The Maharashtra Appellate Authority for Advance Ruling Authority for Advance Ruling (AAAR) has held that the CRP Test kit and HbA1c are classifiable under the chapter heading 3002, and will attract GST at the rate of 5% (CGST @2.5 % +SGST @2.5 %)
M/s. Accurex Biomedical Private Limited, the assessee engaged in the business of supply of various diagnostic reagents. The Appellant has obtained registration and holds a valid registration certificate issued under CGST Act, 2017.
Out of the various range of products, the Appellant sought to rule in respect of the classification of two products:- (A) Turbilatex CRP Infinite and (B) HbA1c Infinite. Infinite Turbilatex CRP (“CRP Test Kit”) is supplied by the Appellant under the brand name “Infinite”. This product is meant for in-vitro diagnostic use only.
CRP Test Kit is used for the quantitative determination of C-Reactive Protein (CRP) in human serum for medical diagnosis of inflammation and infections.CRP Test kit is based on the agglutination principle between latex particles coated with specific anti-human CRP to determine CRP in the sample. To the naked eye, it is impossible to detect the process of agglutination. That is why, to facilitate easy detection of agglutination, “carriers” were chosen on which the specific antibodies could be coated.
The essential component of the CRP Test Kit is R2 since it contains the antiserum. Around 85% of the total cost of the CRP Test Kit is attributable to component R2. Infinite HbA1c 6.1 Infinite HbA1c is supplied by the Appellant under the brand name “Infinite” or “Auto Pure”. This product is meant for in-vitro diagnostic use only.
The appellant supplies RI and R2 separately in the same kit. (iv) Calibrators are used to analyze patient samples per the instructions outlined in the Accurex HbA1c Reagent package insert by generating a calibration curve. The calibrators should be treated in the same manner as patient specimens for the preparation of hemolysate. The values of calibrators are assigned by assaying against the material referenced to NGSP values.
On application, the Maharashtra Advance Ruling Authority(MAAR) held that the CRP kit and Hb1Ac kit do not fall under HSN code 3002, whereas the same is covered by HSN Code 3822
A Coram comprising of Shri Ashok Kumar Mehta, member (Central Tax) and Shri Rajeev Kumar Mital, member (State Tax) observed that HblAc Test Kit, much like the CRP Test Kit, is also a diagnostic kit having different components such as (i) Latex reagent, (ii) Buffered antibody reagent, (iii) Hemolysis Reagent, and (iv) Optional – Calibrator made from human blood, which works on the same principle of the agglutination as was the case with CRP Test kit. While setting aside the order of MAAR, the MAAAR has held that HbA1c, is very similar to the CRP Test kit, in terms of its constitutionality and functionality and will be classified under the chapter heading 3002, and accordingly, will attract GST at the rate of 5% (CGST @2.5 % +SGST @2.5 %).
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