TMI Blog2015 (11) TMI 775X X X X Extracts X X X X X X X X Extracts X X X X ..... . Since, in the present case both the constituents bulk drugs - Diphenoxylate Hydrochloride and Atropine Sulphate are the active ingredients, in our view the Commissioner (Appeals) s order that their ratio in the formulation is not material is correct. In terms of the Apex Court judgment in the case of CCE Varodara vs Allembic 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 ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... hearpeutical or prophylactic activity of the drug for internal or external use of diagnosis, treatment, mitigation 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 that in respect of the formulation of Diphenoxylate Hydrochloride with Atropine Sulphate, the Original Adjudicating Authority denied the duty ex ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... fication, 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 formulation manufactured from the bulk drug specified as the Diphenoxylate Hydrochloride is not mentioned in list-2 and that in view of this, the impugned order is not correct. 4. Sh. B L Narsimhan, Advocate, the Ld. Counsel for the respondent pleaded that the issue involved in this case stands decided by the Apex Courts judgment in the case of CCE Varodara vs Allembic Chemical Wor ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... not interfere with the thearpeutical or prophylactic activity of the drug. The list-2 of the exemption notification covers only Atropine and does not cover Diphenoxylate Hydrochloride. The Departments contention is that Diphenoxylate Hydrochloride being the major constituent about 99% by weight, the formulation has to be treated as made out of this bulk drug i.e. Diphenoxylate Hydrochloride and since this bulk drug is not mentioned in list- 2, the formulation is not covered by serial no. 57 of the exemption notification. The Commissioner (Appeals) has held that since both Diphenoxylate Hydrochloride and Atropine Sulphate are active ingredients and since Atropine Sulphate is mentioned in list-2, the formulation would be eligible for exemp ..... X X X X Extracts X X X X X X X X Extracts X X X X
|
