Customs, Excise and Gold Tribunal - Delhi
Intercare Ltd. vs Commissioner Of Customs on 24 November, 2000
Equivalent citations: 2001(128)ELT203(TRI-DEL)
ORDER Jyoti Balasundaram, Member (J)
1. The authorities below have denied the benefit of exemption from duty in terms of SI. No. 9 of the Table annexed to Notification No. 13/95-Cus. "Agglutinating Sera" imported by the appellants herein on the ground that the goods are not identifiable as 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 SI. No. 216 of the Schedule appended thereto. The relevant extracts from the Tribunal's Order (supra) are reproduced below:
"3. Let us first examine as to what is meant by "agglutinating sera".
3.1 Serum is the fluid fraction separated from blood after clotting. In the Hawley's Condensed Chemical Dictionary, 11th Edition, 'serum' is defined as follows:
"Serum (1) the continuous phase of a biocolloid after the solid or disperse phase has been removed by centrifugation, coagulation or simi- lar means. In the case of milk, for example, the serum or whey is a true solution of sugars, proteins and mineral compounds in water.
(2) Specifically blood from which corpuscles, platelets, etc., have been removed, especially when prepared with antigenic bacteria for inoculation to effect the cure of a disease."
Butterworths Medical Dictionary, Second Edition defines Serum as :
"The yellowish fluid that remains after whole blood or plasma has been allowed to clot. It is free from cells and it will not clot again."
3.2 When an antigen is introduced in an animal, antibodies are produced in the serum. Butterworths Medical Dictionary, Second Edition defines antigen as under:
"A substance which, under suitable circumstances, can stimulate a specific immune response (immunogenicity) and can react specifically with the antibody or cells associated with that response (reactivity)".
Thus the animal becomes immunised against that particular antigen. Butterworths Medical Dictionary defines antibody as under :
"Serum protein with the molecular 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 an-tiserum. Dorland's Pocket Dictionary, 2nd Edition (page 50) describes 'antise-rum' as : 'A serum antibody(ies) obtained from an animal immunised either by injection of antigen or by infection with micro-organism, containing antigen'. Butterworths Dictionary defines antiserum as under :
"A general term for serum (human or animal) containing antibodies, produced naturally or artificially, to pathogenic microbes or their products, e.g. bacterial toxims (antitoxin)".
Depending on the antigen which is injected into the animal, the antiserum containing specific antibody will be produced. For example, if HCG as an antigen is injected in the animal, then the antiserum will contain antibody to the HCG. Likewise, if Salmonella is injected, the antiserum will contain antibody to Salmonella. In both cases they are antisera but containing different types of antibodies. Generally, antisera contain a heterogenous mixture of different antibodies of varying specificity and affinity. These antibodies are commonly known as polyclonal antibodies. For testing as well as for other purposes polyclonal antibodies are not able to give specific results and, therefore, it becomes necessary to purify them to obtain monoclonal antibodies which react to specific antigens. Monoclonal antibodies are antibodies produced by a culture derived from a single cell. These antibodies recognise a single determinant or structure of a given antigen.
3.3 The general procedure for producing monoclonal antibodies has been described in Kirk Othmer Encyclopaedia of Chemical Technology Vol. 23, pages 637 & 638 as follows :
"A mouse is immunised with a purified antigen or a mixture of antigens. Spleen cells, which produce 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 immunoassay or enzyme-linked immunosorbent assay (ELISA). Cultures positive for the desired antibody, which are designated hybridomas, are cloned or purified by the limiting dilution method or the soft agar plate method. The clones are stored frozen grown in large tissue cultures to produce the antibody, or injected into animals to produce myelomas that secrete the antibody. Monoclonal antibody technology provides a practically unlimited supply of uniform highly specific antibodies."
The monoclonal antibodies are often freezedried for giving them a longer shelf life and easy storage and transportation. The process of freeze-drying is technically called 'lyophilization'. Lyophilization is defined as under :
"This is a process by which biologically active substances or their preparations such as blood, plasma, serum, vaccine, enzymes hormones and other similar substances or their derivatives are rendered in the solid (usually powdery amorphous or crystalline) form from their solution phase by using rapid freezing and high vacuum water evaporation process. It is a very important step in the process of manufacture of biologically active substances because lyophilization provides a far extended shelf life with close to 100% biological inactivity order recommended storage conditions compared to the native form or its purified preparation. The restoration of total biological activity of the lyophilized preparation could be brought about by its re-constitution with distilled, deionized 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" specifically made by Anand Brothers, New Delhi indicates that the Drug Controller of India has issued Form 10 for import of 21 categories of agglutinating sera which have also been certified by the Head of the Department of Lady Hardinge Medical College, New Delhi and it is clear that these agglutinating sera are in liquid or freeze-dried form and the clarification obtained by the Department from M/s. Modi Biotek (page 113 of the paper book) about the process of lyophilization which has already been set out earlier in this order. Therefore, the first reason for holding that the imported product is not agglutinating serum is not a valid reason...."
3. Following the ratio of the earlier order cited supra, we hold that the benefit of Notification No. 13/95-Cus. (successor to Notification No. 208/81) is available to the imported goods, set aside the impugned order and allow the appeal.