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2015 (11) TMI 775 - CESTAT NEW DELHI

2015 (11) TMI 775 - CESTAT NEW DELHI - 2015 (329) E.L.T. 452 (Tri. - Del.) - Claim of exemption under notification no. 6/02-CE (serial No. 57) of a formulation made from two bulk drugs - Diphenoxylate Hydrochloride with Atropine Sulphate. Serial No. 57 of the notification no. 6/02-CE covers “formulation manufactured from bulk drugs specified in list-2” - Held that:- The Commissioner (Appeals) has held that since both Diphenoxylate Hydrochloride and Atropine Sulphate are active ingredients and si .....

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c Chemical Works (2015 (11) TMI 810 - SUPREME COURT) if a formulation consist of more than one bulk drug, and out of those bulk drugs only one bulk drug is specified in notification the duty exemption to the formulation cannot be denied. On going through this judgment of the Apex Court, we are of the view that the judgment of the Apex Court is squarely applicable to the facts of this case. We, therefore, do not find any infirmity in the impugned order. - Decided against Revenue. - Excise Appeal .....

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The point of dispute in this case is as to whether the pharmaceutical product, which is a formulation of Diphenoxylate Hydrochloride with Atropine Sulphate is covered for full duty exemption under notification no. 6/2002-CE dated 1.3.2002 (serial No. 57) which covers formulations manufactured from bulk drugs specified in list 2. The list-2 of the notification mentioned various bulk drugs including Atropine but it did not cover by Diphenoxylate Hydrochloride. As per the explanation to serial .....

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igation or prevention of disease in Human being or animals but shall not include any substance to which the provisions of drugs and cosmetics act 1940 do not apply. The department in respect of the formulation with Diphenoxylate Hydrochloride with Atropine Sulphate was of the view that the same is not covered by serial no. 57 of the notification no. 6/02-CE as the bulk of the constituent of the formulation is Diphenoxylate Hydrochloride which is not figuring in list-2. It is on this basis that t .....

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order of the original adjudicating Authority, the Commissioner (Appeals) set aside the order in original and allowed the appeals vide order in appeal dated 25.05.2006 holding that the respondent company would be eligible for the duty exemption under notification no. 6/02-CE (serial no. 57) in respect of formulation of Diphenoxylate Hydrochloride with Atropine Sulphate. Against this order of the Commissioner (Appeals) the Revenue is in Appeal. 2. Heard both the sides. 3. Sh. MS Negi, the Ld. DR, .....

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fication, that the finding of the Commissioner (Appeals) in the impugned order that to avail of the benefit of the said exemption notification, the formulation should have been manufactured from the bulk drug specified in the list-2 of the said notification and the quantity ratio with other drugs and activeness of the said drugs is not relevant, is not correct, that since Diphenoxylate Hydrochloride is the main component 99% by weight, the formulation, in question, cannot be treated as the formu .....

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cation no. 8/95-CE dated 09.02.1995 held that Streptomycene injection is a formulation consisting of streptomyciline and penecyciline would be eligible for exemption even if the penecyciline was not mentioned in the list of the bulk drugs annexed to the notification, that for a formulation, the ratio of the constituent bulk drugs is not relevant and if a particular formulation is made from more than one bulk drug and any one of the bulk drug figures in the list-2 of the exemption notification, t .....

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rom bulk drugs specified in list-2 . In terms of explanation to this serial no., the formulation can be the medicament containing one bulk drug or more than one bulk drug with or without the use of the pharmaceutical aids such as dilutents, disintegrating agents, moistening agents, lubricants, buffering agents, stabilizer or preserver which are therapeutically inert and do not interfere with the thearpeutical or prophylactic activity of the drug. The list-2 of the exemption notification covers o .....

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