Pharmacopoeia-listed medicaments remain generic despite strength or dosage-form changes, excluding proprietary classification.

Medicaments bearing names found in the Indian Pharmacopoeia were treated as generic and not as patent or proprietary medicaments under Chapter 30. Norfloxacin 100 mg and Piroxicam Gel, although marketed in different strength and dosage forms, retained their essential character because the product names corresponded to pharmacopoeial entries. The variation in strength, the "DT" description, and the gel form were insufficient to create a brand or proprietary identity. Accordingly, the products were held outside sub-heading 3003.10 and within the generic medicament classification.

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Issues: Whether Norfloxacin 100 mg. and Piroxicam Gel were classifiable as patent or proprietary medicaments under sub-heading 3003.10 of the Central Excise Tariff Act, or as generic medicaments under sub-heading 3003.20.

Analysis: Note 2(ii) to Chapter 30 treats as patent or proprietary medicaments those drugs or medicinal preparations which bear a name not specified in the relevant pharmacopoeia, formulary, or specified publication, or which bear a brand name. The products in question were marketed under the names Norfloxacin and Piroxicam, both of which were referred to in the Indian Pharmacopoeia 1996. The fact that Norfloxacin was manufactured in 100 mg strength with the description 'DT', and that Piroxicam was marketed in Gel form instead of capsules, did not alter the essential character of the medicaments or make them proprietary. The pharmacopoeia reference was to the medicine names, and the variation in strength or form was insufficient to take them out of the generic category.

Conclusion: The products were not patent or proprietary medicaments and were not classifiable under sub-heading 3003.10.

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