1979 (7) TMI 105 - CGOVT - Central Excise

Summary

Issues:
1. Interpretation of whether `Analgin Injection' can be classified as a drug or medicinal preparation under the Central Excise Tariff.
2. Determining the relevance of monographs in the USSR-Pharmacopoeia and the approval from the Commissioner of Food and Drug Administration of Maharashtra State in classifying the product.
3. Understanding the significance of separate monographs for different forms of pharmacopoeial preparations in the context of the Central Excise Tariff classification.

Analysis:
The judgment involves a review case concerning the classification of `Analgin Injection' under the Central Excise Tariff. The central issue revolves around whether the product should be considered a drug or medicinal preparation falling under a specific tariff item. The Appellate Collector had classified the product based on its compliance with monograph 57 of the USSR-Pharmacopoeia and the approval from the Commissioner of Food and Drug Administration of Maharashtra State. However, the Government of India analyzed that monograph 57 only covers Analgin in powder form, indicating separate monographs for different forms of drug preparations. This led to the conclusion that the mere presence of dosages for injections in a monograph does not automatically categorize the product under that monograph. The absence of a specific monograph for Analgin Injection in the USSR-P implies that the product should be levied duty under Tariff Item 14-E, as per the Central Excise Tariff's scope for patent or propriety medicines.

Furthermore, the judgment emphasizes the importance of distinct monographs for various forms of pharmacopoeial preparations. It highlights examples from both the USSR-Pharmacopoeia and the Indian Pharmacopoeia to illustrate that separate monographs exist for different forms of drug preparations, such as powders, tablets, and injections. The presence of separate monographs for similar substances underscores the necessity for a specific monograph to classify a product as a pharmacopoeial preparation. The absence of comprehensive details, including all constituents and method of assaying, in the monograph for Analgin Injection further supports the decision that the product does not align with the criteria for a pharmacopoeial preparation. This detailed analysis of the monograph system in pharmacopoeias strengthens the Government's stance in classifying Analgin Injection under the relevant tariff item.

In conclusion, the judgment clarifies the interpretation of monographs in pharmacopoeias and the significance of separate monographs for different forms of drug preparations in determining the classification of products under the Central Excise Tariff. The absence of a specific monograph for Analgin Injection in the USSR-Pharmacopoeia led to the decision that the product should be dutiable under Tariff Item 14-E, highlighting the importance of precise classification criteria based on pharmacopoeial standards.