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TMI Blog2013 (8) TMI 788X X X X Extracts X X X X X X X X Extracts X X X X ..... on antigens or monoclonal antibodies derived from culture of micro-organism are not covered by Heading 30.02 and this heading covers only the “cultures of micro-organism”, not the reagents derived from micro-organism cultures. This contention of the Revenue is not correct In terms of Span Diagnostics Ltd. v. CCE, Surat[2007 (4) TMI 617 - SUPREME COURT OF INDIA] the product group “Antisera and other blood fractions” in Central Excise Tariff 30.02 would also include modified immunological products, whether or not obtained by biotechnological process.. HIV detection kits and Hepatitis C detection kits containing antigens obtained from micro-organism cultures, immobilised on a porous immuno-filtration membrane and which work on antigen-antibody reaction (neutralisation) would be covered by Heading 30.02, as in view of the above-mentioned HSN explanatory notes, this heading includes the diagnostic reagents of microbial origin other than those covered by Chapter Note 4(d) [corresponding to Chapter Note 3(d) of Central Excise Tariff Chapter 30], which covers - “Opacifying preparations for X-ray examination and diagnostic reagents designed to be administered to patients, being unmix ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... Antigen to obtain distinct colour. As the patient s sample passes through the membrane, HIV antibodies, if present in the sample, react with the immobilised Antigen and produce a distinct colour. 1.2 Main ingredient of Hepatitis B detecting kit is a combination of monoclonal and polyclonal antibodies. Monoclonal antibodies obtained from the cultures of Micro-organism are conjugated to colloidal gold. The monoclonal antibodies conjugated to colloidal gold and polyclonal antibodies are immobilised on a nitrocellulose strip. When the test sample comes in contact with this strip and if the test sample contains the HbsAg Antigen, it binds with the monoclonal and polyclonal antibodies immobilised on the strips producing a distinct colour, due to formation of an antibody-antigen-antibody colloidal gold complex. 1.3 For making Hepatitis C detection kit the main ingredients is HCV antigen obtained from micro organism culture which is immobilised on a porous immuno-filtration membrane, alongwith a colour conjugate (Protein A), also obtained from the culture of micro organism. When the sample comes in contact with the test membrane and if the sample contains the HCV antibodies, the same c ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ex Court in the case of Span Diagnostics Ltd. v. CCE, Surat reported in 2007 (211) E.L.T. 521 (S.C.) has held that the blood grouping reagents based on monoclonal antibodies are correctly classifiable under Heading 30.02, as the reagents are derived from cultures of micro-organism, and not under heading 30.05, that in this judgment, the Apex Court also held that even though the HSN mentions Antisera, blood fractions and modified immunological products (MIP) including monoclonal antibodies as one class, there is no contradiction between the Chapter Heading 30.02 of Central Excise Tariff and HSN Heading 30.02, that the judgment of the Apex Court in the case of Span Diagnostics Ltd. v. CCE, Surat (supra) is squarely applicable to the facts of this case, that in this case there is no dispute that the main ingredients are obtained from cultures of micro-organism and, therefore, in terms of HSN Explanatory notes to Heading 30.02, the same would be covered by the Heading 30.02 and once the goods, in question, are covered under this heading their classification under heading 3822 would be ruled out. He, therefore, pleaded that the impugned order is not correct. 4. Shri Bharat Bhushan, ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... backing, prepared diagnostic or laboratory reagents whether or not on a backing, other than those of Chapter 30 . 7.1 The HSN Headings 30.02 and 3822 during the period of dispute were as under :- 30.02 Human blood; animal blood prepared for therapeutic, prophylactic or diagnostic uses; antisera and other blood fractions and modified immunological products, whether or not obtained by means of biotechnological processes; vaccines, toxins, cultures of micro-organisms (excluding yeasts) and similar products. 38.22 Diagnostic or laboratory reagents on a backing, prepared diagnostic or laboratory reagents whether or not on a backing, other than those of heading 30.02 or 30.06; certified reference materials. 7.2 A comparison of HSN heading 38.22 and Central Excise Tariff Heading 38.22 would show that except for product group certified reference materials , in which is there, HSN Heading 38.22 but is not there in Central Excise Tariff heading 38.22, the Central Excise Tariff Heading 38.22 and HSN Heading 38.22 are identical. From a plain reading of Central Excise Tariff heading 38.22 it will be seen that it covers those diagnostic or laboratory reagents whether or not on a ba ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ng and common reactions occurring in the use of such kits include agglutination, precipitation, neutralisation, binding of complement, haemagglutination. Enzyme Linked Immuno Sorbent Assay (ELISA) etc.; and (c) monoclonal antibodies which are specific immunoglobulin from selected and cloned hybridoma cells cultured in a culture medium are also covered by this heading under the product group - modified immunological products, whether or not obtained by means of biotechnological process , which according to Apex Court s judgment in case of Span Diagnostic Ltd. (supra) is also covered by the product group - antisera and other blood fractions . 9.1 HIV detection kits and Hepatitis C detection kits containing antigens obtained from micro-organism cultures, immobilised on a porous immuno-filtration membrane and which work on antigen-antibody reaction (neutralisation) would be covered by Heading 30.02, as in view of the above-mentioned HSN explanatory notes, this heading includes the diagnostic reagents of microbial origin other than those covered by Chapter Note 4(d) [corresponding to Chapter Note 3(d) of Central Excise Tariff Chapter 30], which covers - Opacifying preparations fo ..... X X X X Extracts X X X X X X X X Extracts X X X X
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