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2023 (12) TMI 1272

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..... t and UPGST Act respectively). The applicant is engaged in the manufacture of pioneer drugs labelled as 18F-Fluorodeoxyglucose, 18F PSMA, 18 F DOPA and many more Radioactive compounds labelled with F 18. F18 compound are Radioactive isotopes, used as diagnostic reagent, used primarily for diagnosis of cancer. It is also used in cardiology and neurology. As per the applicant, the above mentioned product is classifiable under chapter heading 3006 of the HSN, leviable to GST @ 12% (CGST and SGST both @ 6% each), in terms of entry No 65 of Schedule II of the Notification No 01/2017-CT (Rate), dated 28.06.2017 read with corresponding rate notification issued under UPGST Act, 2017. 3. The applicant has sought advance ruling in respect of the following questions:- i) Whether the F-18 Products would be classified under HSN 30063000, leviable to GST at the rate of 12%, in terms of entry no 65 of Schedule II of the Notification No 01/2017, Central Tax (Rate) issued under Central Goods and services Tax Act, 2017 (CGST Act, 2017) read with corresponding rate notification issued under the provisions of Uttar Pradesh Goods and Services Tax Act (UPGST) Act, 2017, or not? ii) If not, what wou .....

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..... patient, being unmixed products put up in measured doses or products consisting of two or more ingredients which have been mixed together for such uses;' Sub heading 30063000 covers the diagnostic reagents designed to be administered to the patient. Since the term reagent has not been defined in the Tariff, they have placed reliance upon various dictionary definitions. * In the applicant's case FDG/F-18 compounds are synthesized through a chemical process and is used to detect and visualize metabolic activity in various organs and tissues in the human body. FDG is administered to patients as an injectable solution, and it is taken up by cells in the body that require glucose for energy. * The Diagnostic Reagents not designed to be administered on a patient are excluded from the chapter 30 as per the explanatory notes. However the applicant's products are diagnostic reagents which are administered to the patients, the same will fall under tariff heading 30063000. * Classification of product to be done according to entry providing the most specific description. Further it has been held by various judicial forums that if classification is possible based on headings .....

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..... efore, unless a mention is specifically made to such dissimilar provisions, a reference to the CGST Act would also mean a reference to the same provision under the UPGST Act. Further to the earlier, henceforth for the purposes of this Advance Ruling, a reference to such a similar provision under the CGST Act / UPGST Act would be mentioned as being under the 'CGST Act'. 10. We have gone through the submissions made by the applicant and have examined the interpretation submitted by them. At the outset, we find that the issue raised in the application is squarely covered under Section 97(2)(a)of the CGST Act 2017 being a matter related to classification of goods under the provisions of this Act. We therefore, admit the application for consideration on merits. 11. The applicant is engaged in the manufacture of pioneer drugs labelled as 18F-Fluorodeoxyglucose, 18F PSMA, 18 F DOPA and many more Radioactive compounds labelled with F 18. F18 compound are Radioactive isotopes, used as diagnostic reagent, used primarily for diagnosis of cancer. It is also used in cardiology and neurology. As per the applicant, the above mentioned product is classifiable under chapter heading 3006 o .....

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..... eutical products are compounds of the radioisotope 18F. Heading 2844 of the Tariff covers radioactive isotopes and their compounds. 18F-FDG being a compound of the radioisotope 18F, it would fall under the heading 2844. In order to arrive at the correct classification of the product, it is necessary to consider the General Rules for interpretation of the tariff wherein Rule 1 provides that:- GENERAL RULES FOR THE INTERPRETATION OF THE HARMONIZED SYSTEM "Classification of goods in the Nomenclature shall be governed by the following principles: 1. The titles of Sections, Chapters and sub-Chapters are provided for ease of reference only; for legal purposes, classification shall be determined according to the terms of the headings and any relative Section or Chapter Notes and, provided such headings or Notes do not otherwise require, according to the following provisions :.." Hence the Section or Chapter Notes have to be considered before deciding the classification of any product. Products of Chemicals and allied industries are covered under Section VI of the Tariff and the Section Notes provide as follows : SECTION VI-PRODUCTS OF THE CHEMICAL OR ALLIED INDUSTRIES NOTES 1. .....

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..... observed that the Section Note 1(A) specially stipulates that Goods answering to a description in heading 2844 are to be classified in the said heading only. F18 is a radioisotope and Fluorodeoxyglucose (18F-FDG) is a compound. The products being radioactive and compound of the radioisotope 18F, the same merits classification under heading 2844 only although it satisfies the condition mentioned in Chapter 30 i.e diagnostic reagent designed to be administered to the patient. The applicant has also submitted that medicaments are covered under Tariff heading 30 and that the same product has been classified under heading 3006 by some supplies. However, it may be appreciated that the classification of goods are to be guided by the provisions of law and Radioactive chemicals elements and radioactive isotopes are classifiable under ChSh 2844 only and nowhere else. 16. In view of the above discussions, we, both the members unanimously rule as under; RULING i) Whether the F-18 Products would be classified under HSN 30063000, leviable to GST at the rate of 12%, in terms of entry no 65 of Schedule II of the Notification No 01/2017, Central Tax (Rate) issued under Central Goods and services .....

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