2003 (11) TMI 383 - AT - Central Excise

Tribunal overturns duty order for Bistrepen Forte Injections, stresses adherence to notification conditions

The appellate tribunal set aside the order passed by the Commissioner (Appeals) concerning the concessional duty claim for pharmaceutical product ... Medicaments - Formulation Issues:- Challenging order passed by Commissioner (Appeals) on concessional duty claim under Notification No. 8/95-C.E.- Classification of pharmaceutical product Bistrepen Forte Injections for concessional duty.- Interpretation of 'formulation' under Notification No. 8/95.- Failure to substantiate submission by the appellant.- Satisfaction of conditions under the Explanation of Notification No. 8/95.Analysis:The appeal in this case was against the order passed by the Commissioner (Appeals) on 13-7-1998 regarding the claim of concessional duty under Notification No. 8/95-C.E. The issue revolved around the classification of the pharmaceutical product Bistrepen Forte Injections, a combination of Streptomycin and Penicillin, for concessional duty. The appellant claimed eligibility for concessional rate of duty under S.No. 4 of Notification No. 8/95, arguing that the combination of Streptomycin and Penicillin constituted 'other bulk drugs.' However, the demand for differential duty was raised through show cause notices alleging that the concessional duty was not applicable as the combination was not specified in the Drugs and Cosmetics Act, 1940.During the proceedings, it was contended that the combination of Streptomycin and Penicillin should be considered a 'formulation' as per the explanation under Notification No. 8/95. The authorities below had held that the appellant failed to satisfy the explanation, but the appellate tribunal found discrepancies in this conclusion. The tribunal noted that there was no clear reasoning provided as to why the appellant did not meet the conditions of the explanation. Additionally, the statement that the appellant did not provide the ratio of the product was found to be inaccurate, as the ratio was indeed submitted along with the reply to the show cause notice. Notably, the department did not dispute the therapeutical inertness of sodium citrate, a component of the product, which was crucial in determining the product's classification as a formulation.Ultimately, the tribunal disagreed with the lower authorities' assessment and set aside the impugned order, allowing the appeal in favor of the appellant. The decision emphasized the importance of satisfying the conditions laid out in the explanation of Notification No. 8/95 for determining the eligibility for concessional duty, highlighting the need for a clear and reasoned analysis in such matters to ensure a fair adjudication process.