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        Central Excise

        2007 (8) TMI 144 - AT - Central Excise

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        Pharmacopoeial drug combinations sold generically are not patent or proprietary medicines and stay under other medicaments. Medicaments made from combinations of drugs individually specified in the Indian Pharmacopoeia remained classifiable as other medicaments under Heading ...
                        Cases where this provision is explicitly mentioned in the judgment/order text; may not be exhaustive. To view the complete list of cases mentioning this section, Click here.
                          Provisions expressly mentioned in the judgment/order text.

                            Pharmacopoeial drug combinations sold generically are not patent or proprietary medicines and stay under other medicaments.

                            Medicaments made from combinations of drugs individually specified in the Indian Pharmacopoeia remained classifiable as other medicaments under Heading 3003.20 because the Revenue did not show that the combination created a new substance or a proprietary product outside the pharmacopoeial entries. Goods marketed under generic names, with wrapper composition disclosing only simple pharmacopoeial combinations, did not acquire patent or proprietary character merely because the combined formulation was not separately listed. The absence of "I.P." on the wrappers was not decisive on these facts, and the interpretative approach including the singular-plural principle supported classification under Heading 3003.20 rather than Heading 3003.10.




                            Issues: Whether the medicaments comprising combinations of drugs individually specified in the Indian Pharmacopoeia were classifiable as patent or proprietary medicines under Heading 3003.10, or as other medicaments under Heading 3003.20.

                            Analysis: The drugs used in the impugned products were individually listed in the Indian Pharmacopoeia, and the Revenue did not establish that their combination created a new substance outside the pharmacopoeial entries. The products were marketed under generic names, and the presence of two pharmacopoeial drugs in combination did not, by itself, make them patent or proprietary medicines. The reliance on the absence of the words "I.P." on the wrappers and on the cited precedent was found unpersuasive in the facts of the case, because the composition disclosed on the wrappers showed simple combinations of pharmacopoeial drugs and the goods did not acquire a brand or proprietary character. The interpretative approach adopted below, including the principle that singular includes plural, supported the view that combined use of separately listed drugs did not take the products outside the pharmacopoeia.

                            Conclusion: The medicaments were not patent or proprietary medicines and were correctly classifiable under Heading 3003.20, not Heading 3003.10.

                            Ratio Decidendi: A combination of drugs, each individually specified in the Indian Pharmacopoeia and sold under generic names without any proprietary brand character, does not become a patent or proprietary medicament merely because the combination itself is not separately listed in the pharmacopoeia.


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