S.H.Kapadia, J. - (1.) FROM the impugned judgment dated 1.1.2002 delivered by the Customs, Excise and Gold (Control) Appellate Tribunal ('CEGAT', for short), New Delhi, vide Appeal No. E/1644 and 1645 of 2000-C, C.A. No. 5322 of 2002 and C.A. No. 1953-54 of 2003 have been filed by the assessees and by the Department respectively. For the sake of convenience and clarity we proceed to decide each of the following civil appeals serially.
(2.) IN this civil appeal we are concerned with the classification of biotech products. The said assessee was engaged in the manufacture of blood-grouping reagents and diagnostic and laboratory reagents. It had obtained registration on 10.9.99 for the manufacture and clearances of the following products: JUDGEMENT_405_TLPRE0_2007Html1.htm The above six items are called Monoclonal Antibodies (for short, 'MABs'). They were classified by the assessee under Chapter Sub-heading 3002.00 (Chapter Heading 30.02) of Central Excise Tariff Act (for short, 'CETA') whereas the Department classified the MABs under CSH 3005.90 (Chapter Heading 30.05) of CETA. The assessee classified MABs as "cultures of micro- organisms" whereas the Department classified the said MABs as "pharmaceutical products, not elsewhere specified or included". The CEGAT (Tribunal), vide the impugned judgment, upheld the classification of MABs under CSH 3005.90 of CETA as claimed by the Department, hence this civil appeal is filed by the assessee. For the sake of convenience, we quote hereinbelow Chapter Note 3 in Chapter 30 of the CETA concerning pharmaceutical products which reads as under: JUDGEMENT_405_TLPRE0_2007Html2.htm We quote hereinbelow Chapter Heading 30.02 and CSH 3002.00 of CETA which read as under: JUDGEMENT_405_TLPRE0_2007Html3.htm We quote hereinbelow Chapter Heading 30.05 in entirety of CETA which reads as under: JUDGEMENT_405_TLPRE0_2007Html4.htm
(3.) WE also quote hereinbelow relevant extracts of Chapter Note No. 2 in Chapter 30 of HSN (Second Edition) which read as follows: JUDGEMENT_405_TLPRE0_2007Html5.htm We also quote hereinbelow Chapter Heading 30.02 in entirety from the said HSN which reads as under: 30.02 - HUMAN BLOOD; ANIMAL BLOOD PREPARED FOR THERAPEUTIC, PROPHYLACTIC OR DIAGNOSTIC USES; ANTISERA AND OTHER BLOOD FRCTIONS AND MODIFIED IMUNOLOGICAL PRODUCTS, WHETHER OR NOT OBTAINED BY MEANS OF BIOTECHNOLOGICAL PROCESSES; VACCINES, TOXINS, CULTURES OF MICRO- ORGANISMS (EXCLUDING YEASTS) AND SIMILAR PRODUCTS. 3002.10 - Antisera and other blood fractions and modified immunological products, whether or not obtained by means of biotechnological processes 3002.20 - Vaccines for human medicine 3002.30 - Vaccines for veterinary medicine 3002.90 - Other This heading covers: (A) Human blood (e.g., human blood in sealed ampoules). (B) Animal blood prepared for therapeutic, prophylactic or diagnostic uses Animal blood not prepared for such uses falls in heading 05.11. (C) Antisera and other blood fractions and modified immunological products. These products include: (1) Antisera and other blood fractions. Sera are the fluid fractions separated from blood after clotting. The heading covers, inter alia, the following products derived from blood: "normal" sera, human normal immunoglobulin, plasma, fibrinogen, fibrin, blood globulins, serum globulins and haemoglobin. The heading also includes blood albumin (e.g., human albumin obtained by fractionating the plasma of whole human blood), prepared for therapeutic or prophylactic uses. Antisera are obtained from the blood of humans or of animals which are immune or have been immunized against diseases or ailments, whether these are caused by pathogenic bacteria and viruses, toxins or allergic phenomena, etc. Antisera are used against diphtheria, dysentery, gangrene, meningitis, pneumonia, tetanus, staphylococcal or streptococcal infections, snake bite, vegetable poisoning, allergic diseases, etc. Antisera are also used for diagnostic purposes, including in vitro tests. Specific immunoglobulins are purified preparations of antisera. The heading does not cover blood albumin not prepared for therapeutic or prophylactic uses (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) Modified immunological products, whether or not obtained by means of biotechnological processes. Products whose antigen-antibody reaction corresponds to natural antisera and which are 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 (MABs) - specific immunoglobulins from selected and cloned hybridoma cells cultured in a culture medium or ascites. (b) Antibody fragments - parts of an antibody protein obtained by means of specific enzymatic splitting. (c) Antibody and antibody fragment conjugates - enzymes (e.g., alkaline phosphatase, peroxidase or betagalactosidase) or dyes (fluorescin) covalently bound to the protein structure are used for straightforward detection reactions. (D) Vaccines, toxins, cultures of micro-organisms (excluding yeasts) and similar products. These products include: (1) Vaccines - preparations of microbial origin containing either viruses or bacteria suspended in saline solutions, oil (lipovaccines) or other media. These preparations have usually been treated to reduce their toxicity without destroying their immunising properties. The heading also covers mixtures (such as Diphtheria, Tetanus and Pertussis (DPT) vaccine) consisting of vaccines and toxoids. (2) Toxins (poisons secreted by bacteria), toxoids, crypto-toxins and anti-toxins, of microbial origin. (3) Cultures of micro-organisms (excluding yeasts). These include ferments such as lactic ferments used in the preparations of milk derivatives (kephir, yogurt, lactic acid) and acetic ferments for making vinegar; moulds for the manufacture of penicillin and other antibiotics; and cultures of micro-organisms for technical purposes (e.g., for aiding plant growth). Milk or whey containing small quantities of lactic ferments is classifiable in Chapter 4. (4) Virus, human, animal and vegetable and anti-virus. (5) Bacteriophage. The heading also includes diagnostic reagents of microbial origin, other than those provided for in Note 4 (d) to this Chapter - see heading 30.06. It does not cover enzymes (rennet, amylase, etc.) even if of microbial origin (streptokinase, streptodornase, etc.) (heading 35.07) nor dead single-cell micro-organisms (other than vaccines) (heading 21.02). The products of this heading remain classified here whether or not in measured doses or put up for retail sale and whether in bulk or in small packings. ;