1990 (5) TMI 154 - AT - Customs

Summary

Issues:
1. Interpretation of Exemption Notification 234/82-C.E. for Customs duty and additional duty of Customs (CVD) on imported goods.
2. Determination of eligibility for exemption under the notification based on Pharmacopoeial standards.
3. Consideration of evidence from standard works on chemicals and drugs to establish conformity to Pharmacopoeial standards.
4. Assessment of the use of imported goods for treatment, mitigation, or prevention of diseases in humans to qualify as bulk drugs.

Analysis:
The appeal challenged the order of the Collector of Customs (Appeals) upholding the denial of a refund claim for reassessment of imported goods for CVD purposes under Exemption Notification 234/82-C.E. The dispute centered on the inclusion of Cimetidine in the Pharmacopoeia before 1-1-1985, as required for exemption eligibility. The appellants contended that Cimetidine, a histamine H2-receptor antagonist used in gastric and duodenal ulcer treatment, met Pharmacopoeial standards and qualified as a bulk drug under the notification. They cited the Martindale The Extra Pharmacopoeia and the Merck Index to support their claim.

The lower authorities had denied the exemption, citing that Cimetidine was not in the Pharmacopoeia at the time of import and clearance. However, the appellate tribunal noted the evidence presented by the appellants, demonstrating Cimetidine's inclusion in the Martindale The Extra Pharmacopoeia and its therapeutic uses. The tribunal emphasized that the definition of bulk drugs under the notification encompassed chemicals conforming to Pharmacopoeial standards and used for disease treatment. The tribunal found that Cimetidine met these criteria based on the evidence provided by the appellants.

The tribunal highlighted that the notification did not specify adherence to Indian Pharmacopoeial standards, making the inclusion in the Martindale The Extra Pharmacopoeia sufficient for exemption eligibility. The appellants' use of Cimetidine as a single ingredient formulation in medical products further supported its classification as a bulk drug. Consequently, the tribunal ruled in favor of the appellants, allowing the appeal and granting exemption for CVD purposes under Notification 234/82.