Bulk drug exemption turns on official pharmacopoeia status and manufacturing licence support under excise notification.

Eligibility for central excise exemption as a bulk drug depended on whether the product conformed to an official pharmacopoeia; earlier decisions had already accepted Martindale Extra Pharmacopoeia as an official pharmacopoeia of Great Britain, and that view was followed here. The Drug Controller's licence treating the item as a bulk drug also supported the exemption claim. On that basis, the product qualified for the notification benefit and the Revenue's objection that it lacked official pharmacopoeial standards was rejected.

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Issues: Whether the product in question was eligible to be treated as a bulk drug for the purpose of exemption under the relevant central excise notification, including whether Martindale Extra Pharmacopoeia could be regarded as an official pharmacopoeia.

Analysis: The dispute turned on the Revenue's objection that the product did not conform to the standards of an official pharmacopoeia and therefore could not qualify as a bulk drug. The Tribunal noted that the issue had already been decided in earlier cases holding that Martindale Extra Pharmacopoeia is an official pharmacopoeia of Great Britain, and that those decisions had distinguished the contrary view relied upon by the Revenue. The Tribunal also took note that the Drug Controller had granted a licence to manufacture the item as a bulk drug, which supported the respondent's claim to the notification benefit.

Conclusion: The product was held to be a bulk drug eligible for the exemption, and the Revenue's challenge was rejected.

Ratio Decidendi: Where the relevant pharmacopoeia is accepted as an official pharmacopoeia and the manufacturing licence treats the product as a bulk drug, the exemption cannot be denied on the ground that the drug lacks official pharmacopoeial standards.

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