TaxTMI 
TaxTMI 
2018 (5) TMI 855
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....ut for chemical pharmaceuticals by makers of law ? 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 such 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, a reference to such a similar provision under the CGST Act / MGST Act would be mentioned as being under the "GST Act". 02. FACTS AND CONTENTION - AS PER THE APPLICANT The submissions, as reproduced verbatim, could be seen thus- "ANNEXURE 1 - STATEMENT OF FACTS (1) The Applicant is a company engaged in the business of manufacturing of fludeoxyglucose F 18. also commonly called FDG, radiopharmaceutical used in the medical imaging modality positron emission tomography (PET). The Applicant has secured renewal of the license to operate a medical cyclotron from Atomic Energy Regulatory Board (AERB) for plant located at Plot No D/37-1, TTC MIDC, Turbhe, Navi Mumbai - 400703 (Exhibit "A"). (2) The Applicant currently operates t....
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....e Tax Act, on transition, with registration number as 27AADCN5392G1Z9 and continued to discharge the GST liabilities under the Chapter Heading 2844 4000 till date. (6) There are currently about 15-20 medical Cyclotrons operating in various government and private establishments and closest one of them being operated from Radiation Medicine Centre, B.A.R.C., Tata Memorial Centre Annexe, Mumbai which is operated by the Board of Radiation and Isotope Technology, Department of Atomic Energy, Government of India. The Applicant has come across legal infirmity or mis-appreciation of facts or wrong invocation of statutory provisions or mis-interpretation of law or non-standard approach across the manufacturers for classification of same product FDG under the relevant chapter heading at these various government and private establishments. " ANNEXURE 2 - APPLICANT'S VIEW POINT AND SUBMISSIONS ON ISSUES ON WHICH THE ADVANCE RULING IS SOUGHT 1. "The Classification informed by the department and as followed by some of the manufacturers of FDG, under Chapter Sub-Heading 2844 of the Central Excise Tariff, with regard to medicament and pharmaceutical product manufactured by the applica....
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....classification of FDG on these precincts and further conclusion then that all radiopharmaceutical products (whether ready to use diagnostic or/and therapeutic) as referred to in 2 above and their likes are to be classified under Chapter Subheading 2844 of the Central Excise Tariff Act, 1985, suffers with legal infirmity, mis-appreciation of facts and wrong invocation of statutory provisions. Here, the Applicant would like to bring to your kind notice, the following clarificatory provisions of the Central Excise Statute read with the relevant portions of HSN Explanatory Notes and legal pronouncements by Judiciary, if any, in support of our averment that FDG are pharmaceuticals and shall merit classification under Chapter 30. more precisely under Chapter Sub-headings 3006 3000. To substantiate the above, the Applicant further submit that :- 3.1 It is an established fact that chemicals used as pharmaceuticals can be of inorganic or/and of organic nature. It does not mean therefore that they all shall merit classification under Chapter 28 & 29 only and not under Chapter 30, which has been specifically carved out for chemical pharmaceuticals, by makers of the law. Our above averme....
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....ts) covered by the heading are those administered by Ingestion, Injection, etc. Diagnostic reagents not designed to be administered to the patient (e.g. those for carrying out tests on blood. Urine etc., samples taken from a patient or for use as laboratory reagents) are excluded; they fall in the headings appropriate to the materials of which they are made (e.g. Chapter 28, Chapter 29 or heading 30.02 or 38.22). (c) the FDG (F-18 based injectable products) are meant for organ/tissue imaging. The product is also administered in measured doses to the patients and are used for diagnosis in oncology, neurology and cardiology. Therefore the product need to be classified under CETSH 3006 3000 (Technical literature for FDG is attached as Exhibit B). 5. The Applicant further say that the interpretation of the Applicant also coincides with the interpretation of the Board of Radiation and Isotope Technology (BRIT), Department of Atomic Energy, Government of India who is operating the oldest medical cyclotron in the country at Radiation Medicine Centre, B.A.R.C., Tata Memorial Centre Annexe, Mumbai. The Director of Bhabha Atomic Research Centre is designated chairman of BRIT and Joi....
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....ribed services received under reverse charge. The applicant has only availed the benefit of notification for claiming exemption of service tax since the applicant is engaged in the business of providing healthcare services. 7 Copies of Advance Ruling Application/orders if any obtained under the provisions of Central Excise, Service Tax and Sales Tax and their present status. None 8 Copy of Show Cause Notices / Adjudication orders in respect of Central Excise or Service Tax if any issued during Last Five years. The applicant has not been served with any show cause notices/ adjudication orders. Thyrocare Technologies Limited (Unregistered Dealer), the holding company engaged in the business of production of FDG in earlier financial years have been issued summons u/s 14 of the central excise act and the holding company has complied with the relevant regulations by payment of the applicable duties, with interest and penalty for the period. The applicant has also simultaneously during the course of the proceeding, voluntarily ensured to comply with the provisions of the central excise by payment of the central excise duty, interest and penalty. 9 Cases o....
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....Chapter, which govern entries in that Chapter. The Chapter note prevails over heading of the chapter. For the purpose of classification of FDG if we refer the heading and sub-heading with corresponding section notes and chapter notes then apparently there is no ambiguity or confusion for classification as thus - Sr. N Extracts of the Chapter Note/ Chapter Heading, etc. Our comments 1 SECTION VI - PRODUCTS OF THE CHEMICAL OR ALLIED INDUSTRIES NOTES 1. (A) Goods (other than radioactive ores) answering to a description in heading 2844 or 2845 are to be classified in those headings and in no other heading of this Schedule. (B) Subject to paragraph (A) above, goods answering to a description in heading 2843, 2846 or 2852 are to be classified in those headings and in no other heading of this Section. 2. Subject to Note 1 above, goods classifiable in heading 3004, 3005, 3006, 3212, 3303, 3304, 3305, 3306, 3307, 3506, 3707 or 3808 by reason of being put up in measured doses or for retail sale are to be classified in those headings and in no other heading of this Schedule. The highlighted portion of Section Note 2 implies that those chemical products, which qualif....
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....erein, but to their popular meaning, that is to say the meaning attached to that by those using the product. The applicant has sought guidance of the AAR to seek clarification of the radiopharmaceutical FDG and not that of the artificial radioactive isotope F-18. Anyhow the atomic number of fluorine is 9 and mass number is 18. Now reading both the section notes and chapter notes together, the intention of the legislature is to carve out those chemicals that are used as medicament or pharmaceutical product and include those under Chapter 30. 3 CHAPTER 30- Pharmaceutical Products NOTES 3. for the purposes of heading 3003 and 3004 and of Note 4(d) to this chapter the following are to be treated (a) as unmixed products: (1) unmixed products dissolved in water: (2) all goods of Chapter 28 or 29; and (3) simple vegetable extracts of heading 1302. merely standardised or dissolved in any solvent; (b) as products which have been mixed: (1) colloidal solutions and suspensions (other than colloidal sulphur); (2) vegetable extracts obtained by the treatment of mixture of vegetable materials; and (3) salts and concentrates obtained by evapor....
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....red doses products [as discussed in sr. no. 1 above] or products consisting of two or more ingredients which have been mixed together for such uses [as discussed in the first paragraph of the statement of this letter), as per para 4(d) of notes to Chapter 30. (b) they also meet the criteria of HSN, which states that "the diagnostic reagents (including microbial diagnostic reagents) covered by the heading are those administered by Ingestion, Injection, etc. Diagnostic reagents not designed to be administered to the patient (e.g. those for carrying out tests on blood. Urine etc., samples taken from a patient or for use as laboratory reagents) are excluded; they fall in the headings appropriate to the materials of which they are made (e.g. Chapter 28, Chapter 29 or heading 30.02 or 38.22). (c) the FDG (radiopharmaceutical consisting of F-18 radioactive component - based injectable products) are meant for organ/tissue imaging. The product is also administered in measured doses to the patients and are used for diagnosis in oncology, neurology and cardiology. For deciding whether a product is 'medicament', following principles are relevant - (1) presence of pharmaceutica....
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....first PETCT prototype for clinical evaluation was funded by the NCI and installed at the University of Pittsburgh Medical Center in 1998. The first commercial system itself reached the market by 2001, and by 2004, over 400 systems had been installed worldwide. Now understanding this definitely, the context in which the letter was issued in 1993 apparently differs from the context in which the present application is filed and the clarification is sought from the AAR. Nevertheless as mentioned in our statement above, the products of chemicals and allied industries are classified vide Section VI under Chapter 28 to 38 CETA. Chapter 30 has been specifically carved out for chemical pharmaceuticals, by makers of the law. As sighted in our application and mentioned in the table below, due to the different classification being followed by registered dealers under GST, there is abnormality due to higher rates being charged by the applicant and the same is not in the interest of the ultimate beneficiary, given the general principle that where there are two competitive headings in Tariff, heading beneficial to assessee should be adopted Tariff item Description of Goods Unit IGS....
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.... clarification during the course of the hearing and on the basis of further final submissions vide this letter. Capitalised terms used but not defined herein shall have the respective meanings assigned to them in the respective regulation, notifications and our various submissions filed with the department. " 03. CONTENTION - AS PER THE CONCERNED OFFICER The submission, as reproduced verbatim, could be seen thus- "Question (1) (i):- The product fludeoxyglucose or 'FDG' cannot be classified under Chapter 30063000 as the same is rightly classified under Chapter Sub Heading 28444000. The relevant Section Note of Section VI of Central Excise Tariff Act, 1985 is extracted below 1. (A) Goods (Other than radioactive ores) answering to a description in heading 2844 or 2845 are to be classified in those headings and in no other heading of this Schedule. (B) ...................... 2. Subject to Note 1 above, goods classifiable in heading 3004, 3005, 3006, 3212, 3303, 3304, 3305, 3306, 3307, 3506, 3707 or 3808 by reason of being put up in measured doses or for retail sale are to be classified in those headings and in no other heading of this Schedule. (ii) T....
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....oods manufactured i.e Radioactive chemical elements and radioactive isotopes (Including the fissile or fertile chemical elements and isotopes) under Chapter Sub Heading 28444000. This proves that even the applicant accepted the contention of the department and started classifying their product i.e. 18F-FDG(Fludeoxyglucose) under Chapter 28 to discharge Central Excise Duty at appropriate rate. Point (5):- No Comments Annexure-2 - Applicant's view points and submission on issues on which the advance ruling is sought Point (1 to 2):- No Comments Point (3)(i) Applicant has contended that the Department view of classification of subject goods under chapter sub heading 44 suffers from legal infirmity, mis-appreciation of facts and wrong invocation of statutory provisions. However, the contention applicant is factually incorrect and devoid of any merit and deserves to be dismissed. The applicant relied on Note 2 of Section VI of CETA 1985 in support of his contention. However, Note 2 of Section VI of CETA 1985 has to be read in Juxtaposition and subject to Note 1 of Section VI. It is clear from the contents and detailed explanation of Note 2 given in Section VI Note that t....
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....t regarding classification of their product under Chapter 30 is based on mis-interpretation of Section Note. (v) As per CETA, 1985 read with the relevant portions of Harmonized Commodity Description and Coding System, Vol-I, it is evident that FDG-18 would fall under Chapter Heading 2844 of CETA, 1985 as the product falling under chapter 2844 or 2845 are to be classified in those heading only and no other heading of this schedule. Accordingly, the products falling under Chapter Sub Heading 28444000 merit classification in Chapter 28 only. (c) The Explanatory notes from Harmonized Commodity Description and Coding System. Vol-1, relating to chapter heading 28.44 in para III (c) (2) mentions as under: "(2) Compounds of radioactive isotopes referred to under (III) (B) above Artificial radioactive isotopes and their compounds are used : (a)............................... (b) In medicine, e g for diagnosing or treating certain diseases (cobalt 60. iodine 131, gold 198. phosphorous 32 etc " (c) .................... D) ............................. In view of the specific mention of its use in medicine for diagnostic or treatment purpose in the Explanatory note of c....
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....3. In view of the above submissions the application of M/s Nueclear Healthcare Ltd, Navi Mumbai should be decided by rejecting the contention of the applicant as the subject goods merit classification in Chapter 28." 04. HEARING The case was taken up for hearing on dt.30.01.2018, dt.07.02.2018 and dt.15.02.2018 when Sh. Sachin Salvi (Chartered Accountant) attended and reiterated the contention as made in the written submission that the product be classified under Tariff Heading 3006. Sh. M. V. Gholap, Assistant Commissioner (AC), Belapur GST Division-II attended the hearing on dt.30.01.2018. L. Meena, AC, Belapur GST Division-Ill, the concerned officer and Sh. R. V. Salaskar, Superintendent were present during the hearings on dt.07.02.2018 and dt.15.02.2018. 05 OBSERVATIONS We have gone through the facts of the case. The issue put before us is the classification of the product 'Fludeoxyglucose' or 'FDG'. It has been queried as to whether the impugned product can be classified under Chapter 3006 3000 of the Central Excise Tariff Act, 1985. We have seen the invoices issued by the applicant wherein the product "18F-FDG (Fluorodeoxyglucose)"is mentioned as f....
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....ther than those of sub-headings 2844 10, 2844 20 or 2844 30; alloys, dispersions (including cermets), ceramic products and mixtures containing these elements, isotopes or compounds; radioactive residues 2844 50 00 - Spent (irradiated) fuel elements (cartridges) of nuclear reactors 3006 PHARMACEUTICAL GOODS SPECIFIED IN NOTE 4 TO THIS CHAPTER 3006 10 - Sterile surgical catgut, similar sterile suture materials (including sterile absorbable surgical or dental yarns) and sterile tissue adhesives for surgical wound closure; sterile laminaria and sterile laminaria tents; sterile absorbable surgical or dental haemostatics; sterile surgical or dental adhesion barriers, whether or not absorbable : 3006 10 10 --- Sterile, surgical catgut and similar sterile suture materials (including sterile absorbable surgical or dental yarns) and sterile tissue adhesives for wound closure 3006 10 20 --- Sterile laminaria and sterile laminaria tents, sterile absorbable surgical or dental haemostatics, sterile surgical or dental adhesion barriers, whether or not absorbable 3006 20 00 - Blood grouping reagents 3006 30 00 - Opacifying prepa....
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.... produced for the radiolabelling process with a resultant radiopharmaceutical preparation. Kit for radiopharmaceutical preparation In general a vial containing the non radionuclide components of a radiopharmaceutical preparation , usually in the form of a sterilized, validated product to which the appropriate radionuclide is added or in which the appropriate radionuclide is diluted before medical use. In most cases the kit is a multidose vial and production of the radiopharmaceutical preparation may require additional steps such as boiling, heating, filtration and buffering. Radiopharmaceutical preparations derived from kits are normally intended for use within 12 hours of preparation. • www.aerb.gov.in/index.ohp/english/regulatorv-facilities/radiation-facilities/application-in-medicine/medical-cyclotron Medical Cyclotron - A cyclotron is a machine used to make relatively short lived radioisotopes (radioactive atoms) that can be used for medical imaging and research. • http://news.chinatungsten.com/en/tungsten-information/97193-ti-I2449 Tungsten is used as shielding material in radiation medicine. It always uses tungsten container when transportin....
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....ition emitting radionuclides and their indirectly emitted gamma rays. Radionuclides, the so-called tracers, are introduced to the body as parts of biologically active molecules. PET also uses gamma cameras to detect the internally applied radiation, but in modern scanners, three dimentional images are often achieved with the aid of a CT X-ray scan performed at the same time as part of the same machine, Diagnostic X-ray uses external radiation, which is sent through the body to produce a two-dimensional image, whereas scintography is based on the internal accumulation of radionuclides. 10.4.1.99mTechnetium ............................. 10.4.2 18Fluoride: PET scan Fluorine has the chemical symbol F and atomic number 9 and is the most electronegative element. It belongs to group 17 of the periodic table, the so-called halogens. Fluorine typically exists as a diatomic molecule at room temperature. There are 18 isotopes known of fluorine, but only 1 (19F) is stable. Most of the radioactive isotopes have a very short half-life, mostly <1 min. Only the radioisotope 18F has a longer half-life of around 110 min and is clinically used FIGURE 10.23). 18F is a positron-emi....
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....dneys. Additionally, biological processes other than cancer also include rapid division of cells and can lead to misdiagnosis (Figure 10.25). 10.4.3 67Gallium: PET We have certain inferences from the above that - • Fluorine has the chemical symbol F and atomic number 9 and is the most electronegative element. • 18F is a radioisotope. • 18F is a positron-emitting radioisotope and is used in radiopharmaceutical imaging such as PET scanning. • Two compounds, namely fluorodeoxyglucose (18F-FDG) and derivatives of 18F choline, are under intense clinical investigation and/or use. Thus, it can be seen that Chapter 10 is about "Radioactive Compounds" and 18F-FDG is a compound of the radioisotope 18F. In this background, we see the Customs Tariff Heading 2844 which is for "radioactive CHEMICAL ELEMENTS AND RADIOACTIVE ISOTOPES (INCLUDING the fissile or fertile chemical ELEMENTS AND ISOTOPES) AND THEIR COMPOUNDS; MIXTURES AND RESIDUES CONTAINING THESE PRODUCTS". Thus, the Heading 2844 covers radioactive isotopes and their compounds. 18F-FDG being a compound of the radioisotope 18F, it would fall in this Heading 2844. However, it....
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.... classified in either heading 28 44 or heading 28.45) This paragraph of the Note provides, therefore, that, e.g., silver caseinate is classified in heading 28.43 and not in heading 35.01. and that silver nitrate, even when put up for retail sale ready for photographic use, is classified in heading 28.43 and not in heading 37.07. Note 2. Section Note 2 provides that goods (other than those described in heading 28.43 to 28.46 or 28.52) which are covered by heading 30.04. 30. 05, 30.06. 32.12. 33.03. 33.04. 33.05. 33.06, 33.07, 35.06. 37. 07 or 38.08 by reason of being put up in measured doses or for retail sale, are to be classified in those headings notwithstanding that they could also fall in some other heading of the Nomenclature. For example, sulphur put up for retail sale for therapeutic purposes is classified in heading 30.04 and not in heading 25.03 or 28.02. and dextrin put up for retail sale as a glue is classified in heading 35.06 and not in heading 35.05. • CHAPTER 28-NOTES 6. Heading 28.44 applies only to : (a) Technetium (atomic No. 43), promethium (atomic No. 61), polonium (atomic No.84) and all elements with an atomic number greater than 84; ....
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....ds or products which are "labelled" (i.e., contain molecules with one or more radioactive atoms). Such compounds remain classified in this setting, even when dissolved or dispersed in, or mixed naturally or artificially with, other radioactive or non-radioactive materials. These elements and isotopes are also classified in this heading when in the terms of alloys, dispersions or cermets. ............. Artificial radioactive isotopes and their compounds are used : (a) by industry ............................... (b) In medicine, e.g., for diagnosing or treating certain diseases (cobalt 60, iodine 131, gold 198, phosphorus 32, etc.). (c) In agriculture................. (d) In biology ........... Radioactive isotopes and their compounds are normally put up in the form of powders, solutions, needles, thread or sheets. They are generally contain in glass ampoules, in hollow platinum needles, in stainless steel tubes, etc., which are packed in anti-radiation metal outer containers (generally of lead), the choice of the thickness of which depends on the degree of radioactivity of the isotopes. In accordance with certain international agreements, a special label must th....
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....tic agents, but their use, by some way, is essential either to control the reaction process or to provide the necessary conditions for the systematic analysis. Beside the organic reagents used, dyes and stain are an important class of diagnostic agents especially for quantitative determination by colorimetry, which is now the best tool for diagnosis. Radioactive tracers are extensively used in routine clinical diagnosis. Important examples are. studies of the functioning of thyroid gland and to locate the exact site of the tumors of brain by using radioactive iodine, studies of blood circulation time using radioactive sodium and chromium, studies of obscure anaemias and other blood disorders using radioactive iron and studies of important body functions such as digestion, metabolism and excretion. The functioning of different parts and organ systems of the body such as the liver, the kidneys, etc. is also studied by using radioactive isotopes, thus enabling the diagnosis of different disease states. Broadly, we can divide the various compounds used as diagnostic agents into four major classes as : A. Inorganic and organic compounds used directly. B. Dyes and stains specifi....
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....y used for PET is 2-deoxy-2-,8F-fluoro-P-D glucose (18F-FDG), an analogue of glucose, which is used for early detection of tumors [29-31] and assessment of response to cancer therapy [24.26] Although 18F-FDG is the most common PET tracer, other 18F-labeled molecules are also used in PET imaging of tumor proliferation [42-34], herpes simplex virus-1 thymidine kinase (HSV 1-tk) gene expression [35-38]. and many receptor-ligand interactions [39-42]. The nucleophilic radiofluorination reaction has been used to synthesize many compounds, including 18F-FDG (figure 3A) [29], Given the popularity and wide use of 18F-FDG, this compound has been synthesized using both nucleophilic and electrophilic reactions • http://www.nueclear.com/net-ct/ - WEBSITE OF THE APPLICANT The radioisotope 118F in the 18 F - FDG / Sodium Fluoride has a very short half-life of 110 minutes. During short-supply or no supply of this drug, it is likely that few or all scheduled appointments may have to be cancelled or altered. We have referred to many an informative articles to understand the dispute at hand. We have seen above that 18F is a radioisotope AND fluorodeoxyglucose (18F-FDG) is a comp....
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....not designed to be administered to the patient (e.g. those for carrying out tests on blood. Urine etc., samples taken from a patient or for use as laboratory reagents) are excluded; they fall in the headings appropriate to the materials of which they are made (e.g. Chapter 28, Chapter 29 or heading 30.02 or 38.22). While relying on the above, the applicant seems to ignore the inherent differentiation as has been laid down in the HSN (HSN forms the basis for Customs Tariff) and which is - • General Note 1 of Section VI [products or the chemical or allied industries] provides that all radioactive chemical elements and radioactive isotopes, and compounds of such elements and isotopes (whether inorganic or organic, and whether or not chemically defined), are classified under heading 28.44, even though they could also fall under some other heading of the Nomenclature. • General Note 2 of Section VI [products of the chemical or allied industries] provides that goods (other than those described in heading 28.43 to 28.46 or 28.52) which are covered by heading 30.04, 30. 05, 30.06, 32.12, 33.03, 33.04, 33.05, 33.06, 33.07, 35.06, 37. 07 or 38.08 by reason of bei....
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....e are convinced in our view that the impugned product merits classification in Heading 2844. In view of the deliberations held hereinabove, we answer the questions thus - Question 1 Whether the product 'Fludeoxyglucose' or 'FDG' can be classifiable under Chapter 3006 3000 of the Central Excise Tariff Act, 1985? The product 'Fludeoxyglucose1 or 'FDG' is not classifiable under Chapter 3006 3000 of the Central Excise Tariff Act, 1985 or the Customs Tariff Act, 1975 (51 of 1975). Question 2 Whether chemicals used as pharmaceuticals that are inorganic or/ and of organic nature shall merit classification only under Chapter 28 & 29 and not under Chapter 30 which has been specifically carved out for chemical pharmaceuticals by makers of law? It needs to be observed herein that the classification of every product is distinct. A product is to be classified as per the Tariff, Rules of interpretation and other provisions in respect of classification as applicable. The question is of a very general nature and is not for classification of any specific product. In view thereof, this question cannot be entertained under the provisions of section 98 ....