1983 (8) TMI 294 - AT - Central Excise

Summary

Issues:
1. Whether Rolitetracycline is Tetracycline hydrochloride.
2. Eligibility of Rolitetracycline for concession under Notification No. 116/69-C.E.

Analysis:
1. The dispute in this case revolves around determining whether Rolitetracycline is equivalent to Tetracycline hydrochloride. The Appellate Collector initially ruled against Rolitetracycline intramuscular injection's eligibility for a concession due to the presence of lignocaine hydrochloride, which he deemed not therapeutically inert. The issue extended to Rolitetracycline intravenous injection, where M/s. Hoechst claimed it was Tetracycline hydrochloride, but the Assistant Collector disagreed, leading to the appeal ACC/EX/1177 filed by M/s. Hoechst.

2. During the hearing, M/s. Hoechst's counsel argued that various authoritative sources confirmed the equivalence of Rolitetracycline and Tetracycline hydrochloride. However, the department's counsel contended that while the substances may share properties and indications, they are not chemically identical. The presence of lignocaine hydrochloride in the intramuscular injection was highlighted as having therapeutic value, unlike Rolitetracycline.

3. The Tribunal examined the evidence presented by M/s. Hoechst, including references from pharmacological texts and regulatory documents. Despite similarities in therapeutic effects and actions, none of the sources explicitly stated that Rolitetracycline is a hydrochloride of Tetracycline. The distinction was emphasized based on chemical composition and official recognition of Tetracycline hydrochloride.

4. The Tribunal's decision hinged on whether Rolitetracycline could substitute Tetracycline hydrochloride for claiming a concession under Notification No. 116/69-C.E. While Rolitetracycline demonstrated similar functionalities, it was deemed insufficient to replace Tetracycline hydrochloride for exemption purposes. The judgment emphasized the importance of official recognition and eligibility criteria for claiming concessions.

5. Ultimately, the Tribunal upheld the denial of the concession to Rolitetracycline, emphasizing the distinction between the two substances despite their similar effects. The ruling clarified that even if Rolitetracycline could perform comparably to Tetracycline hydrochloride, it could not supersede the latter's claim to the concession unless officially recognized as such.

6. The resolution of the case confirmed that neither the intravenous nor intramuscular injections of Rolitetracycline qualified for the concession under Notification No. 116/69-C.E. Consequently, the appeal filed by M/s. Hoechst was dismissed, affirming the denial of the concession to Rolitetracycline in both forms.