19 August 2013

Medicament or cosmetic – Supreme Court decides whether product cures or cares

A product used mainly to cure or treat diseases, containing curative ingredients even in small quantities, is to be considered as a medicament. Supreme Court of India has, on 14-8-2013, relying on earlier cases, has classified the product (Moisturex in this case) as medicament.  

The Court in this regard observed that ‘care or cure’, is the clue for resolution of the issue as to whether a product is a medicament or cosmetics. Stressing the point that understanding of the people who use the product was also to be seen by the court, the Apex Court held that only if primary function is “care” and not “cure”, a product is not a ‘medicament’. It held that proportion of pharmaceutical ingredient having therapeutic, prophylactic or curative properties is not decisive, but presence of curative properties alone is important.  

Noting that there are several products sold over-the-counter and are yet, medicaments, the Court rejected department’s plea of classification of the impugned product as pharmaceuticals as the product was sold without a prescription of a medical practitioner. It was held that in the case of ‘Moisturex’, there is no dispute that it is prescribed by dermatologist for treating the dry skin conditions and that the same is also available in chemist or pharmaceutical shops.  

The judgment notes that Heading 33 04 of the Central Excise Tariff specifically excludes medicaments and Chapter Note under Heading 33.04(B) also clarified that medicinal preparations used to treat certain skin complaints are to be covered under the Heading 30 03 or 30 04.  According to the Court, if a product comprises of two or more constituents which have been mixed or compounded together for therapeutic or prophylactic use, the same is to be covered by Heading 30 03 and that urea, lactic acid and propylene glycol contained in the product are pharmaceutical constituents as per as Indian Pharmacopoeia.  


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