Pharmacopoeial recognition supports drug classification of imported lysine mono hydrochloride, with ambiguity resolved for the importer.

Lysine mono hydrochloride was treated as eligible for classification as a drug or drug intermediate under the relevant import policy because authoritative pharmacopoeial sources showed recognised medicinal character. The absence of a specific Merck Index reference was not decisive, and a feed-grade description did not by itself exclude drug classification where therapeutic or pharmaceutical character was established. Where doubt remained, classification was to be resolved in favour of the importer, making refusal of clearance unsustainable.

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Issues: Whether lysine mono hydrochloride imported by the appellant was entitled to clearance as a "drug/drug intermediate not elsewhere specified" under Entry 182 of Appendix 6 Part II of the Import Policy 1988-91.

Analysis: The product was shown to have recognised medicinal and pharmacopoeial significance. Its mention in standard pharmacopoeias supported the view that it answered the description of a drug, and the absence of a specific reference in the Merck Index was not ative. A mere feed-grade description did not exclude it from being treated as a drug where its recognised therapeutic or pharmaceutical character was established. In case of doubt, the benefit had to go to the importer.

Conclusion: The import was held to fall within the claimed entry and the refusal of clearance was unsustainable.

Final Conclusion: The appellant succeeded and the order denying clearance was set aside.

Ratio Decidendi: Where an imported product is recognised in authoritative pharmacopoeial sources as having medicinal character, it may be treated as a drug for import classification, and ambiguity in classification should be resolved in favour of the importer.

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