1987 (7) TMI 252 - AT - Central Excise

Summary

Issues Involved:
1. Classification of Analgin Tablets under Tariff Item 14E of the Central Excise Tariff.
2. Compliance with the pharmacopoeial standards.
3. Dosage strength and its relevance to pharmacopoeial classification.
4. Proprietary nature of the medicine.
5. Violation of Rule 96 ZN(2) of the Central Excise Rules, 1944.

Detailed Analysis:

1. Classification of Analgin Tablets under Tariff Item 14E of the Central Excise Tariff:
The department contended that the Analgin Tablets produced by the appellants were not pharmacopoeial drugs and thus fell under Tariff Item 14E. The tribunal noted that the product was specified in both the Indian Pharmacopoeia and the National Formulary of India, rejecting the department's claim. The tribunal emphasized that "all editions" of the specified pharmacopoeias are notified for tariff purposes, making the department's stance on the non-applicability of the 1966 or 1979 editions unsustainable.

2. Compliance with the pharmacopoeial standards:
The department argued that the Analgin Tablets did not meet the pharmacopoeial standards as they contained 0.3 grams of Metamizole per tablet instead of the usual 0.5 grams. The tribunal referred to a government clarification stating that preparations marketed within the dosage range specified by the pharmacopoeia shall be deemed pharmacopoeial. The tribunal found that the product met this criterion, as the dosage range in the National Formulary of India was 0.3 grams to 1 gram, thus dismissing the department's argument.

3. Dosage strength and its relevance to pharmacopoeial classification:
The tribunal highlighted a government clarification which stated that preparations falling within the specified dosage range are considered pharmacopoeial. The tribunal noted that the Additional Collector had dismissed this clarification as "not relevant" without proper examination. The tribunal concluded that the product was indeed pharmacopoeial as it fell within the specified dosage range.

4. Proprietary nature of the medicine:
The department argued that the presence of the manufacturer's name on the carton indicated a proprietary nature, classifying it under Tariff Item 14E. The tribunal found this argument unsubstantiated, noting that it is a statutory requirement for the manufacturer's name to appear on the carton. The tribunal referenced the Madras High Court decision in the case of Indo-French Pharmaceutical Company, supporting the view that the mere presence of the manufacturer's name does not make the product proprietary.

5. Violation of Rule 96 ZN(2) of the Central Excise Rules, 1944:
The department claimed that the appellants violated Rule 96 ZN(2) as the recognised abbreviation for the relevant pharmacopoeia did not appear immediately after the drug name on the carton. The tribunal observed that the abbreviation did appear just below the name of the drug, which sufficed for compliance. Thus, the tribunal found no violation of Rule 96 ZN(2).

Conclusion:
The tribunal allowed the appeal, rejecting the department's contentions on all counts. The tribunal concluded that the Analgin Tablets were pharmacopoeial preparations, did not fall under Tariff Item 14E, and complied with all relevant rules and standards.