1996 (12) TMI 230 - AT - Customs

Tribunal Classifies Lysine Hydrochloride as Drug Import, Emphasizes Therapeutic Value

The Tribunal allowed the appeal, setting aside the Collector (Appeals)' decision to deny clearance for imported lysine mono hydrochloride under the Import ... Lysine Mono hydrochloride Issues:1. Interpretation of entry 182 of App 6 Part II of the Import Policy 1988-91 regarding the import of lysine mono hydrochloride.2. Determination of whether lysine mono hydrochloride qualifies as a drug/drug intermediate for clearance.3. Consideration of the Merck Index certification and other pharmacopoeias in determining the therapeutic value of lysine hydrochloride.4. Analysis of whether lysine in feed grade can be classified as a drug.5. Application of previous judgments and legal principles to determine the classification of lysine hydrochloride.Analysis:The appellant imported lysine mono hydrochloride and sought clearance under entry 182 of the Import Policy 1988-91, which pertains to 'drug/drug intermediate not elsewhere specified.' The Collector (Appeals) initially rejected the claim, citing the absence of certification in the Merck Index that the goods were therapeutic. The appellant argued that lysine hydrochloride has recognized therapeutic value for certain ailments according to Martindale The Extra Pharmacopoeia and The United States Pharmacopoeia. The appellant contended that, in the absence of a specific definition of 'drug/drug intermediates,' reference should be made to The Drugs and Cosmetics Act, 1940, where lysine qualifies as a drug.The Departmental Representative argued that the imported lysine was in feed grade and that the term 'drug' may encompass items beyond those with therapeutic properties. The Martindale Extra Pharmacopoeia provided information on lysine, stating its use as a dietary supplement and in the treatment of specific conditions. The appellant relied on a Bombay High Court judgment to establish that inclusion in pharmacopoeias indicates an item's classification as a drug. The Tribunal's previous decision in Eskayef Limited v. Collector of Central Excise supported the classification of feed supplements as drugs under certain circumstances.The Tribunal allowed the appeal and set aside the impugned order. The decision was based on the finding that the Collector (Appeals) had primarily relied on the absence of the item in the Merck Index to deny classification as a drug, which was deemed insufficient. Additionally, the Tribunal considered previous judgments and legal principles to support the classification of lysine hydrochloride as a drug, even if administered as a feed supplement. The principle of resolving doubts in favor of the importer was also highlighted in the judgment, emphasizing the need to interpret classifications liberally in such cases.