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2009 (3) TMI 173

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.... heading 19.01, and confirmed the demands against the appellants, along with imposition of penalties. The said order of Commissioner is impugned before us. 2. We have heard Shri V. Sridharan, Ld. Advocate appearing for the appellants and Ms. M.I.J. Micheal, Jt. CDR appearing for the Revenue. 3. The ingredients contained in each of 15 ml of Sharkoferrol, as appearing in the label of the product and as detailed by the appellant in their memo of appeal are as under :-    Ingredient  Concn  Official in (a)  Malt extract  4.52g  IP. (b)  Saccharated iron oxide  1.8g  Austria & Swiss Pharmacopoeia (c)  Calcium gluconate  0.18g  IP, B.P (d)  Vitamin A  7800IU  IP, B.P (e)  Cholecalciferol (Vitamin D3)  600 IU  IP, B.P (f)  Niacinamide  45 mg  I.P, B.P (g)  Thiamine (Vitamin B1)  5 mg  I.P, B.P (h)  Riboflavin(Vitamin B2)  5 mg  I.P, B.P 4. The role played by the each gradient stands described by the appellant, as under :- 2.2 The Act....

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....rement of niacinamide varies with the caloric requirement and is in the range of 15 to 20 mg for adults. Each 15 ml. of SHARKOFERROL contains 45 mg. of niacinamide thus a daily dose of 3-4 teaspoonfuls of SHARKOFERROL, provides 45-60 mg of niacinamide which is sufficient to treat pellagra and a dose of 1-2 teaspoonfuls every day provides 15-30 mg of niacinamide which is sufficient to prevent pellagra. (e) VITAMIN-B1 (Thiamine) is required as a cofactor in carbohydrate metabolism. Deficiency of thiamine produces a disease are known as "beri-beri", which produces symptoms referable to the central nervous system or the cardiovascular system. Each 15 ml of SHARKOFERROL provides 5 mg of Thiamine. Thus a dose of 304 teaspoonful per will provide 5 to 6.3 mg of thiamine which is sufficient to treat thiamine deficiency and a dose of a 2 teaspoonfuls per day will provide 3.34 mg. of thiamine which is sufficient to prevent and treat deficiency of thiamine. (f) RIBOFLAVIN (Vitamin-B2) is required by the human body as a coenzyme for the functioning of a wide variety of respiratory flavoproteins. Riboflavin deficiency is usually observed in conjunction with deficiencies of other v....

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....he product in question is being marketed by the appellant as "Malt nutrient tonic". The essential character in the product is being imparted by malt extract and same is also being marketed as Malt Nutrient Tonic, as is clear from the label of the container. The appellant's contention is that Malt is only a medium for conveying the various nutrients in the said product which are mainly for therapeutic use. He has further observed that the said product is to be taken with milk, as mentioned in the label and the dosage mentioned on the label recommended the impugned product for daily use, without indicating any particular ailment. The label on the product meant for export depict a man showing body building, thus indicating that the product is growth oriented rather than curative in nature. The Vitamins used in the said product are in minute amounts and are meant for daily additional dosage, the deficiency of which may give rise to metabolic disturbance or deficiency diseases. He has also rejected the appellant's plea that since the said product is manufactured under the drug license, the same is to be treated as medicament. The product in question is not meant for curing any particula....

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....itamins since the contents of vitamins are of therapeutic quantity is provided under the schedule -V of the Drugs and Cosmetics Act. The demand also stands agitated on the point of limitation, inasmuch as one of the show cause notices adjudicated vide impugned order, was issued on 17-11-1994, for the period November 1989 to October 1993, thus invoking the longer period of limitation. 9. We have already reproduced the contending entries of two different headings. There is no denial of the fact that Malt extract is a main ingredient in the product in question. The other vitamins and minerals are added in small quantities so as to enhance the quality of the product, which is admittedly required to be taken on daily basis so as to improvise the general health of the consumer. There is no indication on the label of the product showing the name of the disease, in which the product is required to be taken for curing or preventing the same. Dosage and duration for which the product is to be taken is also not indicated. The indication on the label clearly show that the said powered product, which is enriched with vitamins and other nutrients is to be taken by dissolving the same in milk,....

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....not require the prescription of any Doctor and any person feeling weak can consume the same. We totally agree with the reasoning of the adjudicating authority that use of various vitamins and minerals of I.P. Standard will not convert the product into medicine. The same only reflect upon the higher quality of the product, which may be useful in improving the general health of the consumer. 12. The appellants, further contended that the product is manufactured by them under a Drug License thus, this fact by itself does not bring the product in the category of medicament inasmuch as various products, which are required to be produced under a Drug License, fall under the different headings other than medicaments. The said plea of the appellants stands effectively dealt by Commissioner with the support of various case laws. 13. At this stage, we also note HSN Explanatory note under heading to 30.03. For better appreciation, we reproduce the same as below :- "The provisions of the heading txt do not apply to foodstuffs or beverages such as dietetic, diabetic or fortified foods, tonic beverages or mineral waters (natural artificial), which fall to be classified under their own a....

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.... cannot be held to be a medicament and would get ousted from the preview of Chapter 30. 14. We, apart from the above, find that an identical product with an identical dispute was dealt with by the Tribunal in the case of M/s. Coral Laboratories and vide order No. A/397-399/WZB/AHD/2008 dated 10-3-2008, [2008 (225) E.L.T. 544 (Tri)] the product was held to be other than medicament. For better appreciation, we reproduce the relevant paragraphs of the order :- "8. As also rightly observed by the appellate authority, a drug licence may be required for manufacture of various products for the purposes of maintaining proper public health and hygiene but still the same cannot be classifiable as medicaments. Reference in this regard may be made to various products like Protinules classifiable under Chapter 19, Alprovit Granules falling under Chapter 21, Hajmola Candy falling under Chapter 30 and Danth Manjan Lalfalling under Chapter 33, it is well settled that a classification of the product cannot be made on the basis of the goods having been manufactured under a drug licence. 9. We have also seen the various constituents reflected on the label of the product. The appellants have ....

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....parlance test, absence of indication of any disease, projection of the product in the market and the ingredients being used for treatment of a particular disease etc. As such, we are of the view that the product in question cannot be held to be a medicament. The same is accordingly classifiable under chapter 21, as food product. 15. The product in the present case is identical to zest power being considered in above order. We do not find any reasons to deviate from the findings arrived at by us in the above order in M/s. Coral Laboratories Limited. 16. In view of the foregoing discussions, we agree with the department that the Sharkoferrol cannot be held to medicament falling under Chapter 30. The same is properly classified under heading 19.01 as held by the Revenue. 17. The appellants have also challenged a part of the demand on limitation. Show cause notice for the period November 1989 to October 1993 was issued on 17-11-1994 i.e. after the normal period of limitation. Admittedly, the classification lists were being filed by the appellant from time to time along with the label of the product indicating ingredients etc. The said classification lists stands approved by th....