TaxTMI 
TaxTMI 
2025 (8) TMI 1533
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....SN 3002 at entry No. 125 of List 1 of serial No. 180 under Schedule-I of the notification No. 1/2017-CT(R) dated 28.6.2017 as "Agglutinating Sera"; or • HSN 3822 at serial No 80 under Schedule -II of the notification No. 1/2017-CT(R) dated 28-06-2017 as "diagnostic kits and reagents"; • CRP test kit is used for the purpose of quantitative determination of C-Reactive Protein (CRP) in human serum; that this kit is based on agglutination principle between latex particles coated with specific anti-human CRP to determine CRP in the sample; that the kit is meant for in vitro diagnostic use; • HbAlc test kit is used for the quantitative determination of hemoglobin Ale (HbAlc) in human blood; that the kit is based on agglutination principle by antigen-antibody interaction to directly determine the HbAlc concentration in the whole blood; that the kit is meant for in vitro diagnostic use. • Microalbumin turbilatex is a quantitative turbidimetric test for the measurement of microalbumin (HALB) in human urine; that the kit is based on agglutination principle where latex particles coated with specific antibodies against human albumin agglutina....
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....omponent R2 & thus a 'principal supply'; • the essential component in Microalbumin Turbilatex is latex particles coated with specific antibodies anti human albumin (i.e. antisera) without which reaction with Microalbumin in the sample/ specimen could not take place and hence, quantitative determination of microalbumin in the human urine could not be determined; that 70%-75% of the total volume of the Kit is attributable to component R2, thus, it is evident that R2 is the 'principal supply'; • that tax liability applicable to the principal supply would apply to the entire composite supply; • that only those diagnostic/laboratory reagents which cannot appropriately be classified under CSH 3002 will fall under CSH 3822; • that they would like to rely on the case of Inter Care Ltd. 1997 (89) ELT 545 (T). • the impugned product CRP Test kit is based on mice anti-CRP antibody/mice antisera & thus covered under chapter 3002 as it is specifically excluded from chapter 3822; that chapter heading 3002 is the default entry for diagnostic kits; • that they would like to rely on the case of Span Diagnostic Ltd. 2007 (....
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.... TARIFF OF INDIA • Chapter 30 Pharmaceutical Products Notes : 1. This Chapter does not cover: (a) to (g) ..; (h) blood albumin not prepared for therapeutic or prophylactic uses (heading 3502); or (ij) diagnostic reagents of heading 3822. 2. For the purposes of heading 3002, the expression-immunological products applies to peptides and proteins (other than goods of heading 2937) which are directly involved in the regulation of immunological processes, such as monoclonal antibodies (MAB), antibody fragments, antibody conjugates and antibody fragment conjugates, interleukins, interferons (IFN), chemokines and certain tumor necrosis factors (TNF), growth factors(GF), hematopoietins and colony stimulating factors(CSF) .; • CTH 3002 3002 HUMAN BLOOD; ANIMAL BLOOD PREPARED FOR THERAPEUTIC, PROPHYLACTIC OR DIAGNOSTIC USES; ANTISERA, OTHER BLOOD FRACTIONS AND IMMUNOLOGICAL PRODUCTS, WHETHER OR NOT MODIFIED OR OBTAINED BY MEANS OF BIOTECHNOLOGICAL PROCESSES; VACCINES, TOXINS, CULTURES OF MICRO-ORGANISMS (EXCLUDING YEASTS) AND OTHER SIMILAR PRODUCTS; CELL CULTURES, WHETHER OR NOT MODIFIED ....
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.... - Other: 3002 90 10 - - - Human blood Kg. 3002 90 20 - - - Animal blood prepared for therapeutic, prophylactic or diagnostic uses Kg. 3002 90 90 - - - Other Kg. • HSN explanatory notes 30.02 - Human blood; animal blood prepared for therapeutic, prophylactic or diagnostic uses; antisera, other blood fractions and immunological products, whether or not modified or obtained by means of biotechnological processes; vaccines, toxins, cultures of micro-organisms (excluding yeasts) and similar products (+). - Antisera, other blood fractions and immunological products, whether or not modified or obtained by means of biotechnological processes : 3002.11 - - Malaria diagnostic test kits 3002.12 - - Antisera and other blood fractions 3002.13 - - Immunological products, unmixed, not put up in measured doses or in forms or packings for retail sale 3002.14 - - Immunological products, mixed, not put up in measured doses or in forms or packings for retail sale 3002.15 - - Immunological products, put up in measured doses or in forms or packings for retail sale 30....
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....ses (heading 35.02) or globulins (other than blood globulins and serum globulins) (heading 35.04). The heading also excludes medicaments which are not separated from the blood but which in some countries are described as "sera" or "artificial sera"; they include isotonic solutions based on sodium chloride or other chemicals and suspensions of pollen which are used against allergic diseases. (2) Immunological products, whether or not modified or obtained by means of biotechnological processes. Products used for diagnostic or therapeutic purposes and for immunological tests are to be regarded as falling within this product group. They can be defined as follows : (a) Monoclonal antibodies (MAB) - specific immunoglobulins from selected and cloned hybridoma cells cultured in a culture medium or ascites. (b) Antibody fragments - active parts of an antibody protein obtained by means of e. g., specific enzymatic splitting. This group includes inter alia single-chain (scFv) antibodies. (c) Antibody conjugates and antibody fragment conjugates - conjugates which contain at least one antibody or an antibody fragment. The simplest types are a combina....
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....ls which are accompanied by a certificate which indicates the values of the certified properties, the methods used to determine these values and the degree of certainty associated with each value and which are suitable for analytical, calibrating or referencing purposes. (B) With the exception of the products of Chapter 28 or 29, for the classification of certified reference materials, heading 3822 shall take precedence over any other heading in the Schedule. • CTH 3822 3822 DIAGNOSTIC OR LABORATORY REAGENTS ON A BACKING. PREPARED DIAGNOSTIC OR LABORATORY REAGENTS WHETHER OR NOT ON A BACKING, WHETHER OR NOT PUT UP IN THE FORM OF KITS, OTHER THAN THOSE OF HEADING 3006; CERTIFIED REFERENCE MATERIALS - Diagnostic or laboratory reagents on a backing. prepared diagnostic or laboratory reagents whether or not on a backing, whether or not put up in the form of kits: 3822 11 00 -- For malaria kg. 3822 12 00 -- For Zika and other diseases transmitted by mosquitoes of the genus Aedes kg. 3822 13 00 -- For blood-grouping kg. 3822 19 -- Other: 3822 19 10 --- ....
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.... which, when presented separately, would be classifiable under another heading. Examples of such kits are those for testing glucose in blood, ketones in urine, etc., and those based on enzymes. However, diagnostic kits having the essential character of products of heading 30.02 or 30.06 (c.g., those based on monoclonal or polyclonal antibodies) are excluded. The reagents of this heading should be clearly identifiable as being for use only as diagnostic or laboratory reagents. This must be clear from their composition, labelling, instructions for in vitro or laboratory use, indication of the specific diagnostic test to be performed or physical form (e.g., presented on a backing or support). With the exception of the products of Chapter 28 or 29, for the classification of certified reference materials, heading 38.22 shall take precedence over any other heading in the Nomenclature. The certified reference materials of this heading are reference materials prepared for the calibration of an apparatus, the assessment of a measurement method or the assignment of values to a material." These reference materials may consist of the following : (a) Substrat....
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....6; certified reference materials". The explanatory notes of HSN 38.22 though reproduced supra, we find that it broadly states as under: • HSN 3822 covers diagnostic or laboratory reagents on a backing, prepared diagnostic or laboratory reagents, other than diagnostic reagents of heading 30.02 or diagnostic reagents designed to be administered to the patient and. blood grouping reagents of heading 30.06; • Diagnostic reagents are used in the evaluation of physical, biophysical or biochemical processes and states in animals and humans; their function IS based upon a measurable or observable change in the biological or chemical substances constituting the reagent; • Prepared diagnostic & laboratory reagents of this heading may be [a] similar in function to those designed to be admmistered to patients (subheading 3006.30), with the exception that they are used for in vitro, rather than for in vivo, applications; [b] include not only diagnostic reagents, but also other analytical reagents used for pmposes other than detection or diagnosis; and |c | may be used in medical, veterinary, scientific or industrial laboratories, in hospitals, in industry,....
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....active Protein (CRP) in human serum or plasma. Latex partial coated with specific anti-human CRP are agglutinated when mixed with samples coating CRP. [c] HbAle Latex is manufactured by using agglutinating sera namely anti human HbAlc monoclonal antibody and anti HbAlc mouse anti human sera. [d] HbAle-Turbilatex ex is manufacture by using agglutinating sera namely anti human HbAlc monoclonal antibody and anti HbAIC mouse anti human sera [e] Microalbumin Turbilatex is a turbidimetric test where latex particles coated with specific antibodies against human albumin agglutinate when mixed with samples containing pALB. This agglutination causes an absorbance change that can be quantified We find that the applicant in his submission dated 31.5.2024 in paragraph 5,6 and 7 under contention 2 has stated that anti sera constitutes 70-80% of the total volume in CRP Test kit, 65% of the total volume in HbAlc test kit and 70-75% of the total volume in Microalbumin Turbilatex Test Kit. 16. The classification of the said product, we find, is no longer res integra having already been decided by the Hon'ble Supreme Court in the case of Span Diagnostics Ltd. 2007 (21....
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.... by the Department. However, according to the Department, since Item Nos. 1 to 15 are manufactured by coating latex particles with protein, they fall under Chapter Heading 38.22 of CETA. However, according to the Tribunal, the said items fall under Chapter Heading 30.05 of CETA. At this stage we may note that according to the Department, the said 15 items came under Chapter Heading 38.22 whereas, according to the assessee, they came under Chapter Heading 30.02. The only question before the Tribunal was whether it came under Chapter Heading 38.22 or whether it came under Chapter Heading 30.02. In M/s. Mitra's case (which we have decided hereinabove vide C.A.No. 5322 of 2002), we have taken the view that "blood fractions" fall under Chapter Heading 30.02. Chapter Heading 30.02 refers to "blood fractions". Merely because the medium used is latex (rubber) or paper, will not bring the items under Chapter Heading 38.22. Once an item is a "Blood Fraction" it falls under Chapter Heading 30.02. The medium is irrelevant. The medium could be paper or rubber. The configuration of the product and the function are important. In our opinion, Item Nos. 1 to 15 are "Blood Fractions". They are "Bloo....