2007 (4) TMI 69

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.... 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 relevant portion of the Notification 122/86 and 30/88 are reproduced below: - "Notification No. 122/86 - Exemption to life saving formulations. - I....

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.... 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 Calcium Carbonate which is otherwise antacid, becomes therapeutically active, while they have added Calcium Carbonate of a lower dosage and furth....

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....ed 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 appellant are required to be accepted viz, that the addition of Calcium Carbonate of the low dosage (44 milligram in the case of 100 gms Diabinese and 110 ....