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TMI Blog2018 (5) TMI 855X X X X Extracts X X X X X X X X Extracts X X X X ..... in cardiology and neurology, it also exhibits cancer tissues that can be detected by conventional methods, or correct the misdiagnosis of these diseases. 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 - 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 - there is no iota of doubt that the impugned product, a compound of the radioisotope ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... s, 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 the medical cyclotron, as per prescribed regulations of the Atomic Energy Act, 1962. the Atomic Energy (Radiation Protection) Rules, 2004. the Atomic Energy (Safe Disposal of Radioactive Wastes) Rules, 1987 and all applicable safety codes, guides on safety and security i ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... te 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 applicant, suffer with certain anomalies, which has crept in due to non-appreciation of vital facts. 2. The classification informed by the department and as followed by some of the manufacturers of FDG appears to have presided over on the basis of following precinc ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... 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 averment gets legal sanctity, support and substantiation by the following :- 3.1 (i) attention is solicited towards Note 2 of section VI of CETA. 1985. which inter-alia mentions that Subject to Note l above, goods classifiable in heading 3004, 3005, 3006 ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... 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 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 ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ax 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 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 ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... nder-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 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, ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... t the cyclotron. While F-18 is the element produced in the medical cyclotron, it does not however have any clinical usage. Since the primary object of and classification under CETA is to raise revenue based on the relevant classification, resort should not be had, for purpose of classification, to the scientific and technical meaning of the terms and expressions used therein, 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 produ ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... d purpose due to, far example, expiry of shelf-life. (k) appliances identifiable for ostomy use, that is, colostomy, ileostomy and urostomy couches cut to shape and their adhesive wafers or faceplates The medicament or pharmaceutical products used as diagnostic reagents merit classification thus under this Chapter in Sub Heading 3006 3000 because - (a) they are diagnostic reagents designed to be administered to the patient, being unmixed products [as discussed in sr. no. 3 above] put up in measured 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; the ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... 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 purpose. The 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. Ch ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... MRF Ltd v. CCE -1986 (24) ELT 273 (SC), Elson Machines v. CCE 1988 (38) ELT 571 (SC) = 1988 (11) TMI 107 - SUPREME COURT OF INDIA , Madras Fertilizers v. CCE (1994) 69 ELT 625 = 51 ECR 337 (SC) = 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- ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... merit classification in Chapter 28 only. Annexure I statement of facts Point (1 to 3):- No Comments Point (4):- The Applicant was apprised about excisability of the product i.e. FDG on 26.07.2016 at time of recording of statement of Shri Sachin Ashok Salvi, General Manager, Finance of the applicant under Section 14 of Central Excise Act, 1944. In reply to the question as to whether the product i.e. 18F-FDG (Fludeoxyglucose) attracts Central Excise Duty and is classifiable under Chapter Sub Heading 28444000 of CETA 1985, Shri Sachin Ashok Salvi replied that the product FDG is Excisable and attracts Central Excise Duty. Further, the applicant 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 Comment ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... 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. (iv) It is further clarified in HSN under Chapter 2844 that Radioactive isotopes of these same elements obtained artificially (e.g. Be 10,F 18, A1 29, P 32, Mn 54) are however to be considered as isotopes. This clarifies that isotope of element F18 are to be considered as isotope only and the same would be appropriately covered under the definition of Chapter 28444000. Hence, the contention of applicant 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 ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ontention 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):- This office has issued Show Cause Notice to M/s Board of Radiation and Isotope Technology (BRIT) for inter-alia classifying goods including FI 8 under Chapter Sub Heading 2844 and the adjudication of the same is under process. As instructed the copy of Show Cause Notice enclosed herewith. 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 ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... alloys, dispersions (including cermets), 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 ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... 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 18 (USAN and USP), also commonly called fluorodeoxyglucose and abbreviated [18F]FDG. 18F-FDG or FDG. is a radiopharmaceutical used in the medical imaging modality positron emission tomograph ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... edical 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 conditions. 18F-FDG can be used to assess glucose metabolism in the heart, lungs, and brain. FDG-PET can be used for cancer diagnosis, staging and treatment monitoring, especially for Hodge's disease, non Hodge'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 ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... that contains a radiolabel (18F) at the 2' position replacing the hydroxyl group. 18F-FDG is administered intravenously and is used as an assessment of problems with glucose metabolism, especially in the brain, often associated with epilepsy and in cancer. Areas where an increased absorption of 18F-FDG are visible correlate to areas where an increased glucose metabolism is present.b 18F-FDG is distributed around the body similar to glucose and is cleared renally. There are no known contraindications known to 18F-FDG (Figure 10.24). 18F-FDG is the main radioimaging agent used in PET scanning. Examples include studies of heart, where it is used to differentiate between dead and live tissue in order to assess the myocardium. In neurology, it can be used to diagnose dementia, seizure disorders or tumours of the brain. 18F-FDG is generally used to assess the extent of the tumour in a 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 ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ion 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 heading 28.43, 28.46 or 28.52 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 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 and in no other heading of the Nomenclature. GENERAL Note 1. Under the provisions of paragraph (A) of this Note, 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. Thus for example, radioactive sodium chloride and radioactive glycerol f ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ly 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, that is, elements of which the natural isotopic composition has been artificially modified. GENERAL (C) Products which remain classified in Chapter 28, even when they are not separate chemical elements nor separate chemically defined compounds Heading 28.44 - Radioactive elements, radioactive isotopes, or compounds (inorganic or organic) and mixtures containing thes ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... e Nomenclature: (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; 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 lab ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... 0 Name and Symbol Form Use (Diagnostic) Americium 241 Am Encapsulated source In bone mineral analyzer. Cobalt 60 Co and 57 Co Radioactive Vitamin B12 For absence of intrinsic factor (P.A.) or defect in absorption (sprue). Metabolic studies. Fluorine 18 F Sodium fluoride (reactor produced) Bone scan https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3478111/ Fuorine-18 is one of the several isotopes of fluorine that is routinely used in radiolabeling of biomolecules for PET; because of it positron emitting property and favorable half-life of 109.8 min. The biologically active molecule most commonly used for PET is 2-deoxy-2-18F-fluoro-B-D-glucose (18F-FDG), an analogue of glucose, for early detection of tumors......................... 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 ha ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... 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 specifically provided 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. Goods (other than radioactive ores) answering to a description in heading 28.44 or 28.45 are to be classified in those headings and in no other heading of the Nomenclature. The Heading 2844 itself acknowledges the fact that - the radioactive chemical elements and isotopes of the heading 2844 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 d ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... her 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 isotopes and their compounds. 18F-FDG being a compound of the radioisotope 18F, it would fall in this Heading 2844. 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 t ..... X X X X Extracts X X X X X X X X Extracts X X X X
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