Classification of pharmaceutical enzyme blends turns on medicament character, drug-law control, and end-use evidence.

Pharmaceutical enzyme blends meeting IP/BP standards were considered for classification either as medicaments under Chapter 30 or as prepared enzymes under Chapter 35. Their manufacture involved blending enzymes with excipients such as lactose and calcium phosphate, and the record did not conclusively establish direct prophylactic or therapeutic use. Compliance with drug law, the drug licence, and the end-use or further processing by buyers were relevant to characterising the goods. The classification issue was remanded for fresh adjudication after the appellant was allowed to produce supporting material and the cited circulars and precedent were to be examined.

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Issues: Whether the impugned products, manufactured as pharmaceutical blends and said to meet IP/BP standards, were classifiable under Chapter 30 as medicaments or under Chapter 35 as prepared enzymes.

Analysis: The products were shown to be manufactured by blending enzymes with other materials such as lactose and calcium phosphate before packing and despatch. The existing record did not conclusively establish direct prophylactic or therapeutic use, but the fact that the products met IP/BP standards and were controlled under drug law was considered relevant to their character as medicaments. The lower authorities had not adequately examined the drug licence and the end-use or further processing by buyers. The material also required comparison with the cited departmental circulars and the earlier decision relied upon for similar pharmaceutical enzyme products.

Conclusion: The classification issue was not finally determined on merits and the matter was remanded to the Original Authority for fresh adjudication after allowing the appellant to produce material in support of its claim.

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