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TMI Blog1996 (10) TMI 201X X X X Extracts X X X X X X X X Extracts X X X X ..... aining buffer solution in glass tube. The labels found with the goods, indicated them as Biological Diagnostic Reagents . The importers catalogue printed in India indicated that the product is about Pregnancy diagnosis through colour change (SPIA technique). Based on the above, the Department was of the view that the goods were not Agglutinating Sera but a pregnancy test kit/Diagnostic reagents for detecting HCG in urine. Trade enquiries revealed that the term Agglutinating Sera would not cover the pregnancy test kits as imported. An opinion was sought from National Institute of Immunology, who clarified, vide their letter dated 30-3-1993 that though the above mentioned kit uses an antibody which is agglutinating in nature, the kit itself does not fall under the category of Agglutinating Sera". Therefore, it appeared that the goods are actually composite diagnostic and laboratory reagents other than those of Customs Tariff Heading 30.02 or 30.06, and classifiable under sub-heading 38.22, that the importers had deliberately misdeclared the goods as Agglutinating Sera only for the purpose of getting the benefit of Notification No. 208/81 and had rendered the goods liable ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... 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 immunoglobutin. 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, 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). ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ovides a practically unlimited supply of uniform highly specific antibodies. The monoclonal antibodies are often freeze-dried 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 vaccum 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 reconstitution with distilled, deionized water or by appropriate buffer solution. The shelf life of such re-constituted product is very short fr ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... is then subjected to the process described above, which refines polyclonal antibodies and produces monoclonal antibodies specific to the antigen HCG. These monoclonal antibodies are then freeze-dried and coated on colloidal gold particles known as SOL particles. The SOL particle acts as a carrier for easy visual detection of the agglutinating reaction of agglutinating sera with HCG antigen in the urine of the pregnant woman. 3.6 From the Collector s order, it appears that there is no dispute with regard to facts upto this stage and he seems to consider monoclonal antibodies as agglutinating sera. However, he seems to consider the appellants product not to be an agglutinating sera for three reasons : (i) that it is in a solid form because of freeze-drying, (ii) that it is coated on a carrier, that is SOL particle, and (iii) that it is in a kit form. The appellants clarify 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. Secondly, the carrier, that is, the SOL particle is necessary because the agglutinating reaction is not visible to the naked e ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ection. The basic principle based upon the finding that HCG is a protein with antigenic properties, was to produce a substance which could detect this HCG antigen which was realised by the antibody response. The drawback in this method was that there are other substances in the urine which is tested for HCG, which resembles HCG, giving rise to false positive results for pregnancy. In 1975, the method of preparation of monoclonal antibodies was discovered. This consists of cell fusion technique. The pregcolor test is based on modern technique known as SOL particle immuno assay (SPIA) technology in which colloidal particles composed of metallic compounds act as carriers. The size of the colloidal particles vary between 1 to 200 mm which forms a smooth suspension in a liquid. The dispersion of these colloidal particles in water/buffer solution are called SOL particles and in Pregcolor, gold particles are chosen as a carrier. The important property of SPIA technique is the change of original colors of the properly dispersed particle upon agglutination. From the above, we are satisfied that the agglutinating sera SOL particle is necessary for the purpose of accurate detection of the pre ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... e Tribunal in the case of Collector of Customs, New Delhi v. Ethnor Ltd. reported in 1996 (86) E.L.T. 558 (Tribunal) = 1996 (16) RLT 166 (CEGAT), pregnancy detection kits bearing trade name of Clear View HCG have been held to be covered by the description Elisa Diagnostic Tests mentioned at Sl. No. 155 of Notification No. 208/81. The list of life saving drugs or medicines stipulated in the notification covers a number of other tests e.g. blood group sera (Sl. No. 215), Enzyme linked Immunoabsorbent Assay Kits Elisa Kits (Sl. No. 186). This clearly indicates that the list appended to the notification covers diagnostic kits also. It is relevant to note at this juncture that the HSN Explanatory Notes to Heading 30.02 states that antisera are used against dysentery, pneumonia, snake bite, allergic diseases, etc. and are also used for diagnostic purposes, including in vitro tests and specific immunoglobulins are purified preparations of antisera. 7. The stand of the appellants that the imported item is agglutinating sera is further fortified by opinions furnished by leading Doctors attached to Government and Private hospitals from all over India, e.g. from the Associate Professor ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... een ruled out apparently because it is in kit form. We have already held earlier that the import of the product is in kit form is not detrimental to the claim of the appellants that what they imported was agglutinating sera. The criterion for value addition is not also relevant for the purpose of this case. On the other hand, the appellants have produced opinion from the Department of Biotechnology, Ministry of Science and Technology, which is the administrative department to give technical clarification on pharmaceuticals diagnostic based on bio-technology techniques. In this letter dated 23-8-1993 (page 196 of the paper book) it is certified that the item Preg color as presently marked is agglutinating sera. 8. In the light of the above, we hold that the imported item is agglutinating sera, covered by the description in Sl. No. 216 of the Schedule appended to the Notification No. 208/81. 9. Lastly, even though there is no finding on classification of the imported product - the appellants had filed a Bill of Entry claiming classification under 3002.90, while the show cause notice proposed classification under Heading 3822.00 as composite diagnostic or laboratory reagents othe ..... X X X X Extracts X X X X X X X X Extracts X X X X
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