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TMI Blog2021 (10) TMI 627X X X X Extracts X X X X X X X X Extracts X X X X ..... the greatest extent the specificity of the test procedure - the subject product cannot be covered under Heading 30.02 of the GST Tariff as contented by the applicant. Whether the subject product can be covered under Heading 38.22 of the GST Tariff? - HELD THAT:- The reagents of heading 38.22 may also be put up in the form of kits, consisting of other components, even if one or more components when presented separately, would be classifiable under another heading. Examples of such include kits used for testing glucose in blood, etc. - the subject goods are covered under Heading 38.22 of the GST Tariff. Applicability of N/N. 05/2021-Central Tax (Rate) New Delhi, the 14th June, 2021 G.S.R (E) - HELD THAT:- It is seen from Sr. No. 18 of the said notification that the GST rate on Ambulances was reduced from 28% to 12%. Similarly as per Sr. No. 7, the GST rate on certain products, including CRP (C-Reactive Protein), falling under Heading 38.22 has been reduced to 5%. It is clear from the said notification that the rate of GST on CRP (C-Reactive Protein) was reduced to 5% for that particular period only else the rate is higher at 12%. The subject goods are covered under Sche ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... n. When mouse antihuman HbA1c monoclonal antibody is added, latex- HbA1c-mouse antihuman HbA1c antibody complex is formed. Finally agglutination is formed when goat anti-mouse polyclonal antibody reacts with this complex, B. APPLICANTS INTERPRETATION OF LAW AND/OR FACTS 2.3 CRP HbA le clearly classify under Chapter 30 - Drugs or medicines including their salts and esters and diagnostic test kits, specified in list 1 appended to this Schedule - under Notification No.1/2017 dt. 28.06.2017: Schedule-1, Sr. No. 180 (List No. 1, List No. 125). Applicant's Submission dated 16.12.2020:- 2.4 M/s Accurex Biomedical Private Limited is an Indian manufacturer and marketer. Out of the various range of products, for following two products the classification in the tariff i.e. harmonized system of nomenclature (HSN) and GST rate has been sought: 1. Turbilatex C-reactive protein (CRP) infinite 2. HbA1c infinite 2.5 The detailed description of above mentioned product is already been drafted in application for advance ruling i.e. GST ARA-01 and submitted along with principle composition usage guide. Proceedings were conducted on 10th December 2020, in which ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... r: CRP (C-reactive protein): ■ Intended use or purpose of CRP diagnostics kit is for the quantitative determination of reactive protein (CRP) in human serum for medical diagnosis of inflammation and infections. ■ Components of CRP diagnostic kit include CRP Turbi Turbilatex Buffer Reagent, CRP turbi Turbilatex Latex Reagent and CRP Turbi Calibrator Lyoph Serum Vial. Hba1c (hemoglobin A1c): ■ Intended use or purpose of HbA1c diagnostic kit is for the quantitative determination of hemoglobin A1C (HbA1c) in human blood for medical diagnosis and monitoring of glycemic control in diabetic patients. ■ Components of HbA1c diagnostic kit include HbA1c R1 latex reagent, HbA1c R2 buffered antibody reagent and HbA1c calibrator sets made from human blood. 3.3 Contention of the applicant: CRP HbA1c clearly classify under Chapter 30 - Drugs or medicines including their salts and esters and diagnostic test kits, specified in List I appended to this schedule - under Notification No.1/2017 dated 28th June, 2017: Schedule- I, Sr. No 180 (List No 1, Sr. No. 125). HbA1c is based on agglutination principle by antigen-antibody interact ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... rate of tax like Beacon diagnostics Pvt. Ltd. and Tulip Diagnostics (P) Ltd. who levy GST@ 5% on supply of CRP. Otherwise the rest levy 12% of GST on supply of CRP as well as on HbA1c. 3.6 Interpretation of Notification with products supplied: Notification No.1/2017 - Central Tax (Rate) dated 28th June, 2017 notifies the rate of tax of goods specified in Schedule - I, Schedule II, III, IV, V and Schedule VI. Under Schedule 1 - 2.5% Sr.No. Chapter/Heading/Sub-heading/Tariff item Description of Goods 174 3002,3006 Animal or Human Blood Vaccines 180 30 Drugs or medicines including their salts and esters and diagnostic test kits, specified in List 1 appended to this schedules. List 1 appended to the Schedule I- Sr. No. (125) Agglutinating Sera. What is agglutinating? What is principle of agglutination? To agglutinate is to cause to adhere. It's a clump of cells, usually red cells, formed by an immune interaction between surface antigens and antibo ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... e mean daily blood glucose concentration over the preceding two months. Measurement of HbA1c is, therefore, considered to be an important diagnostic tool in the monitoring of dietary control and therapeutic regimes during the treatment of diabetes. Glycated haemoglobin (hemoglobin A1c, HbA1c, A1C, or Hb1c; is also known as HbA1c or HGBA1c) is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods. It is being observed that it is formed in a non-enzymatic glycation pathway by hemoglobin's exposure to plasma glucose. HbA1c is a measure of the beta-N1-deoxy fructosyl component of hemoglobin. HbA1c is defined as hemoglobin which is irreversibly glycated at one or both N-terminal valines of the beta chains (3). HbA1c has been the mostly used and accepted test for monitoring the glycaemic 'control in individuals with diabetes. Once a hemoglobin molecule is glycated, it continues to remain in the red blood cell for the rest of its life-span. A hemoglobin is a red protein responsible for transporting oxygen in the blood of vertebrates. HbA1c is hemoglobin A1c, an important diagnostic too ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ritten and oral contentions made by both, the applicant as well as the jurisdictional/concerned officer at the time of preliminary and final hearings. 5.2 The issue before us is in respect of classification of two products/goods namely, CRP diagnostics kit and HbA1c diagnostics kit. 5.3.1 The applicant is of the view that the said goods are covered under Chapter Heading 3002 of the GST Tariff They have cited Entry No.125 of List 1 of Sr.No 180 of Schedule I of the GST Tariff [notification No.1/2017-Central Tax (Rate), dated 28th June, 2017, as amended from time to time]. 5.3.2 The applicant has also stated that there is an another entry at Sr.No 80 of Schedule II of the GST Tariff [notification No.1/2017-Central Tax (Rate), dated 28th June, 2017, as amended from time to time]whereby the goods mentioned therein have been classified under Chapter Heading 3822 attracting GST @ 12%. 5.4 The jurisdictional officer, in his submissions has opined that both the subject goods are covered under Chapter Heading 38.22 attracting GST @ 12%. 5.5.1 We find that Entry No.125 of List I of Sr.No 180 of Schedule I of the GST Tariff [notification No.1/2017-Central Tax (Rate), dated 28th ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... der HSN Code 38.22. 5.6.4 Further, we refer to Explanatory Note (E) to Chapter Heading 30.02 which is reproduced as under:- (E) Diagnostic kits : Diagnostic kits are classified here when the essential character of the kit is given by any of the products of this heading. Common reactions occurring in the use of such kits include agglutination, precipitation, neutralization, binding of complement, haemagglutination, enzyme-linked immunosorbent assay (ELISA), etc. The essential character is given by that single component which governs to the greatest extent the specificity of the test procedure. 5.6.5 We find that the applicant has not given any submission with respect to the component of the kits which governs to the greatest extent the specificity of the test procedure. 5.6.6 Hence, we find that the subject product cannot be covered under Heading 30.02 of the GST Tariff as contented by the applicant. 5.7.1 We now discuss whether the subject product can be covered under Heading 38.22 of the GST Tariff. Chapter Heading 38.22 and Notes thereunder are reproduced as follows: [38.22 - Diagnostic or laboratory reagents on a backing, prepared diagnostic or laborator ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... s must be clear from their composition, labelling, instructions for in vitro or laboratory use, indication of the specific diagnostic test to be performed or physical form (e.g., presented on a backing or support). With the exception of the products of Chapter 28 or 29, for the classification of certified reference materials, heading 38.22 shall take precedence over any other heading in the Nomenclature]. 5.7.2 From the above we observe that the reagents of heading 38.22 may also be put up in the form of kits, consisting of other components, even if one or more components when presented separately, would be classifiable under another heading. Examples of such include kits used for testing glucose in blood, etc. 5.7.3 We have already held that the subject products are not classifiable under Heading 30.02 and therefore in view of the discussions made above we hold that, the subject goods are covered under Heading 38.22 of the GST Tariff. 5.8.1 Further, we reproduce the relevant provisions of Notification No. 05/2021-Central Tax (Rate) New Delhi, the 14th June, 2021 G.S.R (E) which is as under- In exercise of the powers conferred by sub-section (1) of section 11 o ..... X X X X Extracts X X X X X X X X Extracts X X X X
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