TaxTMI 
TaxTMI 
TaxTMI 
2025 (12) TMI 687
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....nt"), 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. miRCURY LNA SYBR Green PCR Kit (200) and miRCURY LNA SYBR Green PCR Kit (600) * The miRCURY LNA SYBR Green PCR Kit contains a high-performance PCR master mix reagent specifically designed for use with the miRCURY LNA miRNA PCR System. These are primarily laboratory kits used for research and development purpose. * The miRCURY SYBR Green PCR Kit also features a built-in control for visual identification of correct template addition, as well as Q-Bond, an additive in the PCR buffer that enables short cycling steps without loss of PCR sensitivity and efficiency. * This kit contains the high-performance ....
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....efore, the Applicant fulfils the requirements under Section 28E(c)(i) of the Customs Act. 1.7.4 The questions on which an application for an advance ruling can be made are provided under Section 28H of the Customs Act. In the instant case, since the Applicant is seeking a ruling on whether the goods imported by the Applicant are classifiable under CTH 38221990 and 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, the same are covered within the scope of Section 28H(2)(b). Non-Applicability of bar under Section 281 1.7.5 Section 281 of the Customs Act, 1962 is set out below: (1) ... (2) The Authority may, after examining the application and the records called for, by order, either allow or reject the application : Provided that the Authority shall not allow the application where the question raised in the application is - (a) already pending in the applicant's case before any officer of customs, the Appellate Tribunal or any Court; (b) the same as in a matter already decided by the Appellate Tribunal....
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....SN Explanatory Notes also clarify the scope of particular subheadings. Pertinently, the HSN Explanatory Notes have also been adopted by the Customs Tariff Act and given a statutory back by including the Section Notes and Chapter Notes at the top of each Chapter in Schedule I of the Customs Tariff Act. 1.8.5 Further, in the case of CCE v. Wood Craft Products Ltd. (1995) 77 ELT 23, the Hon'ble Supreme Court has held that as per the Statement of Objects and Reasons of the Central Excise Tariff Bill, 1985, new tariff has been introduced, based on HSN to reduce classification of disputes. Thus, in case of doubt, HSN is a safe guide for ascertaining true meaning of any expression used in the Tariff, unless there is an express different intention indicated in the Tariff itself. This decision was subsequently confirmed in the case of CC v. Business Forms, 2002 (142) ELT 18 (SC). As such therefore, reliance placed by the Applicant on the WCO HSN is valid and sustainable Submissions on classification under CTH 38221990 1.8.6 It is submitted that the Tariff Heading for Item 3822 under WCO HSN is as under: Tariff Item Description 3822 DIAGNOSTIC OR LABORATORY REAGENTS ....
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....ed as backings or support), impregnated or coated with one or more diagnostic or laboratory reagents, such as litmus pH or pole-finding papers or pre-coated immuno-assay plates. Reagents of this heading may also be put up in the form of kits, consisting of several components, even if one or more components are separate chemically defined compounds of Chapter 28' or Chapter 29, synthetic coloring 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. 1.8.8 Accordingly, what flows from the above is that: i) The items in this heading are used for in vitro applications ii) The items under this heading are strictly for diagnostic or laboratory use and not for administering to a patient. iii) Reagents may be in any form, such as paper, plastics or other materials. iv) The reagents may also be put up in kits with its components being separate. 1.8.9 Further, the relevant Tariff Heading 3822 under Customs Tariff Act is as under: Tariff Item Description A....
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....e under CTH 38221990 for following reasons: i) The goods sought to be imported are strictly used for in-vitro diagnosis. i) All the goods are put up on the form of kits for medical diagnosis and contain reagents for amplification of pathogen DNA which assist in identification of the presence of the pathogen. iii) The reagents are not directly administered. Infact, samples are taken from the patient and prepared to be used with the reagents. iv) Reagents are delivered in various forms, like liquid put up in tubes (such as Certal Residual DNA Detection Kits) or impregnated in strips (such as QIAstat-Dx Respiratory SARS-COV-2 Panel). v) Further, the kits may be used with other devices to deliver results. However, the amplification of pathogen DNA is performed by the kit itself, and it is only the delivery of the results and its analysis that may depend on an independent machine for certain goods Accordingly, the goods sought to be imported are squarely classifiable under CTH 38221990. Submissions on availability of exemption under Entry 167(A) 1.8.14 It is also pertinent to note at this juncture that all the kits mentioned in....
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....Table) ( ... ) 24) Cobalt-60 ( ... ) 34) Fibrinogen ( ... ) 41) Gallium Citrate" (c) Whole Kit such as Immunoassay kits and Pneumocystis carinii IF kits. The relevant extract of the Entry in List 4 is as under: List 4 (See S. No. 167 and 607 of the Table) ( ... ) 49) Immunoassay kit for blood Fibrinogen degradation product for direct estimation for diagnostic test in D.I.C ( ... ) 79) Pneumocystis carinii IF kits" 1.8.18 In that regard, it is submitted that presence of BSA in the kit would qualify the said kit for exemption under Notification No. 50/2017-Customs dated 30.06.2017. It may noted that while "BSA" is a serum which facilitates the process of amplification of pathogens, Serial no 167(A) of Notification No. 50/2017-Customs dated 30.06.2017 specifies Nil rate of duty on 'Lifesaving drugs/medicines including their salts and esters and diagnostic test kits specified in List 4'. Entry No. 16 to List 4 mentions "BSA". BSA is neither a drug/ medicine, nor its salt/ esters, and therefore reference to BSA under Notification No. 50/2017-Customs dated 30.06.2017 can only ....
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....roviso (1) of section 28-1 (2) of the Customs Act. 1962 regarding the question raised in the application: As per records available in the Section, no such case of the applicant is pending with any officer of the Customs, other Appellate Tribunal or any Court as per proviso of Section 28(1) (2) of Customs Act, 1962. 2.4 Whether the claim of the applicant regarding the nature of activity, i.e. it is ongoing/proposed is correct: As per available records, Importer has imported these items before under CTH 3822. 2.5 Comments on merit: Items to be imported are: * miRCURY LNA SYBR Green PCR Kit (200) and miRCURY LNA SYBR Green PCR Kit (600) In this regard, it is submitted that the above-said items are diagnostic kits and appear to be classified under CTH 38221990. Further, goods do not appear to be eligible for benefit of no. 167(A) of Notification no. 50/2017-Customs. 2.6 The goods sought to be imported are used for the applications as under: * miRCURY LNA SYBR Green PCR Kit (200) and miRCURY LNA SYBR Green PCR Kit (600) As per Importer's submission, the goods sought to be imported are put up on the form of kits for medical diagnosis and contain....
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.... The applicant, vide email dated 17.11.2025 forwarded additional submission to this office, pursuant to personal hearing dated 26.08.2025, which are as follows :- 4.1 On our hearing dated 26.08.2025, the Ld. CAAR questioned whether BSA in the Kits is an active ingredient such that the kits would merit exemption under Entry 167(A) of Notification No. 50/2017 - Customs dated 30.06.2017 ("Exemption Notification") read with S. No. 16 of List 4 of said notification. 4.2 In that regard, it is imperative to lay down the mechanism which is used in the Kits to diagnose presence of pathogens. The said mechanism is detailed hereunder: (i) The kits contain various components such as reagents, enzyme, buffer solutions and consumables. (ii) The test performed by first separating the nucleic acids (DNA. LNA, RNA etc) from the sample to purify the sample of any impurities. (iii) The aforementioned preparation of samples is performed by use of enzymes and buffers provided in the kits. (iv) Thereafter, Bovine Albumin (also known as Bovine Serum Albumin, which is a protein found in cow's blood and has property to bind with fatty acids, hormones or stero....
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.... "3822 - DIAGNOSTIC OR LABORATORY REAGENTS ON A BACKING, PREPARED DIAGNOSTIC OR LABORATORY REAGENTS WHTHER OR ONT 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 Accordingly, it is humbly prayed that this Hon'ble Authority may be pleased to rule that: (a) All the items hereinabove are classifiable under CTH 38221990 and eligible for exemption from payment of 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 [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] (b) Any other order that the Hon'ble Authority may deem fit 5. Discussion, Findings and Conclusion: 5.1 After finding that the a....
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....on 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 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 - 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 ....
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....ith 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". Hence, I am agreeing with contention of the applicant (which is agreed by the department also) that they were wrongly classifying these goods as "other reference material". As the existing classification was based on their wrong interpretation of tariff, a fresh interpretation of tariff heading can be considered as a valid ground for changing existing classification. In this regard, I note that in case of Commissioner of Central Excise, Nagpur Vs Vicco Laboratories [2005 (179) E.L.T. 17 (S.C.)], Apex court ruled that a fresh interpretation of tariff heading can be considered as a valid ground for changing existing classification. Further, I rely upon the case of Dharampal Premchand Ltd. Vs Commi....
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....n 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 expressly listed. Illustratively, diagnostic kits such as the "Immunoassay kit for blood Fibrinogen degradation product for direct estimation for diagnostic test in D.I.C." (Entry 29) and "Pneumocystis carinii IF kits" (Entry 46) appear by name. This demonstrates the legislative intent that only those diagnostic kits which are specifically and exhaustively enumerated in List 3 qualify for exemption. b. Entry 9 Applies Only to Bovine Albumin as an Independent Product - Entry 9 of List 3 mentions "Bovine Albumin" as a standalone product. The entry does not refer to diagnostic kits, reagents, or compound formulations containing Bovine Albumin. Under settled principles of exemption interpretation, particularly the rule that exemption entries must be construed strictly and as written, the benefit of Entry 9 cannot be extended to any product merely because it contains Bo....
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....omponents, 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, had noted that the active and principal ingredient of the kit was "Agglutinating Sera" itself, and that the other component merely served as a diluent or medium for reconstitution. 6.4.1 In the present case, however, the facts stand on a different footing. It appears from the documents and submissions on record that the diagnostic kits proposed to be imported by the Applicant contain Bovine Serum Albumin along with other reagents and constituents. Thus, the composition and essential nature of the impugned goods are materially distinct from those examined in Inter Care case (supra) 6.4.2 Accordingly, the ratio decidendi of the Inter Care decision cannot be extended to the present matter, as the same was rendered in the context of goods consisting solely of "Agglutinating Sera" as the active ingredient, whereas the instant product is a composite di....