1994 (11) TMI 132 - SC - Central Excise

Whether Kemicentine Vaginal Suppositories (KVS), a patent and proprietary medicine which contained the antibiotic chloramphenicol (CAF) was chloramphenicol and its esters for oral and parenteral use within the meaning of the Notification No. 116/69-C.E., dated 3-5-1969 as amended by the Notification No. 106/80-C.E., dated 19-6-1980 issued in exercise of powers conferred by sub-rule (1) of Rule 8 of Central Excise Rules, 1944? Held that - Once it is found that a medicine falls in the category of parenteral medicine then the benefit cannot be denied because it falls in category of those medicines which are applied locally. Topical or medicines used for local absorption appear to be included in the word parenteral . In fact the definitions which have been extracted earlier do support the claim of the appellant that there are only two classifications of the medicines - one, which are known as enteral, that is which passed through an alimentary canal and other parenteral which extends to all other medicines which are not enteral. The subsequent classification of the medicines used locally for convenience cannot take it away from the main and the broader classification of it being parenteral. Appeal succeeds and is allowed. The question raised by the appellant is decided by saying that the suppositories produced by the appellant were covered in the Notification No. 106/80-C.E., dated 19th June 1980 and, therefore, were entitled for total exemption.

Issues Involved:
1. Classification of Kemicetine Vaginal Suppositories (KVS) under the Notification No. 116/69-C.E., as amended by Notification No. 106/80-C.E.
2. Definition and scope of "parenteral use" in the context of the Notification.
3. Applicability of exemption for KVS based on its method of administration.
4. Interpretation of the term "parenteral" in pharmacological and legal contexts.

Detailed Analysis:

1. Classification of Kemicetine Vaginal Suppositories (KVS) under the Notification No. 116/69-C.E., as amended by Notification No. 106/80-C.E.
The main issue was whether KVS, containing the antibiotic chloramphenicol (CAF), qualified as "chloramphenicol and its esters for oral and parenteral use" under the amended Notification No. 116/69-C.E., dated 3-5-1969, and Notification No. 106/80-C.E., dated 19-6-1980. The Customs, Excise & Gold (Control) Appellate Tribunal had previously ruled against the appellant, stating that KVS did not meet the criteria for exemption as it was neither for oral nor parenteral use.

2. Definition and scope of "parenteral use" in the context of the Notification.
The appellant argued that the term "parenteral" should not be confined to injections only and should include other routes of administration that bypass the alimentary canal. The Tribunal, after examining various definitions from medical dictionaries and pharmacological texts, concluded that "parenteral" refers to the introduction of medicine by routes other than the alimentary canal. This includes methods like subcutaneous, intramuscular, and intravenous injections, but the Tribunal did not agree that all non-oral methods, such as vaginal administration, could be classified as parenteral.

3. Applicability of exemption for KVS based on its method of administration.
The Tribunal found that KVS was used for local absorption to treat infections and inflammations of the female genital tract. It concluded that since the absorption was local and not systemic, KVS did not qualify as a parenteral medicine. The Tribunal noted that systemic absorption was a key factor in defining parenteral administration, and since KVS was primarily for local use, it did not meet this criterion.

4. Interpretation of the term "parenteral" in pharmacological and legal contexts.
The court analyzed various definitions and interpretations of "parenteral" from medical and pharmacological sources. It noted that while "parenteral" generally referred to methods bypassing the alimentary canal, it also included a broader range of administration methods, such as inhalers. The court emphasized that the term "parenteral" should be understood in a wider sense, not limited to injections, and should include all methods that bypass the alimentary canal and enter the bloodstream directly.

Conclusion:
The court concluded that the term "parenteral" was broad enough to include medicines administered through routes other than the alimentary canal, including vaginal suppositories like KVS. It held that the Tribunal's narrow interpretation was incorrect and that KVS should be considered parenteral since it entered the bloodstream directly, bypassing the alimentary canal. Consequently, the court ruled that KVS was covered under the Notification No. 106/80-C.E., dated 19th June 1980, and was entitled to total exemption from excise duty.

Judgment:
The appeal was allowed, and the court decided that the suppositories produced by the appellant were covered under the Notification No. 106/80-C.E., dated 19th June 1980, and were therefore entitled to total exemption from excise duty. There was no order as to costs.

← Previous Next →