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2024 (8) TMI 1000

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..... found that the item imported is Immunological Adjuvant used in the preparation of vaccines for human and animals. Immunological Adjuvant was classified by the Department under Tariff Item 30023000 as Vaccine for veterinary medicine as against the appellants declaration under Tariff Item 38249090 as chemical products not elsewhere mentioned even though the imported goods are injectable mineral oil and emulsifier obtained from mannitol and purified oleic acid of vegetable origin. The Adjuvants are of different types and they are used for the purpose of enhancing the immune response in the Immunological vaccines administered for humans and animals. It is found that to classify Adjuvant as a vaccine by the Department is incorrect and not legal .....

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..... ppeals) against the dropping of penalty. Commissioner (Appeals) confirmed the demand with interest and imposed penalty under Section 114A of the Customs Act, 1962. Aggrieved by the order of the Commissioner (Appeals) this appeal is filed before the Tribunal. 3. The appellant in the appeal contends that the Adjudicating Authority, held that; though the goods were only an Adjuvant and does not qualify to be called a vaccine either in terms of composition or function, since the imported item gets formulated with vaccine and it acquires the qualities of a vaccine when mixed with the vaccine, hence, it can be classified as a vaccine. 4. The Learned Counsel for the appellant contends that; on the sole ground on which the classification has been d .....

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..... e, whereas the vaccine is administered for the immunity. 5. The Learned Counsel contends that; Commissioner (Appeals) classified the goods under CTH 3002 on the grounds that rule 3(b) of the general rules of interpretation is applicable. This rule is applicable when the goods imported consists of mixture of composite goods; the imported goods being Adjuvant has no mixture or composite within it which is a vaccine; Commissioner (Appeals) finding that the predominant use of the product shall be considered for classification and since predominant use is in vaccine it has to be classified as a vaccine is highly erroneous; the imported goods without being processed any further cannot be used as a vaccine; the predominant use or end use for the p .....

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..... an be directly placed under vaccines and the department itself admitted they are not vaccines by themselves, they are only Adjuvant , where there is no specific entry for Adjuvants even under common parlance the importer does not treat the Adjuvant as vaccines and the department also does not treat the Adjuvant as vaccine, therefore allegation of wilful misdeclaration and suppression of facts is unsustainable. 8. The Learned Counsel contends that equal penalty alleging suppression and wilful misstatement is not warranted in cases involving classification disputes and this issue is no more res integra and they relied on the following case laws:- i. Abraham J Tarakan Vs. CCE, Cochin 2007 (210) ELT 112 (tri-Bang) ii. CC Import Nhava Sheva Vs. .....

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..... tem. Types of adjuvants: Inorganic compounds: alum, aluminum hydroxide, aluminum phosphate, calcium phosphate hydroxide Mineral oil: paraffin oil Bacterial products: killed bacteria Bordetella pertussis, Mycobacterium bovis, toxoids Nonbacterial organics: squalene, thimerosal Delivery systems: detergents (Quil A) Cytokines: IL-1, IL-2, IL-12 Combination: Freund's complete adjuvant, Freund's incomplete adjuvant Alum is the most commonly used adjuvant in human vaccination. It is found in numerous vaccines, including diphtheria-tetanus-pertussis, human papillomavirus, and hepatitis vaccines 11. The above adjuvants are to be classified as per the material composition in the respective Tariff heading. The appellant imports different Adju .....

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