BD Viper System Classifiable Under 9031 49 00: CAAR Delhi

In re Becton Dickinson India Pvt Ltd (CAAR Delhi)

Summary: The Customs Authority for Advance Rulings (CAAR), New Delhi held that the BD ViperTM LT System imported by Becton Dickinson India Pvt. Ltd. is classifiable under Customs Tariff Item 9031 49 00 and not under CTI 9027 50 90 or 9027 89 90. The automated real-time PCR-based system is used with in-vitro diagnostic assays for extraction, amplification and detection of nucleic acids, particularly high-risk HPV DNA in cervical cancer screening. The applicant sought classification under Heading 9027 as an instrument for chemical analysis, whereas the jurisdictional Commissionerate proposed Heading 9031.

CAAR observed that the system does not measure the composition, concentration, quantity or other property of the specimen presented to it. Instead, it processes the specimen through lysis, DNA extraction, purification and amplification, creates a fluorescent signal, compares that signal with a predetermined criterion and ultimately reports a positive or negative result. The Authority characterised this function as “checking” rather than physical or chemical analysis. Accordingly, Heading 9027 was held inapplicable.

CAAR also rejected the applicant’s reliance on the HSN Explanatory Note covering instruments used in clinical laboratories for in-vitro diagnostic testing. It noted that the CDSCO import licence described the BD ViperTM LT System as being used “in conjunction” with appropriate IVD assays. The Authority further held that classification under the Customs Tariff is governed by the terms of the Tariff and that characterisation as a medical device under another enactment is not determinative of customs classification.

Having excluded Heading 9027 and other relevant headings of Chapter 90, CAAR held that the system satisfies Heading 9031 because it checks each specimen by subjecting it to a defined procedure, comparing the resulting signal against a criterion and reporting whether that criterion is met. While agreeing with the Commissionerate’s ultimate classification under Heading 9031, CAAR disagreed with its reliance on GRI Rules 3(b) and 3(c). It held that Rule 3 was unnecessary because the goods were not prima facie classifiable under two headings; classification was determinable under GRI Rule 1 itself.

At the tariff-item level, CAAR found that the system functions through optical elements and optical processes and therefore falls within “other optical instruments and appliances” under CTI 9031 49 00 rather than residual CTI 9031 80 00. Consequently, Basic Customs Duty was held leviable at 7.5% ad valorem. Import IGST was held leviable at 18% under Entry 580 of Schedule II to Notification No. 9/2025-Integrated Tax (Rate) dated 17.09.2025.

Cases Discussed

• Ascensia Diabetes Care India Pvt. Ltd. vs. Union of India — Bombay High Court decision concerning classification of glucometers under Heading 9027.
• Bayer Pharmaceuticals Ltd. vs. Commissioner of Customs, 2016 (331) E.L.T. 317 (Tri.-Mumbai) — distinguished because the glucometer determined blood sugar content, whereas the BD ViperTM LT System was found not to determine the content of the specimen.
• Goodyear India Ltd. vs. Commissioner of Customs, 1999 (109) E.L.T. 488 (Tribunal) — distinguished as concerning an ozone ageing tester found on its own facts to be an instrument for chemical analysis.
• Western India Plywoods Ltd. vs. Collector of Customs, 2005 (188) E.L.T. 365 (SC) — principle that resort to a residuary entry should be made only after examining applicable specific entries was accepted.
• Mauri Yeast India Pvt. Ltd. vs. State of U.P., 2008 (225) E.L.T. 321 (SC) — relied upon regarding preference for an applicable specific classification over a residuary entry.

FULL TEXT OF THE ORDER OF CUSTOMS AUTHORITY OF ADVANCE RULING, DELHI

M/s Becton Dickinson India Private Limited, 6′¹‘ Floor, Signature Tower B, South City I, Gurugram, Haryana- 122001, having IEC No. 596004729and PAN AAACB2656A (hereinafter referred as the ‘applicant’) has filed an application dated 08.05.2026, seeking advance ruling under section 28-H of the Customs Act, 1962, before the Customs Authority for Advance Rulings, New Delhi (CAAR, New Delhi in short). The application was accordingly registered under Serial No. 2⁶/₂026-27 dated 11.05.2026. The applicant has requested for Classification of medical diagnostic instrument (namely BD Viper¹M LT System) imported in India which is intended to be used for cervical cancer screening to detect high-risk HPV types under Customs Tariff Act, 1975.

1.1. The applicant in their application, submitted as follows:

STATEMENT OF RELEVANT FACTS HAVING A BEARING ON THE QUESTION (S)  ON WHICH ADVANCE RULING IS REQUIRED

1.2. The application is being preferred by Becton Dickinson India Private Limited (`the Applicant’), a company incorporated in India under the provisions of the Companies Act, 1956 and having its corporate office located at 6th Floor, Signature Tower B, South City I, Gurugram, Haryana 122001, and has branch offices at multiple locations across India. The Applicant holds IEC No. 596004729 under Section 7 of the Foreign Trade (Development and Regulation Act), 1992:

1.3. The Applicant is engaged in importing and the distribution of medical devices, laboratory equipment, and diagnostic products that arc used by healthcare institutions, clinical laboratories, the pharmaceutical industry and the general public. The Applicant import goods from outside India and thereafter, the said goods are distributed through its network of distributors to across PAN India users who are mainly hospitals, healthcare institutions and clinical / research laboratories. The Applicant also has manufacturing plants in Bawal, Haryana wherein certain medical devices are also manufactured.

1.4. The Applicant is filing present application to understand the classification of the one of the products imported by them from outside India. The necessary background and functionality of the product is set out in the subsequent paragraphs.

Technical description and overview of product

1.5. The product for which advance ruling is being sought is an BD ViperTM LT System, an in-vitro diagnostic (IVD) instrument (`the product’), which is an automated, real-time PCR-based in-vitro diagnostic instrument. It is intended for use in clinical laboratories for the automated extraction, amplification, and detection of nucleic acids from clinical specimens, specifically for the detection of high-risk human papillomavirus (HPV) DNA as part of cervical cancer screening protocols.

1.6. The product is combination of various modules as follows;

• A temperature control/ heating sub-system to control temperatures for onboard heaters
• A robotic pipetting arm to transfer samples, puncture troughs, and seal the amp/PCR plate
• An extractor that chemically extracts DNA from samples
• A color LCD (Liquid Crystal Display) monitor with touchscreen
• An onboard reader, to measure the amplification reaction and report results; and The main computer, which is responsible for instrument control, self-calibration and the user interface

1.7.The image of BD ViperTM LT System for quick visual understanding has been provided below:

1.8. The function of the BD ViperTM LT System is to automate the process of nucleic acid extraction, amplification, and detection using Polymerase Chain Reaction (PCR) technologies. The product is used in conjunction with the appropriate IVD assays, such as BD OnclarityTM HPV Assay, which is an amplified DNA test designed for the qualitative detection of 14 high-risk HPV genotypes associated with cervical cancer and its precursor lesions.

1.9. The product uses PCR technologies as amplification method and fluorescent energy transfer (ET) as the detection method to test for the presence of pathogens by their genetic content in clinical specimens. For the excitation of fluorescent dyes, the instrument emits visible light in the range of approximately 460 nm to 670 nm, which is generated by high-intensity LEDs, which are then detected by CCD camera through specific emission filters.

1.10. For achieving the above analysis, the pre-warmed specimens are loaded onto the BD ViperTM LT System and are mixed with multiple chemicals in a pre-defined process which includes ferric oxide particles, acid to lower the pH and induce a positive charge on the ferric oxide, high pH elution buffer is added to recover the purified DNA. The prepared specimens are placed in sealed PCR tubes (contain amplification primers, fluorescent-labeled detector probe, heat-activated enzyme (Taq DNA polymerase), and other reagents necessary), where the amplification and detection occur and the onboard reader, based on the algorithm identified in the assay-specific reagent package, produces the result. A detailed product manual of the product is enclosed.

1.11. The instrument is a state-of-the-art, automated, real-time PCR-based diagnostic tool for the detection and genotyping of high-risk HPV types in cervical and self-collected vaginal specimens. Its intended use is for routine cervical cancer screening, triage, and risk assessment, following professional guidelines. The procedure is highly automated, ensuring consistency, reliability, and high-throughput capability, with robust internal controls and quality assurance measures. The product is marketed in a similar manner to healthcare institutions, with supporting brochures and technical documentation. A sample product brochure for the product is enclosed.

1.12. BD ViperTM LT System is imported into India under an import license issued by the Central Drugs Standard Control Organisation (CDSCO), Government of India, as a Class A medical device for in vitro diagnostic use. This license also supports the intended use of the instrument as highlighted above. A copy of import license number IMP/IVD/2019/000175 dated 3 October 2022 is enclosed.

1.13. The Applicant had earlier imported the product by classifying the same under Customs Tariff Hearing (CTEI) 9031 of the First Schedule to the Customs Tariff Act, 1975 (`the Tariff Act’). CTE1 9031 is a residuary category for instruments falling under Chapter 90. Based on internal technical discussions, the Applicant understands that the product may merit classification under specific chapter heading, instead of residuary heading.

1.14. In the above backdrop, the Applicant has approached this Hon’ble Authority seeking an advance ruling in respect of the classification of the product. The Applicant submits that the application is maintainable, in as much as:

• The Applicant is holding a valid :IEC Number 596004729 and is covered under the definition of ‘applicant’ as provided under Section 28E (c) (i) of the Customs Act, 1965 (`the Customs Act’)
• The question relates to classification of goods and accordingly admissible under Section 281-1 (2) (a) of the Customs Act.
• The question raised in the application are not pending or decided in any proceedings in case of the Applicant under any provisions of the Customs Act.
• The application is accompanied by adequate lees,

STATEMENT CONTAINING APPLICANT’S INTERPRETATION OF LAW AND/ OR  FACTS. AS THE CASE MAY BE. IN RESPECT OF THE QUESTION(S) ON WHICH  ADVANCE RULING IS REQ1.11RED

1.15. The questions in respect of which an advance ruling from the Floifble Customs Authority for Advance Ruling (`CAAR’) has been sought by the Applicant is:

Q1. I Whether BD ViperTm LT System imported by the Applicant merits classification under Customs Tariff Item (`ClT) 9027 50 90 or 9027 89 90 of the First Schedule of the Customs Tariff Act, 1975 (`Customs Tariff )?

Q.2 What shall be the rate of BCD and Import IGST on the import of BD ViperTm LT System upon import of the product ill India?

Q.1 Whether BD Viper^.” LT System imported by the Applicant merits classification under Customs Tariff Item (`CM 9027 50 90 or 9027 89 90 of the First Schedule of the Customs Tariff Act, 1975 (`Customs Tariff)?

1.16. For the product BD ViperTM LT System to be imported by the Applicant in India, the proposed classification and Applicant’s interpretation to reach to the proposed classification is discussed as under.

1.17. The import and export of goods into and out of India is regulated by the Customs Act. Section 12 of the Customs Act is the charging section which stipulates that duties of customs shall be levied on all goods imported into India or exported out of India at such rates as may be specified under the Customs Tariff.

1.18. Section 2 of the Tariff Act provides that the rates at which BCD shall be levied under the Customs Act are specified in two schedules, namely, the First Schedule and the Second Schedule. First Schedule of the Tariff Act deals with the applicable duty structure on import of goods and the Second Schedule deals with the applicable duty structure on export of goods.

1.19. To determine the said rates of BCD applicable on the imported goods it is important to identify the tariff heading in which the goods would fall under the First Schedule of the Tariff Act.

1.20. The classification of goods covered under the Tariff Act is done as per the General Rules of Interpretation (`GRI’). GRI 1 to 5 lay down the principles for determining classification of goods under a specific Heading whereas GRI 6 is applicable if the objective is to determine the classification of goods in the Sub-headings of a Heading.

1.21. GRI 1 stipulates that the goods under consideration should be classified in accordance with the terms of the Headings and any relevant Section or Chapter Notes. These Section or Chapter Notes and Sub-Notes give detailed explanation as to the scope and ambit of the respective Sections and Chapters. These Notes have been given statutory backing and have been incorporated at the beginning of each Section / Chapter. For ready reference, Rule 1 is extracted herein below:

“Classification of goods in this Schedule shall be governed by the following principles:

1. 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 … “

1.22. Further, the entries in the Customs Tariff are further divided into sub-categories using dashes. The classification of a product under a heading (four-digit entry) is to be done using dashes. Firstly, the entries at single dash level under the heading are to be compared, then entries at double-dash level are compared and so on.

1.23. In the light of above legal provisions, to analyze the classification of above product following needs to be kept in mind:

• General Rules of Interpretation (GRI)
• Heading/ Sub-heading of the First Schedule in conjunction with Section/ Chapter/ Explanatory notes.
• Entries at equivalent dash level under a heading
• Other statutory principles and judicial precedents

The Applicant understand that “BD ViperTM LT System” is classifiable under CTI 9027 50 90

1.24.It is reiterated that the BD ViperTM LT System (`the product’) is used in clinical laboratories for vitro diagnostic (IVD) testing. It is designed for the automated extraction of nucleic acids from multiple specimen types as well as amplification and detection of target nucleic acid sequences by PCR technologies.

1.25.Upon the application of GRI 1, since the product is used in chemical analysis, the Applicant submits that the product may be classified is CTH 9027 which covers “Instruments and apparatus for physical or chemical analysis (for example, Polarimeters, Refractometers, Spectrometers, Gas Or Smoke Analysis Apparatus); Instruments and apparatus for measuring or checking viscosity, porosity, expansion, surface tension or the like; Instruments and apparatus for measuring or checking quantities of heat, sound or light (including exposure meters); Ilicrotomes”. The relevant extracts of Heading 9027 and Heading 9031 for the First Schedule (which are germane to the present discussion are reproduced below, and thereafter the Applicant has given their understanding of the classification.

Heading, Sub- heading, Tariff Item			Description of Goods	Rate of duty
9027			INSTRUMENTS AND APPARATUS FOR PHYSICAL ORCHEMICAL ANALYSIS (FOR     EXAMPLE, POLARIMETERS,                      REFRACTOMETERS, SPECTROMETERS, GAS OR SMOKE ANALYSIS APPARATUS); INSTRUMENTS AND APPARATUS FOR MEASURING OR CHECKING VISCOSITY, POROSITY, EXPANSION, SURFACE TENSION OR THE LIKE; INSTRUMENTS AND APPARATUS FOR MEASURING OR CHECKING QUANTITIES OF HEAT, SOUND OR LIGHT (INCLUDING EXPOSURE METERS); MICROTOMES
9027	10	00 00	–  Gas or smoke analysis apparatus	I0%
9027	20		–  Chromatographs and electrophoresis instruments	Free
9027	30 30		– Spectrometers, spectrophotometers and spectrographs using optical radiations (UV, visible, IR) :
9027		10	— Spectrometers	Free
9027	30	20	— Spectrophotometers	Free
9027	30	90	— Other	Free
9027	50		–  Other instruments and apparatus using  optical radiations (UV, visible, IR):
9027	50	10	— Photometers	Free
9027	50	20	— Refractometers	Free
9027	50	30	— Polarimeters	Free
9027	50	90	— Other	Free
			–  Other instruments and apparatus:
9027	81	00	— Mass spectrometres	Free
9027	89		–  Other:
9027	89	10	— Viscometres	Free
9027	89	20	— Calorimetres	Free
9027	89	30	— Instruments and apparatus for measuring the surface or interfacial tension of liquids	Free
9027	89	90	— Other	Free
9027	90		–   Microtomes; parts and accessories :
9027	90	10	— Microtomes, including parts and accessories thereof	7.5%
9027	90	20	— Printed circuit assemblies for the goods of sub-heading 9027 80	7.5%
9027	90	90	— Other	7.5%

–

Heading, Sub-heading, Tariff Item			Description of Goods	Rate of duty
9031			MEASURING OR CHECKING INSTRUMENTS, APPLIANCES AND MACHINES, NOT SPECIFIED OR INCLUDED ELSEWHERE TN THIS CHAPTER; PROFILE PROJECTORS
9031	10	00	– Machines for balancing mechanical parts	7.5%
9031	20	00	– Test benches	7.5%
			– Other optical instruments and appliances :
9031	41	00	— For inspecting semiconductor wafers or devices (including integrated circuits) or for inspecting photomasks or reticles used in manufacturing semiconductor devices (including integrated circuits)	Free
9031	49	00	— Other	7.5%
9031	80	00	– Other instruments, appliances and machines	15%
9031	90	00	– Parts and accessories	7.5%

Analysis of CTH 9027

1.26.The Heading 9027 falls in Section XVIII ‘Optical, photographic, cinematographic, measuring, checking, precision, medical or surgical instruments and apparatus’, which deals generally with measuring, checking and precision instruments of various kinds. Within this scheme, Heading 9027 is one of the headings covering analytical instruments used for physical or chemical analysis and measurement.

1.27.The instruments under Heading 9027 could be logically grouped into four functional categories, as follows;

i. Instruments or Apparatus for physical or chemical analysis

ii. Instruments or Apparatus for measurement or checking of certain material properties (viscosity, porosity, expansion, surface or interfacial tension and similar properties);

iii. Instruments or Apparatus for measurement or checking of quantities of heat, sound or light;

iv. Instruments or Apparatus for microtomy — precise cutting of very thin sections for microscopic examination.

1.28.The first category above covers instruments or apparatus for physical or chemical analysis. Hence for the product to be covered in this category, it should be (i) ‘an instrument or apparatus’ and (ii) it should be able to do physical or chemical analysis.

Instruments or apparatus

I.29.The word ‘instrument’ in technical sense means, ‘a material thing or mechanical devise for performing a work’ [1³ Ramanatha Aiyar Advanced Law Lexicon, Online Edn.]. An instrument is a tool or device that is used to do a particular task, especially a scientific task [Collis Dictionary, Online version]. According to the Black’s Law Dictionary [Online Edit], the definition of ‘apparatus’ is same as machine.

1.30.Further an ‘apparatus’ is a compound instrument designed to carry out a specific function or for a particular use. The word ‘apparatus’ means the compound instrument or chain of series of instruments designed to carry out specific function or for a particular use [C.Cus vs C-Net Communications (1) Pvt. Ltd. [2007 (216) ELT 337 (SC)]. Thus, it may be said that any tool individually or a combination of such tools for performing a particular task or function may be considered as instrument or apparatus.

Chemical or physical analysis

1.3 I .The term ‘chemical analysis’ means determining the chemical nature, identity or concentration of one or more components in a sample, by observation of chemical behaviour. This is usually done by causing specific chemical reactions or using the way a substance interacts with light, electricity, etc., and then measuring the response. The Explanatory Notes to I ISN 9027 list many typical analytical instruments. The underlying theme is that each of them is designed to reveal composition or concentration.

I.32.The term ‘physical analysis’ involves evaluating the fundamental, non-chemical characteristics of materials such as density, viscosity, melting point, structural integrity, particle size etc. I lence the instrument for physical analysis refers to instruments that determine physical properties or response characteristics of materials as opposed to chemical composition. The Lxplanatory Notes give many examples that illustrate this branch of ‘physical analysis’, for example Tolarimeters’ which is designed to measure the optical rotation of polarized light as it passes through optically active, often chiral, substances.

I.33.Thus, read together, instrument or apparatus can be any tool or machine or equipment or a compound instrument for undertaking chemical analysis (determining the chemical nature, identity or concentration) or physical process (evaluating the fundamental, non-chemical characteristics of materials).

BD ViperTM LT System qualify as instruments or apparatus for chemical or physical analysis

1.34.BD ViperTM LT System is a diagnostic device to diagnose cervical cancer. The product is used in conjunction with in-vitro assay, which is an amplified DNA test designed for the qualitative detection of high-risk types of 1-11³V (virus). The assay is intended to identify the presence of DNA from 14 high-risk HPV genotypes associated with cervical cancer and its precursor lesions.

I .35.The BD ViperTm LT System is an integrated analytical machine composed of a temperature control and heating sub-system, chemical DNA extraction module, onboard reader for amplification detection, and a main computer responsible for instrument control and calibration. The instrument autonomously performs controlled laboratory processes, including specimen preparation, reagent mixing, nucleic acid extraction, amplification and optical detection. A step-by-step process as to how chemical analysis is done with the product is detailed below.

1.36.Specimen log in and pre-warming: A specimen (patient’s sample is collected for testing for example, a swab from the cervix, vagina, or urethra). The specimen is placed into a specimen tube. Several such tubes (each representing one patient specimen) are held in a specimen rack in a grid. The rack is placed on the pre-warm heater, which gently heats the tubes for a set time. For SDA assays, this helps dissolve mucus and make the specimen uniform. For PCR assays, this pre-warm step also breaks open (lyres) the cells to release DNA into the liquid. After pre-warming, the rack cools down and is moved onto the main BD Viper LT instrument deck, into the specimen rack station.

1.37.Moving specimen to extraction tube: A robotic pipetting arm with disposable tips picks up small volumes of liquid from the patient’s specimen tubes. It transfers this liquid into a new type of tube, called an extraction tube, which contains ferric oxide particles packed in a dissolvable film at the bottom.

1.38.Chemical extraction: In the extraction module, a high-pH (alkaline) solution is added to the extraction tube. These breaks open cells (lysis) in the specimen and releases their DNA into the solution. Then acid is added to bring the pH down. This causes the ferric oxide particles to gain a positive charge, so they attract and bind the negatively charged DNA. The ferric oxide particles (now carrying the DNA) are pulled to the tube walls. The liquid that does not contain DNA (waste) is then sucked out and discarded. The particles are washed several times to remove impurities. A high-pH elution buffer is then added which makes the DNA come off the ferric oxide particles and go back into the liquid – this is now purified DNA.

1.39.Moving purified DNA into reaction wells or tubes: The robotic pipetting arm moves the purified DNA from each extraction tube into either SDA priming wells (for SDA assays), or PCR tubes (for PCR assays). These wells/ tubes already contain dried reagents, including, primers (short DNA pieces that recognize the target pathogen DNA), fluorescent-labelled detector probes (dyes that will light up if target DNA is amplified), enzymes (e.g., DNA polymerase, restriction enzymes for SDA, Taq polymerase for PCR), and other required chemical components. The plate of reaction wells/ tubes is sealed with a clear adhesive film by the robot and placed into the reader module.

1.40.Amplification and detection: Inside the reader module, the instrument runs either an SDA protocol or a PCR protocol. The reader has a Peltier heat block and a heated lid. For PCR, it repeatedly heats and cools the tubes (thermocycling) in steps that cause DNA strands to separate, primers to attach, and polymerase to copy the target DNA many times. If the target pathogen DNA is in the specimen, that specific segment will be copied over and over, increasing its amount to a level that can be easily detected. While the amplification is happening, the reader module also performs real-time fluorescent detection. After a complete run, the system shows a tube result showing the diagnostic answer showing whether the target pathogen’s DNA was detected or not in that sample.

1.41.From the above process, and by application of GRI 1, it may be seen that the product performs chemical analysis on the specimen wherein the chemical properties of the specimen are compared with the pathogen to diagnose whether the specimen has the virus or not. And the whole product along with its various modules is built for that function. Therefore, it may be seen that the product fits into the description ‘instrument or apparatus for chemical analysis and accordingly merits classification under CTH 9027.

1.42.In Bayer Pharmaceuticals Ltd. vs C.Cus [2016 (331) E.L.T. 317 (Tri. – Mumbai)], the question before the Hon’ ble Tribunal was with respect to classification of glucose meter which is capable of drawing blood and testing the same for indicating blood sugar content. It was observed by the Tribunal that testing blood and then its analysis for indicating blood sugar content as revealed by the Glucometer is undisputedly the outcome of a chemical analysis. It was accordingly held that the product is classifiable under CTUI 90.27. The judgment was subsequently approved in Ascensia Diabetes Care India Pvt. Ltd. vs U01 (2023) 3 Centax 248 (Born.), and revenue’s SLP against this judgment was also dismissed by Hon’ble Supreme Court in U01 vs Ascensia Diabetes Care India Pvt. Ltd. [2024 (387) E.L.T. 139 (S.C.)].

1.43.The above understanding is also supported by a long line of judgments including the I-Ion’ble Supreme Court’s judgment in CCE vs Simplex Mills Ltd. [2005 (181) E.L.T. 345 (S.C.)], wherein it was observed that as per Rule I of the GRI, the classification shall be determined according to the terms of the headings and any relevant section or Chapter Notes. If neither the heading nor the notes suffice to clarify the scope of a heading, then it must be construed according to the other following provisions contained in the Rules. Rule I gives primacy to the Section and Chapter Notes along with terms of the headings. They should be first applied. If no clear picture emerges then only one can resort to the, subsequent rules.

Explanatory Notes to I-ISN 9027 covers in-vitro diagnostic testing instruments and apparatus

1.44.The Applicant submits that reference may also be taken from the WCO Explanatory Notes which gives indication as to the coverage of products under I-ISN 9027. The Explanatory Notes (Seventh Edition 2022) from page XV111-9027-1 to XV111-9027-6 enumerates illustrative lists of various instruments which are included under HSN 9027, such as Polarimeters, Saccharimeters, Refractometers etc. The relevant item No. 33 at page XVIII-9027-6 (see below) specifically includes “Instruments and apparatus used in clinical laboratories for in vitro diagnostic testing^–.

^–(i3) Instruments and apparatus used in clinical laboratories jitr in vitro diagnostic testing^–.

I.45.The term ‘in-vitro diagnostics’ has been defined by World I Icalth Organization (WI I(_))¹ as tests that can detect disease, conditions and infections. In-vitro simply means ‘in glass’, meaning these tests are typically conducted in test tubes and similar equipment, as opposed to in vivo tests, which are conducted in the body itself^–. In vitro tests may be done in laboratories, health care ateilities or even in the home. The tests themselves can be performed on a variety of instruments ranging from small, handheld tests to complex laboratory instruments. They allow doctors to diagnose patients effectively and work to provide appropriate treatments.

1.46.The Applicant submits that the product does in-vitro diagnostic by extracting the vaginal specimens from human body in the tubes and undertaking tests in a laboratory for diagnosis of cervical cancer. The extracted specimens are mixed with diagnostic reagents, which allows a molecular diagnosis to be performed for identifying DNA genetic sequence for infectious disease. It is to be noted that molecular diagnosis is a common type of chemical analysis, which uses precise chemical and molecular biology techniques, including PCR, to detect molecular-level alterations.

1.47.1t is submitted that the product is also marketed to the healthcare institutions for HPV testing. A copy of the brochure of the product is enclosed in this regard. Further in the product license obtained for CDSCO also, the product is listed as product for in vitro diagnosis. In this regard, a copy of the relevant extracts pages of the CDSCO license are enclosed.

1.48.In view of the above, the Explanatory Notes also supports the view that the product merits classification under CTH 9027. Given the text of HSN and CTH for 9027 are similar, the HSN Explanatory are safe guide for classification of the goods under CTH 9027 [CCE vs Wood Craft Products Ltd. 1995 (77) E.L.T. 23 (S.C.)].

Classification at Tariff Item level

1.49.It is submitted that the within Heading 9027, Sub-heading 9027 50 covers “Other instruments and apparatus using optical radiations (UV, visible, IR)”. The product, BD ViperTM LT System employs real-time PCR and fluorescent energy transfer, both of which are based on optical radiation for detection and analysis.

1.50.1t is submitted that inside the reader module, visible light (optical radiation) in the range of approximately 460 nm to 670 nm, generated by high-intensity LEDs, are thrown for the excitation of fluorescent dyes. The emitted fluorescence from these dyes is then detected by a CCD camera through specific emission filters. This process allows the observers to detect, identify, and analyze even a tiny amount of genetic material from a sample.

1.51.Accordingly, within heading 9027, the product may merit classification under Sub­heading 9027 50 as “Other instruments and apparatus using optical radiations (UV, visible, IR)”. Further, not being a ‘photometer’ or `refractometer’ or `polarimeter’, the product may merit classification under CTI 9027 50 90, under the others category of Sub­heading 9027 50.

1.52.Alternatively, the product may also merit classification under CTI 9027 89 90 under the residuary heading.

The product does not fall under CTH 9031

1.53.It is submitted that for the sake of completeness, the Applicant submits that while they had imported an earlier consignment under CTH 9031, however the Applicant based on internal deliberation understands that the product may not merit classification CTH 9031, based on following paragraphs.

1.54.It is submitted that the CTH 9031 is a residuary heading for “Measuring or checking instruments, appliances and machines, not specified or included elsewhere in this chapter.” From the very text of CTH 9031 it is clear that it covers those instruments, appliances or machines which are not covered elsewhere in this chapter. Further the Explanatory Notes also provides that this group does not include any instruments, apparatus, etc., falling in headings 90.01 to 90.12 or 90.15 to 90.30.

1.55.It is submitted that the product, BD ViperTM LT System is specifically covered under heading 9027 in as much as it is an instrument or apparatus for chemical analysis and also specifically covered as in-vitro diagnostic device, therefore it is excluded from Heading 9031

1.56.The law is well settled that classification under a residuary heading has to be a matter of last resort. The application of residuary entry should be made with extreme caution, being attracted only when no other provision expressly or by necessary implication applies to goods in question [Western India Plywoods Ltd. vs C.Cus 2005 (188) E.L.T. 365 (S.C.)]. In the present case, the product is identifiable with a more specific heading based on its function under CTH 9027, therefore CTH 9031 should not be applicable based on general application.

1.57.In Mauri Yeast India Pvt. Ltd. vs State of UP [2008 (225) E.L.T. 321 (S.C.)], also it was observed by the Hon’ble Supreme Court that in interpreting different entries, attempts shall be made to find out as to whether the same answers the description of the contents of the basic entry and only in the event it is not possible to do so, recourse to the residuary entry should be taken by way of last resort.

1.58.In Goodyear India Ltd. vs C.Cus [1999 (109) E.L.T. 488 (Tribunal)], it was held by the I-lon’ble Tribunal that Ozone aging tester, an instrument for chemical analysis which does calculation with the help of micro-processor and makes it easy for analyzing and controlling total measurements is classifiable under sub-heading 9027.80 and not under sub-heading 903 I .80.

Applicant’s interpretation for Q.1

1.59.In view of the above, it is respectfully submitted that the BD ViperTm LT System merits classification under CTI 9027 50 90 of the First Schedule to the Tariff Act, as an “Other instrument and apparatus using optical radiations (UV, visible, IR) for physical or chemical analysis.” The product may also merit classification under CTI or 9027 89 90.

Q.2 What shall be the rate of BCD and Import IGST on the import of BD ViperTM LT System upon import of the product in India?

BCD

1.50.1t is submitted that based on the Applicant’s understanding that the product fall under CTI 9027 50 90 or 9027 89 90, the rate of BCD shall be “Free”, as per the First Schedule to the Tariff Act.

Import IGST

1.5I.The Import IGSI is leviable on the imported goods in terms of Section 5 of the Integrated Goods and Services Tax Act, 2017 (`the IGST Act’) read with Section 3 (7) of the Customs Act. The rate of IGST is specified under the IGST rate notifications issued under the IGST Act, and are applicable for levying of import IGST as well.

1.52.For the ease of reference, the relevant entries applicable to  9027 and 9031 under Notification No. 9/2025-IT (Rate) dated 17 September 2025 (`IGST rate notification’) are tabulated below for ease of reference;

Schedule	S. No.	Chapter/ Heading/ Sub- heading/ Tariff item	Description of goods	Rate of IGST
I	489	9027	Instruments and apparatus for medical,	5%
			surgical, dental or veterinary uses, for
			physical or chemical analysis
II	576.	9027	Instruments and apparatus for physical or chemical analysis (for example, polarimeters, re fractometers, spectrometers, gas or smoke analysis apparatus); instruments and apparatus for measuring or checking viscosity, porosity, expansion, surface tension or the like; instruments and apparatus for measuring or checking quantities of heat, sound or I ight(includ i ng exposure meters);microtomes (other than instruments andapparatus for medical, surgical, dental orveterinary uses for physical or chemicalanalysis]	18%
II	580	9031	Measuring or checking instruments, appliances and machines, not specified or included elsewhere in this Chapter; profile projectors	18%

1.53.It is submitted that based on the Applicant’s understanding that the product falls under CTH 9027, the relevant entries under the IGST are Entry 489 of Schedule I and Entry 576 of Schedule II. Both these entries cover ‘Instruments and apparatus for physical or chemical analysis’, and the difference between the two is that Entry 489 covers `Instruments and apparatus ‘for medical, surgical, dental or veterinary uses’. These expressions are not defined either under the IGST rate notification or the Tariff, hence these may be understood through other aids.

1.54.Definition of the terms;

Term	Source	Definition
Medical	Black’s Law Dictionary Revised 4th Edn.	Pertaining, relating, or belonging to the study and practice of medicine, or the science and art of the investigation, prevention, cure, and alleviation of disease
	P. Ramanatha Aiyar Major Law Lexicon Online Edn.	Of, pertaining to or having to do with the art of healing disease, or the science of medicine; containing medicine; used in medicine.
	Cambridge Dictionary Online Edn.	related to the treatment of illness and injuries: an examination of a person’s body by a doctor in order to discover if that person is healthy, sometimes done before a person can be accepted for a particular job of or relating to medicine, or for the treatment of disease or injury: relating to medicine or to the treatment of illness or injury:
Surgical	Black’s Law Dictionary Revised 4th Edn.	SURGICAL OPERATION. – An act or series of acts performed on a patient’s body by a surgeon to produce a cure. Hartford Live Stock Ins. Co. v. McMillen, C.C.A.Ohio, 9 F.2d 961, 962.
	Cambridge Dictionary Online Edn.	used for medical operations: involved in performing medical operations: (of clothing) worn in order to treat a particular medical condition:
Dental	Black’s Law Dictionary Revised 4th Edn.	DENTISTRY. – A special department of medical science, dealing with the treatment of the diseases, etc., of human teeth. Commonwealth v. Heller, 277 Pa. 539, 121 A. 558, 559. The term includes the supplying of dentures, bridges and other artificial substitutes to the user or prospective user thereof. Curtis v. State, 78 OkLCr. 282, 147 13.2d 465, 468. Winner v. Kadow, 373 III. 192, 25 N.E.2d 882, 883.
	Cambridge Dictionary Online Edn.	relating to the teeth: a speech sound in which your tongue touches your front teeth
Veterinary	Black’s Law Dictionary Revised 4n Edn.	VETERINARIAN. – One who practices the art of treating diseases and injuries of domestic animals, surgically or medically. Tucker v. Williamson, D.C.Ohio, 229 F. 201, 210.
	Cambridge Dictionary Online Edn.	connected with taking care of the health of animals:

I.55.From the above definition it may be seen that the four different terms represents the study of medical science, the term ‘medical’ is a broad term pertaining, relating, or belonging to the study and practice of medicine, or the science and art of the investigation, prevention, cure, and alleviation of disease. The term ‘surgical’ appears to be a sub set of the medical science involving surgical treatment. The other two term ‘dental’ and `veterinary’ represents specific science which are relating to teeth and relating to animals respectively.

1.56.The phrases “medical, surgical, dental or veterinary’ is also used in the context of certain specific devices under Heading, 9018 of the Tariff Act. While the devices covered therein are different, however some guidance may be taken from the Explanatory notes as to coverage of these specific terms. From the judgment M/s Alga Healthcare India Pvt. Ltd. vs ADO (Adjn.) [2026-VIL-326-CESTAT-DEL-CU], it follows that ‘instruments and apparatus which are ‘specifically designed’ or ‘intended for use’ or ‘meant for use’ in medical sciences are covered under CTI-I 9018 by virtue of being medical in nature.

I.57.Thus, reading the Entry 489 along with the understanding of the above terms, it could be deducted that the instruments or apparatus for chemical or physical analysis which are used in with respect to medical practices (study and practice of medicine, or the science and art of the investigation, prevention, cure, and alleviation of disease), are covered therein. The instruments or apparatus are such which by design, intended use or meant use are usable in medical science setting.

1.58.In the present case the product BD Viper”'”‘ LT System is used for diagnosing cervical cancer, and it is used in hospitals and diagnostic centers. Therefore, the product clearly has medical use in as much as it is used for diagnosing the disease.

I.59.The product is specially designed to be used in diagnostic setting in the presence of technologists, supervisors, and other trained laboratory personnel who operate and maintain the BD ViperTm LT System on a regular basis.

1.60.Further the import of medical device is regulated by the Drugs and Cosmetics Act, 1940 (`the DCA’). The Medical Device Rules, 2017 have been framed under the DCA to provide for rules of regulation of import, manufacture, sale etc. of medical devices. Thus the product is categorized as ‘medical device’ for the purpose of DCA and the Medical Device Rules as well, and the Applicant has to have a license to import for importing the same in India as per these rules. The Applicant’s license to this effect, is taken from the CDSCO.

1.61.Further submitted the product is designed in a manner that its usage only fits in a hospital or diagnostic center. The product is in vitro diagnostic device which also means that the product is usable for medical use.

1.62.In view of the above, the Applicant understands that the product is covered by Entry 489 of Schedule I of the IGST rate notification and therefore IGST rate should be 5%.

PRAYER

1.63. In light of the above, the Applicant respectfully prays that Hon’ble Authority may be pleased to:

i. Admit the instant application;

ii. Rule upon the questions raised in application;

iii. Hold that BD ViperTM LT System merits classification under CTI 9027 50 90 or CTI 9027 89 90

iv. Allow the Applicant to alter, amend or modify any of the aforesaid grounds or submissions made herein this application and make such additional submissions and such further additional documents in support of its submissions at the time of hearing of the said application.

v. Allow an opportunity of hearing in person.

2. Comments of the Port Commissionerate:

2.1 The comments of the Jurisdictional port Commissionerate have been received vide letter dated 22.07.2026 from the Office of the Commissioner of Customs, Chennai -II (Import), Chennai and are as follows:

2.2. The matter has been examined with reference to the application, the technical literature furnished by the applicant, the provisions of the Customs Tariff Act, 1975, the General Rules for the Interpretation (GIR), the relevant Section Notes and Chapter Notes, the HSN Explanatory Notes, and the applicable notifications. The factual findings are submitted below for kind consideration.

2.3. Classification of the Goods

2.3.1. The applicant has sought classification of the imported equipment under Customs Tariff Item (CTI) 9027 50 90, or alternatively under CTI 9027 89 90. On examination of the technical literature, it is observed that the BD ViperTM LT System is an integrated and fully automated molecular diagnostic platform designed to perform multiple laboratory processes in a sequential and automated manner. The system performs the following functions:

• Cell lysis;
• Sample preparation;
• Automated pipetting;
• DNA extraction and purification using magnetic particles;
• Polymerase Chain Reaction (PCR) amplification; and
• Fluorescence-based detection for generation of analytical results.

2.3.2. it is observed that the fluorescence-based optical detection module constitutes only the final stage of the overall analytical workflow and does not represent the principal function of the equipment. The essential character of the system is derived from its capability to perform integrated molecular diagnostic processing, including sample preparation, nucleic acid extraction, amplification, and automated analytical checking.

2.3.3. Accordingly, in terms of Rule I of the General Rules for the Interpretation (GIR) read with the relevant Section Notes, Chapter Notes and the FISN Explanatory Notes to Chapter 90, the subject goods are not appropriately classifiable under Heading 9027, which primarily covers instruments whose principal function is optical or physical/chemical analysis.

2.3.4. Further, applying Rule 3(b) of the GIR, the essential character ofthe composite machine is imparted by its integrated molecular processing and checking functions rather than by the fluorescence-based detection module. Consequently, the goods are more appropriately classifiable under Heading 9031, which covers other measuring or checking instruments, appliances and machines.

2.3.5. Without prejudice to the above, even if the goods were considered equally classifiable under Headings 9027 and 903 I, Rule 3(c) of the GIR provides that classification shall be under the heading occurring last in numerical order among those equally meriting considerations. Accordingly, heading 9031 would prevail.

2.3.6. In view of the foregoing, it is concluded that the BD ViperTM LT System is appropriately classifiable under Customs Tariff Heading 903I .

2.4.Applicability of Concessional IGST

2.4.1. The applicant has also claimed the benefit of concessional Integrated Goods and Services Tax (IGST) at the rate of 5% under Entry No. /189 of Schedule I to Notification No. 9/2025-Integrated Fax (Rate) , which covers the sub heading” 9027 – Instruments WO appal^–W/1/S fin’ Medical, surgical. dental or on veterinary uses, for physical or chemical analysis” on the ground that the goods are classifiable under CTI 1 9027.

2.4.2. However it is submitted that the technical literature indicates that the BD V iperTm ;1^. System is an In-Vitro Diagnostic (IVD) laboratory instrument intended for processing and analysing extracted biological specimens in a controlled laboratory environment. The equipment neither directly examines nor interacts with patients during any clinical diagnostic procedure and functions solely as a laboratory-based molecular diagnostic platform. Therefore, the subject item is not classifiable under under CTI-I 9027.

2.4.3. Accordingly, the subject goods do not satisfy the conditions prescribed under Entry No. 489 of Schedule I to Notification No. 9/2025-Integrated Tax (Rate). Therefore, the goods are liable to Integrated Goods and Services Tax (IGST) at the rate applicable to goods classifiable under Customs Tariff Heading 9031.

2.5.Conclusion

2.5.1. Based on the examination of the Advance Ruling Application, the technical literature and the applicable legal provisions, the following factual findings emerge:

2.5.2. The BD Viper”‘ LT System is an integrated automated molecular diagnostic platform performing multiple laboratory processes, including sample preparation, DNA extraction, PCR amplification and fluorescence-based detection.

2.5.3. The fluorescence-based detection module is ancillary to the principal function of the equipment and does not determine its essential character.

2.5.4. Applying Rules 1 and 3(b) of the General Rules for the Interpretation, read with the relevant HSN Explanatory Notes, the subject goods are appropriately classifiable under Customs Tariff Heading 9031.

2.5.5. Even assuming equal merit between Headings 9027 and 9031, Rule 3(c) mandates classification under Heading 9031, being the heading occurring last in numerical order.

2.5.6. The equipment is an In-Vitro Diagnostic (ND) laboratory instrument and is not eligible for the concessional IGST rate under Entry No. 489 of Schedule Ito Notification No. 9/2025-Integrated Tax (Rate).

2.5.7. In view of the above, the examination report and factual comments are submitted for kind consideration while deciding the Advance Ruling Application.

3. Record of Personal Hearing:

3.1 During the course of personal hearing on 29.07.2026, the authorised representative informed that the product is being imported under CTH 9031, however the product is classifiable under CTH 9027 for the reasons mentioned in CAAR application. The authorised representative requested to grant ruling under CTH 9027.

4. Rebuttal by the Applicant:

4.1. The comments received from the Jurisdictional port Commissionerate i.e. Office of the Commissioner of Customs, Chennai -II (Import), Chennai were forward to the applicant via email dated 29.07.2026.

4.2. The applicant vide e-mail dated 04.08.2026 has submitted their detailed response to the comments dated 22.07.2026 received from the Jurisdictional port Commissionerate and are as under: –

4.3. The Applicant had filed the application for seeking before this Hon’ble Authority for seeking classification and import duties applicable on one of the products imported by them namely BD ViperTM LT System.

4.4. The Applicant appeared through their authorized representatives before this Hon’ble Authority on 29 July 2026 and submitted the synopsis and explained as to their understanding of the interpretation of law. On the same date the Applicant was emailed a copy of the reply dated 22 July 2026 containing the comments of the Port vis-a-vis the questions involved. In this letter, the Applicant are reiterating their submissions made during the PH and submitting their counter comments against the letter dated 22 July 2026.

4.5. It is submitted that on an earlier occasion the product was imported through Chennai Port under Heading 9031, but the Applicant believes that the product is classifiable under Heading 9027. Further there are no pending or concluded proceedings against the Applicant in respect of the product.

Submissions made during the PH

4.6.The Applicant during the PH had explained that BD Viper^TM LT System is an automated, real-time PCR-based in-vitro diagnostic instrument used in clinical laboratories to extract, amplify and detect nucleic acids from clinical specimens, specifically for detection of high-risk HPV DNA in cervical cancer screening. It is licensed by CDSCO as a Class A in-vitro diagnostic medical device. The product is an automated product, after the insertion of the warmed specimen into the instruments, all steps are undertaken automatically, and a robotic pipetting arm is there inside the instrument.

4.7.lt is intended for use in clinical laboratories for the automated extraction, amplification, and detection of nucleic acids from clinical specimens, specifically for the detection of high-risk human papillomavirus (HPV) DNA as part of cervical cancer screening protocols.

4.8.The step-by-step process of the working of the product was explained in brief (for detailed explanation, para 33-38, Pg. 19-20 of the application may be referred);

4.9. Pre-warm the specimen: the patient’s specimens are placed into the pre-warm heater, which gently heats the tubes for a set time, this pre-warm step also breaks open (lyses) the cells to release DNA into the liquid.

4.10. Chemical extraction: This breaks open cells (lysis) in the specimen and releases their DNA into the solution. Then acid is added to bring the pH down. This causes the ferric oxide particles to gain a positive charge, so they attract and bind the negatively charged DNA. The ferric oxide particles (now carrying the DNA) are pulled to the tube walls. The liquid that does not contain DNA (waste) is then sucked out and discarded.

4.11. Moving purified DNA into reaction wells or tubes: The purified DNA is moved tube into either SDA priming wells (for SDA assays), or PCR tubes (for PCR assays). These wells/ tubes already contain dried reagents, including, primers, fluorescent-labelled detector probes, enzymes and other required chemical components.

4.12. Amplification: The purified-DNA is amplified multifold for detection of pathogen. While the amplification is happening, the reader module also performs real-lime fluorescent detection. Alter a complete run, the system shows a tube result showing the diagnostic answer showing whether the target pathogen’s DNA was detected or not in that sample.

4.13. From the above, it may be seen that the product. performs chemical analysis of the specimen to identify whether the specimen has pathogen or not. Thereby the product clearly under I leading 9027 basis Rule I of General Rules of Interpretation (GRI).

4.14. The reference was also made to the Explanatory Notes to HSN, as follows;

• HSN 9027 inter alia at S. No. 33 includes ‘instruments and apparatus used in clinical laboratories for in vitro diagnostic testing’
• HSN 9018 – the exclusion note (q) also specifies that the instruments and appliances used in laboratories to test blood, fluids, urine etc. whether or not such tests serve in diagnosis are excluded from HSN 9018 and included in HSN 9027.
• HSN 9031 – this heading does not include any instruments, apparatus, etc., falling in headings 90.01 to 90.12 or 90.15 lo 90.30.

4.15. The term ‘in-vitro diagnostics’ has been defined by World Health Organization as tests that can detect disease, conditions and infections. In-vitro simply means ‘in glass’, meaning these tests are typically conducted in test tubes and similar equipment, as opposed to in vivo tests, which are conducted in the body itself. The is therefore a vitro diagnostic testing instrument which is used by clinical laboratories. In the product license obtained from CDSCO, the product is categorized as product for in vitro diagnosis.

4.16. The product supports a software presents a simplified user interface on the LCD monitor, with buttons and icons to represent the functions, operations, setup parameters, and status conditions. Routine instrument operations are performed by tapping the icon that corresponds to the desired activity.

4.17. During the PH, your goodself had sought explanation as to how the product runs, in this regard, Section 4 of the Product manual may be referred, which explains step by step process, briefly captured as below;

• Using the interface system – 4.2
• Preparing Specimen, and Logging specimen tubes – 4.3, 4.4
• Preparing the instrument- 4.5; Tube and runs status – 4.6
• Starting the run-4.7
• Responding to alarms and errors – 4.78 clean-up -4.9 and power failures- 4.10

4.18. Your goodself had also sought explanation as to the end test report once the run is complete. This information is explained in Section 5.8 of the Product manual, briefly capturing following reports;

4.19. Tube layout report – Section 5.8.1 [Pg. 148 of the application] – this report explains the specimen rack, showing exactly which tube [patient sample or quality control] is sitting in the rack. This report confirms whether every tube is loaded in its correct spot before running the test.

4.20. Tube result report- Section 5.8.2 [Pg 150 of the application] – this report shows the actual test results for a specimen rack once testing has been completed. The test report shows symbols like’+’ or’-‘ to indicate whether the tests are positive or negative (pathogen is found or not).

4.21. It was also explained that vide para 5, 6, 6.1 of the judgment in Bayer Pharmaceuticals Pvt. Ltd., that the product namely Glucometer was held to be classifiable under Heading 9027 because of the Tribunal’s finding that “the testing of blood and then its analysis for indicating blood sugar content as revealed by the Glucometer is undisputedly the outcome of a chemical analysis”. It was explained that likewise the product in question also do chemical analysis of the specimen to identify whether the target pathogen is present or not in the specimen. The judgments in Ascensia [Pg 39, 43], Aspen Diagnostics [Pg. 44], and Life Scan [Pg. 52] were relied upon to the similar effect.

4.22. The Applicant in the PH had submitted vide para 15 of the judgment in M/s Afga Healthcare India Pvt. Ltd. that the decisive criterion for medical use devices is their specific adaption, construction or design for professional medical or surgical use. This judgment is in the context of Heading 9018, however it clarifies the understanding of ‘medical use’ which is also specified in Entry 489 for the purpose of 5% rate as above. The product being designed for medical use therefore clearly attracts GST as per Entry 489.

Submission against letter dated 22 July 2026

4.23. At Para I, Pg. 2 of the letter, it has been stated that “the fluorescence-based optical detection module constitutes only the final stage of the overall analytical workflow and does not represent the principal junction of the equipment” and that the “essential character of the system is derived from its capability to perform integrated molecular diagnostic processing, including sample preparation, nucleic acid extraction, amplification, and automated analytical checking” On this basis, it concludes that the goods are “not appropriately classifiable under Heading 9027” and instead merit classification under Heading 9031.

4.24. The Applicant submits that the letter fundamentally fails to understand the functionality of the product, therefore the aforesaid comments are non sequitur.

4.25. The Applicant has detailed with minute detail that the product is an in vitro diagnostic instrument for diagnosing the HPV pathogen. The instrument performs a chemical analysis of the specimen to detect whether the targeted pathogen is present or not. Therefore firstly, as per GRI I, the product clearly falls under Heading 9027 in as much as it is an instrument or apparatus for the physical or chemical analysis. Secondly, by virtue of HSN Explanatory Notes XVIII-9027-6, clearly the in-vitro diagnostic testing instruments are covered in Heading 9027.

4.26. It is thirdly submitted that the comment as to “fluorescence-based optical detection module” being not the principal function is also non sequitur and factually erroneous. The product is an apparatus for performing chemical analysis on the specimen to identify whether the HPV pathogen is found or not.

4.27. It is also fourthly submitted that the submission of the revenue as to “essential character of the system is derived from its capability to perform integrated molecular diagnostic processing, including sample preparation, nucleic acid extraction, amplification, and automated analytical checking”, and therefore excluded from Heading 9027 is also contradictory and ex facie erroneous. The very fact that the instrument performs this function and the revenue admits this position, itself takes the product under Heading 9027. It is reiterated that the product performs chemical analysis and therefore fall under 1-leading 9027, for detailed understanding please refer the above paragraphs and the paragraphs in the application.

Incorrect application of GRI

4.28. In view of above, the submission in letter dated 22 July 2026 that as per GRI I the product is not classifiable under I leading 9027 is non sequitur and baseless. Further. the application of CRI 3 (b) is also non sequitur in as much as the instrument performs is chemical analysis and the Heading 903 I clearly excludes the instruments which are covered in I leading 9027. Therefore, by description itself the product is not covered by Heading 9031. The letter dated 22 July 2026 is silent on the reason as to how the product falls under I leading 9031 except for the hare mention of Heading 9031. Likewise, the application of GRI 3 (c) is also erroneous.

4.29. In Welkin Foods C.Cus vs Welkin Foods 2026 (395) ELT 273 (SC), the Hon’ble Supreme Court quoting its earlier judgments clearly observed that GRI I are to be applied sequentially from Rule 1-4. The classification begins, and in most cases, ends at the first door: GRI 1. Therefore, the application of Rule 3 is not relevant when the goods by their description are classifiable under a particular Heading in terms of Rule I [para 36 of the judgment]. The letter dated 22 July 2026 is therefore erroneous on this count as well. A copy of the judgment is enclosed with this letter.

BCD rate

4.30. The letter dated 22 July 2026 do not make any submissions with respect to I3CD. The Applicant in view of their explanations above and in the application and the synopsis understands that the product is classifiable under CTI 9027 50 90 or CTI 9027 89 90 which inter alia attracts BCD of Free.

IGST rate

4.31. At Para 2, Pg. 3 of the letter dated 22 July 2026, it has been stated that “the technical literature indicates that the BD Viper^–TM LT System is an In-Vitro Diagnostic (11/D) laboratory instrument intended for processing and analysing extracted biological specimens in a controlled laboratory environment. The equipment neither directly examines nor interacts with patients during any clinical diagnostic procedure and functions solely as a laboratory-based molecular diagnostic platform. Therefore, the subject item is not classifiable under CTH 9027,” and concludes that the product does not satisfy Entry No. 489 of Schedule Ito Notification No. 9/2025- Integrated Tax (Rate).

4.32. The Applicant firstly submits that this finding on the rate follows the assertion that the product does not fall under Heading 9027, which has already been demonstrated to be erroneous in the foregoing paragraphs. Since the product merits classification under CTH 9027, the very premise on which the denial of concessional IGST is based does not survive.

4.33. Without prejudice to the above, the Applicant secondly submits that the very condition as stated in the letter dated 22 July 2026 as to “direct patient interaction” is non sequitur and de hors of what is stated in Entry 489. For ease of reference, the terms of the entry and the comments in the letter are placed side by side.

Entry 489 of Schedule I [Pg 79 of the synopsis]	Letter dated 22 July 2026
Instruments and apparatus for medical, surgical, dental or veterinary uses, for physical or chemical analysis	The equipment neither directly examines nor interacts with patients during any clinical diagnostic procedure and functions solely as a laboratory-based molecular diagnostic platform. Therefore, the subject item is not classifiable under CTH 9027.

4.34. From the above, it may be seen that letter dated 22 July 2026 has invented a condition beyond the law to submit that the product is not covered by Heading 9027 and not satisfying condition of Entry 489. This approach is clearly impermissible, as the revenue cannot invent anything which is not provided for in the law.

4.35. The Applicant in their application had explained that the product is used in medical [referring to the definition of medical use – Para 62-69, Pg. 26-29 of the application], and the product is used by hospitals and diagnostic centers for diagnosing the disease. Therefore, the product clearly is for ‘medical use’ and therefore attracts GST as per Entry 489 of Schedule I. 4.36. In view of the above, the Applicant understands that the product merits classification under CTI 9027 50 90 or CTI 9027 89 90 and merits BCD as “Free” and Import IGST as 5% under Entry 489.

5. Findings, Discussion & Conclusion:

5.1.1. Having examined the CAAR-1 application, the comments received from the jurisdictional Customs Commissionerate, the record of personal hearing, and rebuttal by the applicant dated 04.08.2026 and the applicable legal framework, I find the application to be valid in terms of the Customs Act, 1962 and the CAAR Regulations, 2021. I, therefore, allow the application and proceed to determine the Classification of BD ViperTM LT System imported in India which is intended to be used for cervical cancer screening to detect high-risk HPV types under Customs Tariff Act, 1975 on the basis of the information on record. The questions posed for advance ruling is:

“Q. I. Whether BD ViperTM LT System imported by the Applicant merits classification under Customs Tariff Item (`CTI) 9027 50 90 or 9027 89 90 of the First Schedule of the Customs Tariff Act, 1975 (`Customs Tariff)?

Q.2. What shall be the rate of BCD and Import IGST on the import of BD Viper”‘ LT System upon import of the product in India?”

5.1.2. The applicant claims classification under tariff item 9027 50 90 and, in the alternative, under tariff item 9027 89 90. The jurisdictional Commissionerate has opposed that claim and has contended for classification under heading 9031. The contest therefore lies, first, between heading 9027 and heading 9031 and, thereafter, at the sub-heading and tariff item level within whichever heading is found to apply. The rate of basic customs duty and of integrated tax will follow from that determination.

5.2. Product description

5.2.1. The description of the goods which follows is drawn entirely from the application, the product manual filed with it, and the import licence under the MEDICAL Device Rules, 2017 produced by the applicant.

5.2.2. The product is the BD Viper TM LT System, described by the applicant as an automated, real-time PCR-based in-vitro diagnostic instrument intended for use in clinical laboratories for the automated extraction, amplification and detection of nucleic acids from clinical specimens, and in particular for the detection of high-risk human papillomavirus (1 WV) DNA as part of cervical cancer screening protocols. It is used in conjunction with in-vitro diagnostic assays such as the 13D Onclarityrm 1-1PV Assay, which is stated to be an amplified DNA test for the qualitative detection of 14 high-risk I WV genotypes associated with cervical cancer and its precursor lesions.

5.2.3. The product is combination of various modules as follows;

• • A temperature control/ heating sub-system to control temperatures for onboard heaters
  • A robotic pipetting arm to transfer samples, puncture troughs, and seal the amp/PCR plate
  • An extractor that chemically extracts DNA from samples
  • A color LCD (Liquid Crystal Display) monitor with touchscreen
  • An onboard reader, to measure the amplification reaction and report results; and The main computer, which is responsible for instrument control, self-calibration and the user interface

These are housed together as a single bench instrument, as appears from the photograph reproduced in the application.

5.2.4 The system performs the following functions:

• • Cell lysis;
  • Sample preparation;
  • Automated pipetting;
  • DNA extraction and purification using magnetic particles;
  • Polymerase Chain Reaction (PCR) amplification; and
  • Fluorescence-based detection for generation of analytical results.

5.2.5. The applicant has produced import licence No. IMP/IVD/2019/000175 dated 03.10.2022 issued by the Central Drugs Standard Control Organisation, under which the product is licensed as a Class A medical device to be used in conjunction with appropriate in vitro diagnostic (IVD) assays.

5.3. Statutory Framework

5.3.1. I note that Rule 1 of the General Rules of Interpretation (GRI) provides that 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 succeeding provisions. The Hon’ble Supreme Court in Commissioner of Central Excise v. Simplex Mills Co. Ltd., 2005 (181) E.L.T. 345 (S.C.) held that the Rules are to be applied in sequence, that Rule l gives primacy to the terms of the headings read with the Section and Chapter Notes, and that only if no clear picture emerges from that exercise does recourse lie to the succeeding Rules. The applicant has also placed reliance upon the decision of the Hon’ble Supreme Court in the case of Welkin Foods for the proposition that the Rules are to be applied sequentially and that classification begins, and in most cases ends, at Rule 1. I accept that proposition and apply it below.

5.3.2. Rule 6 provides that the classification of goods in the sub-headings of a heading shall be determined according to the terms of those sub-headings and any related sub-heading Notes and, mutatis mutandis, to the preceding Rules, on the understanding that only sub-headings at the same level are comparable.

5.3.3. The First Schedule to the Customs Tariff Act, 1975 is aligned with the Harmonized System, and it is settled by the Hon’ble Supreme Court in Collector of Central Excise v. Wood Craft Products Ltd., 1995 (77) E.L.T. 23 (S.C.) that where a tariff entry corresponds to the Harmonized System, the Explanatory Notes are a safe guide to its interpretation. Heading 9027 and heading 9031 of the First Schedule reproduce headings 90.27 and 90.31 of the Harmonized System without alteration. The Explanatory Notes are, however, an aid to the construction of a heading and not a substitute for it.

5.4. Issue of classification

5.4.1. The applicant has sought an advance ruling on the classification of BD ViperTM LT System. The applicant contends that the instrument is an apparatus for chemical analysis and is therefore covered by the terms of heading 9027 upon the application of Rule 1 of the General Rules for the Interpretation of the First Schedule (GRI). It relies upon the enumeration in the Explanatory Notes to heading 9027, the last item of which refers to instruments and apparatus used in clinical laboratories for in-vitro diagnostic testing, and upon the exclusion in the Explanatory Notes to heading 90.18 relating to laboratory instruments used to test blood, tissue fluids and urine. It contends that heading 9031 is a residuary heading which cannot be resorted to when a specific heading is available, and that the Explanatory Notes to heading 90.31 exclude instruments falling in headings 90.15 to 90.30.

5.4.2. However, I note that the jurisdictional Commissionerate, in its comments has contended that the most appropriate classification for the impugned goods is 9031. The jurisdictional Commissionerate contends that the fluorescence-based optical detection module constitutes only the final stage of the overall analytical workflow and does not represent the principal function of the equipment; that the essential character of the system is derived from its capability to perform integrated molecular diagnostic processing, including sample preparation, nucleic acid extraction, amplification, and automated analytical checking; that in terms of Rule I of the General Rules for the Interpretation (GIR) read with the relevant Section Notes, Chapter Notes and the HSN Explanatory Notes to Chapter 90, the subject goods are not appropriately classifiable under Heading 9027, which primarily covers instruments whose principal function is optical or physical/chemical analysis; that as per Rule 3(b) of the GIR, the essential character of the composite machine is imparted by its integrated molecular processing and checking functions rather than by the fluorescence-based detection module; that consequently, the goods are more appropriately classifiable under Heading 9031, which covers other measuring or checking instruments, appliances and machines; that even if the goods were considered equally classifiable under Headings 9027 and 903 I , Rule 3(c) of the GIR provides that classification shall be under the heading occurring last in numerical order among those equally meriting considerations; that it is concluded that the BD Viper””‘ LT System is appropriately classifiable under Customs Tariff Heading 9031; that the instrument neither directly examines nor interacts with patients; that the equipment is not eligible for the concessional IGST rate under Entry No. 489 of Schedule I to Notification No. 9/2025-Integrated Tax (Rate).

5.4.3. I have examined the submissions made by the applicant and the comments of the jurisdictional Commissionerate, and have also considered the applicable statutory provisions, Explanatory Notes to the Harmonized System, and relevant judicial precedents. The classification of goods under the Customs Tariff is governed by the General Rules for Interpretation (CUR), read with relevant Section and Chapter Notes. Where, by application of GIR 2 (b) or for any other reason, the goods are prima facie classifiable under more than one heading, Rule 3 (a) of the GIR applies, and by this rule the most specific description is preferred.

5.4.4. To ascertain the classification Of the impugned goods, the following competing, tariff headings require examination: heading 9027 (Instruments and Apparatus for Physical or Chemical Analysis (For Example, Polarimeters, Refractometers, Spectrometers, Gas or Smoke Analysis Apparatus); Instruments and Apparatus For Measuring or Checking Viscosity, Porosity, Expansion, Surface Tension or the Like; Instruments and Apparatus for Measuring or Checking Quantities of Heat, Sound or Light (Including Exposure Meters); Microtomes) and Heading 9031 (Measuring or Checking Instruments, Appliances and Machines, Not Specified or Included Elsewhere in this Chapter; Profile Projectors).

Heading, Sub- heading, Tariff Item	Description of Goods	Rate of duty
9027	INSTRUMENTS AND APPARATUS FOR PHYSICAL OR CHEMICAL ANALYSIS (FOR EXAMPLE, POLARIMETERS, REFRACTOMETERS, SPECTROMETERS, GAS OR SMOKE ANALYSIS APPARATUS); INSTRUMENTS AND APPARATUS FOR MEASURING OR CHECKING VISCOSITY, POROSITY, EXPANSION, SURFACE TENSION OR THE LIKE; INSTRUMENTS AND APPARATUS FOR
9027 10 00	Gas or smoke analysis apparatus	10%
9027 20 00	Chromatographs and electrophoresis instruments	Free
9027 30	Spectrometers, spectrophotometers and spectrographs using optical radiations (UV, visible, IR)	—
9027 30 10	Spectrometers	Free
9027 30 20	Spectrophotometers	Free
9027 30 90	Other	Free
9027 50	Other instruments and apparatus using optical radiations (UV, visible, IR)	—
9027 50 10	Photometers	Free
9027 50 20	Refractometers	Free
9027 50 30	Polarimeters	Free
9027 50 90	Other	Free
9027 81 00	Mass spectrometers	Free
9027 89	Other	—
9027 89 10	Viscometers	Free
9027 89 20	Calorimeters	Free
9027 89 30	Instruments and apparatus for measuring the surface or interfacial tension of liquids	Free
9027 89 90	Other	Free
9027 90	Microtomes; parts and accessories	—
9027 90 10	Microtomes, including parts and accessories thereof	7.5%
9027 90 20	Printed circuit assemblies for the goods of sub-heading 9027 80	7.5%
9027 90 90	Other	7.5%

—

Heading, Sub-heading, Tariff Item	Description of Goods	Rate of duty
9031	MEASURING OR CHECKING INSTRUMENTS, APPLIANCES AND MACHINES, NOT SPECIFIED OR INCLUDED ELSEWHERE 1N THIS CHAPTER; PROFILE PROJECTORS
9031 10 00	Machines for balancing mechanical parts	7.5%
9031 20 00	Test benches	7.5%
9031 41 00	For inspecting semiconductor wafers or devices (including integrated circuits) or for inspecting photomasks or reticles used in manufacturing semiconductor devices (including integrated circuits)	Free
9031 49 00	Other	7.5%
9031 80 00	Other instruments, appliances and machines	15%
9031 90 00	Parts and accessories	7.5%

5.4.5. I find that the issue for consideration is the proper classification of the product under import, namely BD ViperTM LT System. The applicant has urged that the instrument is an apparatus for chemical analysis and is therefore appropriately classifiable under heading 9027 upon the application of Rule I of the General Rules for the Interpretation of the First Schedule (GRI). First, I examine scope of heading 9027 which is contended by the applicant.

5.5. Examination of scope under Heading 9027

5.5.1. I find that I leading 9027 comprises limber limbs as under: –

a. Instruments and Apparatus for Physical or Chemical Analysis (For Example. Polarimeters, Refractometers, Spectrometers. Gas or Smoke Analysis Apparatus);

b. Instruments and Apparatus for Measuring or Checking Viscosity, Porosity, Expansion, Surface Tension or The Like;

c. Instruments and Apparatus for Measuring or Checking Quantities of I teal, Sound or Light (Including Exposure Meters); and

d. Microtomes.

The applicant’s claim rests upon the first limb alone. The second limb is plainly inapplicable, and the goods are not microtomes. Third limb is applicable to the Instruments and Apparatus whose object is the measurement of Heat, Sound or light

5.5.2. The heading “Instruments and Apparatus fir Physical or Chemical Analysis (For Example, Polarimeters, Refractometers, Spectrometers, Gas or Smoke Analysis Apparatus)” itself supplies the guide. The four illustrations given in the heading — polarimeters, refractometers, spectrometers and gas or smoke analysis apparatus — and the extensive enumeration in the Explanatory Notes to heading 90.27 — saccharimeters, colorimeters, nephelometers, turbidimeters, absorptiometers, iluorimeters, densitometers, photometers, pH and di meters, conductivity meters, electronic titration instruments, calorimeters, chromatographs and electrophoresis instruments — disclose a common characteristic. Each of these instruments is applied to a substance as it is presented to the instrument, and each determines some property or constituent of that substance. The analysis, in each case, consists in the examination and measurement of the substance itself.

5.5.3 The instrument before me does not work in that manner. On the applicant’s own description, the specimen as presented is not the thing which the instrument examines. The specimen is placed into a specimen tube. Several such tubes (each representing one patient specimen) are held in a specimen rack in a grid. The rack is placed on the pre-warm heater, which gently heats the tubes for a set time. For SDA assays, this helps dissolve mucus and make the specimen uniform. For PCR assays, this pre-warm step also breaks open (lyses) the cells to release DNA into the liquid. After pre-warming, the rack cools down and is moved onto the main BD Viper LT instrument deck, into the specimen rack station. A robotic pipetting arm with disposable tips picks up small volumes of liquid from the patient’s specimen tubes. It transfers this liquid into a new type of tube, called an extraction tube, which contains ferric oxide particles packed in a dissolvable film at the bottom. In the extraction module, a high-pH (alkaline) solution is added to the extraction tube. These breaks open cells (lysis) in the specimen and releases their DNA into the solution. Then acid is added to bring the pH down. This causes the ferric oxide particles to gain a positive charge, so they attract and bind the negatively charged DNA. The ferric oxide particles (now carrying the DNA) are pulled to the tube walls. The liquid that does not contain DNA (waste) is then sucked out and discarded. The particles are washed several times to remove impurities. A high-pH elution buffer is then added which makes the DNA come off the ferric oxide particles and go back into the liquid – this is now purified DNA. The robotic pipetting arm moves the purified DNA from each extraction tube into either SDA priming wells (for SDA assays), or PCR tubes (for PCR assays). These wells/ tubes already contain dried reagents, including, primers (short DNA pieces that recognize the target pathogen DNA), fluorescent-labelled detector probes (dyes that will light up if target DNA is amplified), enzymes (e.g., DNA polymerase, restriction enzymes for SDA, Taq polymerase for PCR), and other required chemical components. The plate of reaction wells/ tubes is sealed with a clear adhesive film by the robot and placed into the reader module. Inside the reader module, the instrument runs either an SDA protocol or a PCR protocol. The reader has a Peltier heat block and a heated lid. For PCR, it repeatedly heats and cools the tubes (thermocycling) in steps that cause DNA strands to separate, primers to attach, and polymerase to copy the target DNA many times. If the target pathogen DNA is in the specimen, that specific segment will be copied over and over, increasing its amount to a level that can be easily detected. While the amplification is happening, the reader module also performs real-time fluorescent detection. After a complete run, the system shows a tube result showing the diagnostic answer showing whether the target pathogen’s DNA was detected or not in that sample. The instrument does not measure any property of the specimen. It creates a signal and then reads the signal it has created.

5.5.3.1. Nor is the output an analytical one. The instrument reports no composition, no concentration and no quantity. The tube result report, as described in Section 5.8.2 of the product manual, shows a positive or negative symbol against each specimen. The instrument compares the observed fluorescence against a criterion laid down in the assay-specific reagent package and reports whether that criterion has been met. That is the answering of a yes-or-no question. It is checking, and not analysis.

5.5.4. The applicant relies heavily upon the last of the enumerated item (Item No. 33) in the Explanatory Notes to heading 90.27, which states “Instruments and apparatus used in clinical laboratories for in-vitro diagnostic testing.”

In order to examine whether it is used in clinical laboratories for in-vitro diagnostic testing, reliance is made on Medical Devices Rules, 2017. According to the Medical Devices Rules, 2017, in vitro diagnostic medical devices shall be classified on the basis of parameters specified in Part II of the First Schedule, in the following classes, namely: —

(i) low risk – Class A;

(ii) low moderate risk – Class B;

(iii)moderate high risk – Class C;

(iv) high risk – Class D”.

It is further stated in the rules that-

“2. The parameters for classification of in vitro diagnostic medical devices as follows:

…………..

(v) In vitro diagnostic medical devices used in in vitro diagnostic procedures: – An in vitro diagnostic medical device shall be assigned to Class A:

(1) if it is a reagent or an article which possesses any specific characteristic that is intended by its product owner to make it suitable for an in vitro diagnostic procedure related to a specific examination;

(2) an instrument intended ,specifically to be used for an in vitro diagnostic procedure; or

(3) a specimen receptacle.”

Under Medical Device Rules, 2017, the importer shall provide Following details of medical device: –

Generic Name	Model No.	Intended Use	Class of Medical Device	Material of Construction	Dimension (if any)	Shelf Life	Sterile or Non-Sterile	Brand Name (if registered under the Trade Marks Act, 1999)

I observe that the applicant has submitted ‘Import Licence under Medical Device Rules, 2017″ issued by CDSCO in which the intended use of the impugned product is given as follows:

“The BD Vipcerm LT System used in conjunction with appropriate in vitro diagnostic (IVD) assays, is intended fir the automated extraction of nucleic acids from multiple specimen types as well as amplification and detection of target nucleic acid sequences by either Strand Displacement Amplification or Polymeras Chain reaction (PCR) technologies.”

It is obvious from the Licence that the intended use of the BD Vipers’ LT System is to be used “in conjunction” with appropriate in vitro diagnostic (11(D) assays. It can be derived from this that the product itself’ is not an in vitro diagnostic instrument but is used in conjunction with them. Hence the last of the enumerated items (item No. 33) in the Explanatory Notes to heading 90.27, which refers to instruments and apparatus used in clinical laboratories for in-vitro diagnostic testing is not applicable in this case.

5.5.5. The applicant next relies upon the exclusion in the Explanatory Notes to heading 90.18, by which instruments and appliances used in laboratories to test blood, tissue fluids, urine and the like, whether or not such tests serve in diagnosis, are excluded from heading 90.18. I observe that the note directs such instruments to heading 90.27 only “generally”. The office of that exclusion is to keep laboratory instruments out of heading 9018; it does not fix them in heading 9027 whether or not they answer the terms of that heading. Where a laboratory instrument does not perform physical or chemical analysis, it must find its place elsewhere within Chapter 90.

5.5.6. As regards the decision of the Hon’ble Tribunal in Bayer Pharmaceuticals Ltd. v. Commissioner of Customs, 2016 (331) E.L.T. 317 (Tri. -Mumbai), the goods there were a glucometer which drew blood and tested it to indicate blood sugar content, and the finding was that the testing of blood and its analysis for indicating blood sugar content is the outcome of a chemical analysis. That finding turns upon the determination of content, that is to say the quantity of a constituent actually present in the specimen as presented. The instrument before me determines no content.

5.5.7. The decision in Goodyear India Ltd. v. Commissioner of Customs, 1999 (109) E.L.T. 488 (Tribunal) concerned an ozone ageing tester which was found upon its own facts to be an instrument for chemical analysis. It is a finding upon different goods and does not assist the applicant here.

5.5.8. The applicant has also relied upon the licence issued by the Central Drugs Standard Control Organisation and upon the regulation of the product as a medical device under the Drugs and Cosmetics Act, 1940 read with the Medical Devices Rules, 2017. Classification under the Customs Tariff Act, 1975 is governed by the terms of the Tariff, and the characterisation of goods under another enactment enacted for a different purpose is not determinative of their tariff classification. However, it may be mentioned that the licence establishes that the product is to be used in conjunction with appropriate in vitro diagnostic (IVD) assays.

5.5.9. For the foregoing reasons, I find that the BD ViperTM LT System is not an instrument or apparatus for physical or chemical analysis, and that it does not qualify in heading 9027. The claim to tariff item 9027 50 90, and the alternative claim to tariff item 9027 89 90, must accordingly fail.

5.6. Examination of scope under Heading 9031

5.6.1. I find that Heading 9031 comprises four limbs as under: –

a. Measuring or Checking Instruments, Appliances and Machines, Not Specified or Included Elsewhere in Chapter 90; and

b. Profile Projectors.

5.6.2. The impugned product is not a Profile Projectors. The question, therefore, narrows to whether the BD ViperTM LT System is Measuring or Checking Instruments, Appliances and Machines, Not Specified or Included Elsewhere in Chapter 90. Two conditions must therefore be satisfied:

a. the goods must be a measuring or checking instrument, appliance or machine;

b. they must not be specified or included elsewhere in the Chapter;

5.6.3. As to the ^.first, the instrument checks. It subjects each specimen to a defined procedure, compares the resulting signal against a criterion, and reports whether that criterion is met. Its entire output, as described in Section 5.8 of the product manual, consists of the identification of each tube and a positive or negative result against it. The jurisdictional Commissionerate has described the function as automated analytical checking, and that description is borne out by the material on record. The instrument is a checking machine within the meaning of the heading.

5.6.4. As to the second, I have found in Part (F) above that the goods do not answer heading 9027. Heading 9018 is not available, laboratory instruments used to test material taken from the patient being excluded from that heading by its own Explanatory Notes. I have also considered the remaining headings of Chapter 90 and find that none of them describes these goods. The condition that the goods be not specified or included elsewhere in the Chapter is therefore satisfied.

5.6.5. The applicant contends that heading 9031 is a residuary heading, that resort to a residuary entry must be had with extreme caution and only as a last resort, and it relies upon Western India Plywoods Ltd. v. Collector of Customs, 2005 (188) E.L.T. 365 (S.C.) and Mauri Yeast India Pvt. Ltd. v. State of U.P., 2008 (225) E.L.T. 321 (S.C.). I accept the principle without reservation. Its requirement is that the specific entries be examined first, and that recourse be had to the residuary entry only i Inoue of them applies. That is precisely the exercise which has been undertaken) above. !leading 9031 is residuary only in the sense that its application is conditioned upon no other heading of the Chapter specifying the goods. Where that condition is satisfied, the heading applies according to its own terms, and there is nothing exceptional or grudging about its application.

5.6.6. The applicant further relies upon the Explanatory Notes to heading 90.31, which state that the group does not include instruments or apparatus falling in headings 90.01 to 90.12 or 90.15 to 90.30. That note is a restatement of the condition contained in the heading itself. It operates where the goods do in fact fall within one of the excluded headings. Since I have found that these goods do not fall within heading 9027, or within any other heading in those ranges, the exclusion is not attracted.

5.6.7. I should record my respectful disagreement with one part of the reasoning of the jurisdictional Commissionerate, although not with its conclusion. The Commissionerate reached heading 9031 by applying Rule 3(b) of the GRI and, in the alternative, Rule 3(c). Recourse to Rule 3 was, in my view, unnecessary and indeed unavailable. Rule 3 operates only where goods are prima facie classifiable under two or more headings. Upon the view I have taken, heading 9027 does not describe these goods at all, and no conflict of headings arises for resolution. The classification is determined at Rule I itself: The applicant’s submission, founded upon the decision in Welkin Foods, that the Rules must be applied sequentially and that Rule 3 cannot be invoked where Rule 1 furnishes the answer, is well founded and has been given effect to in this ruling. The conclusion of the Commissionerate is upheld; the route by which it was reached stands corrected.

5.6.8. It is also significant that the applicant it self cleared these very goods under heading 9031 on an earlier occasion.

5.6.9. I accordingly hold that the BD ViperTM LT System is classifiable under heading 9031 of the First Schedule to the Customs Tariff Act, 1975.

5.7. Classification at the sub-heading and tariff item level

5.7.1. Heading 9031 having been found to apply, I turn to Rule 6 of the GRI. The relevant entries are extracted below:

Heading / Sub-heading / Tariff Item	Description of Goods	Rate of duty
9031	MEASURING OR CHECKING INSTRUMENTS, APPLIANCES AND MACHINES, NOT SPECIFIED OR INCLUDED ELSEWHERE IN THIS CHAPTER; PROFILE PROJECTORS
9031 10 00	– Machines for balancing mechanical parts	7.5%
9031 20 00	– Test benches	7.5%
	– Other optical instruments and appliances:
9031 41 00	— For inspecting semiconductor wafers or devices (including integrated circuits) or for inspecting photomasks or reticles used in manufacturing semiconductor devices (including integrated circuits)	Free
9031 49 00	— Other	7.5%
9031 80 00	– Other instruments, appliances and machines	15%
9031 90 00	– Parts and accessories	7.5%

5.7.2. The impugned goods are neither machines for balancing mechanical parts (9031 10 00) nor test benches (9031 20 00), and they are not parts or accessories (9031 90 00).

5.7.3. The comparison, therefore, lies between the group of other optical instruments and appliances on the one hand and other instruments, appliances and machines (9031 80 00) on the other.

5.7.4. The test laid down is thus whether the impugned instrument functions through the use of optical elements or optical processes. The impugned instrument functions through the use of optical elements and optical processes and falls within the group of other optical instruments and appliances

5.7.5 Sub-heading 9031 4100 is confined to instruments and appliances for inspecting semiconductor wafers or devices, or photomasks or reticles used in the manufacture of semiconductor devices. It has no application.

5.7.6. For the purposes of sub-heading 9031 4900, the test is the narrower whether the instrument functions through the use of optical elements or processes, and upon the material on record. The impugned instrument functions through the use of optical elements and optical processes and therefore fall to sub-heading 9031 4900.

5.7.7. Sub-heading 9031 8000, which covers other instruments, appliances and machines, is a residual entry and takes in those measuring or checking instruments oldie heading which are not optical. Since the goods within the optical group, sub-heading 9031 8000 is not reached.

5.7.8. I hold that the RD Viper”‘ Li System is classifiable under tariff item 9031 49 00 of the First Schedule to the Customs Tariff Act, 1975.

5.8. Rate of basic customs duty

5.8.1. The rate of basic customs duty specified against tariff item 9031 49 00 in the First Schedule to the Customs Tariff Act, 1975 is 7.5% ad valorem. The goods will accordingly attract basic customs duty at that rate as it stands on the date of this ruling. This finding is confined to the rate of basic customs duty under the First Schedule.

5.9. Rate of integrated tax

5.9.1. Integrated tax on imported goods is levied under sub-section (7) of section 3 of the Customs Tariff Act, 1975 at the rate applicable under section 5 of the Integrated Goods and Services Tax Act, 2017 to a like article on its supply in India. The rates have been notified by Notification No. 9/2025-Integrated Tax (Rate) dated 17.09.2025 as under: –

Schedule	S. No.	Chapter / Heading / Sub-heading / Tariff item	Description of goods	Rate
II	580	9031	Measuring or checking instruments, appliances and machines, not specified or included elsewhere in this Chapter; profile projectors	18%

5.9.2. Entry 580 of Schedule II covers goods falling under heading 9031, described in the terms of the heading itself, at the rate of 18%. The goods having been held classifiable under tariff item 903149 00, integrated tax is leviable upon their import at the rate of 18% under that entry.

6. For the reasons recorded in the foregoing discussion and Findings, the answers to the questions raised by the applicant are as –

Q.1. Whether BD ViperTm LT System imported by the Applicant merits classification under Customs Tariff Item (CIT) 9027 50 90 or 9027 89 90 of the First Schedule of the Customs Tariff Act, 1975 (‘Customs Tari ft)?

Answer: – No, BD ViperTM LT System imported by the Applicant does not merit classification under Customs Tariff Item (‘CTII) 9027 50 90 or 9027 89 90 of the First Schedule of the Customs Tariff Act, 1975. It is classifiable under tariff item 9031 49 00.

Q.2. What shall be the rate of BCD and Import IGST on the import of BD ViperTM LT System upon import of the product in India?

Answer- Basic Customs duty on the BD ViperTM LT System, classifiable under tariff item 9031 49 00, is leviable at the rate of 7.5% ad valorem as specified in the First Schedule to the Customs Tariff Act, 1975. IGST is leviable at the rate of 18% under Entry 580 of Schedule II to Notification No. 9/2025-Integrated Tax (Rate) dated 17.09.2025.

7. I rule accordingly.
Notes:

¹ httpslfwww,who.intilleal(1)….topicsiin-vitro-diauostics accessed on 18 February 2026