2013 (8) TMI 467 - SC - Central Excise

Supreme Court affirms 'Moisturex' as medicament under Heading 30.03 of Central Excise Tariff Act

The Supreme Court upheld the Tribunal's decision classifying 'Moisturex' as a medicament under Heading 30.03 of the Central Excise Tariff Act, 1985. The ... Classification of goods as medicament or cosmetic - primary use - cure versus care - effect of pharmaceutical constituents on classification - over the counter sale not determinative of medicament status - commercial parlance theory - Heading 30.03 (medicaments) vis a vis Heading 33.04 (beauty / skin care preparations)Classification of goods as medicament or cosmetic - primary use - cure versus care - effect of pharmaceutical constituents on classification - over the counter sale not determinative of medicament status - Whether the cream 'Moisturex' is a medicament falling under Heading 30.03 or a cosmetic/skin care preparation falling under Heading 33.04. - HELD THAT: - The Court held that the determinative test is the product's primary use - whether it is put to a therapeutic/prophylactic (cure) purpose or primarily for care/appearance. Where a product comprises pharmaceutical constituents having curative or prophylactic properties, that composition and curative attribute govern classification irrespective of the proportion of such constituents. The Court rejected the contention that sale without prescription or availability over the counter converts a medicament into a cosmetic, observing that over the counter sale is not decisive. Chapter notes expressly exclude medicaments from Heading 33.04 and treat medicinal preparations for treatment of skin complaints under Heading 30.03 (or 30.04 where appropriate). Applying these principles to Moisturex - whose ingredients (urea, lactic acid, propylene glycol) are pharmaceutical substances and whose indicated uses include treatment of pathological dry skin conditions (ichthyosis, fissure feet, dryness associated with leprosy and clofazimine) - the product's character is therapeutic/prophylactic and not merely cosmetic or protective. Prior decisions cited by the Court support that minimal quantity of medicinal ingredient or sale without prescription does not preclude classification as a medicament. Consequently, Moisturex is a medicament classifiable under Heading 30.03. [Paras 17, 18, 19, 20, 21]Moisturex is a medicament liable to be classified under Heading 30.03 and not a cosmetic under Heading 33.04; the appeals are dismissed.Final Conclusion: The appeals by Central Excise are dismissed: Moisturex, by reason of its pharmaceutical constituents and primary therapeutic/prophylactic use, is a medicament classifiable under Heading 30.03 rather than a cosmetic/skin care preparation under Heading 33.04. Issues Involved:1. Classification of the product 'Moisturex' as either a medicament or a cosmetic.2. Interpretation of relevant headings and notes under the Central Excise Tariff Act, 1985.3. Consideration of pharmaceutical ingredients and their therapeutic or prophylactic uses.4. Determination of the primary function of the product: care or cure.5. Relevance of product availability without prescription in classification.Issue-wise Detailed Analysis:1. Classification of 'Moisturex':The core issue is whether 'Moisturex' should be classified as a medicament or a cosmetic. The Tribunal ruled in favor of the assessee, classifying 'Moisturex' as a medicament, which the Central Excise appealed against. The Supreme Court upheld the Tribunal's decision, emphasizing that the product's pharmaceutical constituents and their curative properties make it a medicament.2. Interpretation of Relevant Headings and Notes:The Central Excise Tariff Act, 1985, under Chapter 30, deals with pharmaceutical products. Heading 30.03 covers medicaments, and Heading 33.04 deals with beauty or make-up preparations and preparations for the care of the skin, excluding medicaments. The Court noted that 'Moisturex' falls under Heading 30.03 due to its therapeutic uses, as defined in Note 2(i) and 2(ii) of Chapter 30.3. Consideration of Pharmaceutical Ingredients:The product 'Moisturex' contains Urea I.P., Propylene Glycol I.P., Lactic Acid I.P., and Liquid Paraffin I.P., all recognized as pharmaceutical constituents. The Court emphasized that these ingredients are used for therapeutic or prophylactic purposes, making 'Moisturex' a medicament. The presence of these ingredients was decisive in classifying the product under Heading 30.03.4. Determination of Primary Function:The Court distinguished between products meant for care and those meant for cure. 'Moisturex' is intended for treating dry skin conditions and other skin complaints like fissure feet and ichthyosis, indicating its primary function is cure, not care. The Court rejected the argument that 'Moisturex' is merely a moisturizing cream, emphasizing its therapeutic role.5. Relevance of Product Availability Without Prescription:The Court dismissed the argument that 'Moisturex' cannot be a medicament because it is sold over the counter without a prescription. Citing previous judgments, the Court reiterated that the availability of a product without a prescription does not preclude it from being classified as a medicament. The primary criterion is the product's use and the curative properties of its ingredients.Conclusion:The Supreme Court concluded that 'Moisturex' is a medicament, primarily intended for treating skin conditions and containing pharmaceutical ingredients with therapeutic properties. The product is classified under Heading 30.03 of the Central Excise Tariff Act, 1985. The appeals by the Central Excise were dismissed, affirming the Tribunal's decision.