TMI Blog2019 (8) TMI 308X X X X Extracts X X X X X X X X Extracts X X X X ..... o the articles of food shall not exceed the recommended daily allowance as specified by the Indian Council of Medical Research and in cases such standards are not specified the standards laid down by international food standards body, namely, Codex Alimentarius Commission, shall apply. 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 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. The products in question are classifiable under HSN 2106, and taxable under Sl.No. 23 Schedule III or Notification 1/2017-C.T (Rate) dated 28-06-2017 under the Cent ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... d 1.5 mg Vitamin B12 15 mg Sodium selenite equ to elemental selenium 40 mcg Zinc ascorbate equ to elemental Zinc 12 mg 3. Folcovit Distab Bacillus Coagulans 1.25 billion spores Folic acid 1.5 mg Vitamin B12 15 mcg 4. Myova/Myowin tablet Myo -Inositol 550 mg D-chiro-lnositol 13.8 mg L-Methylfoate calcium 1.0 mg Chromium 100 mcg (As chromium picolinate) Vitamin D3 1000 IU 5. Candyflora Tablet Lactobacillus reuteri 200 million CFU Lactobacillus rhamnosus 50 million CFU Bifidobacterium Iongum 50 Million CFU 6. Carisma Tablet Carica Papaya Extract 1100 mg Excipients Q.S. 7. Lactolite syrap Sodium chloride 520 mg Potassium Chloride 300 mg Sodium Citrate 580 mg Dextose (anhydrous) 2.7 mg Purified Water, Sucrose, Dextrose Preservative 8. ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... (hereinafter referred to as the WBAAAR) in the matter of Akansha Hair Skin Care Herbal unit Pvt. Ltd. (Appeal Casc No. 2/WBAAAR/Appeal/2018 dated 01-08-2018) = 2018 (8) TMI 772 - APPELLATE AUTHORITY FOR ADVANCE RULING, WEST BENGAL . 5. The Appellant has filed the instant Appeal against the above Advance Ruling with the prayer to set aside/modify the 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 the Food Safety and Standards Authority of India (FSSAI) under the Food Safety and Standards Act, 2 ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... he products for which classification has been sought fall under the category of dietary/health supplement or they are drugs and medicines as claimed by the Appellant. 8. Central Drugs Standard Control Organisation (CDSCO) is a regulatory body for Indian pharmaceuticals and medical devices, set up under the Ministry of Health and Family Welfare and is responsible for approval of drugs, conduct of clinical trials and laying down the standards for drugs and overseer aspects of safety, rights and well being of patients. As per provisions of sub-section (b) of section 3 of the Drugs and Cosmetics Act, 1940, drug includes inter alia all medicines for internal or external use in human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals. Further, sub-section (c) of section 18 of the said Act prohibits manufacture, stocking or sale of any drug without a license procured under the Act. In course of hearing the Appellant stated that he does not hold a drug license under the Drugs and Cosmetics Act, 1940. On being asked as to why the Appellant did not obtain drug license ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ugs 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 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 Act is based. excludes food and beverages like fortified food, food supplements, tonics, etc.. even if they have therapeutic and prophylactic properties. In view of above discussion we find no infirmity in the ruling pronounced by the WBAAR. The products in question are clas ..... X X X X Extracts X X X X X X X X Extracts X X X X
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