2018 (5) TMI 855 – AUTHORITY FOR ADVANCE RULING – MAHARASHTRA – 2018 (12) G. S. T. L. 497 (A. A. R. – GST) – Classification of goods – Fludeoxyglucose or 'FDG' – classifiable under Chapter 3006 3000 of the Central Excise Tariff Act, 1985 or otherwise – 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? – rules of interpretation.
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Held that: – Fluorodeoxyglucose is a fluoro derivative of 2-deoxyglucose, usually referred to as 18F-FDG or FDG. FDG is most commonly used in positron emission tomography (PET) medical imaging equipment. After injecting FDG into the patient, the PET scanner can construct an image that reflects the distribution of the FDG in vivo. Then, the nuclear medicine physician or radiologist evaluates these images to make a diagnosis of various medical health conditio
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uation is 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”. Heading 2844 covers compounds of radioactive isotopes – there is no iota of doubt that the impugned product, a compound of the radioisotope 18F, is covered by the Heading 2844.
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Even if the compounds of radioactive isotopes may have uses in medicine, they fall in Heading 2844 only. We very determinedly feel that we need not enter into any discussion or any case law as to what would be a medicament and the properties thereof.
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The Tariff item 28444000 reads “Radioactive elements and isotopes and compounds other than those of sub-heading 2844 10, 2844 20 or 2844 30; alloys, dispersions (including cermets), ceramic products and mixtures containing these elements, isotopes or compounds; radioactive residues”. Hence, the impugned product would fall in the
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t;] by Nueclear Healthcare Limited, the applicant, seeking an advance ruling in respect of the following questions : Whether the product 'Fludeoxyglucose' or 'FDG ' can be classifiable under Chapter 3006 3000 of the Central Excise Tariff Act, 1985 ? 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 ? 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
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G and directives/ other applicable regulatory documents issued by AERB from time to time. (3) The Applicant conducts series of prescribed scientific processes at the medical cyclotron to manufacture a radiopharmaceutical called as Fludeoxyglucose (18F), or fludeoxyglucose F 18. also commonly called fluorodeoxyglucose and abbreviated [18F]FDG, 18F-FDG or FDG (hereinafter referred to as "18F-FDG" or "FDG"). The details of the product FDG, the synthesis/ manufacturing procedure, mechanism of action, metabolic end-products, and metabolic rate, distribution, production and application thereof is mentioned in a separate note as sourced from WIKIPEDIA (Exhibit "B"). The Applicant currently manufactures only FDG and no other product at the medical cyclotron facility. (4) The Applicant currently manufactures and dispatches the labelled 18F-FDG compound in measured doses of ordered mCi (unit of measurement) into individual sterile vials for administering to the sche
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visions of the Central Excise Act. The Applicant has obtained registration under Goods and Service 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
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or organic, of these elements or isotopes, whether or not chemically defined, whether or not mixed together; (d) alloys, dispersions (including cermets), ceramic products and mixtures containing these elements or isotopes or inorganic or organic compounds thereof and having a specific radioactivity exceeding 74 Bq g (0.002 micro uci g): (e) spent (irradiated) fuel elements (cartridges) of nuclear reactors; (j) radioactive residues whether or not usable. The term ''isotopes", for the purposes of this Note and of the wording of headings 2844 and 2845. refers to: (i) individual nuclides, excluding, however, those existing in nature in the monoisotopic state; (ii) mixtures of isotopes of one and the same element, enriched in one or several of the said isotopes, that is, elements of which the natural isotopic composition has been artificially modified; – Section Note 1A of Section VI – Goods (other than radioactive ores) answering to a description in heading 2844 or 2845 are to
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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 averment gets legal sanctity, support and substantiation by the following :- 3.1 (i) attention is solicited towards Note
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heading and in no other heading of this Schedule 3.2 (iii) to support the fact that FDG are put up in measured doses and are supplied in packings for therapeutic or prophylactic use, the Applicant hereby submits the following documents for your kind perusal. – "Exhibit C" – I/II/III indicate sample copies of our invoices indicating that sale of such pharmaceutical products are made to hospitals or such institutions for medicinal purpose. 4 The Applicant further say that the FDG shall be reclassified and shall attract classification as 3006 3000 (diagnostic reagents designed to be administered to the patients). This is because the product meet the requirement as stated at 3.2 (i) & 3.2(ii) above for being classified under Chapter 30. – the diagnostic radiopharmaceuticals merit classification under Chapter Sub-heading 3006 3000 because – (a) they are diagnostic reagents designed to be administered to the patient, being unmixed products put up in measured doses or products
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ture 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 Joint Secretary (I&M), Department of Atomic Energy are amongst the designated members of BRIT. Enclosed as Exhibit D is the tax invoice issued by BRIT for selling of FDG to their client categorising FDG under classification as 3006 3000. Capitalist term used but not defined herein shall have the respective meanings assigned to them in the HSN, the CETSH and our various submissions/returns filled with the department Additional requirement for hearing scheduled on 30.01.2018 1 Registration No, of Central Excise or Serv
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Based on the same the product FDG was classified under the relevant classification and tariff heading -Radioactive chemical elements & Radioactive isotopes Rate of tax – 12.50% Benefits availed – The applicant has not availed any benefit, other than the exemption to SSI unit till the turnover has not exceeded the prescribed exemption limit. 6 a) Classification of Service/Services as applicable, b) Rate / Rates of Service Tax as applicable to services provided. c) Details of benefits of Notification of Service Tax availed. The applicant is engaged in the business of providing healthcare services for diagnosis of cancer. The applicant has registered as service recipient under the relevant provisions of the Service Tax and complying with the payment of tax at the prescribed rates for the prescribed 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 pr
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e / Service Tax if any booked during Last Five years. There are no any such violations of central excise/ service tax provision by the applicant apart from the mentioned above, and the Applicant has already complied with relevant provisions of the central excise by payment of duty, interest and penalty as per the direction of the Superintendent (Prev.), Central Excise, Belapur. Additional submission dt.09.02.2018 "Any PET-CT imaging, primarily needs a "radiopharmaceutical". The radiopharmaceutical typically comprises of two components, one a "radioisotope" and another a "pharmaceutical" or a drug or a ligand. In a medical cyclotron facility, the first operation always involves the production of a radioisotope, like in our case, F-18. This radioisotope as such does not have any clinical application unless it is formulated and incorporated into a pharmaceutical for the synthesis of a radiopharmaceutical, which is Fluorodeoxyglucose or Fludeoxyglucose an
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for medical treatment are specifically covered under Chapter 30 of the Section VI. Now with reference to the classification of the product Fludeoxyglucose (18F) (the "FDG") we wish to further state as under-Rules for interpretation of Schedules to Tariff are given in the Tariff itself. These are terms as 'General Interpretative Rule (GIR). The chapter notes are given at the beginning of each 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
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ganic chemicals, organic or inorganic compounds of precious metals, of rare-earth metals, of radioactive elements or of isotopes NOTES 6. Heading 2844 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: (b) natural or artificial radioactive isotopes (including those of the precious metals or of the base metals of Sections XIV and XV), whether or not mixed together; (c) compounds, inorganic or organic, of these elements or isotopes, whether or not chemically defined, whether or not mixed together; (d) alloys, dispersions (including cermets), ceramic products and mixtures containing these elements or isotopes or inorganic or organic-compounds thereof and having a specific radioactivity exceeding 74 Bq/g (0.002 micro uci g); (e) spent (irradiated) fuel elements (cartridges) of nuclear reactors; (f) radioactive residues whether or not usable. The term "isotopes ", for the pur
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g 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
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statics; sterile surgical or dental adhesion barriers, whether or not absorbable: (d) opacifying preparations for X-ray examinations and diagnostic reagents designed to be administered to the 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; (e) blood-grouping reagents: (f) dental cements and other dental fillings; hone reconstruction cements; (g) first-aid boxes and kits; (h) chemical contraceptive preparations based on hormones, on other products of heading 2937 or on spermicides, (i) gel preparations designed to be used in human or veterinary medicine as a lubricant for parts of the body for surgical operations or physical examinations or as a coupling agent between the body and medical instruments; and (j) waste pharmaceuticals, that is, pharmaceutical products which are unfit for their original intended purpose due to, far example, expiry of shelf-life. (k) appliances identifiabl
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rine 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 pharmaceutical ingredients that have therapeutic or prophylactic or curative properties is relevant and proportion of medicaments is not decisive (2) even if a product is sold without a prescription of medical practitioner, it may be medicament (3) people who actually use such product must understand it to be medicament and (4) its primary' function must be 'cure' and not 'care
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distribution is shared with us. For purpose of uniform interpretation of US, the WCO has published detailed Explanatory Notes to various headings/ sub-headings. WCO in its various committees discussed classification of individual products and gives classification opinion on them. Such information is not binding in nature and only provides a useful guideline for classifying goods. The opinion vide circular bearing reference no TAR/W/87 dated 21 June 1993 is issued of about more than 25 years ago and since then the regulation, trade and tariff has undergone significant changes also the relevant letter is not accompanying Harmonized System Committee documents and reports and due to which evidently it would be difficult to understand as to classification questions currently under consideration. As explained in Annexure 1 to our application, the FDG manufactured by the applicant is administered to the scheduled cancer patients at the respective PETCT scanning facilities and for no other pur
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timate 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 IGST Rate after transition to GST 2844 40 00 Radioactive elements and isotopes and compounds other than those of sub-heading 2844 10, 2844 20 or 2844 30; alloys, dispersions (including cermets), ceramic products and mixtures containing these elements, isotopes or compounds; radioactive residues kg. 18% 3006 30 00 Opacifying preparations for X-ray examinations; diagnostic reagents designed to be administered to the patient, being unmixed products put up in measured doses or products consisting of two or more ingredients which have been mixed for such uses kg. 12% Lastly, during the course of the hearing reference was also made as to classification and payment being followed by the applicant till this date and no protest being filed during the course of the investigation too. We wish to state thereo
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= 1994 (1) TMI 85 – SUPREME COURT OF INDIA . The applicant and the parent company of the applicant has paid duty during investigation before issue of show cause notice due to coercion and to avoid any litigations. The amount deposited during investigation is deemed to have been paid under protest and therefore that shall not be considered a ground either to decide or dismiss this application. In the circumstance, to clear the ambiguity, we sincerely request the AAR to pass an appropriate order based on our application, the submissions subsequent, the 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
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ontaining these elements, isotopes or compounds; radioactive residues" (iii) The product fludeoxyglucose -FI8 manufactured by Applicant is a Radioisotope obtained artificially through Cyclotron machine and answers to the description under Chapter Sub Heading 28444000. (iv) It is clear from the contents and detailed explanation of Note 2 given in Section VI above that the goods mentioned in Note 1 (A) i.e goods falling under Chapter 2844 or 2845 will not be classified under any other heading irrespective of the products being put up in measured doses or for retail sale. Hence, the product falling under chapter 2844 or 2845 are to be classified in those headings only and no other heading of the Schedule. Accordingly, the products falling under Chapter Sub Heading 28444000 will merit classification in Chapter 28 only. Question (2) – It is clear from the contents and detailed explanation of Note 2 given in Section VI above that the goods mentioned in Note 1 (A) i.e goods falling under
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plicant in their application dated 02/08/2016 for Central Excise Registration (Form A-1) has also classified their excisable goods 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
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, dispersions (including cermets), ceramic products and mixture containing these elements, isotopes or compounds, radioactive residues" (iii) Further Shri Sachin Ashok Salvi. General Manager. Finance also admitted in his statement dated 26.07.2016 that the product "fludeoxyglucose -F18 manufactured by Applicant is a Radioisotope obtained artificially through Cyclotron machine. He further admitted that their product i.e. FDG is excisable and attract Central Excise Duty. From the reading of Chapter Sub Heading 28444000 read with Section Note 2 of Section VI that the product manufactured by the applicant will be rightly classifiable under Chapter 28444000 and not under any other Chapter heading in terms of Note 1(A) of Section VI of CETA 1985 It is clear from the contents and detailed explanation of Note 2 given in Section VI that the goods mentioned in Note 1 (A) i.e goods falling under Chapter 2844 or 2845 will not be classified under any other heading irrespective of the prod
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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 chapter subheading 2844 of Harmonized Commodity Description and Coding System, the applicant's clai
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clearly stated that Chapter I heading 2844 and 2845 covers not only isotopes in their pure state but also chemical elements whose natural isotopic composition has been artificially modified by enriching the elements in some of their isotopes or by converting through a nuclear reaction, some isotopes into other, artificial isotopes. Radioisotopes of these same elements obtained artificially (e.g..Be 10, F 18, AI 29, P 32, Mn 54) are however to be considered as isotopes. (ii) In support of Revenue's contention that Fludeoxyglucose F 18 (FDG) is classifiable under Chapter Sub-Heading 28444000, please find enclosed herewith classification decision of International Non Proprietary Name (INN) Substances agreed by the Harmonized System Committee of General Agreement on Tariff & Trade ( Now World Trade Organization i.e. WTO) for consideration. (iii) In view of the above, the products Fludeoxyglucose F 18 (FDG) is classifiable under Chapter Sub Heading 28444000 of CETA. 1985. (5):- Thi
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sent 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 falling under the HSN Code of 28444000 and attracting GST @18%. The applicant has also submitted the invoice issued by the Board of Radiation and Isotope Technology wherein the product "FDG 18" is shown as falling under HSN Code 30063000" and attracting GST @12%. The reason to mention the aforesaid is the applicant's humble plea during hearing to clear the controversy surrounding the classification so as to have a uniform tax discharge by all dealing with the said commodity. However, it
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, ceramic products and mixtures containing uranium enriched in U235, plutonium or compounds of these products 2844 30 – Uranium depleted in U235 and its compounds; thorium and its compounds; alloys, dispersions (including cermets), ceramic products and mixtures containing uranium depleted in U 235, thorium or compounds of these products : 2844 30 10 Uranium depleted in U235 and thorium and their alloys, unwrought or wrought and compounds thereof Compounds of thorium or of uranium depleted in U235 2844 30 21 Thorium oxide 2844 30 22 Thorium hydroxide 2844 30 23 Thorium nitrate 2844 30 29 Other 2844 30 30 Waste and scrap of uranium depicted in U235 or of thorium 2844 30 90 Other 2844 40 00 – Radioactive elements and isotopes and compounds other 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 elem
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ts and other dental fillings; bone reconstruction cements 3006 50 00 – First-aid boxes and kits 3006 60 – Chemical contraceptive preparations based on hormones, or other products of heading 2937 or on spermicides: 3006 60 10 Based on hormones 3006 60 20 Based on other products of heading 2937 3006 60 30 Based on spermicides 3006 60 70 – Gel preparations designed to be used in human or veterinary medicine as a lubricant for parts of the body for surgical operations or physical examinations or as a coupling agent between the body and medical instruments – Other: 3006 91 00 – Appliances identifiable for ostomy use 3006 92 00 – Waste pharmaceuticals To understand which of the Headings would cover the impugned product, we need to understand the product and the principles of interpretation. The applicant has preferred to refer to Wikipedia to explain us the impugned product. We see thus – https://en.wikipcdia.org/wiki/Fludeoxyglucose (18F) Fludeoxyglucose (18F) (INN), or fludeoxyglucose F
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r used for production of a radiopharmaceutical preparation. Radiopharmaceutical precursor A radionuclide 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 r
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odge's lymphoma, colorectal cancer, breast cancer, melanoma, and lung cancer. In addition, FDG-PET also has been used for the diagnosis of Alzheimer's disease. In the field of nuclear medicine, compound 18F-FDG, besides its important use in cardiology and neurology, it also exhibits cancer tissues that can be detected by conventional methods, or correct the misdiagnosis of these diseases. Essentials of Inorganic Chemistry: For Students of Pharmacy. Pharmaceutical Sciences and Medicinal Chemistry by KATJA A. STROHFELDT – Chapter 10 Radioactive Compounds and Their Clinical Application 10.2 Radiopharmacy: dispensing and protection Radiopharmacy deals with the manufacture and dispensing of radioactive materials that are used as radioactive medicines (or better known as radiopharmaceuticals). Radiopharmaceuticals can be used as diagnostic or therapeutic tools. Radionuclides that are used for a diagnosis should have as little an impact as possible on the health of the patient. 10.4 R
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me 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-emitting radioisotope and is used in radiopharmaceutical imaging such as PET scanning. Two compounds, namely fluorodeoxyglucose (18F-FDG) and derivati
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cancer patient. Cancerous tissue is characterised by increased cell proliferation, which requires energy, and therefore an increased amount of glucose. This leads to an accumulation of 18F-FDG in malignant tumours and allows judging the degree of metastasis formed. This information is important for any surgical procedure and also for the initial assessment of the cancer stage. Unfortunately, there are limitations to the use of 18F-FDG, as its uptake is not very specific. As a result, other conditions can also cause an accumulation of 18F-FDG and can lead to misdiagnosis. These conditions include inflammation and healing of wounds, which also show increased glucose metabolism. Therefore, a variety of other 18F-labelled compounds are under intense scrutiny as alternative PET scanning agents, mainly compounds with a more specific biological pathway. This includes 18F-choline. Choline is a compound incorporated into the cell membrane and therefore cells dividing at a fast rate have an inc
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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 has been argued that the impugned product being a chemical pharmaceutical, falls in the Heading 30.06. Since the whole gamut of the arguments revolve around the Harmonized Commodity Description and Coding System Explanatory Notes (HSN), we may now look at the relevant portion of the said Notes thus – SECTION VI – PRODUCTS OF THE CHEMICAL OR ALLIED INDUSTRIES NOTES 1. (A) Goods (other than radioactive ores) answering to a description in heading 28.44 or 28.45 are to be classified in headings and in no other heading of the Nomenclature. (B) Subject to paragraph (A) above, goods answering to a description in
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n heading 28.44. It should be noted, however, that radioactive ores are classified in Section V of the Nomenclature. In the case of non-radioactive radioactive isotopes and their compounds, the Note provides that these (whether inorganic or organic, and whether or not chemically defined) are classified in heading 28.45 and not elsewhere in the nomenclature docs the isotope of carbon is classified under heading 28.45 and not under heading 28.03. Paragraph (B) of the Note provides that goods described in heading 28.43. 28.46 or 28.52 are to be classified under whichever of those headings of those headings is appropriate and under no other heading in Section VI. provided always they are not radioactive or in the form of isotopes (in which case they are 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
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precious metals or of the base metals of Sections XIV and XV), whether or not mixed together; (c) Compounds, inorganic or organic, of these elements or isotopes, whether or not chemically defined, whether or not mixed together; (f) Radioactive residues whether or not usable. The term "isotopes", for the purposes of this Note and of the wording of headings 28.44 and 28.45, refers to: – individual nuclides, excluding, however, those existing in nature in the monoisotopic state; – mixtures of isotopes of one and the same element, enriched in one or several of the said isotopes, that is, elements of which the natural isotopic composition has been artificially modified. The term "isotopes", for the purposes of this Note and of the wording of headings 28.44 and 28.45, refers to: – Individual nuclides, excluding, however, those existing in nature in the monoisotopic state; – Mixtures of isotopes of one and the same element, enriched in one or several of the said isotopes,
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their compounds; Mixtures and residues containing these products ……………………… (C) Radioactive compounds; mixtures and residues containing radioactive substances The radioactive chemical elements and isotopes of the present heading are often used in the form of compounds 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…..
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or more ingredients which have been mixed together for such uses; HEADING 30.06 – NOTES (6) Opacifying preparations for X-ray examinations and diagnostic reagents designed to be administered to the 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. The opacifying preparations are used in X-ray examination of internal organs, arteries, veins, urinary passages, bile duct, etc. They are based on barium sulphate or other substances opaque to X-rays and may be put up for injection of for oral administration (e.g.. barium meal). 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 headi
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alysis. 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 us
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rs……………………. based on information from the Isotopes of Fluorine Wikipedia page [20], fluorine has several isotopes. 19F, 18F. 17F. 20F, and 21F. Except For 19F, these isotopes are radioactive and have very short half-lives, especially 17F, 20F and 21F. 19F and 18F are used by the scientific community, especially 18F, which has a half-life of 109.8 min. 18F emits a positron that collides with an electron which is called an "annihilation reaction'' and produces two photons with 511 Kev (gamma radiation) 180° apart [21 22] Because of its short half-life and positron emission, 18F is widely used in molecular imaging of biological and biochemical processes, including early detection of many diseases and assessment of treatment response by positron emission tomography (PET) [24-34]. PET is a nuclear medicine imaging technique that produces a three-dimensional image of functional processes in the body [27,28]. The system detects pairs of gamma rays emitted indi
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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 compound. And since all point to the impugned product being a compound of the radioisotope 18F, the Tariff Heading which covers the situation is 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". Heading 2844 covers compounds of radioactive isotopes. And it has been spec
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, e.g., for diagnosing or treating certain diseases (cobalt 60, iodine 131, gold 198, phosphorus 32, etc.). The applicant has informed that the impugned product is transported in specialised shielded tungsten containers. Articles from the Internet also reveal that radioactive isotopes and the compounds are packed in anti-radiation metal outer containers. In view of all above, we do not have an iota of doubt that the impugned product, a compound of the radioisotope 18F, is covered by the Heading 2844. We see that the applicant's argument revolves around the point that – A chemical pharmaceutical, falls in the Heading 30.06. Heading 3006 covers diagnostic reagents. 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
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ing 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. While reading this Note, we cannot forget the words in the bracket and which are "other than those described in heading 28.43 to 28.46 or 28.52". Here also, exception is made to goods falling in Heading 28.44. Therefore, even if the compounds of radioactive isotopes may have uses in medicine, they fall in Heading 2844 only. We very determinedly feel that we need not enter into any discussion or any case law as to what would be a medicament and the properties thereof. 18F-FDG is a radioactive compound (Essentials of Inorganic Chemistry: For Students of Pharmacy, Pharmaceutical Sciences and Medicinal Chemistry' by K.ATJA A. STROHFELDT – Chapter 10 – Radioactive Compounds and Their Clinical Application) and We are guided by the Notes which unambiguously make it clear that – Heading 2844 covers radioactive
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point that certain other supplier is classifying the impugned product as falling in Chapter 30 (Heading 30.06). With regard to this, we feel that it would have to be appreciated that classification is based on the applicable provisions and not on treatment by suppliers of similar goods. In the present proceedings, we remain unaffected by any mis-classification. For the present, we 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
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