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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 ..... ame provision under the MGST Act. Further to the earlier, henceforth for the purposes of this Advance Ruling, the expression 'GST Act' would mean CGST Act and MGST Act. 2. FACTS AND CONTENTION - AS PER THE APPLICANT The submissions made by the applicant are as under:- CRP: 2.1 Intended use or purpose of CRP diagnostics kit is for the quantitative determination of C-reactive protein (CRP) in human serum for medical diagnosis of inflammation and infections. Components of CRP diagnostics kit include CRP Turbi Turbilatex Buffer Reagent, CRP Turbi Turbilatex Latex Reagent and CRP Turbi Calibrator Lyoph Serum Vial. CRP is based on agglutination principle between latex particles coated with specific anti-human CRP & CRP in the sample. HbA1c: 2.2 Intended use or purpose or HbA1c diagnostics kit is for the quantitative determination hemoglobin Ale (HbA1c) in human blood for medical diagnosis and monitoring of glycaemic control in diabetic patients. Components of HbA1c diagnostics kit include HbA1c R 1 latex reagent, HbA1c R2 buffered antibody reagent and HbA1c Calibrator sets made from human blood. HbA1c is based on agglutination principle by antigen-antibody interaction. When mou ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... is the principle on which CRP & HbA1c works. 2. In the case of M/s Span Diagnostics Ltd V/s Commissioner of Central Excise, it has been stated that:- If one reads Chapter Heading 38.22, it becomes clear that there could be all diagnostic kits or reagents which could fall under Chapter Heading 30.02 and also under Chapter Heading 38.22. However, if a diagnostic or laboratory reagent falls under Chapter Heading 30.02 then it stands excluded from Chapter Heading 38.22. 2.10 Applicant's Interpretation: Since CRP & HbA1c works on the principle of Agglutinating Sera, according to us, products should be classified under heading 3002, chargeable at CGST rate 2,5%. 03. CONTENTION - AS PER THE CONCERNED OFFICER: Officer Submission dated 16.03.2020:- 3.1 M/s Accurex Biomedical Pvt. Ltd. manufactures reagents and sells to various labs. It is a supplier of products/goods. It is registered under GST having GSTIN- 27AACCA3730G171. The reagents are chemicals made up of anti-gene / antibody of mouse/ goat/ non-human etc. 3.2 The applicant has submitted the description of CRP & HbA1c as under: CRP (C-reactive protein): ■ Intended use or purpose of CRP diagnostics kit is for the qu ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... supply of CRP. c) Proton Biologicals India Private Limited: - is registered under GST with GSTIN-29AAGCP5976PIZB in the state of Karnataka & levies GST @12% on the supply of CRP. d) Beacon Diagnostics Pvt. Ltd.:- is registered under GST with GSTIN-24ABCB2080R111 in the state of Gujarat and levies GST @5% on the supply of CRP. e) Shripad Enterprises: - is registered under GST with GSTIN- 27ADTES0066J1ZK in the state of Maharashtra and levies GST @ 12% on supply of CRP. f) Tulip Diagnostics (P) Ltd.:- is registered under GST with GSTIN-30,4AACT1411B1ZH in the state of Goa and levies GST@5% on supply of CRP. The HSN mentioned in Invoice for Turbilyte CRP-100 is 30029090. g) Anand Chemiceutics: - is registered under GST with GSTIN- 27ACHP59796G1ZP in the state of Maharashtra and levies GST@12% on the supply of D10 Dual Reorder Pack (HbA1c). The HSN mentioned in Invoice for D10 Dual Reorder Pack is 3822. 3.5 It appears that few registered persons have confusion over the 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 ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... c test may be used to check for diabetes or pre-diabetes in adults. Pre-diabetes means your blood sugar levels show you are at risk for getting diabetes. If you already have diabetes, an HbA1c test can help monitor your condition and glucose levels. * HbA1c is measured in a latex agglutination inhibition assay. * HbA1c is formed by the non-enzymatic glycation of free amino groups at the N-terminus of the B-chain of hemoglobin Ao. The level of HbA1c is proportional to the level of glucose in the blood. As the glucose remains bound to the red cell throughout its life cycle, measurement of HbA1c provides an indication of the 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 ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... Final hearing was held on 14.09.2021. The Authorized representatives of the applicant, Shri. Anil Sutar, CA and Abhinav Thakur (Director) was present. The Concerned officer Shri Promod Patil DC-E-624 LTU-2 was also present. The Authorized representatives made oral and written submissions in this matter. 4.3 We heard both sides. 05. OBSERVATIONS AND FINDINGS: 5.1 We have gone through the facts of the case, written 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 tim ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... fy their product from HSN Code 38.22 (which is used by them presently) to HSN Code 30.02 not on the basis of any actual evidence but only because some of their competitors are clearing similar goods under HSN Code 30.02. 5.6.3 Further, from the submissions made by the jurisdictional officer we find that there are many more players in the market who are also classifying these goods under 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 ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ading 32.04 or any other substance which, when presented separately, would be classifiable under another heading. Examples of such kits are those for testing glucose in blood, ketones in urine, etc., and those based on enzymes. The reagents of this heading should be clearly identifiable as being for use only as diagnostic or laboratory reagents. This 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 ..... X X X X Extracts X X X X X X X X Extracts X X X X
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