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2007 (4) TMI 69

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..... manufactured and cleared by the appellants herein during the period April 1986 to July 1996 and imposing penalty of amount equal to duty upon the assessee. 2. The product in question contains Chlorpropamide which is specified item under the notifications in question - In Notification 122/86, it is listed at Sr. 3 of the Annexure to the Notification; it is covered at sr. 11 of the Annexure to the Notification 30/88 and under sr.11 of successor Notification 9/94. The benefit has been denied on the ground that the product contains Calcium Carbonate which is not therapeutically inert, while the Notification provides that any ingredients not specified in the Annexure can be pharmaceutical necessities which are therapeutically inert. The rele .....

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..... taining drugs (including salts, esters and derivatives, if any), specified in the Annexure hereto appended, from the whole of the duty of excise thereon, which is specified in the said Schedule: Provided that such medicaments may contain pharmaceutical aids (such as diluent, disintegrating agent, moistening agent, lubricant, buffering agent, stabilizer or preserver) which are therapeutically inert and do not interfere with the therapeutic or prophylactic activity of the drugs specified in the said Annexure." 3. The submission of the appellant is 2 fold, one, that the addition of Calcium Carbonate of a particular dosage alone will make it therapeutically active for the reason that it is only beyond the particular level of dosage that C .....

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..... ute is such as to make it as an antacid. The stand of the appellant remains un-rebutted on this point. Further, both the decisions of the High Court relied upon by the appellant hold that it is not sufficient to find that the pharmaceutical necessity added is therapeutically inert but it is also required to be shown that the addition of pharmaceutical necessity does not interfere with the therapeutic or prophylactic activity of the ingredient or ingredients specified in the Schedule. There is no allegation in the present case that addition of the Calcium Carbonate interferes with therapeutic activity of the ingredient or ingredients specified in the Schedule to the Notification viz. chloropropamide. Therefore, both the contentions of the ap .....

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