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Turbilatex C-reactive protein (CRP) infinite & HbA1c infinite classifiable under Heading 38.22

Case Law Details

TaxGuru Citation
2021 taxguru.in 2551
Case Name
In re Accurex Biomedical Private Limited (GST AAR Maharashtra)
Date of Judgement/Order
Only available for paid members
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In re Accurex Biomedical Private Limited (GST AAR Maharashtra)

Question: – HSN Classification and GST rate to be charged on below products:

1. Turbilatex C-reactive protein (CRP) infinite

2. HbA1c infinite

Answer:- The said products are classifiable under Heading 38.22 and under Sr.No 80 of Schedule II of the Notification No. 1/2017 – Central Tax (Rate) dated 28th June, 2017 attract GST @ 12% (6% each of CGST and SGST/UTGST or 12% IGST)

Read AAAR Order- CRP Test Kit & HbA1c Test kit classifiable under chapter heading 3002

FULL TEXT OF THE ORDER OF AUTHORITY OF ADVANCE RULING, MAHARASHTRA

PROCEEDINGS

(Under section 98 of the Central Goods and Services Tax Act, 2017 and the Maharashtra Goods and Services Tax Act, 2017)

The present application has been filed under Section 97 of the Central Goods and Services Tax Act, 2017 and the Maharashtra Goods and Services Tax Act, 2017 [hereinafter referred to as “the CGST Act and MGST Act” respectively ] by M/s. Accurex Biomedical Private Limited, the applicant, seeking an advance ruling in respect of the following questions.

HSN Classification and GST rate to be charged on below products:

1. Tar bilatex C-reactive protein (CRP) infinite

2. HbAlc infinite

At the outset, we would like to make it clear that the provisions of both the CGST Act and the MGST Act are the same except for certain provisions. Therefore, unless a mention is specifically made to any dissimilar provisions, 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 haemoglobin A1c (HbA1c) in human blood for medical diagnosis and monitoring of glycaemic control in diabetic patients. Components of HbA1c diagnostics kit include HbA1c R1 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 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. APPLICANT’S INTERPRETATION OF LAW AND/OR FACTS

2.3 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 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 (F1SN) 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 we were requested to reframe the question.

2.6 M/s Accurex Biomedical Private limited, would like to reframe the question as follows:

HSN Classification and GST rate to be charged on below products may be provided:

1. Turbilatex C-reactive protein (CRP) infinite

2. HbA1c infinite

2.7 As per Notification “01/2017-central tax rate diagnostic kits & reagents are classified in schedule 1 serial no. 180 heading 3002 as well as in schedule II serial no.80 heading 3822. The extract of the schedule read as

Schedule I serial no. 180 heading 3002:- Chargeable at CGST Rate 2.5% Drugs or medicines including their salts and esters and diagnostic test kits, specified in list 1 appended to schedule

Schedule II serial no.80 heading 3822:- Chargeable at CGST Rate 6% All diagnostic kits & reagent

2.8 Due to multiple classifications possible, the trade industry at large, classify the above mentioned products in different schedule and charge GST rate accordingly. Therefore we would like to opt for correct classification in order to settle the questions raised to us by various vendors in relation 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 I leading 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 & HbAlc as under:

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 Ale):

> Intended use or purpose of HbA1c diagnostic kit is for the quantitative determination of hemoglobin AIC (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:

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