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2026 (4) TMI 1655

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....' for short), falling under Chapter 28444000 of CETA, 1985. M/s. Health Care Global Advances Isotopes Pvt. Ltd., which was incorporated on 30.05.2005, was amalgamated with the holding company M/s. Banashankari Medical and Oncology Research Centre Ltd., from 03.02.2011 vide Order OLR No.2/2011 in Company Petitions Nos.148 & 149 of 2010, of the Hon'ble High Court of Karnataka. Further, M/s. Banashankari Medical and Oncology Research Centre Ltd., was amalgamated with M/s. Health Care Global Enterprises Pvt. Ltd., on 16.03.2011 vide order in Company Petition Nos.148 & 149 of 2010. 3. The brief facts are alleging that the Appellant had evaded excise duty on the goods manufactured by them, proceedings were initiated and show cause notice dated 30.10.2014 was issued demanding excise duty for the period from 01.11.2009 to 31.03.2014 and thereafter Adjudication authority as per the impugned order confirmed the demand with interest and imposed penalty. The Adjudication authority also confiscated the goods manufactured and cleared by the Appellant during the relevant period and imposed redemption fine of Rs. 6,00,000/- under Section 34 of the Central Excise Act, 1944. Aggrieved by ....

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.... word "manufacturer" shall be construed accordingly and shall include not only a person who employs hired labor in the production or manufacture of excisable goods, but also any person who engages in their production or manufacture on his own account; 6. Learned Counsel to substantiate the contention that the activity does not amount to manufacture, draws our attention to the activities where it is explained, while submitting reply to show cause notice which includes:- a. The FDG is highly instable and starts decaying the moment it comes into existence. There is decrease in radio activity by 50% in 110 minutes (half-life period). Usually, one batch processing around 2000 Mcl of FDG is produced which is subject to quality check that takes 15-20 minutes. FDG starts decaying once dispensed from Cyclotron. FDG is taken in vial and administered to patients under a radio-active container. For dispatch of FDG to third party to be delivered at client's doorstep, the time required for transportation is crucial. b. The important aspect is that life of FDG is only the time gap between production of the FDG and the time of administering to patient at appointed time. It....

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....upport of their contention: i. CCE, Boroda Vs. United Phosphorus Ltd., (2004) 4 SCC 18; ii. UOI Vs. Delhi Cloth & General Mills Co. Ltd., (1997) 5 SCC 767; iii. Bhor Industries Ltd., Vs. CCE, Bombay - (1989) 1 SCC 602, g. FDG is reducing by 50% every 110 minutes, thus it is not marketable. Further, an unstable intermediate product which is not marketable is not goods even if there is a specific entry in the Central Excise tariff Act, 1985. In this connection, they rely on the following decisions, wherein it was held that the product is unstable having short life and not marketable or not capable of being marketed, no excise duty can be levied and therefore the noticee have argued that FDG is not goods and consequently production of FDG is not leviable to duty: i. CCE Vs. Satia Paper Mills - 2004(173) ELT 178 (Tri-Del); ii. Viral Laminates Pvt. Ltd. Vs. CCE - 1996 (85) ELT 191 (CEGAT-LB) h. The noticee have placed reliance on the judgment of Shri Ramakrishna Industries Ltd. vs CCE, Madras, - 1996 (82) 575 (Tribunal Larger Bench), wherein it was held that, Revenue has not produced any material to show marketability, not t....

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....d compounds other than those of subheading 2844 10, 2844 20 or 2844 30; alloys, dispersions (including cermets), ceramic products and mixtures containing these elements, isotopes or compounds; radioactive residues Kg. 12.5% 8. Learned Counsel further submits that the process undertaken by the Appellant is for preparation of pharmaceutical products and even if it is held that the process undertaken by the Appellant amounts to manufacture, it can be classifiable Chapter sub-heading 3006 30 00 under the pharmaceutical goods specified in Note 4 to this Chapter:- 3006 30 00 Opacifying preparations for X-ray examinations; diagnostic reagents designed to be administered to the patient Kg. 6% 8.1. In support the above contention, Learned Counsel draws our attention to the following documents:- a. Copy of the Paper named "Fludeoxyglucose F 18 Injection" (1981). In NDA 21-870: FDG F 18 Injection. b. Copy of the Article named What is Fludeoxyglucose F-18 used for? (n.d.).https://synapse.patsnap.com/article/what-is-fludeoxyglucose-f-18-used-for c. Copy of the Paper named Kilicoglu, O., Sepay, N., Ozgenc, E., Gundogdu, E., Kara, U., Alomairy, S....

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....riod. The appellant wish to place the quantification for the period in the written submission to be filed by the noticee. The value mentioned in the notice is at Rs.10,06,59,210/- which is not correct and contrary to the value adopted by the appellant. b. The allegation that the noticee is not entitled for the benefit of Notification No.8/2003-CE dated 01.03.2008 is not correct. As per notification No.8/2003- CE, SSI units whose turnover is less than Rs. 4 Crore are eligible for the concessions. If SSI unit does not avail CENVAT on inputs, turnover up to Rs.150 lakhs is fully exempt. The correct value of clearance for the purpose of SSI Exemption is as follows: Sl. No. Year Value of FDG Clearance to in patients Value of FDG Clearance to third parties Total Value 1 2009-10 21,04,500 1,03,57,625 1,24,62,125 2 2010-11 14,94,500 1,33,73,924 1,48,68,424 3 2011-12 12,13,000 72,11,650 84,24,650 4 2012-13 24,19,500 69,55,701 93,75,201 5 2013-14 21,96,000 25,52,129 47,48,129 10.1 Learned Counsel also submits as seen from the above, in none of the year total amount has crossed Rs.150 lakhs a....

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....ords. 15. As regards marketability of the product to demand excise duty, we find that the Appellant admits there was third party supply of goods and facts being so the product manufactured by the Appellant is marketable and even if the shelf life is limited, it cannot be held that the goods are not marketable, specifically when evidences are available on record to show that the Appellant had sold the goods to third party entities. Even if it is admitted that the 'FDG F-18' manufactured by the Appellant is reduced by 50% every 110 minutes (half-life period), it is marketable and the activity amounts to manufacture. 16. As regards classification of the goods under Chapter Heading 2844 4000 of the Central Excise Tariff Act, 1985, considering the documents relied by the appellant, we find that the product 'FDG F-18' is a 'radioactive pharmaceutical' used in medical imaging in Positron Emission Tomography (PET), 'FDG F-18' does not find a place in goods classifiable under Chapter Heading 2844 4000 of the Central Excise Tariff Act, 1985. Pharmaceutical products are classifiable under Chapter 30 of the Central Excise Tariff Act, 1985. Chapter sub-Head....