In re Qiagen India Pvt Ltd (CAAR Delhi)
Qiagen India Pvt Ltd (“Applicant”), a wholly owned subsidiary of QIAGEN GmbH, Germany, applied to the Customs Authority for Advance Rulings (CAAR), New Delhi, on 24 December 2024, seeking clarification on the classification and customs duty applicability for certain imported diagnostic kits, specifically the miRCURY LNA SYBR Green PCR Kits (200 and 600). The Company imports these kits for laboratory research and medical diagnostic purposes, containing reagents including Bovine Serum Albumin (BSA), which the Applicant claimed as critical to the kits’ functionality.
The Applicant sought a ruling on two issues: (i) whether the imported diagnostic kits are classifiable under CTH 38221990, which covers diagnostic or laboratory reagents in the form of kits not intended for direct patient administration, and (ii) whether the kits qualify for exemption from Basic Customs Duty under Entry 167(A) of Notification No. 50/2017-Customs, read with List 4 (Item 16), due to the presence of BSA.
The Applicant argued that the kits are intended strictly for in vitro diagnosis, with reagents used to amplify pathogen DNA and facilitate identification of pathogens. They contended that the kits, though sometimes used for research purposes (denoted by “RUO”), retain their essential diagnostic character and should be classified based on their composition, not end use. The kits contain BSA, which stabilizes enzymes, binds residual impurities, and ensures reliable test results, making it an active ingredient. The Applicant further relied on Harmonized System of Nomenclature (HSN) and General Rules of Interpretation (GI Rules) for classification, asserting that CTH 38221990 specifically covers diagnostic or laboratory reagents in kit form and is more specific than the generic heading 38229090 for “other reference materials.”
The Customs Port Commissionerate submitted comments acknowledging the Applicant’s eligibility under Section 28E(c) of the Customs Act, 1962, and that no proceedings were pending against the Applicant under Section 28I(2). The Commissionerate noted that while the kits appeared classifiable under CTH 38221990, they did not qualify for exemption under Entry 167(A), as BSA is only mentioned in the context of standalone products, not composite diagnostic kits.
During a personal hearing on 26 August 2025, the Applicant reiterated that BSA is a critical reagent, stabilizing enzymes and preventing interference during pathogen DNA amplification. The Applicant provided a detailed mechanism demonstrating the active role of BSA in the diagnostic process. They contended that the presence of BSA should entitle the kits to exemption, citing a precedent involving pregnancy test kits containing “Agglutinating Sera.” The Applicant requested classification under CTH 38221990 and exemption under Entry 167(A) (later referenced as Entry 102 of Notification No. 45/2025-Customs following supersession).
The Authority examined the classification issue, noting that Rule 1 of GI Rules requires goods to be classified based on the heading terms and Chapter Notes. The Authority found that the kits are laboratory reagents in kit form intended for in vitro diagnostic use, not for direct patient administration, and are therefore specifically classifiable under CTH 38221990 rather than the generic 38229090. Reference to prior Supreme Court and CESTAT decisions confirmed that prior erroneous classification does not prevent reclassification, and specific headings should be preferred over residual ones. Consequently, the classification change requested by the Applicant was accepted, to be applied prospectively.
Regarding the exemption claim, the Authority analyzed Notification No. 45/2025-Customs, which replaced the earlier 50/2017-Customs notification. Entry 102 provides exemption for lifesaving drugs/medicines and fully identifiable diagnostic kits specifically listed in List 3. Entry 9 in List 3 refers to Bovine Albumin as a standalone product. The Authority concluded that the Applicant’s kits, although containing BSA, are composite products with multiple reagents, and the notification does not extend exemption to kits merely due to the presence of BSA. The precedent cited by the Applicant (Inter Care v. Commissioner of Customs) was distinguished, as it involved a diagnostic kit with a single active ingredient, unlike the multi-component PCR kits here.
FULL TEXT OF THE ORDER OF CUSTOMS AUTHORITY OF ADVANCE RULING, DELHI
QIAGEN India Private Limited, Baani Building, Corporate One, Plot No. 5, District Centre Jasola, New Delhi – 110025 (herein referred to as “applicant”), having IEC No. 0510019731 submitted an application dated 24.12.2024 before the Customs Authority for Advance Rulings, New Delhi (CAAR, New Delhi in short) for obtaining Advance Ruling under Section 28H of the Customs Act, 1962, to seek clarity on the classification on the import of some items to India. The application was accordingly registered under Serial No. 23/2025 dated 24.12.2024.
1.1 QIAGEN India Private Limited (hereinafter referred to 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 arc mentioned herein-below:
i. miRCURY LNA SYBR Green PCR Kit (200) and mercury 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 miRCURY SYBR Green Master Mix for quantitative real-time PCR amplification. The detection is based on SYBR Green, which allows quality control of the resulting PCR amplicon by melting curve analysis. LNA-enhanced primer sets require specific PCR reaction conditions for optimal performance.
1.4 It is also pertinent to note at this juncture that all the aforementioned kits have a common thread, i.e., presence of BSA.
1.5 On the said imported items, requisite Customs duty is paid by the Applicant at the time of clearance of goods for home consumption, and thereafter these are supplied to the Company’s customers 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 38221990?
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 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.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 requires,
(i) “applicant” means any person,-
(ii) holding a valid Importer-exporter Code Number granted under section 7 of the Foreign Trade (Development and Regulation) Act, 1992 (22 of 1992); or
(iii) exporting any goods to India; or
(iv) with a justifiable cause to the satisfaction of the Authority, who makes an application for advance ruling under section 28H; “
1.7.3 The Applicant herein has been granted a valid Importer-Exporter Code Number (IEC) under section 7 of the Foreign Trade (Development and Regulation) Act, 1992. The same is 0510019731. As such therefore, the Applicant fulfills 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 or any Court..”
1.7.6 As such therefore, for the goods sought to be imported, the Applicant is not involved in any dispute/ case before any authority/ court. Thus, the bar under Section 28I(2)(a) of the Act above will not apply. Accordingly, the present application must be allowed to be proceeded with.
1.8 Issues requiring advance ruling
1.8.1 In view of above, the Applicant is seeking an Advance Ruling on whether the diagnosis kits imported by the Applicant are classifiable under CTH 38221990 and 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?
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 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 the GI Rules, the WCO HSN also includes the Explanatory Notes (hereafter referred to as “HSN Explanatory Notes”) which provide a commentary on the scope of each heading, giving a list of the main products included and excluded, together with technical descriptions of the goods concerned (their appearance, properties, method of production and uses) and practical guidance for their identification. Where appropriate, Explanatory Notes also clarify the scope of particular subheadings. Pertinently, the 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 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 | |
| 3822.11 | — For malaria |
| 3822.12 | –For Zika and other diseases transmitted by mosquitoes of the genus Aedes |
| 3822.13 | — For blood-grouping |
| 3822.19 | — Other: |
| 3822.90 | – Other |
1.8.7 With reference to the above, it is apropos to note that the Harmonized Commodity Description and Coding System, HSN Explanatory Notes to HSN 3822 in WCO HSN state that:
i) 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 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 the home.
iii) Moreover, with regards to Reagents, the chapter notes state that reagents of this heading are either on a backing or in the form of preparations and thus comprise more than a single constituent. For example, they may consist of admixtures of two or more reagents or of single reagents dissolved in solvents other than water. They may also be in the form of paper, plastics or other materials (used 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 | Unit | Rate of Duty |
|---|---|---|---|
| 3822 | DIAGNOSTIC OR LABORATORY
REAGENTS ON A BACKING, PREPARED DIAGNOSTIC OR LABORATORY REAGENTS |
||
| – 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% |
| 382219 | — Other: | ||
| 38221910 | —Pregnancy Test Kit | Kg | 10% |
| 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 arc 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 research purposes have no bearing on the classification of the said kits. Reliance in this regard is placed upon the decision of the Hon’ble Supreme Court in the case of Dunlop India v. Union of India 1983 (13) ELT 1566 (SC) and CCE v. Mannampalakkal Rubber (2007) 217 ELT 16.1 (SC).
1.8.13 In that regard, it is submitted that as per understanding of the Applicant, the goods sought to be imported by them ought classifiable under CTI1 38221990 for following reasons:
i) The goods sought to be imported are strictly used for in-vitro diagnosis.
ii) All the goods arc 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. Inflict, samples arc 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 QlAstat-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 CHI 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 this application have a common thread, i.e., presence of Bovine Serum Albumin.
1.8.15 Bovine Serum Albumin (hereinafter referred to as “BSA”) is a serum albumin protein derived from cows. It is often used as a protein concentration standard in lab experiments. BSA is highly stable and biochemically inert substance, which causes enhanced signals in enzyme linked immune-histochemical, immunosorbent and immunoblotting assay. That is to state that BSA interacts with the reagents to ensure amplification of pathogen DNA and is therefore an active ingredient in the reagents put up in the form of kits in the goods sought to be imported.
1.8.16 Further, it is submitted that Entry 167(A) of Notification No. 50/2017-Customs dated 30.06.2017 states that Lifesaving drugs/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 | IGS T | Conditi on |
| 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 can be broadly categorized as under:
(a) Process, i.e., the exemption is granted to a certain process such as CLIA diagnostic kits.
List 4 (See S. No. 167 and 607 of the Table)
(—)
57) Iscador, CLIA diagnostic kits
(b) Components of the Kit such as presence of Cobalt — 60, Gallium Citrate or Fibrinogen in a certain kit. The relevant extract of the entry is as under:
List 4 (See S. No. 167 and 607 oldie Table)
(…)
24) Cobalt-60
(…)
34) Fibrinogen
41) Gallium Citrate”
(c) Whole Kit such as Immunoassay kits and Pneumocystis carinae 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.1.0
(…)
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 be in the context diagnostic kits. Furthermore, the quantity of BSA in the Kit is immaterial. In fact, the exemption entry is silent on the quantity of BSA in the kit. Accordingly, mere presence of BSA 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.
1.8.19 In that regard, the Applicant places reliance on the case of Inter care vs Commissioner of Customs [997 (89) E.L.T. 545 (Tribunal)] wherein the Hon’ble CESTAT Delhi, dwelled upon the availability of exemption for ‘Agglutinating Sera’ in the context of pregnancy kits. The Appellant therein was claiming exemption from customs duty for pregnancy kits since they 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 Port, and requested to furnish the requisite comments in the instant matter. The port authority vide their letter dated 23.05.2025 furnished their comments, which are reproduced as under:
2.2 Eligibility of the applicant, in terms of Section 28E(c) of the Customs Act, 1962 to seek such advance ruling: Yes Qiagen India Pvt. Ltd. is a valid applicant within the meaning of Section 28E(c) (i) of the Customs Act, 1962, having IEC Code 0510019731.
2.3 Applicability of proviso (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 I,NA SYBR Green PCR Kit (200) and miRCURY LNA SYBR Green PCR Kit (6001
As per Importer’s submission, the goods sought to,be imported 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. They are strictly used for in-vitro diagnosis. The reagents arc not directly administered but samples arc taken from the patient and prepared to be used with the reagents. It appears the goods are diagnostic reagents.
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 |
From above, the goods appear to be laboratory diagnostic kits classifiable under CTI-I 38221990.
Further, it is submitted that Entry 167(A) of Notification No. 50/2017-Customs dated 30.06.2017 states that Lifesaving drugs/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. As per Entry 16 of above-said List 4 of Notification No. 50/2017-Customs dated 30.06.2017, benefit of NIL duty is extended to “Bovine Albumin”. However, the goods arc not bovine albumin themselves, but appear to contain bovine albumin apart from other reagents that form part of the kit. Accordingly, it appears the goods in contention do not appear to be eligible for benefit of Sr no. 167(A) of Notification no. 50/2017-Customs.
3. Personal Hearing:
Personal hearing in the matter was conducted through physical mode on 26.08.2025 wherein the authorized representative of the applicant i.e Sh. Shubh Dixit, Sh. Ankur Mittal, Sh. Manish Mishra and Ms. Dhwani Vyas attended the same and reiterated the same which were already submitted with the application of the applicant.
4. Additional Submission of the Applicant pursuant to Personal Hearing
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 steroids), is used to stabilize the solution of purified nucleic acids.
(v) It is imperative to use Bovine Albumin since it 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 Description | Item
Description in brief |
Earli er
HSN |
Heading Description | Contended HSN Code and entry under Exemption | Heading Description |
|---|---|---|---|---|---|---|
| 1 | miRCURY LNA SYBR Green PCR Kit (200) | This kit contains high- performance PCR master mix reagent for quantitative real-time PCR amplification. For the said purpose it contains BSA. | 3822
9090 |
“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 |
| 2 | miRCURY LNA SYBR Green PCR Kit (600) | This kit contains high- performance PCR master mix reagent for quantitative real-time PCR amplification n. For the said purpose it contains BSA. This item is identical to item no. 8. However, since it is imported in a pack of 600 units, the same is considered a different SKU. | 3822 9090 | “3822 – DIAGNOSTIC OR LABORATORY REAGENTS ON A BACKING, PREPARED DIAGNOSTIC OR LABORATORY REAGENTS WI ITI IER 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 arc 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 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:
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 miRCURY SYBR Green Master Mix for quantitative real-time PCR amplification. The detection is based on SYBR Green, which allows quality control of the resulting PCR amplicon by melting curve analysis. LNA-enhanced primer sets require specific PCR reaction conditions for optimal performance.
Issue of classification:
5.3 On issue of classification, I find that the applicant has claimed the classification of products “miRCURYLNA SYBR Green PCR Kit (200) and miRCURYLNA SYBR Green PCR Kit (600) (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 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 |
5.5. 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 ofSections, 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”
5.6. I find that “the subject goods” arc laboratory reagents in form of kit which is aptly classifiable under CTH 38221990 as other Kit. As the product is aptly classified by application of Rule 1 itself; there is no need to go in further details.
5.7. So far as previous classification of subject goods as “Other reference material’ under CTI 38229090 is concerned, I observed that the applicant has considered this as their bonafide error and has requested to change classification.
5.8. I find that 38229090 is a generic heading for other reference material. As discussed above CTH 38221990 is more specific classification of the product which should be preferred over generic classification in view of various 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 – li can be resorted to only when by liberal construction specific Entry cannot cover goods in question – It covets 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, 1 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”. 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 Vicon 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 Dharmapala Premchand Ltd. Vs Commissioner of Central Excise, Noida [2020 (373) E.L.T. 423 (Tri.-All.) wherein CESTAT regional bench, Allahabad ruled that “Classification-Estoppk against re-classification-Settled in catena of decisions that there is no estopple in taxation matter and erroneous classification done earlier is not a bar for Department to make correct re-classification subsequently.” In view of above, the request of change of excising classification of applicant is accept able.
5.9. Apart from these legal backing, I also observe that department has not bejade the proposed classification and find it acceptable on merit. However, I must clarify as per settled legal principle that change in classification proposed by the applicant will only be effective prospectively.
5.10. In view of facts and circumstances, it is my considered and unequivocal conclusion that the “the subject goods” as these are laboratory reagents, are rightly classifiable under Tariff Item 38221990 of the Customs Tariff Act, 1975.
Issue regarding eligibility for exemption under Entry 102 of Notification No. 45/2025-Cus dated 24.10.2025 read with Entry No. 9 of List 3
6.1. 1 observe that the applicant had originally raised the issue regarding benefit of Sr. No. 167(A) of Notification No. 050/2017 dated 30.06.2017. 1 find that Clause A of Sr. No 167 in Notification no. 50/2017 was omitted in February 2025, and the same was inserted as Sr. No. 167B. Further, the notification 50/2017 has been superseded by Notification no. 45/2025-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 arc 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 arc 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 Bovine Albumin as one of several constituents. The exemption attaches only to the import of Bovine Albumin as such, i.e., in its individual and identifiable form.
c. Exemption Cannot Be Obtained Through Ingredient-Based Claim – An exemption meant for a specific item cannot be claimed indirectly through the presence of that item within a composite good, unless the notification expressly provides such a benefit. The notification contains no provision stating that diagnostic kits or reagents containing Bovine Albumin shall be eligible for exemption merely because Bovine Albumin is one of their ingredients. If the legislative intent were to grant exemption to all kits or reagents containing Bovine Albumin, the notification would have so provided. Its absence is deliberate and must be respected.
d. Explicit Listing of Diagnostic Kits Indicates Exhaustiveness – The express listing of particular diagnostic kits in List 3 shows that the legislature has consciously selected those kits which merit exemption. The applicant’s product does not find mention in List 3. The interpretive maxim expression units est exclusion alterius (expression of one is the exclusion of others) applies squarely; inclusion of certain diagnostic kits necessarily excludes those not listed.
6.3. In light of the above, the applicant’s argument that their diagnostic kits qualify for exemption merely due to the presence of Bovine Albumin is devoid of legal merit. Entry 9 of List 3 provides exemption 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, 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 diagnostic kit comprising multiple reagents. Therefore, the said precedent is not applicable to the facts of the present case.
7. In view of facts and circumstances, answer to the question posed by the applicant arc as follows:
8. Whether the diagnostic kits imported by the Applicant arc classifiable under CTI-1 38221990 Ans. Yes, it is my considered and unequivocal conclusion that the diagnostic kits imported by the applicant arc rightly classifiable under Tariff Item 38221990 of the Customs Tariff Act, 1975.
9. Whether the kits imported by the Applicant eligible for exemption from Basic Customs duty under Entry 102 of Notification No. 45/2025-Customs dated 24.10.2025 read with S. No. 9 of List 3 of same notification, available to “Diagnostic Kits” containing BSA?
Ans. No. The kits imported by the Applicant are not eligible for exemption from Basic Customs duty under Entry 102 of Notification No. 45/2025-Customs dated 24.10.25 read with S. No. 9 of List 3 of same notification.
8. I rule accordingly.
(Shailesh Kumar)
Customs Authority for Advance Rulings, New Delhi
F. No. VIII/CAAR/Delhi/Qiagen/ACC Import New Delhi/20/2025 Dated:26 .11.2025
