In Re : Nueclear Healthcare Limited
GST
2018 (5) TMI 855 – AUTHORITY FOR ADVANCE RULING – MAHARASHTRA – 2018 (12) G. S. T. L. 497 (A. A. R. – GST)
AUTHORITY FOR ADVANCE RULING – MAHARASHTRA – AAR
Dated:- 21-2-2018
GST-ARA-02/2017/B- 06
GST
Shri B.V. Borhade, Joint Commissioner of State Tax and Shri Pankaj Kumar, Joint Commissioner of Central Tax
PROCEEDINGS
(Under section 98 of the Maharashtra Goods and Services Tax Act, 2017
The present application has been filed under section 97 of the Central Goods and Services Tax Act, 2017 and the Maharashtra Goods and Services Tax Act, 2017 [hereinafter referred to as the CGST Act and MGST Act”] 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
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cal 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 issued by AERB for the manufacturing/ handling of FDG 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
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B and operated by the Applicant, by-adhering to the stipulated safe transport regulation, in specialised shielded tungsten containers.
(5) The Applicant has obtained registration under the erstwhile provisions of Central Excise Act, Maharashtra Value Added Tax Act and the Central Sales Tax Act, as assesse/ dealer for the nature of business as 'manufacturer' and has paid the applicable duties/ taxes. The Applicant has been informed during the course of the excise proceedings that the product FDG is a keen to Chapter Heading 2844 4000 and the Applicant has accordingly discharged the duty payable as per the provisions 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
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l 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 precincts under Chapter Sub-Heading 2844, which inter-alia states that :
Chapter Note 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 (cart
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cially 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 l8, Al 29, P 32. Mn 54) are however to be considered as isotopes;
3. The 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 sha
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Chapter 30, “for the purpose of headings 3003 and 3004 and of Note 4(d) to this Chapter, all goods of Chapter 28 or 29; are to be treated as unmixed products”.
This clearly implies that those chemical products, which qualify to be classified under Chapter 30 (Heading 3004 etc.) are not required to be classified as chemical under Chapter 28 or 29.
3.2 The Applicant further say that FDG having pharmaceutical use shall merit classification under Chapter 30 due to the following:-
3.2 (i) as per Note 4(d) of Chapter 30 – Heading 3006 applies only to the following, which are to be classified in that 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 hospit
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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 Direct
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Central Excise or Service Tax Offices
Central Excise – BELAPUR-I, RANGE-03 of BELAPUR-1 DVN. Service Tax – Division II New – Range IV of New Belapur
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a) Classification of Goods & Their Central Excise Tariff Heading.
b) Rate of Central Excise duty as applicable.
c) Details Is of benefit of notification of Central Excise if any availed.
In pursuance to the enquiry conducted in respect of M/s Thyrocare Technologies Limited (Unregistered Dealer], the holding company of the Applicant, during the course of the proceeding, the applicant has been informed that the product FDG is a keen to HSN 2844 4000. 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
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ces/ 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 of violation of Central Excise / 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, Be
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resent in the imaging system and with the help of computer algorithms, the signals received by detectors are converted into an image.
The true clinical application therefore is derived from the synthesized radiopharmaceutical 18F-FDG at the radiochemistry laboratory and not from F-18 produced at the cyclotron.
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. Thus the products or the compounds, mixtures or substance thereof used 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
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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 qualify to be classified under Chapter 30 (Heading 3004 etc.) are not required to be classified as chemical under Chapter 28 or 29.
Further to support the fact that FDG are put up in measured doses and are supplied in packings for therapeutic or prophylactic use, the applicant has already submitted the invoices and also explained during the course of the hearing the transportation and handling of FDG.
2
CHAPTER 28 – Inorganic 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
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f our letter, the true clinical application is derived from the synthesized radiopharmaceutical 18F-FDG at the radiochcmistry laboratory and not from F-18 produced at 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 th
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r, all goods of chapter 28 and 29 [in this case the artificial radioactive isotope F-18, the compound of radiopharmaceutical 18F-FDG] is to be considered as unmixed product only.
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CHAPTER 30 – Pharmaceutical products NOTES
4. Heading 3006 applies only to the following, which are to be classified in that heading and in no other heading of this Schedule
(a) sterile surgical catgut, similar sterile suture materials (including sterile absorbable surgical or dental yarns) and sterile tissue adhesives for surgical wound closure;
(b) sterile laminaria and sterile laminaria tents:
(c) sterile absorbable surgical or dental haemostatics; 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-gro
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ent, 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; 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/
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es. For the purpose of clarification we wish to state than in medicine, cobalt-60 is extensively employed as a radiation source in external radiotherapy to treat cancer, to arrest the development of cancer. Other radioactive isotopes are used as tracers for diagnostic purposes as well as in research on metabolic processes. This also coincides with our comments above in (b) in sr. no. 4.
During the course of the hearing reference was also made of classification of INN substances agreed by the harmonized system committee in April 1993 and the copy of the letter with annexure bearing reference no TAR/W/87 dated 21 June 1993 having limited/ restricted 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
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ssued 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
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
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take once committed can never be rectified. Mere wrong classification of goods by assessee at one stage does not operate as estoppel/ res judicata against them for claiming classification under correct heading of CETA – CCE v. Mahakoshal Potteries (2005) 183 ELT 289 (CESTAT) = 2005 (2) TMI 183 – CESTAT, NEW DELHI .
The Principle of res judicata or estoppel is not applicable in taxation matters CIT v. Brij Lal Lohia – 1972 84 ITR 273 (SC) = 1971 (7) TMI 13 – SUPREME Court , 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
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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) The description of goods under Chapter Sub Heading 28444000 is as under:-
“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”
(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 explanati
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pter Sub Heading 28444000 will 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 eve
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s 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 heading only and no other heading of the Schedule. Accordingly the products falling under chapter Sub Heading 28444000 will merit classification in Chapter 28 only.
(ii) it is further substantiated by the description of goods given under Chapter Sub Heading to 28444000 as follows:-
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 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
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larified 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 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
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en 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. As per the Explanatory note to Chapter Sub Heading 2844 of Harmonised Commodity Description and Coding System. Vol-I, Page No. VI-2844-1, VI-2844-2. VI-2844-3 and VI-2844-4 wherein it is 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 iso
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pplication 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 t
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ocation of statutory provisions. To appreciate the issue, it would be better if we reproduce the competing Custom Tariff Headings and Tariff items thus-
2844
RADIOACTIVE CHEMICAL ELEMENTS AND RADIOACTIVE ISOTOPES (INCLUDING THE FISSILE OR FERTILE CHEMICAL ELEMENTS AND ISOTOPES) AND THEIR COMPOUNDS; MIXTURES AND RESIDUES CONTAINING THESE PRODUCTS
2844 10 00
–
Natural uranium and its compounds; alloys, dispersions (including cermets), ceramic products and mixtures containing natural uranium or natural uranium compounds
2844 20 00
–
Uranium enriched in U235 and its compounds; plutonium and its compounds; 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
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ile 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 preparations for X-ray examinations; diagnostic reagents designed to be administered to the patient
3006 40 00
Dental cements 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
Bas
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edicines/publications/pharmacopoeia/Radgenmono.pdf
Introduction
Radiopharmaceuticals are unique medicinal formulations containing radioisotopes which are used in major clinical areas for diagnosis and/or therapy.
Definition
Radiopharmaceuticals can be divided into four categories:
Radiopharmaceutical preparation A radiopharmaceutical preparation is a medicinal product in a ready-to-use form suitable for human use that contains a radionuclide. The radionuclide is integral to the medicinal application of the preparation, making it appropriate for one or more diagnostic or therapeutic applications.
Radionuclide generator A system in which a daughter radionuclide (short half-life) is separated by elution or by other means from a parent radionuclide (long half-life) and later used for production of a radiopharmaceutical preparation.
Radiopharmaceutical precursor A radionuclide produced for the radiolabelling process with a resultant radiopharmaceutical preparation.
Kit for radioph
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ation medicine. It always uses tungsten container when transporting fluorodeoxyglucose, whose high energy makes the fluoro-18 lead container unusable.
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 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 medi
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will determine to which organ the radioactive molecule is transported. y-Radiation is detected externally by using special scintillation detector, also known as a gamma camera. The camera captures the emitted radiation and forms a two-dimensional image. this diagnostic test is also called scintigraphy.
In contrast, PET produces a three-dimensional image of the functional processes in the human body. The method is based on the use of position 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 inter
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enously 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 a
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imination via the kidneys. 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”
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3.05, 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 fall in heading 28.44 and not in heading 25.01 or 29.05. Similarly, radioactive ethyl alcohol, radioactive gold, and radioactive cobalt are in all circumstances classified in 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 prov
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ich 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;
(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
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nts nor separate chemically defined compounds
Heading 28.44 – Radioactive elements, radioactive isotopes, or compounds (inorganic or organic) and mixtures containing these substances
* HEADING 28.44 – NOTES
(I) Isotopes
It should be noted that elements existing in nature in the monoisotopic state, e.g.. beryllium 9, fluorine 19. aluminium 27, phosphorus 31, manganese 55. etc., are not to be considered as isotopes, but are to be classified, in either the free or the combined state, according to the case, in the more specific headings relating to chemical elements or to their compounds. 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.
(Ill) Radioactive chemical elements, radioactive isotopes and their compounds; Mixtures and residues containing these products
………………………
(C) Radioactive compounds; mixtures and residues containing radioactive substances
The rad
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dles, 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 then be affixed to the container, giving particulars of the isotope contained therein and its degree of radioactivity.
* CHAPTER 30 – NOTES
4. Heading 30.06 applies only to the following, which are to be classified in that heading and in no other heading of the 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 pu
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ENTS-TYPES AND APPLICATIONS: A DISCUSSION
Sunil K. Misra, Atulya Varma and Anjani Kumar Mishra
1 Department of Chemistry. D. A. V. College, C.S.J.M. University. Kanpur (U.P.) INDIA
2 Department of Chemistry, M.R.M. College, L.N Mithila University, Darbhanga (Bihar) INDIA
Basically, diagnostic agents includes chemical compounds of inorganic or organic nature, most of these being modified in their structural moeity, so as to become specific for their test reactions. These modifications make them biochemicals, depending upon their constitution and functional groups. Inorganic chemicals are not directly functioning as diagnostic 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 tr
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………………………………………………..
(C) Radioactive Tracers 9,10
Name and Symbol
Form
Use (Diagnostic)
Americium 241 Am
Encapsulated source
In bone mineral analyzer.
Cobalt
60Co and 57Co
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 isoto
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nsional images of the radiotracer concentrations within the body are then reconstructed by a computer using appropriate software and analysis. The biologically active molecule most commonly 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 – FD
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y 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 dissolved or dispersed in, or mixed naturally or artificially with, other radioactive or non-radioactive materials.
* artificial radioactive isotopes and their compounds are used in medicine, 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
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ing 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 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 o
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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.
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 aforesaid Tariff item
The applicant has placed an argument that medicaments have been consciously place in Chapter 30 of the Tariff and hence, the same principle should be followed in the case of the instant product. The applicant has also put forth a 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
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?
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 of the GST Act.
05. In view of the extensive deliberations as held hereinabove, we pass an order as follows :
ORDER
(Under section 98 of the Maharashtra Goods and Services Tax Act, 2017)
NO.GST-ARA-02/2017/B- 06 Mumbai, Dated 21st February, 2018
For reasons as discussed in the body of the order, the questions, as posed by Nueclear Healthcare Limited having GSTIN 27AADCN5392G1Z9, are answered thus –
Q.1 Whether the product 'Fludeoxyglucose' or &
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