TaxTMI 
TaxTMI 
2025 (12) TMI 775
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....o as "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: (a)QIAstat-Dx Respiratory SARS-COV-2 Panel * The QIAstat-Dx Respiratory SARS-COV-2 Panel Cartridge is a disposable plastic device that allows performance of fully automated molecular assays for the detection of respiratory pathogens and is used specifically for medical diagnosis. The main features of the QIAstat-Dx Respiratory SARS-COV-2 Panel Cartridge include compatibility with nasopharyngeal swab in transport medium (liquid samples), hermetical containment of the pre-loaded reagents necessary for testing, and true walk-away operation. All sample preparation and assay testing steps are....
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....esearch institute, the 'RUO' kit is purchased. . The function of the Kit is to detect cytomegalovirus (CMV) DNA in human biological samples through reagents (such as Bovine Serum Albumin) and enzymes which amplify the CMV genome. (e) artus HSV-1/2 QS-RGQ Kit (24) CE,Box [SKU no. 1064291] * The artus HSV-1/2 QS-RGQ Kit constitutes a ready-to-use system for the detection of HSV-1 and HSV-2 DNA using polymerase chain reaction (PCR). The said kit is used for medical diagnosis. * The HSV-1/2 RG Master contains reagents and enzymes for the specific amplification of the HSV-1 and HSV-2 genomes. In addition, the artus HSV-1/2 QS-RGQ Kit contains a second heterologous amplification system to identify possible PCR inhibition. Moreover, the reagents in the kit contain Bovine Serum Albumin. * Pathogen detection by the polymerase chain reaction (PCR) is based on the amplification of specific regions of the pathogen genome. In real-time PCR the amplified product is detected via fluorescent dyes. These are usually linked to oligonucleotide probes that bind specifically to the amplified product. Monitoring the fluorescence intensities during the....
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....hether 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 S. No. 16 of List 4 of same notification, available to "Diagnostic Kits" containing BSA? Statement containing the applicant's interpretation of law and/or facts, as the case may be, in respect of the aforesaid question (i.c. 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 requires, (c) "applicant" means any person,- (i) holding a valid Importer-exporter Code Number granted under section 7 of the Foreign Trade (Development and Regulation) Act, 1992 (22 ....
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....he 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 to the terms of the headings and any relative Section or Chapter Notes and, provided such headings or Notes do not otherwise require, according to the following provisions" 1.8.4 Further, it is submitted that along with ....
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....s 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 heading 30.06. ii) Further, it is submitted that as per the HSN Explanatory Notes, diagnostic reagents are used in the evaluation of physical, biophysical or biochemical processes and states in animals and humans. Their function is based upon a measurable or observable change in the biological or chemical substances constituting the reagent. Prepared diagnostic reagents of this heading may be similar in function to those designed to be administered to patients (subheading 3006.30), with the exception that they are used for in vitro rather than for in vivo, applications. Prepared laboratory reagents include not only diagnostic reagents, but also other analytical reagents used for purposes other than detection or diagnosis. Prepared diagnostic and laboratory reagents may be used in medical, veterinary, scientific or industrial laboratories, in hospitals, in industry, in the field or, in some cases in th....
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.... 38221990 --- Other Kg 10% 382290 - Other: 38229010 --- Certified Reference Material Kg 30% 38229090 --- Other Kg 30% 1.8.10 It is apposite to note that the Section Notes and Chapter Notes are silent about laboratory and diagnostic reagents. Therefore, reliance shall be placed upon the reference made on the HSN. 1.8.11 It is further submitted that certain kits imported by the Applicant are used for research purposes as well as for medical diagnosis. The kits which are imported for research purposes are denoted by 'RUO' in the name of the Kit. However, it is pertinent to note that the essential character of the kit remains the same, be it used for medical diagnosis or for research purposes. 1.8.12 In that regard, it is submitted that the end use of any product cannot be the determinative factor for the classification of the product. The imported goods are required to be classified as they are present at the time of import before the customs. That is to say that the end use of the goods imported has no bearing on the classification of goods. As such therefore, the mere fact that certain kits are used for....
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....gs/medicines including their salts and esters and diagnostic test kits specified in List 4 and also classifiable under Chapter 38 are eligible for exemption from whole of the duty of customs. Entry 16 of List 4 of Notification No. 50/2017- Customs dated 30.06.2017 refers to Bovine Albumin 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) ( ... ) 16) Bovine Albumin" 1.8.17 It is apropos to note at this juncture that the upon a bare perusal of the exemptions granted by Notification No. 50/2017-Customs dated 30.06.2017, it is evident that the Notification No. 50/2017-Customs dated 30.06.2017 contemplates three kinds of exemptions qua medical diagnostic kits which c....
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....contained Agglutinating Sera. 1.8.20 As such therefore, in light of the submissions hereinabove, the goods sought to be imported by the Applicant ought to be classified under CTH 38221990 since the same are diagnostic or laboratory reagents in the form of kits. 1.8.21 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 30.06.2017 since the goods sought to be imported have the presence of BSA in them. Accordingly, the goods sought to be imported are eligible for Nil rate of duty at the time of import. 1.8.22 In view of the legal provisions and submissions made herein, it is most humbly submitted before this Hon'ble Authority that goods mentioned hereinabove should be classified under CTH 38221990 and eligible for exemption under Entry 167(A) of Notification No. 50/2017-Customs dated 30.06.2017 read with S. No. 16 of List 4 of the same notification. 2. Comments of Custom Port Commissionerate: 2.1 As per the provision of CAAR Regulation, 2021, the complete application of the applicant was provided to the concerned Custom P....
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....melting curve analysis in the LightCycler Instrument. As per Importer's submission, the Kit contains Bovine Serum Albumin which amplifies specific regions of the pathogen genome. In real-time PCR the amplified product is detected via fluorescent dyes. Monitoring the fluorescence intensities during the PCR run (i.e., in real-time) allows the detection and quantitation of the accumulating product without having to reopen the reaction tubes after the PCR run. * artus CMV OS-RGO Kit (24) CE.Box As per Importer's submission, the artus CMV QS-RGQ Kit is an in vitro nucleic acid amplification test for the quantitation of cytomegalovirus (CMV) DNA in human biological samples. The said kit is used for medical diagnosis. The CMV RG Master contains reagents and enzymes (such as Bovine Serum Albumin} for the specific amplification of the CMV genome. The amplification assists in the detection of the virus in human samples. * artus CMV OS-RGO Kit (24) RUO.Box As per Importer's submission, this kit is similar to above (artus CMV OS-RGO Kit (24) CE, Box). However, this Kit is used for research purposes only, as signified by 'RUO' in the name.....
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....iable under CTH 3822. CTH 3822 includes: 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 Tariff Item Description - 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 38221200 -- For Zika and other diseases transmitted by mosquitoes of the genus Aedes 38221300 -- For blood-grouping 382219 -- Other: 38221910 --- Pregnancy Test Kit 38221990 Other 382290 - Other: 38229010 Certified Reference Material 38229090 --- Other The goods in contention appear to be supplied in the form of kits which contains the reagent which is used for analysis. In view of the above, the goods appear to be laboratory kits/reagents used for medical, research and development purposes which are classifiable under CTH38221990. Further, it is submitted that Entry 167(A) of Notification No. 50/2017-Customs dated 30.06.2017 s....
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....helps in firstly stabilizing the enzymes used in the test, such that the enzymes and proteins are resistant to thermal degradation. In other words, Bovine Albumin acts as a protein matrix that shields sensitive regions of the enzyme from heat-induced unfolding or aggregation. (vi) Further, Bovine Albumin also binds itself with any impurities remaining in the sample and prevents them from interfering with the test. (vii) Thereafter the sample is ready to undergo pathogen culture or any other process for gene sequencing and PCR reactions. 4.3 In sum and substance, Bovine Albumin in a kit is a critical component to ensure that the result of the test is not compromised by degradation of proteins and/or presence of any inhibitors in the sample. Therefore, without Bovine Albumin, which is an active ingredient in the kits, the test results are unreliable and unusable for analysis. 4.4 A brief description of the items in all the applications is hereunder for ready reference. S. No. Material Descript ion Item Description in brief Earlier HSN Heading Description Contended HSN Code and entry under Exemption Notification Heading Description 1. ....
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.... artus CMV QS-RGQ Kit (24) RUO, Box This kit is similar to item no. 3 hereinabove, i.e., this kit is an in-vitro nucleic acid amplification test for the quantitation of cytomegalovirus (CMV) DNA in human biological samples. However, this specific SKU is only used for research purposes. 382290 90 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 38221990 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 382219 -- Other 38221990 --- Other 5. artus HSV-1/2 QS-RGQ Kit (24) CE, Box This kit is used for detection of HISV-1 and HSV-2 DNA (type of herpes) for medical diagnosis purposes. For the said purpose it contains BSA. 382290 90 "3822 - DIAGNOSTIC OR LABORATORY REAGENTS ON A BACKING, PREPARED DIAGNOSTIC OR LABORATORY REAGENTS WHTHER OR ONT ON A BACKI....
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....e notification [now Entry 102 of Notification No. 45/2025 - Customs dated 24.10.2025 read with Entry No. 9 of List 3 with effect from 24.10.2025] 5. Discussion, Findings and Conclusion: 5.1 After finding that the application is valid in provisions of the Custom Act, 1962 and the CAAR Regulations, 2021, having gone through CAAR-1 application, reply from Jurisdictional Commissionerate, oral submissions made during the hearing, additional submission and the legal framework, I first allow the application and proceed to deliberate upon the issue on the basis of information available on record. Product Description: 5.2 As per applicant's submission, following are the goods in the application seeking advance ruling: (a) QIAstat-Dx Respiratory SARS-COV-2 Panel * The QIAstat-Dx Respiratory SARS-COV-2 Panel Cartridge is a disposable plastic device that allows performance of fully automated molecular assays for the detection of respiratory pathogens and is used specifically for medical diagnosis. The main features of the QIAstat-Dx Respiratory SARS-COV-2 Panel Cartridge include compatibility with nasopharyngeal swab in transport medium (liquid samples), herme....
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....#39; in the name. Pertinently, the function of the kit is similar to the kit used in medical diagnosis. However, whenever this kit is ordered by a research institute, the 'RUO' kit is purchased. * The function of the Kit is to detect cytomegalovirus (CMV) DNA in human biological samples through reagents (such as Bovine Serum Albumin) and enzymes which amplify the CMV genome. (e) artus HSV-1/2 QS-RGQ Kit (24) CE,Box [SKU no. 1064291] * The artus HSV-1/2 QS-RGQ Kit constitutes a ready-to-use system for the detection of HSV-1 and HSV-2 DNA using polymerase chain reaction (PCR). The said kit is used for medical diagnosis. * The HSV-1/2 RG Master contains reagents and enzymes for the specific amplification of the HSV-1 and HSV-2 genomes. In addition, the artus HSV-1/2 QS-RGQ Kit contains a second heterologous amplification system to identify possible PCR inhibition. Moreover, the reagents in the kit contain Bovine Serum Albumin. * Pathogen detection by the polymerase chain reaction (PCR) is based on the amplification of specific regions of the pathogen genome. In real-time PCR the amplified product is detected via fluorescent dyes. Th....
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.... CMV QS-RGQ Kit (24) RUO,Box, artus HSV-1/2 QS-RGQ Kit (24) CE, Box, QIAscreen HPV PCR Test-RUO and Certal Res DNA Detection Kit(100),Box (hereinafter referred as 'the subject goods')" under CTH 38221990, which is also agreed by the department in its comments sought by the Authority. 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 38221990 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 and without any bias to their earlier classification. 5.4. Thus, it appears that the issue involved is whether "the subject goods" can merit classification under tariff item 38221990 or 38229090 of the Customs Tariff Act, 1975. In order to decide the same, it is imperative to examine both co....
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....s decision of Apex court in various cases. Further, in case reported in 2016 (339) E.L.T. 500 (S.C.), it was held as under: Classification of goods - Residuary heading - It can be resorted to only when by liberal construction specific Entry cannot cover goods in question - It covers only those category of goods which clearly fall outside ambit of main Entry - Unless revenue establishes that goods cannot be brought under any of tariff items, residuary entry cannot be resorted to. [para 22] 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 produce....
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....2025-Customs dated 24.10.2025 and the same has been referred to by the applicant in its additional submission. Entry 102 of Notification No. 45/2025-Cus. dated 24.10.2025 grants 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. 9 of List 3 refers to Bovine Albumin. 6.2. The applicant has contended that the diagnostic reagents/kits proposed to be imported by them merit exemption solely because they contain Bovine Albumin as one of their constituents, and that the presence of this ingredient attracts the benefit of Entry 9 of List 3. This contention is untenable for the following reasons: a. Scheme and Structure of List 3 A perusal of List 3 under Notification No. 45/2025-Cus. reveals that it consists of two broad categories: (i) specific lifesaving drugs/medicines (including salts and esters), and (ii) fully identifiable, complete diagnostic test kits. Wherein diagnostic kits are intended to be exempted which are individually and ex....
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....on solely to Bovine Albumin imported in its isolated form, not to composite laboratory reagents or kits in which Bovine Albumin is merely an ingredient. Consequently, the diagnostic kits proposed to be imported by the applicant do not fall within the scope of Entry 102 read with List 3 of Notification No. 45/2025-Customs and are not eligible for exemption from customs duty. 6.4. Further, the Applicant has placed reliance upon the decision of the Hon'ble CESTAT, New Delhi, in the case of Inter Care v. Commissioner of Customs [1997 (89) E.L.T. 545 (Tribunal)], wherein the Hon'ble Tribunal had occasion to examine the issue relating to the admissibility of exemption in respect of "Agglutinating Sera" used in pregnancy test kits. Upon perusal of the aforesaid judgment, I observe that the product under consideration therein comprised a diagnostic kit containing two distinct components, viz. (a) agglutinating sera in solid form, and (b) a buffer solution. These two components, when mixed together, resulted in the reconstitution or reconversion of the agglutinating sera into liquid form for use in diagnostic testing. The Hon'ble Tribunal, while allowing the exemption benefit, ha....
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....ation Date: March 2024 See Section "Stability Assessment". ISO 9001 Storage: Store unopened in freezer (-10 ℃ to -25 ℃). Shipping: Ambient. See Section "Stability Assessment". CI. Chemical formula: CIHICINO . HC CAS No .: 1067-66-9 NH Regulatory: USDEA Exempt | Canadian TK # 61-1257 1 HCI CH. (*)-2-(2-Chlorophenyl) -2-(methylamino)cyclohexanone hydrochloride K-002-1ML 1067-66-9 NH Certified Concentration + associated uncertainty U, Analyte u=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 compansons. See "Details on metrological traceability" on page 2. Measurement method: The certified value is calculated from high precision weighing of thoroughly page 2. characterized starting material. See "Details about certification process' on Intended use: This Certified Reference Material is suitable for the in vitro identification. calibration, and quantification of the analyte(s) in analytical and P &D applications. Not suitable for human or animal consumption. Minimum sample size: 1 uL for quantitative applications Instructions f....