Bulk drug exemption requires more than pharmacopoeial conformity where commercial packaging and use show non-medicinal character.

Monosodium glutamate imported in 100 gm consumer packs was analysed against customs and central excise exemption notifications for bulk drugs. The decisive factors were its packaging in small retail packs, the absence of NF grade on the packets, and the declared use as a flavour enhancer in the food industry. Mere conformity with a recognised pharmacopoeia and possible medicinal use were held insufficient to treat the product as a bulk drug. The surrounding commercial context and the lack of satisfactory end-use support showed predominant non-medicinal use, so the exemption benefit was not available.

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Issues: Whether monosodium glutamate imported in 100 gm packs was a bulk drug entitled to exemption under the customs and central excise notifications.

Analysis: The imported goods were packed in small consumer packs, the packets did not indicate NF grade, and the declared use on the packing showed use as a flavour enhancer in the food industry. The claim that conformity with a recognised pharmacopoeia and capability of medicinal use was sufficient to treat the product as a bulk drug was rejected. The reasoning distinguished the earlier view relied on by the assessee and applied the principle that a product does not become a drug merely because it can be used medicinally; all surrounding facts, including predominant commercial use and the absence of supporting indicia of drug character, must be considered. The absence of satisfactory end-use support also weighed against the claim.

Conclusion: The imported goods were not a bulk drug and the benefit of the exemption notifications was not available.

Ratio Decidendi: Conformity with pharmacopoeial standards and mere capability of medicinal use do not, by themselves, make a product a bulk drug when the surrounding facts show predominant non-medicinal use.

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