2005 (12) TMI 441 - AT - Central Excise

Summary

Issues:
1. Interpretation of Notification No. 8/95 and 8/96 regarding concessional rate of duty for Bulk drugs.
2. Determination of whether the impugned item qualifies as a Bulk drug under the relevant notifications.
3. Validity of using Martindale Pharmacopoeia as an official reference for classification.
4. Comparison of decisions in similar cases to establish the status of Martindale Pharmacopoeia.
5. Assessment of the Commissioner (Appeals) decision and the role of the Drug Controller's license in the case.

Analysis:
1. The case involves a dispute over the applicability of Notification No. 8/95 and 8/96, providing a concessional rate of duty for Bulk drugs. The Respondents claimed this benefit for 'Amlodipine Besylate,' classified under Chapter heading 2942. The Revenue challenged this claim, leading to proceedings initiated against the Respondents for denial of the notification's benefit.

2. The main contention was whether the impugned item met the criteria to be considered a Bulk drug eligible for the exemption. The Assistant Commissioner demanded differential duty, but the Commissioner (Appeals) ruled in favor of the Respondents, stating that the item qualified as a Bulk drug eligible for the exemption under Notification No. 8/1996-CE.

3. The Revenue argued that the impugned item did not adhere to the standards of Indian Pharmacopoeia or any official pharmacopoeia, questioning the validity of using Martindale Pharmacopoeia as a reference. However, previous Tribunal decisions, including CCE v. Reddy's Laboratories and Alembic Ltd. v. CCE&C, Vadodara, established Martindale Pharmacopoeia as an official pharmacopoeia of Great Britain, contradicting the Revenue's stance.

4. By referencing these prior decisions, the Tribunal dismissed the Revenue's appeal, emphasizing that Martindale Pharmacopoeia was recognized as official in specific cases. The Tribunal differentiated these cases from the precedent cited by the Revenue, indicating a consistent stance on the status of Martindale Pharmacopoeia in previous judgments.

5. Additionally, the Commissioner (Appeals) provided a detailed rationale for her decision, highlighting the significance of the Drug Controller's license permitting the manufacture of the item as a Bulk drug. The Tribunal criticized the Revenue for filing an appeal without sufficient groundwork, upholding the Order-in-Appeal and rejecting the Revenue's appeal based on the established legal precedents and the Commissioner's reasoning.