Viswanathan C
National Plasma Fractionation Centre, KEM Hospital, Parel, Mumbai.
Indian J Pediatr. 2001 Jan;68(1):69-75. doi: 10.1007/BF02728866.
Blood is defined as a 'drug' under the Drugs and Cosmetics Act. The Standard of drugs is laid down in the Indian Pharmacopoeia. The first step towards blood safety is to encourage blood donations, which are voluntary, non-remunerated and obtained from low-risk and regular donors. A regular donor is one who donates blood two to three times a year and continues to donate at least once a year. Over the last 8 years, the Drug Control Authority has been taken up many steps to improve the quality of blood in circulation. As a result, blood centres are now equipped with minimum modern tests for making blood safer. The inspectors are also emphasising the need to employ uniform procedures for donor selection, donor deferral, validation of equipment, and so on. Over the last 5 years, quality control of diagnostic kits prior to their registration and marketing have been streamlined to ensure that blood centres use highly sensitive kits while testing for blood transmissible diseases. Therefore, current methods of donor screening and testing of donated blood have led to a remarkable decrease in the incidence of transfusion-transmitted infection and a blood supply that is very safe. The greatest threat to blood safety is donation by seronegative individuals during the infectious window period when they are undergoing seroconversion and infection cannot be detected by available laboratory tests. Look-backs is the process whereby blood collection facilities attempt to indentify prior recipients of blood donated by individuals who subsequently test positive TTD. This alone can assure safety.
根据《药品和化妆品法案》，血液被定义为一种“药物”。药品标准在《印度药典》中有规定。保障血液安全的第一步是鼓励自愿、无偿献血，献血者应为低风险且定期献血的人群。定期献血者是指每年献血两到三次且持续每年至少献血一次的人。在过去八年里，药品管理局采取了多项措施来提高流通血液的质量。因此，血液中心现在配备了最低限度的现代检测手段以使血液更安全。检查人员也在强调在献血者选择、延期献血、设备验证等方面采用统一程序的必要性。在过去五年里，诊断试剂盒在注册和上市前的质量控制得到了简化，以确保血液中心在检测血液传播疾病时使用高灵敏度的试剂盒。因此，目前的献血者筛查和所献血液检测方法已使输血传播感染的发生率显著下降，血液供应非常安全。血液安全面临的最大威胁是处于感染窗口期的血清学阴性个体献血，此时他们正在经历血清转化，现有实验室检测无法检测出感染。追溯是指血液采集机构试图识别那些随后检测出输血传播疾病呈阳性的个体所献血液的先前受血者的过程。仅此一项就能确保安全。
