TaxTMI 
TaxTMI 
2025 (12) TMI 1324
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....s "QIAGEN"/ "Company"/ "Applicant"), is a wholly owned subsidiary of QIAGEN GmbH, Germany, which is engaged in manufacturing and supply of diagnostic reagents, kits and instruments for medical testing, academics, and pharmaceutical research. 1.2 In connection with its business operations in India, the Company imports various diagnostic reagents, kits and instruments. All imports of the Company are made at Indira Gandhi International Airport, New Delhi. 1.3 The relevant details including technical description of the items imported by the Company are mentioned herein-below: i. RT2 qPCR Primer Assay * RT2 qPCR Primer Assays is in the form of solution of synthetic oligonucleotides. * These are specifically designed and experimentally verified for real-time PCR analysis. RT2 qPCR Primer Assays are suited for applications including validation of microarray-derived gene expression data, confirming gene expression knockdown by RNAi (RNA interference), identifying and confirming disease-associated biomarkers, and monitoring phenotypic changes related to gene expression. * The primer contains nucleotides of 19-23 length. Through a comparison of the p....
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....se in wide range of downstream applications, including PCR and quantitative real-time PCR and RT-PCR, biomarker research and validation for blood-based cancer detection, viral nucleic acid detection. v. FlexiTube - GeneSolution * FlexiTube GeneSolution is in the form of solution of nucleotides/ nucleosides. * This kit is a gene-specific package of 4 preselected siRNAs (Small Interfering RNA) (1 nmol) for a target gene. The kit is used for functional genomics (study of genome and its products i.e., the RNA and proteins that are encoded for in the RNA) or pathway analysis with small numbers of gene targets. The kit enables use of multiple siRNAs for each target gene ensuring reliable results. * The Kit is a package of siRNAs. siRNAs are artificially synthesized 19-23 nucleotide long double stranded RNA molecules, routinely used in molecular biology for transient silencing (a treatment technique) of gene of interest. A package of such siRNA forms the Kit which is then used in study of genome. vi. Carrier RNA (Poly A) (310ug) (SKU no. 1068337) * Carrier RNA (Poly A) (310ug) is a solution of adenine nucleotides. It is used to simplif....
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....stomers for end use. 1.6 Question on which advance ruling is sought: A. Whether the diagnosis kits imported by the Applicant are classifiable under CTH 29349990? B. Whether the kits imported by the Applicant eligible for exemption from Basic Customs duty under Entry 167(A) of Notification No. 50/2017-Customs dated 30.06.2017 read with Entry 90 of List 4 of same notification, available to "Diagnostic Kits" containing solution of Nucleotides and Nucleosides? Statement containing the applicant's interpretation of law and/or facts, as the case may be, in respect of the aforesaid question (i.e. applicant's viewpoint and submissions on issues on which the advance ruling is sought). 1.7 Applicant's eligibility for Advance Ruling 1.7.1 In order to file an application before the Customs Authority for Advance Ruling, the Applicant must satisfy the conditions prescribed under the Customs Act, 1962 (hereinafter referred to as 'Customs Act'). 1.7.2 Provisions relating to Advance Ruling are prescribed under Chapter VB of the Customs Act. Clause (c) of Section 28E of the Customs Act defines an "Applicant" as: "In this Chapter, unless the context otherwise ....
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.....06.2017 read with Entry 90 of List 4 of Notification No. 50/2017-Customs dated 30.06.2017 available to "Diagnostic Kits" containing Solution of Nucleotides or Nucliosides 1.8.2 Classification of the goods mentioned in the First Schedule of the Customs Tariff is governed by General Rules for Interpretation (hereinafter referred to as "GI Rules"). The said rules for interpretation have been adopted from the General Rules for the Interpretation of the Harmonized System as prescribed by World Customs Organization (hereinafter referred to as "WCO"). 1.8.3 As per Rule 1 of the GI Rules, goods under consideration should be classified in accordance with the 'terms' of the heading or the relevant Section or Chapter Notes. It further states that in the event the goods cannot be classified solely on the basis of said Rule 1, and if the headings and legal notes do not otherwise require, the remaining Rules 2 to 6 may then be applied in sequential order. Rule 1 of the GI Rules is extracted below for ready reference: "The titles of Sections, Chapters and sub-Chapters are provided for ease of reference only; for legal purposes, classification shall be determined according ....
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....N), ketazolam (INN), mesocarb (INN), oxazolam (INN), pe~oline (INN), phendimetrazine (INN), pbenmetraz11le (INN) and sufentaml (INN); salts thereof 2934.92 -- Other fentanyls and their derivatives 2934.99 * Other 1.8.7 With reference to the above, it is apropos to note that Harmonized Commodity Description and Coding System, HSN Explanatory Notes to HSN 2934 in WCO HSN state that this heading includes nucleic acids and their salts. These are complex compounds which, when combined with proteins, form the nucleo-proteins found in the nucleii of animal and vegetable cells. They are combinations of phosphoric acids with sugar and pyrimidine or purine compounds. Generally, in the form of white powders, soluble in water. 1.8.8 Further, the relevant Tariff Heading under Customs Tariff Act is as under: Tariff Item Description Unit Rate of Duty 2934 NUCLEIC ACIDS AND THEIR SALTS; WHETHER OR NOT CHEMICALLY DEFINED; OTHER HETEROCYCLIC COMPOUNDS 29341000 - Compounds containing an unfused thiazole ring (whether or not hydrogenated) in the structure Kg 7.5% 29342000 - Compounds containing in the structure a benzothiazo....
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....stic test kits specified in List 4 and also classifiable under Chapter 38 are eligible for exemption from whole of the duty of customs. Entry 90 of List 4 of Notification No. 50/2017-Customs dated 30.06.2017 refers to Solution of Nucleotides and Nucliosides in goods under Entry 167(A) of Notification No. 50/2017-Customs dated 30.06.2017. The extract of the relevant entry is as under: SI No. Chapter or Heading or sub- heading or tariff item Description of Goods Standard Rate IGST Condition 167 28, 29, 30 or 38 The following goods, namely :- (A) Lifesaving drugs/medicines including their salts and esters and diagnostic test kits specified in List 4 Nil - - List 4 (See S. No. 167 and 607 of the Table) ( ... ) 90) Solution of Nucleotides and Nucliosides" 1.8.12 It is submitted that a nucleotide is a molecule that is the basic building block of the nucleic acids DNA and RNA. A nucleotide is made up of a nitrogen-containing base (adenine, guanine, thymine, and cytosine in DNA, and adenine, guanine, uracil, and cytosine in RNA), a phosphate group, and a sugar molecule (deoxyribose in DNA, and ribose in RNA). DNA and RNA ....
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.... and diagnostic test kits specified in List 4'. Entry No. 90 to List 4 mentions "Solution of Nucleotides and Nucleosides". Nucleotides and Nucleosides is neither a drug/ medicine, nor its salt/ esters, and therefore reference to Solution of Nucleotides and Nucleosides under Notification No. 50/2017-Customs dated 30.06.2017 can only be in the context diagnostic kits. Furthermore, the quantity of Nucleotides and Nucleosides in the Kit is immaterial. In fact, the exemption entry is silent on the quantity of Nucleotides and Nucleosides in the kit. Accordingly, mere presence of Nucleotides and Nucleosides in the kit is sufficient to render the kit eligible for exemption under Serial no. 167(A) of Notification No. 50/2017-Customs dated 30.06.2017. 1.8.15 As such therefore, in light of the submissions hereinabove, the goods sought to be imported by the Applicant ought to be classified under CTH 29349990 since the same are diagnostic or laboratory reagents in the form of kits. 1.8.16 Further, the said kits are also eligible for exemption under Entry 167(A) of Notification No. 50/2017-Customs dated 30.06.2017 read with Entry 16 of List 4 of Notification No. 50/2017-Customs dated 3....
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....nder CTH 29349990. Further, benefit of Sr. No. 167{A) of Notification no. 050/2017 cannot be extended to the applicant as the same has been omitted vide Notification No. 05/2025-Cus dt. 01.02.2025. Though Clause A of Sr no 167 in Notification in question (50/2017) was omitted in Feb 2025, same was added in form of insertion of Sr. no. 167 B.CAAR may examine possibility of applicability of Sr. no. 167 B. 2.6 As per importer's submission, the goods sought to be Imported are used for the applications as under: * RT2 qPCR Primer Assay {SKU no. 330001) RT2 qPCR Primer Assays is in the form of solution of synthetic oligonucleotides. These are specifically designed and experimentally verified for real-time PCR analysis. RT2 qPCRPrimer Assays are suited for applications including validation of microarray-derived gene expression data, confirming gene expression knockdown by RNAi (RNA interference), identifying and confirming disease-associated biomarkers, and monitoring phenotypic changes related to gene expression. The solution contain synthetic Oligonucleotides which are short, artificially created DNA sequences designed to bind specifically to target gen....
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....ons * Carrier RNA(poly A) 12K1350ug (SKU no. 1017647 Carrier RNA(poly A) 12x1350ug is a solution of adenine nucleotides. It is also known as the QIAamp Circulating Nucleic Acid Kit and used to simplify concentration and purification of free-circulating DNA and RNA from plasma or serum. The QIAamp Circulating Nucleic Acid technology yields circulating DNA and RNA from human plasma, serum, or urine. This procedure is done in 4 steps, i.e., lyse, bind, wash and elute. This process Is carried out using QIAamp Mini columns on a vacuum manifold. The Kit contains Polyadenylic Acid (Poly A) which is a type of single-stranded RNA {Nucleic Acid) that consists of a long chain of adenosine nucleotides. It's often used as a carrier RNA to enhance the stability and recovery of RNA during extraction and purification procedures. * FlexiTube - GeneSolution (SKU no. 1027416) FlexiTube GeneSolution is in the form of solution of nucleotides/ nucleosides. This kit is a gene-specific package of 4 preselected siRNAs (Small Interfering RNA) for a target gene. The kit is used for functional genomics (study of genome and its products i.e., the RNA an....
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....r analysis. From the above, the concerned items appear to merit classification under CTH 2934. CTH 2934 is reproduced below: 2934: NUCLEIC ACIDS AND THEIR SALTS, WHETHER OR NOT CHEMICALLY DEFINED; OTHER HETEROCYCLIC COMPOUNDS Tariff Item Description 2934 1000 - Compounds containing an unfused thiazole ring (whether or not hydrogenated) in the structure 29342000 - Compounds containing in the structure a benzothiazole ring- system (whether or not hydrogenated), not further fused 29343000 - Compounds containing in the structure a phenothiazine ring- system (whether or not hydrogenated), not further fused 29349100 - Other: -- Arninorex (INN), brotizolam (INN), clotiaze,e _~ (INN), cloxazolam (INN), dextromoramide (INN), haloxazolam (INN), ketazolam (INN), mesocarb (INN), oxazolam (INN), pe~oline (INN), phendimetrazine (INN), pbenmetraz11le (INN) and sufentaml (INN); salts thereof 29349200 -- Other fentanyls and their derivatives 29349910 --- Chloro thiophene-2-carboxylic acid 29349920 --- Morpholine 29349930 --- Buprofezin (ISO) 29349990 --- Other The goods appear to contain nucleic acid molecules in modified forms. F....
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....eagents or kits used for diagnosis or research and development and contain nucleotides in as much as the items imported by the Applicant are reagents or kits used for diagnosis or research and development being solutions nucleotides or oligonucleotides. 3.6 Pertinently, in the past, the Applicant has classified the goods under CTH 38229090 which pertains to 'other reference materials'. The relevant text of CTH 3822 is reproduced hereunder for ready reference. Tariff Item Description Unit Rate of Duty 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 38221100 -- For malaria Kg 10% 38221200 -- For Zika and other diseases transmitted by mosquitoes of the genus Aedes Kg 10% 38221300 -- For blood-grouping Kg 10% 38221....
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....stic test kits specified in List 4 Nil - - List 4 (See S. No. 167 and 607 of the Table) ( ... ) 90) Solution of Nucleotides and Nucliosides" 3.7 It is further submitted that on our hearing dated 26.08.2025, the Ld. CAAR sought an explanation as to why the goods under this consideration in this application are classified under Chapter 29 and not under Chapter 38. In that regard, it is submitted that the items under consideration in this application are not reagents or solutions which are used for diagnosis or put up in the form of kits. The said items are merely salts of nucleic acids which cannot be used for diagnosis. Accordingly, the items merit classification under Chapter 29 and not Chapter 38. 3.8 A brief description of the items in the application is hereunder for reference. S. No. Material Description Item Description in brief Earlier HSN Heading Description Contended HSN Code Heading Description 1. RT2 qPCR Primer Assay (200) This kit is in the form of solution of synthetic oligonucleotid es. It is used for real time PCR analysis in identifying and confirming disease associated biomarks. 38229090 ....
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....proteins that are encoded for in the RNA. 38229090 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 382290 - Other 38229090 -- Other 29349990 2934 - NUCLEIC ACIDS AND THEIR SALTS; WHETHER OR NOT CHEMICALLY DEFINED; OTHER HETEROCYCLIC COMPOUNDS 293499 - Other 29349990 - Other 6. (Poly A) (310ug) Carrier RNA This kit is in the form of solution of adenine nucleotides. It is used to simplify RNA purification form sample materials. 38229090 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 382290 - Other 38229090 -- Other 29349990 2934 - NUCLEIC ACIDS AND THEIR SALTS; WHETHER OR NOT CHEMICALLY DEFINED; OTHER HETEROCYCLIC COMPOUNDS 293499 - Other 29349990 - Other 7. QuantiNova LNA PCR Assay (200) This kit is in the form of solution of synthetic oligonucleotid es. It is used for det....
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....oducts: * RT2 qPCR Primer Assay {SKU no. 330001) RT2 qPCR Primer Assays is in the form of solution of synthetic oligonucleotides. These are specifically designed and experimentally verified for real-time PCR analysis. RT2 qPCR Primer Assays are suited for applications including validation of microarray-derived gene expression data, confirming gene expression knockdown by RNAi (RNA interference), identifying and confirming disease-associated biomarkers, and monitoring phenotypic changes related to gene expression. The solution contain synthetic Oligonucleotides which are short, artificially created DNA sequences designed to bind specifically to target genes or sequences. They are used as primers in real-time PCR reactions to amplify and detect specific DNA sequences. Further, the kit contains synthetic nucleic acid molecules (oligonucleotides) that serve as primers. * miRCURY LNA miRNA Inhibitor {SI (SKU no. 339121) miRCURY LNA miRNA Inhibitors are antisense oligonucleotides, used in study of miRNA loss-of-function, i.e., reduction in activity of a gene. Such a study is carried out by assessing the biological consequences of inhibiting mi....
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.... out using QIAamp Mini columns on a vacuum manifold. The Kit contains Polyadenylic Acid (Poly A) which is a type of single-stranded RNA {Nucleic Acid) that consists of a long chain of adenosine nucleotides. It's often used as a carrier RNA to enhance the stability and recovery of RNA during extraction and purification procedures. * FlexiTube - GeneSolution (SKU no. 1027416) Flexi Tube Gene Solution is in the form of solution of nucleotides/ nucleosides. This kit is a gene-specific package of 4 preselected siRNAs (Small Interfering RNA) for a target gene. The kit is used for functional genomics (study of genome and its products i.e., the RNA and proteins that are encoded for in the RNA) or pathway analysis with small numbers of gene targets. The kit enables use of multiple siRNAs for each target gene ensuring reliable results. The Kit contains nucleic acids in form on siRNAs. * Carrier RNA (Poly A) (310ug) (SKU no. 1068337) Carrier RNA (Poly A) (310ug) is a solution of adenine nucleotides. It is used to simplify RNA purification from a wide range of sample materials. It is a kit enabling rapid and efficient purification of hi....
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....ity. During the personal hearing, the applicant submitted that they have earlier imported the subject goods under CTH 38229090, the goods under this heading covers 'other reference materials' and however after due deliberation, they realised that they were classifying it wrongly, therefore, they are now seeking the classification of subject goods under CTH 29349990 to ensure the correct classification of subject goods for imports in future. Regarding change of existing classification, the applicant has submitted additional submission and has requested to decide the classification on the basis of merit. Thus, it appears that the issue involved is whether "the subject goods" can merit classification under tariff item 29349990 or 38229090 of the Customs Tariff Act, 1975. In order to decide the same, it is imperative to examine both competing tariff headings which cover following: CTH 3822 includes: DIAGNOSTIC OR LABORATORY REAGENTS ON A BACKING. PREPARED DIAGNOSTIC LABORATORY OR 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 Tariff Item Description -....
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....a phenothiazine ring-system (whether or not hydrogenated) not further fused - Other 2934 91 00 -- Aminorex (INN), brotizolam (INN), clotiazepam (INN), cloxazolam(INN), dextromoramide (INN), haloxazolam (INN), ketazolam (INN), mesocarb (INN), oxazolam (INN), pemoline (INN), phendimetrazine (INN), phenmetrazine (INN) and sufentanil (INN); salts thereof 2934 92 00 -- Other fentanyls and their derivatives 2934 99 -- Other 2934 99 10 --- Chloro thiophene-2-carboxylic acid 2934 99 20 --- Morpholine 2934 99 30 --- Buprofezin (ISO) 2934 99 40 --- Goods specified in Supplementary Note 18 to this Chapter 2934 99 90 --- Other 5.6. 1 have carefully examined the competing tariff entries proposed for classification, namely CTH 38229090 and CTH 29349990. At the outset, it is pertinent to note that both entries are residuary in nature within their respective chapters. CTH 38229090 covers "other" ....
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....ds must be preferred. This method is consonant with the General Rules for the Interpretation of the Tariff, which require classification to be determined according to the heading which provides the most specific description (Rule 3(a)). Accordingly, I find that the appropriate classification of the impugned goods is under CTH 29349990. On further scrutiny, I note that the subject goods do not fall under the "Certified reference materials" because it is not a reference material accompanied by a certificate of reference material indicating; (a) Value of certified properties. (b) Method used to determine these value. (c) And degree of certainty associated with each value. I have gone through certificate of reference material as available on open source data (samples posted below) and find that most important part for classifying the goods as certified reference material is degree of certainty associated with each value as evident from certificates produced below: The documents as submitted by the applicant do not have any data for "degree of certainty" associated with material which shows that it is not a "certified reference material". ....
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....ts exemption from the whole of the customs duty to lifesaving drugs/medicines, including their salts and esters, as well as diagnostic test kits, provided they are specifically enumerated in List 3 and classifiable under Chapter 28, 29, 30 or 38. Entry No. 55 of List 3 refers to Solution of Nucleotides and Nucleosides. 6.2. I have carefully considered the submissions advanced by the applicant. It is noted that the applicant has specifically contended that the subject imported goods, i.e., nucleotides and nucleosides, are neither drugs nor medicines and do not constitute salts or esters thereof. The applicant has, therefore, taken the position that the impugned goods do not possess the character of pharmaceutical formulations or therapeutic substances that are ordinarily covered under drug or medicinal categories for the purposes of customs exemption. 6.3. Further, in the additional submissions placed on record, the applicant has argued that the items under consideration are not reagents, diagnostic solutions, or materials put up in the form of diagnostic kits. As per the applicant's own contention, in its additional submission, the goods are merely salts of nucleic acids ....
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....n Certified Reference Material - Certificate of Analysis Ketamine, Primary Measurement Standard (+)-2-(2-Chlorophenyl)-2-(methylarmino)cyclohexanone hydrochloride Cecilionl Qually ISO 17034 ISO/IEC 17025 K-002-1ML Product No .: Lot No .: FE01211902 Description of CRM: Ketamine HCI in Methanol (Solution) ISO 13485 ISO 14001 Nominal concentration is adjusted for HCI content. Expiration Date: March 2024 See Section "Stability Assessment". ISO 9001 Storage: Store unopened in freezer (-10 ℃ to -25 ℃). Shipping: Ambient. See Section "Stability Assessment". C CHI&CINO · Ha Chemical formula: 0 CAS No .: 1867-66-9 NH 1 HCI USDEA Exempt | Canadian TK # 61-1257 Regulatory: CH Analyte Certified Concentration # associated uncertainty U, w=k'u (k=2) Ketamine 1.000 + 0.006 mg/mL Metrological traceability: Traceable to the SI and higher order standards from NIST through an unbroken chain of comparisons. See "Details on metrological traceability" on page 2. Measurement method: The certified charactenzed page 2. value is calculated from high precision weighing of thoroughly star....