiatives have been taken by the regulatory authorities worldwide to control the disease and so far they have been successful but we can be never 100% sure as the topic of article indicates .

Most risk of the disease is from Gelatin which is largely used in capsule manufacturing although other products are also there like Carmine dye , Glycerin .

TSE and BSE certificates should have detailed description of  country of origin and parts of animal used in manufacturing of particular product .

Certain countries have been declared with negligible risk of TSE and BSE by regulatory authorities which can seen in draft issued by WHO for  it also contains other regulatory requirements for TSE and BSE .