TaxTMI 
TaxTMI 
2019 (8) TMI 308
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...., Kolkata- 700 091 1. This Appeal has been filed by Eskag Pharma Pvt. Ltd. (hereinafter referred to as "the Appellant") on 29.04.2019 against Advance Ruling No. 46/WBAAR/2018-19 dated 26.03.2019 = 2019 (3) TMI 1407 - AUTHORITY FOR ADVANCE RULING, WEST BENGAL, pronounced by the West Bengal Authority for Advance Ruling (hereinafter referred to as the WBAAR) in the matter of Eskag Pharma Pvt. Ltd. 2. Eskag Pharma Pvt. Ltd located at AG-112, 8^th Floor, Suite No. 804, Baishakhi, Salt Lake Sector-II, Kolkata- 700 091 holding GSTIN 19AAACE5646H1ZJ and is stated to be a manufacturer of pharmaceuticals, active pharmaceutical ingredients (APIs), medicaments, etc. 3. The Appellant sought an advance ruling under section 97 of the West Bengal ....
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.... Citrate IP 0.58 gm Dextrose (anhydrous) IP 2.7 mg Zinc sulphate monohydrate 10.98 mg Eqv. to elemental zinc 4 mg Bacillus coagulans 0.5 billion spores Lactobacillus acidophilus 0.25 billion cells Lactobacillus rhamnosus 0.25 billion cells Excipients q.s. 9. Biogut Dry Syrup Each 5 ml contais probiotics 1.25 bilion cells strains 10. Enterobiotic Dry Syrup Lyophilizes saccaromyces Boulardii 2.5 billion cells 11. Gutclausy Dry Syrup Each 5 ml contains Bacillus clausii 2 billion cells 12. Evaday Capsule Evening primrose oil, Isoflavonoids, Vitamin E Acetate, Vitamin C, Vitamin B6, Cynocobalamide, Niacinamide, Folic acid, Dibasic Calcium Phosphate, Magnesium sul....
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....he impugned Advance Ruling passed by the WBAAR or pass any such further or other orders as may be deemed fit and proper in the facts and circumstances of the case on the following grounds: (i) The WBAAR erred in law by accepting the Appellant's application partially. The issue of classification of products; Biogut Capsule (Serial no. 2), Zinc Ascorbate Syrup (Serial no. 14) and Lactoin Drop (Serial no. 15) have not been answered. (ii) The WBAAR while classifying the products relied solely on the details/ inscriptions mentioned on the packages of the products and has ignored the usage of the products. The affixation of label "Not for Medicinal Use" on packaging of the products in question is as per regulations issued by....
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.... Siddha or Bio-chemic systems of medicaments. The Appellant submitted relevant extracts of the Indian Pharmacopoeia, 2018, prescriptions issued by medical practitioners prescribing the products in question, invoices issued by various pharmacists, certificate issued by Dr. Agnik Pal of JNM Hospital, Kalyani, stating that the products in question are used as medicaments. Further the Appellant stressed on the judgement of the Apex Court in the matter of Kalyani Breweries Ltd. vs Assistant Collector of Customs, Calcutta [2001 (134) ELT 12 (SC)] = 2001 (10) TMI 97 - SUPREME COURT. The Appellant also submitted that stickers on its products proclaiming Health/Dietary Supplements", "Health Drinks" and "Not for Medicinal Use" have been pasted to mee....
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....ning the same is a lengthy and difficult process and it is easier to get license under Food Safety and Standards Authority of India (FSSAI). 9. FSSAI is an autonomous body also created under the Ministry of Health and Family Welfare and is responsible for protecting and promoting public health through the regulation and supervision of food safety. Notification No. 1-4/Nutraceutical/FSSAI-2013 dated 23.12.2016 (hereinafter referred to as "the Regulations") issued by FSSAI cover eight categories of functional food, namely: (i) Health Supplements, (ii) Nutraceuticals, (iii) Food for Special Dietary Use, (iv) Food for Special Medical Purpose, (v) Speciality Food containing Plant or Botanicals, ....
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....nutritional or beneficial physiological effect, which are presented us such and are offered alone or in combination, but are not drugs us defined in the clause (b) of section 3 Drugs Cosmetics Act, 1940 and the rules made thereunder. So being prescribed by medical practitioners for a limited period use or sold by pharmacists are not sufficient parameters for the products in question to be classified us medicaments as per HSN classification in the light of the current Regulations laid down by FSSAI, It is clear that products under the Drugs and Cosmetics Act, 1940, will not fall under those categories regulated by FSSAI and vice versa. These two categories, namely the products under the Drugs and Cosmetics Act. 1940, and these regulated b....