9911796707
TMI Blog2019 (8) TMI 308X X X X Extracts X X X X X X X X Extracts X X X X ..... as 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, 8th 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 Goods and Services Tax Act, 2017/ the Centr ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... lion 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 sulphate, Zinc Sulphate Monohydrate, biotin 13. Zink Ascorbate (Dry syrup) Each 1ml contains Zinc Ascorbate Eqv. To elemental Zinc 20mg 14. Zink ascorbate (syrup) ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... 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 the Food Safety and Standards Authority of India (FSSAI) under the Food Safety and Standards Act, 2006. This is just a statutory regulation and has no bearing on the usage of the products. The products on which ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... 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 meet procedural requirements only and nothing else. The prescription and use of the products themselves arc altogether different. 7. The matter is examined and written and oral submissions made before us are considered. The moot questio ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... 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, (vi) Food containing Probiotics, (vii) Food containing Prebiotics, and (viii) Novel Food 10. The Appellant is a license holder under FSSAI and as per the Appellant's submission and observations of WBAAR, the products have stickers pasted on packaging proclaiming "Hea ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... 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 by FSSAI are mutually exclusive. In fact the products in question are not eligible drug license under the Drugs and Cosmetics Act, 1940 as these are mainly prebiotic and probiotic supplements, oral rehydration formulate and tonic. Chapter 30 of Customs Tariff Code on which classification under the GST ..... X X X X Extracts X X X X X X X X Extracts X X X X
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