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TMI Blog2007 (4) TMI 617X X X X Extracts X X X X X X X X Extracts X X X X ..... s. 3. 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 : (1) Anti-A Mono Clonal (2) Anti-B Mono Clonal (3) Anti-Decoders Mono Clonal (4) Anti-Decoders Mono Clonal (5) Anti-Decoders 1g M Mono Clonal (6) Anti-Decoders 1g G Mono Clonal 4. 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". 5. 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 ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ntibodies (MABs), antibody fragments, antibody conjugates and antibody fragment conjugates." 10. We also quote herein below 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 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. 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. &nbs ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... 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 ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... metals (stainless steel, tantalum, silver, bronze). The item also covers tissue adhesives such as those consisting of butyl cyanoacrylate and a dye; after application, the monomer polymerises and the product is therefore used in place of conventional suture materials for closing internal for closing internal or external wounds of the human body. The heading excludes non-sterile suture materials. These are classified according to their nature e.g. catgut (heading 42.06), silkworm put, textile yarns, etc. (Section XI), metal were (Chapter 71 or Section XV). (2) Sterile laminaria and sterile laminaria tents. This item is restricted to sterile laminaria and sterile laminaria tents (small lengths of algae, sometimes brown and with a rough grooved surface). They swell considerably on contact with moist substances and become smooth and flexible. They are therefore used in surgery as a means of dilation. Non-sterile products are excluded (Heading 12.12) (3) Sterile absorbable surgical or dental haemostatics. This item covers sterile products used in surgery or dentistry to stop bleeding and having the property of being absorbed by the ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... nbsp; xxx xxx" 12. According to the assessee, MAB is produced by hybridoma technology in which hybrids (fused cells) are allowed to grow by multiplication in culture medium and in that process they secrete the antibodies. According to the assessee, these hybrids (fused cells) are micro-organisms and as they grow in culture medium, therefore, they are classifiable under CSH 3002.00 as "cultures of micro-organisms". In this connection, reliance is place on "Compendium of Transfusion of Medicine" by Dr. R.N. Makroo. In his book Dr. R.N. Makroo has stated that with advancement in biotechnology, hybridoma technology has made available a new source of reagents; that before the introduction of hybridoma technology, the A.B.O. grouping reagents were derived from human donors with or without immunization. According to Dr. Makroo, the main reagent used in blood-bank laboratory is antisera (which is an antibody). Essentially MAB, according to Dr. Makroo, is obtained from cell culture. It helps in blood-grouping. The developmen ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ng 30.02 of CETA does not deal with items like human blood and MIP which items are dealt with by HSN and, therefore, according to the Department, in the present case, one should not rely upon the Explanatory Note to HSN. 14. We find merit in the arguments advanced on behalf of the assessee. There is no dispute that MAB is a blood-grouping reagent. The question is : whether merely because MAB is a blood-grouping reagent, should it be classified under Chapter Heading 30.05 on account of Note No. 3(e) to Chapter 30 of CETA, even though MAB is a "culture of micro-organism" falling under CSH 3002.00 (Chapter Heading 30.02). It is well-settled that the width of the Heading under CETA cannot be expanded by reading Note 3(e) to Chapter 30. In our view, MAB is a "culture of micro-organism". It falls specifically under Chapter Heading 30.02 of CETA. MAB is not a sera of human or animal origin, it is not a vegetable extract, it is not a plant extract and on the other hand it is obtained by hybridoma technology (cellular fusion). Therefore, it cannot fall under Chapter Heading 30.05 of CETA. Moreover, Chapter Heading 30.05 is residuary. The width of Chapter Heading 30.05 is restricted to prod ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... es MAB. Therefore, if one reads the third item as a separate class as "antisera and blood fractions" then abridgement of HSN entries by CETA cannot rule out MIP which includes MAB. Therefore, when HSN treats antisera, blood fractions and MIP including MAB as one class then there is no contradiction between Chapter Heading 30.02 of CETA and Chapter Heading 30.02 of HSN. Therefore, taking any view of the matter, HSN cannot be ruled out. 15. For the above reasons, we find merit in the civil appeal filed by the assessee (Civil Appeal No. 5322 of 2002) and, accordingly, we classify the above six items under Chapter Heading 30.02 of CETA. 16. Accordingly, the said civil appeal is answered in favour of the assessee and against the Department. C.A. Nos. 1953-1954/2003 - filed by the Department 17. The short question which needs to be decided in these civil appeals is : Whether Beta Visipreg, Visipreg Strip, Pregnancy Test Card fall as "antisera" under Chapter Heading 30.02 of CETA (according to the assessee) or whether it falls under Chapter Heading 38.22 of CETA as "diagnostic or laboratory reagent" (as contended by the Department). 18. The above three products were cleared by the as ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... apter Heading 30.02 and also under Chapter Heading 38.22. However, if a diagnostic or laboratory reagent like antisera falls under Chapter Heading 30.02 then it stands excluded from Chapter Heading 38.22. 22. Before concluding we may record the statement made on behalf of M/s. J. Mitra & Co. Ltd. that they have closed down their business in producing the following two items, namely, Syphilis RPR (VDRL) and Salmonella Antigens. Hence, they do not seek to press the classification issue concerning the said two items. 23. Hence we answer C.A. Nos. 1953-54 of 2003, filed by the Department, in favour of the assessee and against the Department. 24. For the above reasons, the assessee succeeds on Item Nos. 1 to 9, mentioned at page No. 5 of the paper book in C.A. Nos. 1953-54/2003 and, therefore, the Department was not entitled to invoke the extended period of limitation under Section 11A of the Central Excise Act, 1944. C.A. Nos. 1076-1080/2002 - filed by M/s. Span Diagnostics Ltd.(assessee) 25. These civil appeals are filed by M/s. Span Diagnostics Ltd. (assessee) under Section 35(L) of the Central Excise Act, 1944, against the decision of the CEGAT (for short, 'Tribunal' dated 4-12 ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... f T.B. mycobacteria. According to the Adjudicating Authority, these reagents are of mycobacterium origin but they are injected intradermally into the patient and, therefore, they are classifiable under Chapter Heading 30.05 (CSH 3005.90). According to the Department, the above three items are put up by the assessee for sale in measured doses and, therefore, they were classifiable under Chapter Heading 30.05. In this connection, reliance is placed on Chapter Note 3(d) to Chapter 30 which reads as under : "CHAPTER 30 PHARMACEUTICAL PRODUCTS Notes : l. to 2. xxx xxx xxx 3. Heading No.30.05 applies only to the following, which are to be classified in that heading and in no other heading of this Schedule : - (a) to (c) xxx ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... l Assayed Normal 5x3 ML 9. 19444A Chem. Control Assayed Abnormal 5x3 ML 10. 25907 R.A. Test (Latax Test) 10 T 11. 25907A R.A. Test (Latax Test) 20 T 12. 25934 C.R.P. (Latax Test) 20 T 13. 25947 ASO (Latax Test) 20 T 14. 25946B Austragen (Latax Test) 25 T 15. 25946C Austragen (Latax Test) 50 T" 36. According to the assessee, the above 15 items fall under Chapter Heading 30.02 as they are "blood fractions". This is not disputed 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 ..... X X X X Extracts X X X X X X X X Extracts X X X X
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