2015 (11) TMI 775

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..... 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 no. 57 of the notification for the purpose of this notification the expression Formulation means medicaments processed out of or containing one or more bulk drugs with or without the use of any pharmaceuticals aids such as dilutents, disintegrating agents mois .....

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..... /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, assailed the impugned order by reiterating the grounds of appeal and pleaded that the formulation, in question, consists mainly of Diphenoxylate Hydrochloride whose proportion is about 99% by weight and only the remaining 1% ingredient is Atropine Sulphate, that since the bulk drug - Diphenoxylate Hydrochloride is not mentioned in list-2 of the notification no. 6/02-CE and list-2 covers only the minor ingredient Atropine, the formulation, in question, would not be covered by this exemption notification, that th .....

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..... tion would be covered for exemption under this notification. He, therefore, pleaded that there is no infirmity in the impugned order. 5. We have considered the submissions from both the sides and perused the records. The dispute is about the eligibility for 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". 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 ag .....

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