TaxTMI 
TaxTMI 
2021 (10) TMI 627
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....a reference to the CGST Act would also mean a reference to the same 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 i....
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....n to GST rate charged. 2.9 Points to be considered for judgment: 1. List 1 to schedule has entry No. 125 "Agglutinating Sera" which 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....
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....4AAHCM1404G1ZZ in the state of Gujarat and levies GST @12% on the sale of CRP. b) ARK Diagnostics Private Limited: - is registered under GST with GSTIN-27AAACA8872F1ZK and levies 12% of GST on 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 pe....
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....ISMS (EXCLUDING YEASTS) AND SIMILAR PRODUCTS. 3822 Diagnostic or laboratory reagents on a backing, prepared diagnostic or Laboratory reagents whether or not on a backing, other than those of heading 3002 or 3006; * What is HbA1c & whether it falls under Head 30 or 38? : - An HbA1c 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 (h....
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....IGST). 04. HEARING 4.1 Preliminary e-hearing in the matter was held on 10.12.2020. Shri. Abhinav Thakur, Shri. Minesh Jambusariya, CA and Sint. Hema Patel, Dy. Finance Manager appeared, and requested for admission of the application. Jurisdictional Officer Shri. Prof-nod Patil, Dy. Commnr., E-624, LTU-2 also appeared. 4.2 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.N....
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....principle of 'Agglutinating Sera'. 5.6.2 From the submissions made by the applicant, we observe that the subject goods are not agglutinating sera by themselves. Rather they are diagnostic kits which may work on the principle of 'agglutinating sera'. The applicant has not helped their own case in as much as they have sought to reclassify 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 assa....
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....or support), impregnated or coated with one or more diagnostic or laboratory reagents, such as litmus, pH or pole-finding papers or pre-coated immune-assay plates. Reagents of this heading may also be put up in the form of kits, consisting of several components, even if one or more components are separate chemically defined compounds of Chapter 28 or Chapter 29, synthetic colouring matter of heading 32.04 or any other substance which, when presented separately, would be classifiable under another heading. Examples of such kits are those for testing glucose in blood, ketones in urine, etc., and those based on enzymes. 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 w....