TaxTMI 
TaxTMI 
TaxTMI 
2024 (2) TMI 1640
X X X X Extracts X X X X
X X X X Extracts X X X X
.... CD Idx and NextSeq 1000/2000 reagent for imports through the Airport & Air Cargo Complex, Bangalore. 2. Applicant has stated as follows in their statement of relevant facts having a bearing on the question(s) raised enclosed with the CAAR-1 application: Illumina India, which is a part of the Illumina group, is involved in the creation, manufacture and distribution of sequencing and array-based solutions for analysing genetic variation and function in various domains ranging from cancer research to agriculture. The Applicant is primarily engaged in import, distribution and sale of life science tools and integrated systems, reagents and DNA sequencing instruments. The key details such as general description, form, end usage and technical description of the Products as submitted by the applicant are discussed below. TruSeq Stranded mRNA ('TruSeq') with Illumina part no. 20020594 is a library preparation kit that comprises of: (A) reagents; and (B) buffers. These library preparations are essentially standard molecular biological reactions used for preparing sample materials for sequencing. The reagents present in the kit are used to break the external layer of the cel....
X X X X Extracts X X X X
X X X X Extracts X X X X
....y, the reagents play a key role in adding dye to the samples which helps in identification of different segments of the DNA and RNA strands used for generating sequencing data. Thus, the reagent gives the essential character to the kit. Some of the common characteristics present in the Products which may potentially have a bearing on the classification are: i. The Products are meant for laboratory research use and not for diagnostic purposes; ii. They are presented in the form of kits; iii. They are prepared laboratory reagents having no backing in the form of plastic, paper or other material impregnated or coated with reagent; iv. They are meant solely for in vitro application. On reviewing the classification of the Products, the Applicant is of the view that tariff item 3822 1990 of the First Schedule of the Customs Tariff Act, 1975 ('CTA') would be most appropriate for the products. 3. The applicant further submits that the Products are kits which are used for the purpose of library preparation, indexing and adding dyes to the samples to study the different profiles of the RNA/ DNA strands. The reagents carry out the ....
X X X X Extracts X X X X
X X X X Extracts X X X X
....application Yes Yes Yes 4. Mixture of reagents/single reagent dissolved in solvent Mixture of multiple reagents, dissolved in a solvent Mixture of multiple reagents, dissolved in a solvent Mixture of multiple reagents, dissolved in a solvent 5. Form - paper, plastics or other materials impregnated/ coated with reagents or kit Kit Kit Kit 6. Usage clearly identifiable from packaging and labelling For Research Use Only. Not for use in diagnostic procedure For Research Use Only. Not for use in diagnostic procedures For Research Use Only. Not for use in diagnostic procedures Labels of the Products evidencing use thereof for research purpose is enclosed below for reference on sample basis: In view of above, it is evident that the Products meets all the parameters prescribed in the Explanatory Notes to Heading 3822 for coverage under said Heading. The Products do not find any specific mention in the Sub-Headings listed under CTH 3822. Therefore, it is pertinent to examine coverage of the Products under the Sub-Heading 3822 19 or 3822 90. Sub-Heading 3822 19 covers within its ambit prepared diagnostic or laboratory reagent whethe....
X X X X Extracts X X X X
X X X X Extracts X X X X
....ling Product under consideration Classification upheld NY K82289 dated 15 January 2004 Kit used for carrying out DNA sequencing reactions using microliter-scale handling equipment and protocols 3822.00.5090 N019762 dated 10 December 2007 Reagent kit used for DNA replication 3822.00.5090 NY E87869 dated 17 February 2000 Product comprising of reagents (put up dissolved in an aqueous mixed buffer solution) used for laboratory research for the detection and analysis of human, mouse, or rat mRNA 3822.00.5090 It is pertinent to mention that Tariff Item 3822 0050 90 of the Harmonized Tariff Schedule of the United States (prior to HSN 2022 amendment) corresponds to the tariff item 3822 1990 of the First Schedule. Further, the Applicant also places reliance on the decision of the European Binding Tariff Information under GB122466392, wherein goods similar to the Products of the Applicant were held to be classifiable under Combined Nomenclature ('CN') code 38220000. CN code 38220000, post HSN 2022 amendment, is read as CN code 38221900 which is aligned to the Sub-Heading 3822 19 of the First Schedule. Though the Applicant has substantiated above....
X X X X Extracts X X X X
X X X X Extracts X X X X
....ined, imported in packings not exceeding 500 gms or 500 ml, are classifiable under CTH 98020000). 5. A personal hearing in the matter was conducted on 16.01.2024 in the office of CAAR, Mumbai. The authorised representatives of M/s. Illumina India Biotechnology Private Limited, Shri Himanshu Tewari and Ms. Deepika Menon appeared for Personal hearing and they reiterated the submission and explained the content of their application. They also cited some international rulings/clarification on this product. They contended that their products are laboratory reagent kits to be used in DNA sequencing instruments and expressed that their products "Truseq Stranded mRNA, Nextera DNA CD Idx and NextSeq 1000/2000 reagents merit classification under CTH 38221990 and the same is in accordance with WCO explanatory notes 1.8 (page 37 A-II). They further submitted that the product in question is prepared reagent for research, for in vitro use, and is to be put up in the form of kit. They also filed additional supporting documents regarding product classification/clarification referred in WCO analysis. Nobody appeared for PH from the department side physically or through e-hearing module. Th....
X X X X Extracts X X X X
X X X X Extracts X X X X
.... (3) products put up as charges for fire-extinguishers or put up in fire-extinguishing grenades (heading 3813); (4) certified reference materials specified in Note 2 below; (5) products specified in Note 3 (a) or 3 (c) below; ... 2. (A) For the purpose of heading 3822, the expression "certified reference materials" means reference materials 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. WCO HSN Explanatory Notes to Heading 3822: This heading covers 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, including blood grouping reagents, other than diagnostic reagents designed to be administered to the patient of headi....
X X X X Extracts X X X X
X X X X Extracts X X X X
....assified here. Malaria diagnostic kits, for example those based on monoclonal antibodies to pLDH (plasmodium lactate dehydrogenase), are also classified here. However, diagnostic kits having the essential character of products of heading 30.06 (e.g., blinded (or double-blinded) clinical trial kits for a recognized clinical trial, put up in measured doses) are excluded. --------------------- 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) Substrate materials containing added analytes, the concentration of which has been accurately determined; (b) Unmixed materials, the concentration of certain components of which has been accurately determined (e.g., the protein and fat content of milk powder); (c) Materials, whether natural or synthetic, certai....
X X X X Extracts X X X X
X X X X Extracts X X X X
....ucts in question under the first schedule of the Customs Tariff Act, 1975. First and foremost, it is pertinent to mention that the concerned Jurisdictional Commissionerate i.e. Airport & Air Cargo Complex, Bengaluru has concurred with the contention of the applicant that "Truseq Stranded mRNA, Nextera DNA CD Idx and NextSeq 1000/2000 reagents" merit classification under CTI 3822 1990. 6.1 The applicant has stated that TruSeq Stranded mRNA ('TruSeq') with Illumina part no. 20020594 is a library preparation kit that comprises of: (A) reagents; and (B) buffers; that Nextera DNA CD Idx with Illumina part no. 20018708 is an index kit which comprises of an index plate with wells holding reagent containing Oligonucleotides compounds, and buffer solutions, which is present in a liquid state; and that NextSeq 1000/2000 reagent kit ('NextSeq reagent') with Illumina part no. 20046811 contains (A) reagent in liquid state stored in cartridge (B) flow cell; and (C) resuspension buffer. From these submissions of the applicant about the products, it is amply clear that all the three products in question contain reagents. Further, it is also observed that these products con....
X X X X Extracts X X X X
X X X X Extracts X X X X
....('WCO'). The HSN Explanatory Notes released by the WCO aid in the interpretation of the Headings of the Tariff and may be used as a safe guide for the same. It has been held so by the Supreme Court in the case of Collector of Customs, Bombay v. Business Forms Ltd. Thr. O.L., 2002 (142) E.L.T. 18 (S.C.). The classification of the goods under the Customs Tariff is governed by the principles as enumerated in the General Rules of Interpretation ('GRI') set out in the First Schedule to the Customs Tariff Act, 1975 ('Tariff'). General Interpretation Rule 3: Where any article is classifiable under two or more headings - (a)In case of where an article is classifiable under two or more headings, the article should be classified under specific heading instead of general heading. (b)Mixture, composite goods consisting of different materials or made up of different components cannot be classified by referring rule 3(a). However, it should be classified as if it consists of the material or component which gives them their essential character. In view of the above, to answer the question of classification of the products under consideration asked b....
X X X X Extracts X X X X
X X X X Extracts X X X X
....er, it is to be examined whether these products satisfy the condition of being other than those of heading 3006 or not. Heading 3006 covers pharmaceutical goods specified in chapter note 4 to chapter 30. Note 4 to chapter 30 states that Heading 3006 inter alia applies only to the following, which are to be classified in that heading and in no other heading of this Schedule: opacifying preparations for X-ray examinations and diagnostic reagents designed to be administered to the patient, being unmixed products put up in measured doses or products consisting of two or more ingredients which have been mixed together for such uses. Firstly, the product under consideration here are prepared laboratory reagents not opacifying preparation for X-ray examination and secondly, from the submissions of the applicant it is observed that these reagents are not designed to be administered to the patients and these reagents are for research use only and are meant solely for in vitro application. Further, Note 4 to chapter 30 states that Heading 3006 inter alia applies only to the following, which are to be classified in that heading and in no other heading of this Schedule: placebos an....
X X X X Extracts X X X X
X X X X Extracts X X X X
....nts) employed in a drug product must be generally regarded as safe for use in humans, otherwise they could not be employed. (13) Blinded (or double-blinded) clinical trial kits. Blinded (or double-blinded) clinical trial kits are for the sole purpose of blinded medical trials and contain either the trial medicaments, the corresponding placebos or both and are designed to anonymize the medicament. For new pharmaceutical trials, a randomized double-blind design is normally used. Information regarding the exact content of any given double-blinded kit i.e., whether it contains the active drug product or placebo or both, does not accompany the kit, and is not available for Customs purposes. The kits may contain any item or packaging which is necessary solely for the safe transport or storage of the goods, for example, temperature recorders, tamper detectors or coolant pads and any associated and necessary documentation and forms whether in hard copy or electronic form. Placebos or blinded (or double-blinded) clinical trial kits of this heading are put up in measured doses for use in recognised clinical trials. Clinical trials are intended for....
X X X X Extracts X X X X
X X X X Extracts X X X X
....sting of several components, even if one or more components are separate chemically defined compounds of Chapter 28 or Chapter 29, synthetic colouring matter of heading 32.04 or any other substance 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. 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). Diagnostic kits based on reactions such as agglutination, precipitation, neutralization, binding of complement, haemagglutination, enzyme-linked immunosorbent assay (ELISA), etc are classified here. Malaria diagnostic kits, for example those based on monoclonal antibodies to pLDH (plasmodium lactate dehydrogenase), are also classified here. However, diagnostic kits having the essential character of products of heading 30.06 (e.g., blinded (....