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2000 (11) TMI 497

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..... sera because sera is a fluid fraction separated from blood after clotting, while imported goods were in freeze dried form. 2. We have heard Ms. Reena Khair, Learned Counsel and Dr. D.K. Verma, SDR. The Bill of Entry describes the goods as Agglutinating Sera for detection of Human Chorionic Gonadotrophin in Urine classifiable under Customs Tariff Heading 3002.10. We find that in the importers own case reported in 1997 (89) E.L.T. 545, the Tribunal has accepted the contention of the importers that agglutinating sera can either be in liquid form or freeze dried form, and that the freeze dried form is also eligible to exemption from duty in terms of Notification No. 208/81 at Sl. No. 216 of the Schedule appended thereto. The relevant extr .....

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..... ar properties of an immunoglobulin. Antibodies are produced in the body by cells of thelymphoid series, especially plasma cells in response to stimulation by an antigen. Antibodies are usually referred to according to the method for their demonstration, e.g. precipitating, agglutinating or complement-fixing, and as they react specifically with their corresponding antigens their specifically makes them useful laboratory reagents for the recognition of the latter Antibody serum taken from the blood of an immunised animal is called antiserum. Dorland s Pocket Dictionary, 2nd Edition (page 50) describes antiserum as : A serum antibody(ies) obtained from an animal immunised either by injection of antigen or by infection with micro-organism .....

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..... antibodies but cannot be cultured in vitro, from the immunised mouse are fused in the presence of poly (ethylene glycol) with mouse myeloma cells deficient in the enzyme hypoxanthine-guanine phosphoribosyltransferase (HPGRT). These myeloma cells can be cultured in vitro, but die in the presence of a medium containing hypoxanthine-aminopeterin- thymidine (HAT). After the fusion, the cells are distributed into individual cell cultures containing the selective HAT medium and are incubated. Only the cells that have been successfully fused grow. Two to four weeks later, culture medium from the growing cells (the hybrids) is examined for the presence of the specific antibody of interest by using a very sensitive method, e.g. solid phase radio imm .....

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..... ed water or by appropriate buffer solution. The shelf life of such re-constituted product is very short from few days to few weeks only especially in connection with the diagnostic kits. Butterworths Medical Dictionary defines lyophilization as : A method used for the preservation of sera, plasma, bacteria, viruses, or tissues by drying them from the frozen state in vacuo. 4. The appellants clarified that if any antiserum is to be used for diagnostic purposes and if it is to be given a longer shelf life for the convenience of transport and storage, it is necessary to freeze-dry it. This stand is supported by the recital in paragraph 6 of the show cause notice that the scrutiny of some of the imports of "agglutinating sera" specific .....

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