Therapeutic product classification as medicament under Heading 30.03 upheld, defeating food-heading treatment and SSI exemption claim.

A product compounded for therapeutic use, manufactured under a drug licence, labelled for administration on physician's prescription, and containing pharmaceutical-grade vitamins and minerals was classifiable as a medicament under Heading 30.03. The HSN notes and Chapter 30 Note 2(i)(a) supported medicament classification because preparations intended for prevention or treatment of disease fall outside the food heading; later drug-control correspondence on similar products did not apply retrospectively to the 1992 clearance. Chapter 21 Note 5(a) did not assist the assessee, as the mixture could not be treated as a protein concentrate. The Revenue's classification was upheld and the claim to SSI exemption based on Heading 21.07 failed.

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Issues: Whether SAFEZ syrup was classifiable as a medicament under Heading 30.03 or as a food substitute under Heading 21.07 of the Central Excise Tariff.

Analysis: The product was manufactured under a drug licence and was described on the label as meant for therapeutic use and to be administered on physician's prescription. Its ingredients included pharmaceutical-grade vitamins and minerals, and the composition showed that it was compounded for therapeutic use. The later letters of Drugs Control authorities treating similar products as food for special dietary use were not applicable retrospectively to a 1992 clearance. The HSN note for Heading 21.06, corresponding to Heading 21.07, excludes preparations intended for prevention or treatment of diseases or ailments from that heading. Note 2(i)(a) to Chapter 30 treats products compounded together for therapeutic or prophylactic use as medicaments, and the product satisfied that description. Note 5(a) to Chapter 21 did not assist the assessee because a mixture of protein hydrolysates with vitamins and minerals could not be treated as a protein concentrate.

Conclusion: The product was correctly classifiable as a medicament under Heading 30.03 and not as a food substitute under Heading 21.07.

Final Conclusion: The classification adopted by the Revenue was upheld and the assessee's claim to SSI exemption based on Heading 21.07 failed.

Ratio Decidendi: Where a product is compounded for therapeutic use, held out by the manufacturer for use only on prescription, and falls within the tariff description of medicaments, HSN notes excluding disease-treatment preparations from food headings govern classification in favour of Heading 30.03.

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