TMI Blog1995 (12) TMI 130X X X X Extracts X X X X X X X X Extracts X X X X ..... had accorded approval to classification list No. R. II/H/27/90-91 for the Siloderm Ointment under sub-heading 3003.10 which had been challenged by the Revenue on the ground that the product contains Dimethicone B.P.C., Zinc Oxide I.P. Calamine I.P. and Cetramide which are basically used in products to protect the skin from skin irritants and disinfecting wounds. The product has been described on the carton, as a skin protective barrier ointment. As per Chapter 33 Note 5, barrier creams are classified under Chapter sub-heading 3304.00 attracting 105% ad valorem basic duty plus 5% special excise duty. According to Note 2 under Chapter 33, Heading Nos. 33.03 to 33.07 apply inter alia to products whether or not they contain subsidiary pharmaceutical or antiseptic constitutents, or are held out as having subsidiary curative or prophylatic value. As Siloderm Ointment contains ingredients which are basically used for the protection of skin against irritants and for dis-infecting wounds, the product would merit classification under Chapter 33, and such products would not be covered under Chapter 30, i.e. pharmaceutical products, even if they have therapeutic or prophylatic properties as ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... market Siloderm Ointment is sold on prescription to hospitals, doctors and patients suffering from bed sores, skin diseases and rash for healing. (vi) In any case, it is settled law that change of a long standing classification approved by the department is not justified unless there is a change in composition or some new fact has emerged which was now known in the past. 4. The ld. Collector took up both the appeal of the department together and decided the case against the assessee and in favour of the Revenue. The ld. Collector has taken into consideration the judgment of the Tribunal in the case of M/s. Espi Industries Chemicals Pvt. Ltd. v. Collector of Central Excise as reported in 1991 (53) E.L.T. 618. The ld. Collector referring to the Tribunal s judgment and the discussion of the Tribunal in respect of product Oil of Olay is to be treated as barrier cream held that the item in question satisfies the characteristics of barrier cream in all respects and as reported in `Martindale, The Extra Pharmacopoeia - 28th Edition which he has held that the reading of Pharmacopoeia, it is seen that the use of silicone barrier cream is identical to the use for which the product sil ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... only a beauty cream. The ld. Counsel emphasises the finding of the Hon ble Supreme Court which held that the mere fact that it is also described as a beauty cream does not necessarily exclude it from being a barrier cream . The ld. Advocate s contention is that the product in question is a medicament, which helps in the process of skin healing and all the ingredients used are of BPC and IP standard and therefore, it has to be classified under Chapter-heading 30.03 as a medicament. In this context, he submitted that the product has been considered as a medicament under the Drugs and Cosmetics Act and also by all the physicians, who prescribes this ointment as a medicine for skin diseases. Ld. Advocate referred to the Technical literature more particularly to the Martindale, The Extra Pharmacopoeia and British Pharmaceutical Codex, 1973 wherein all the ingredients are mentioned. He relied on the judgments relied in the case of (i) G.D. Pharmaceuticals Ltd. v. Collector of Central Excise, Merrut - 1995 (79) E.L.T. 442 (Tri.) = 1995 (9) R.L.T. 870 (ii) B.P.L. Pharmaceuticals Ltd. v. Collector of Central Excise, Vadodara - 1995 (77) E.L.T. 485 (SC) (iii) Alpine Industries ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ng creams, cold creams, make-up creams, cleaning creams, skinfoods, skin tonics face powders, baby powders, toilet powders, talcum powders and grease paints, lipsticks, eye shadow and eybrow pencils, nail polishes and varnishes, cuticle removers and other preparations for use in manicure or chiropody and barrier creams to give protection against skin irritants." 9. The appellant s contention is that note 1(d) of Chapter 30 is not applicable, as the product is not a mere preparation to give protection against skin irritants but it is a medicaments and is covered by Chapter Note 2 of the Chapter 30 and being a recognised medications for healing or curing bed sores, napkin rash and to protect the skin against trauma due to inconvenience of urine and faeces or ileostomy or colostomy discharge, contact dermatities and pruvitus. One ingredient of the product, Silicone, is also injected intra-articularly in Osteo and Rheumatoid Arthritis. They therefore, rely on Note 2 of Chapter 30, to seek classification under Chapter sub-heading 3003.10 which reads as follows : 3003.10 - Patent or proprietary medicaments, other than those medicaments which are exclusively Ayurvedic, Unani, ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ts whether or not they contain subsidiary pharmaceutical or antiseptic constituents or are held out as having subsidiary, curative or prophylactic value. Although, the product is put up in packings with labels and literature, but, the item is not a cosmetic or toilet preparation or a mere barrier cream to give protection to skin and it has not been put up in a form clearly specialised for such use. The Note 2 of Chapter 33 states that the product should be put to use as cosmetics or toilet preparation or of any item of such use and it is classified in these headings irrespective of such items containing subsidiary. Pharmaceutical or antiseptic constituents, or even those which are held out as having subsidiary, curative or prophylactic value. This means that a product may be per se a cosmetics or toilet preparation or barrier cream, but may have due to its ingredients some antiseptic, curative or prophylactic value, but that by itself, will not take it out from Chapter 33. Note 5 of Chapter 33 lists the products, which are in the nature of cosmetic, toilet preparation and skin care ointments etc. and also Barrier Creams to give protection against skin irritants. Barrier Creams m ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... re in coma and confined to bed for prolonged periods. In support of above claim, we give below an extract from a leading medical journal : A bed sore in an 86 years old man healed completely in 4/5 months when an ointment containing 20% dimethicone was applied twice daily. Within two days of the treatment starting, the serous secretion ceased and the surface of the ulcer began to heal. P. M.C. Ewan (letter), Lancet, 1/1968, 45 In further support of our above claim we also enclose clinical trials reports (Annexure 1, II, III) extracted from leading medical journals which prove beyond doubt that Siloderm plays an important therapeutic role in healing of bed sores and has been classified as a therapeutic medicinal drug. Siloderm also plays a very important therapeutic role in the management of skin around ileostomies and colostomies. In support of the above claim we have pleasure in submitting an extract (Annexure IV) from a leading medical journal which also clearly proves beyond doubt that Siloderm is a medicinal durg used in therapeutic management of various dermal ailments. (3) Dimethicone is also employed in the treatment of osteo-arthritis and rheumatoid arthriti ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... edients present in Siloderm exert soothing and antiseptic action and thus prevent secondary infection in damaged skin. Zinc oxide and calamine are also medicinal drugs as mentioned in various international pharmacopoeias. From the above it is concluded that Siloderm is a medicament or a drug used in medicine for various aliments of the skin. Yours faithfully, Thanking you, for Neo-Pharma Private Limited Sd/- (V.K. Patil) Dy. Factory Manager" A reading of the technical literature and the certificates issued by doctors clearly rule out the product as a cosmetic or toilet preparation or as a mere Barrier Cream, to give protection against skin irritants and hence Note 1(d) of Chapter 30 is not applicable to the facts of this case. So also Chapter Notes 2 and 5 of Chapter 33 the product in question is clearly a medicament as per the definition given in Note 2 of Chapter 30, and all the ingredients are mentioned in Pharmacopoeia. The product is sold in the name of `siloderm ointment , it is not specified in a monograph or in a pharmacopoeia, Formulary or other publications, as mentioned i ..... X X X X Extracts X X X X X X X X Extracts X X X X
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