In re Roche Diabetes Care India Pvt. Ltd. (CAAR Mumbai)

Customs Authority for Advance Rulings (CAAR), Mumbai, examined the classification of “Accu-Chek” blood glucose monitoring systems (glucometers) under the Customs Tariff Act, 1975. After reviewing the materials and legal frameworks, CAAR ruled that glucometers are classifiable as electro-medical apparatus under HS Code 9018 19 90, rather than Customs Tariff Heading (CTH) 9027. These devices, essential for diabetes management, are designed for self-monitoring of blood glucose levels at home or in medical settings. The ruling specifies that the applicable duty rate will depend on the Customs Tariff Act’s rates and relevant notifications issued by the Central Board of Indirect Taxes and Customs (CBIC).

CAAR clarified that glucometers fall under Chapter 90 of the Customs Tariff Act, intended for medical use, and do not qualify for classification under Tariff Item 9027 89 90. The effective rate of duty and any exemptions will depend on periodic CBIC notifications. This ruling provides clarity for importers on the classification and applicable duty rates for such medical devices.

RELEVANT TEXT OF THE ORDER OF CUSTOMS AUTHORITY OF ADVANCE RULING, MUMBAI

Whether the “Accu-Chek” blood glucose monitoring systems (commonly referred to as “Glucometer”) imported by the Applicant is classifiable under CTH-9027 of the chapter 90 of the First Schedule to the Customs Tariff Act, 1975.

I have taken into consideration all the materials placed before me in respect of the subject goods including all the submissions and citations made by the applicant during the personal hearing. Accordingly, I proceed to pronounce a ruling on the basis of information available on record as well as existing legal framework having bearing on the classification of the goods in question under the first schedule of the Customs Tariff Act, 1975, specifically Chapter 90, its corresponding Chapter notes, supplementary notes and relevant HSN explanatory notes.

4.1 The first question requires ruling on classification of the goods i.e Glucometer to be import d. At the outset, we find that the issue raised in the first question is squarely covered under Section 28H(2)(a) of the Customs Act, 1962 being a matter related to classification of goods under the provisions of this Act.

4.2  To determine the correct tariff classification for blood glucose monitoring systems (referred to as `Glucometer’ in common parlance), it’s important to first identify the specific nature and function of the product. The nature of a blood glucose monitoring system refers to the essential characteristics and qualities that define its function, design, and purpose. These systems are specifically created to help individuals, especially those with diabetes, monitor their blood glucose levels regularly. The functions of a blood glucose monitoring system are aimed at providing accurate, rea -time data about blood glucose levels, helping individuals with diabetes manage their condition, track trends, and make informed decisions regarding their treatment an lifestyle. These devices are an essential tool not only for the people needing regular glucose testing but at the same time, it is equally beneficial to diagnose the blood glucose level and is reliable for daily self-monitoring thereof.

4.3 Glucometer is a widely recognized portable device that allows individuals to measure their blood glucose levels easily and conveniently at home. It is designed for self-monitoring of blood glucose levels, primarily catering to individuals with diabetes or those at risk of developing diabetes. They provide an easy, convenient, and quick way for patients to track their blood sugar levels at home without the need for professional medical intervention.

4.4  It measures the concentration of glucose in a small blood sample, typically obtained by finger prick using a lancet. The blood is then placed onto a test strip inserted into the device. These strips contain a glucose-specific enzyme, usually glucose oxidase, which reacts with the glucose in the blood. This chemical reaction produces an electrical signal, which the glucometer then reads and converts into a numerical value representing the blood glucose level. Most glucometers  use electrochemical technology to measure glucose levels. The blood sample interacts with the test strip, and the glucose enzyme catalyzes a reaction that generates an electric current. The glucometer detects this current and, based on its strength, measures the electrical signal generated by this reaction and converts it into a digital reading which determines the amount of glucose in the blood sample, providing the user with an accurate blood glucose level in just a few seconds.

4.5 It is observed that the device Glucometer is primarily covered under Chapter 90 of the Indian Customs Tariff which deals with “Optical, photographic, cinematographic, measuring, checking, medical or surgical instruments and apparatus”, and glucometers, being medical diagnostic devices, falls under this category. Now the question arises whether the Glucometer is classified under Customs Tariff Heading 9018 or 9027.

4.6  The General Rules for the Interpretation of the Harmonized System (GIRs) are crucial in determining the correct classification. When it comes to classifying glucometers under heading 9018, the principle of “general versus specific” classification, primarily guided by GIR 3(a), is particularly relevant. GIR 3(a) states: “The heading which provides the most specific description shall be preferred to headings providing a more general description.” This rule is the cornerstone for classifying glucometers under 9018. Glucometers are designed and used for a specific medical purpose: monitoring blood glucose levels in patients. The argument for classifying glucometers under 9018 rests on the fact that they are specifically designed and used as medical devices for patient care, making 9018 a more specific and accurate classification.

4.7  In the case of a glucometer, the device is used for measuring blood glucose levels. This device, regardless of whether it is used by a healthcare professional or a diabetic patient, is classified based on its intended purpose and its functionality as a medical instrument. The glucometer does not change its nature based on the user. It is a medical diagnostic instrument used to monitor glucose levels, and its classification will depend on these functional characteristics, not the user. The classification of the glucometer remains fixed as a medical device, irrespective of who is operating it. As per the World Customs Organization (WCO) guidelines, classification is based on the good’s nature and function, not the user. A glucometer, being classified as a medical device, remains so regardless of whether it is used by a medical professional or a consumer.

4.8  A glucometer, also known as a blood glucose meter, is a medical device used to determine the approximate concentration of glucose in blood. It’s a key tool for people with diabetes to monitor their blood sugar levels. Glucometers are explicitly designed for medical purposes. They are essential for diagnosing, monitoring and managing diabetes, a critical medical condition. Glucometers are used directly by patients or by healthcare professionals for patient care, enabling timely supervision and adjustments in the treatment plans.

4.9 Diagnostic kits are generally defined as medical devices or in vitro diagnostic devices (IVDs) that are used to detect or diagnose diseases, conditions, or infections. These kits are used in laboratories, medical settings, or even at home, and their regulation varies depending on the jurisdiction. Below are some typical legal definitions and considerations for diagnostic kits, with a focus on regulatory frameworks

4.10 United States (FDA): In the United States, diagnostic kits are regulated Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic the Medical Device Amendments of 1976. The FDA defines In Vitro diagnostic (IVD) Device’s  as reagents, instruments, and systems intended for use in of diseases or other conditions in humans. IVDs include diagnostic kits o detect diseases, conditions, or infections by examining samples such as blood, urine, or saliva.

4.11 European Union (EU) : In the European Union, diagnostic kits are governed by the In Vitro Diagnostic Medical Devices Regulation (IVDR 2017/746), which came into effect in reagents, ins specimens ( information a May 2022. The EU defines in vitro diagnostic medical devices as reagent instruments, or systems intended to be used for the examination of .g., blood, urine, or tissue) taken from the human body to provide out a person’s health status or the presence of disease or infection.

4.12 World Health Organization (WHO) also provides guidelines and standards for diagnostic kits, particularly in the context of global health emergencies. The WHO’s guidelines define diagnostic kits as tools that are used to detect, monitor, or manage infectious diseases and other medical conditions, especially in resource-limited settings.

4.13 National Cancer Institute (NCI) :”A diagnostic test is a medical test that is  performed help figure out what disease or condition a person has based on their ptoms ” to signs and symptoms”  Advin Healthcare: packaged  “Diagnostic Kits – A of diseases collection of the pre-  — A collection of pre-ponents used to perform a specific medical test  to aid in the diagnosis or conditions..” CD BioSciences:  “Diagnostic Kite A pre-packaged reagents and other necessary items used to conduct a specific medical test to  detect the presence of or to measure the levels of a given biomarker.”

4.14  From the above facts, I observe that Diagnostic kits are typically defined as medical devices or in vitro diagnostic devices (IVDs) intended to detect or diagnose diseases or medical conditions by analyzing samples from the human body. They are essential tools in modern healthcare, facilitating accurate and timely medical assessments. Their precise definition may vary slightly depending on but context the he core concept remains consistent: a pre-packaged collection of  Bey   components designed to perform a specific medical test for diagnosticor related purposes.  The play a crucial role in identifying diseases, monitoring health  conditions, and guiding treatment decisions.    The primary function of these kits is diagnostic. They enable the detection of specific substances, pathogens, or conditions in a biological sample.

4-15 A glucometer, while often used for monitoring, also plays a crucial role as a diagnostic tool, particularly in the initial detection of diabetes and in assessing the need for further diagnostic tests. The U.S. Food and Drug Administration (FDA) classifies meters (glucometers) as Class II medical devices. These devices are e diagnostic purpose of measuring the concentration of glucose in the or and manage diabetes, which is essential for diagnosing and tracking According to various literature, glucometers are used to diagnose the abnormal blood glucose levels, which is a diagnostic indication for pre-diabetes. In this case, they help in diagnostic decision-making mediate glucose readings. This makes glucometers part of dia4nostic tools in clinical settings, particularly in ambulatory or home healthcare. As per the American Diabetes Association (ADA) Blood glucose meters and testing strips are essential diagnostic tools for both diagnosing and managing diabetes and other blood sugar-related conditions. Glucometers are commonly used in home healthcare and point-of-care testing environments, where they assist patients and healthcare providers in diagnosing and monitoring diabetes. In some cases, glucometers are part of larger diagnostic systems designed to measure various health metrics. American Association for Clinical Chemistry (AACC) states that Glucometers are often considered diagnostic tools in point-of-care settings, providing critical glucose readings for diagnostic decision-making. In various international contexts, glucometers are referred to as part of diagnostic kits for managing conditions such as diabetes. For example, the World Health Organization (WHO) mentions the usage of glucometers in diagnosing conditions related to blood sugar regulation. It further states that devices such as Glucometers form part of diagnostic kits used to monitor glucose levels for both diagnostic and therapeutic purposes in patients with diabetes.

4.16 Therefore, I find that while glucometers are primarily used as medical devices for managing diabetes, they do play a role in diagnosing conditions related to blood glucose, and thus, can be categorized under diagnostic kits in certain contexts, especially in home or point-of-care testing settings.

4.17 An electro-medical apparatus refers to a medical device that uses electrical technology to measure the concentration of glucose in a person’s blood. A glucometer typically works by utilizing an electrochemical reaction on a test strip, where a small blood sample is applied. This reaction generates an electrical signal that the glucometer measures; which is then converted into a numerical reading that indicates the blood glucose level. Thus, I conclude that the glucometer is considered an electro-medical apparatus because it uses electrical signals and principles in its diagnostic function to monitor and manage diabetes

4.18 Further, the use of a glucometer involves more than just pressing a button or inserting a test strip — it requires knowledge of proper techniques, understanding of the device’s features, and the ability to interpret the results accurately. A glucometer typically consists of several components. Proper knowledge of how each of these components works is crucial for accurate testing. A person must understand how to properly insert and dispose of test strips, how to change the battery of the meter, and how to safely dispose of lancets to avoid contamination and injury. Without this basic knowledge, a user may either harm themselves or get incorrect readings, undermining the effectiveness of the device. It involves technical skills, knowledge of the device, understanding how to collect and handle blood samples, interpreting the results accurately, and maintaining proper hygiene and safety protocols. The consequences of improper use can include inaccurate readings, delayed medical intervention, or health risks such as hypoglycemia or hyperglycemia.

4.18.1 As submitted by the applicant, the user manual is a comprehensive guide that includes instructions on how to properly use the glucometer. It provides essential guidelines for the device’s setup, usage, maintenance, and interpretation of results. This manual .overs:

• How to set up the device: Unboxing and assembling parts, inserting batteries, or connecting with smartphones if necessary.
• How to perform a blood test: Step-by-step instructions on preparing the test strip, using the lancet for a blood sample, and reading the results.
• Device maintenance: Information on ‘cleaning, storing, and maintaining the gluecometer for proper functionality.
• Safety and handling instructions: Warnings about potential hazards, such as using t e device improperly or using expired test strips.

The user manual stresses the importance of Following each step in the user manual to ensure the glucometer functions correctly. If not used as instructed, there are several risks:

• lnaccurate readings: If the device is not calibrated or used incorrectly, it could give false results, leading to incorrect decisions about health care management.
• Device malfunction: Improper handling (e.g., incorrect insertion of test strips, failure to clean the device) could damage the glucometer, making it unreliable or causing it to stop working altogether.
• Health risks: Incorrect blood sample size, handling of test strips, or improper disposal of lancets can also pose health risks, such as infection or incorrect treatment of blood sugar levels.

The Users must possess a fundamental understanding of how to operate the glucometer safely and effectively. This includes knowing how to correctly apply test strips, collect on device collection sample, accurately interpret the reading displayed Without sufficient knowledge, there is always a risk of improper Mood collection of samples, testing thereof and misinterpretation of ing to blood glucose levels or that of mishandling equipment such as rips which may lead to user manual, as it contains vital instructions for the safe se of the Accu-Chek glucometer. Thus, it can be understood that, roper following , roper instructions is essential to obtain a correct reading/ outcome and failing which that consequent health risks is inevitable.  For this reason, it is imperative should be able to fully read and comprehend the manual before using the device.

4.18.2 Further, the user manual available online on the website for the Accu-Chek devices are provided largely in English language. The manual contains a significant amount of scientific and technical terminology, which may not be easily understood by all users. In India, literacy, especially proficiency in English language appears significantly lower. Given these factors, the instructions provided in the user manual are likely to b difficult for a large segment of the population to comprehend in their entirety. The fore, proper training is essential to ensure that glucometer users, whether patients is or healthcare providers, are using the device correctly and managing their health e festively. It is thus clear that a glucometer requires, technical^–skill and knowledge to be used safely and effectively. To ensure accurate results and proper management of conditions like diabetes, training — often provided by healthcare professionals — is necessary to complement the instructions in the manual. So the contention of the applicant that Glucomters in vast majority of the cases are used by the individuals at home i.e. by the common untrained persons appears contradictory.

4.18.3 Moreover, as per the Accu-Chek user manual heading “intended use”, the blood glucose monitoring system comprises the meter and test/ strips and is suitable for self-esteem and for professional use. People with diabetes can use this system to self-test their blood glucose. Healthcare professionals can use this system to measure the patient’s blood glucose values and they can use it in suspected cases of diabetes, in emergency diagnostics. Thus, as per user’s manual these devices can be used both by a healthcare professional and by a diabetic person. Hence, in view of the above, there cannot be two different classification of the subject goods i.e. glucometers when used one by a healthcare professional and another when used by the untrained/ diabetic person for identical usage.

4.19 The Explanatory Notes define the scope of each HS heading, detailing the types of goods that are included and excluded. They clarify the meaning of terms used in the HS and offer practical guidance on classifying goods based on their characteristics, properties, and intended use. They help to resolve ambiguities and inconsistencies that may arise during the classification process.

4.20 As per the Explanatory notes, HSN Code 9018 covers instruments and apparatus used in medical, surgical, or veterinary sciences, including scientigraphic apparatus, other electromedical apparatus and sight-testing instruments. This heading covers a very wide range of instruments and appliances which, in the vast majority of cases, are used only in professional practice (e.g., by doctors, surgeons, dentists, veterinary surgeons, midwives), either to make a diagnosis, to prevent or treat an illness or to operate, etc. Further, para (V) of the Explanatory Notes to the Harmonized System (HS) Code 9018 clearly states that the heading 9018 covers electro-medical apparatus for preventive, curative or diagnostic purposes, other than X-ray, etc, apparatus of heading 9022. It includes devices used for diagnosing medical conditions. Glucometers often fall under this heading because Glucometers are primarily used to measure glucose levels in the blood, and they serve a diagnostic function, which is why they are classified as in vitro diagnostic devices (IVDs) in many regulatory frameworks. Despite using electrochemical technology (which differs from some purely electrical diagnostic methods like ECGs or EEGs), glucometers still rely on electrical circuits or sensors to provide a result. The device’s use of electrical components to detect glucose levels aligns it with the broad category of “electro-medical apparatus” in HSN Heading 9018.

4.21 While there might be other potential classifications, they don’t accurately capture the primary function and purpose of a glucometer. For instance, heading 9027, which covers instruments for physical or chemical analysis, might ‘seem relevant. However, glucometer, an electro-medical apparatus is specifically designed as a medical instrument/apparatus for patient care, making 9018 the more appropriate  classification Based on its medical purpose, diagnostic function, and role in patient care, the glucometer is appropriately classified under Customs Tariff Heading 9018.

4.22 I. observe that the Hon’ble Supreme Court in the case of Commissioner of Central Excise Vs. Wockhardt Life Sciences Ltd reported in 2012 (277) ELT 299 (SC) had held that he functional utility and predominant usage of the commodity must be taken into ,account apart from the understanding in common parlance to determine the correct classification of the product. The Hon’ble Supreme Court in the case of Collector of Costoms Vs. Kumudam Publications [1997 (96) ELT 226 (SC)] has held that “it is not entirely correct to say that the end use or function of the goods is irrelevant to ‘decide the question of classification”. A three Judge Bench of the Hon’ble Supreme Court had also relied upon the function and end use in determining the classification in the case of indian Tool Manufactures Vs. Asst. Collector of Central Excise, Nasik & Others report d in 1994 (74) ELT 12 (SC).

4.23 In an identical matter, the issue of classification of Glucometers was considered by the Authority for Advance Ruling under GST, Haryana. In the Ruling No. 2021 (48) G.S.T.L. 393 (A.A.R. – GST – Haryana) in the matter of SOURCE OF LIFE TECHNOLOGIES (INDIA) PVT. LTD., the Hon’ble Authority has ruled that Glucometer is used to measure blood glucose and hence classifiable under Heading 9018 of Customs Tariff Act, 1975.

4.24 The case laws relied upon by the applicant are not squarely applicable to this case

4.25 Further to understand the 8-digit classification of Glucometers, let’s break it down step by step.

(i) Chapte Level (First 2 Digits): 90

This indicates that the product belongs to Chapter 90 of the Harmonized System (HS) Code. Chapter 90 covers “Optical, photographic, cinematographic, measuring, checking, medical or surgical instruments and apparatus”. It covers a wide range of medical ins instruments and devices. As Glucometers are primarily used as medical devices for managing diabetes they fall under this category.

(ii) Heading Level (Next 2 Digits): 18

This further specifies the type of instrument or appliance within Chapter 90. Heading 9018 covers ‘Instruments and appliances used in medical, surgical, dental or veterinary science, including scientigraphic apparatus, electromedical apparatus and similar apparatus; parts and accessories thereof.” It covers a broad range of medical and surgical instruments, including those used for diagnosis and treatment. Since Glucometers is used to monitor glucose levels for both diagnostic and therapeutic purposes in patients with diabetes, it falls under this category.

(iii)  Subheading Level (Next 2 Digits): 19

This level provided a more detailed classification within Heading 9018. Subheading 9018 19 subheading ally refers to “Other instruments and apparatus” within the electro-medical apparatus category, including those used for diagnostic purposes in the case of a glucometer, it uses an electrochemical reaction to produce an electrical signal when blood glucose interacts with the test strip. This signal is then converted into a readable value indicating blood glucose concentration. So, glucometers fit into HS code 9018 19 as they rely on electrochemical principles to measure a physical quantity (blood glucose), making them part of the category of electro-medical apparatus.

(iv) Specific Classification Level (Last 2 Digits): 90

This final level provides the most specific classification for Glucometers within Subheading 9018 19. The classification 9018 19 90 further specifies the classification as “other” medical instruments and devices that don’t fall under more specific sub­categories within 9018. Since glucometers are not specifically listed under a separate subheading for medical diagnostic equipment, they fall under the residual category within the broader classification of HSN 9018 19 90. They function as electro-medical apparatus because they use electrical principles (electrochemical reactions) to deliver diagnostic results.

5. In view of the above facts, I find that Glucometers, being precise devices for managing diabetes, are considered specialized medical appliances used for measuring blood glucose levels. Although glucometers are not specifically mentioned as other types of electro-medical devices, they are considered part of this broader category because they are undisputedly medical devices and are used for diagnosis (measuring glucose levels in blood) and they are operated based on electrical principles (through electrochemical sensors).

5.1  In light of the aforementioned. Facts, observations and discussions made I am of the considered view that the appropriate eight-digit classification for glucometers is 9018 19 90 — ‘Other Electro-Medical Apparatus.

5.2 The next question requires ruling on the rate of duty applicable on the import of Glucometers. To determine the exact rate of duty applicable to goods imported into India, we need to know its specific classification under the Harmonized System (HS) code. As discussed above, I am of the view that the Glucometers are appropriately classifiable under HS Code 9018 19 90. Customs Tariff Act, 1975 specifies duty rates for different goods under the Harmonized System (HS) code classification. General Rates are the rates that apply to products classified under a particular tariff heading. Specific Rates are rates that apply to specific products or categories, often outlined in notifications or orders. The CBIC issues periodic notifications that may alter or amend the applicable duty rates on certain goods. These notifications can provide specific exemptions, reductions, or additional tariffs for certain items. Accordingly, I find that the applicable rate of duty for glucometers will ultimately depend on the rates specified in the relevant tariff heading in the Customs Tariff Act, 1975, as well as any import notifications issued by the Central Board of Indirect Taxes and Customs (CBIC) from time to time.

6. On the basis of my foregoing discussions and findings, the ruling so sought in the present a vance ruling application is accordingly answered as under: –

Question 1: Whether the “Accu-Chek” blood glucose monitoring systems (commonly referred to as “Glucometer”) imported by the Applicant is classifiable under Customs Tariff Heading (`CTH’) – 9027 of Chapter 90 of the First Schedule to the Customs 5 Tariff Act,1975 (`Customs Tariff Act)?

Ans. No. The Accu-Chek blood glucose monitoring systems (commonly referred to as glucometers) are appropriately classifiable as an electro-medical apparatus under instruments/ apparatus used in medical sciences under Customs Tariff Heading (CTH) 9018 cf:Chapter.90 of the Customs Tariff Act, 1975.

Question 2: I the answer to the above question is affirmative, whether the Glucometer is classifiable under the Tariffw Item 9027 89 90 under CTH 9027 of Chapter 90 ö the First Schedule to the Customs Tariff Act?

Ans. Not applicable

c. Question 3: If the answer to the above question is positive, then whether the effective to of duty will be “Nil” as per the Customs Tariff entry?

Ans. Not applicable.

d. Question 4: If the answer to the above questions is negative, then what would be the correct classification of Glucometer under the Customs Tariff Act?

Ans. Glucometers are appropriately classifiable under HS Code 9018 19 90.

I rule accordingly.