Bulk drug exemption applied to ethopabate used as a therapeutic ingredient in a veterinary formulation.

Ethopabate used in the manufacture of Amprol Plus was treated as a bulk drug eligible for Notification No. 31/88. The fact that the final product was not itself a medicament did not disqualify the drug from the exemption, because the notification focused on the drug's character and use as a therapeutic ingredient. Ethopabate was identified as a coccidiostat used to treat coccidiosis in birds, which supported its classification as a bulk drug. The notification also did not require the resulting formulation to meet pharmacopoeial standards. On that basis, denial of exemption was unsustainable and the benefit of the notification was available.

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Issues: (i) Whether ethopabate used in the manufacture of Amprol Plus was entitled to the benefit of Notification No. 31/88 as a bulk drug.

Analysis: The exemption was intended for bulk drugs subject to specified conditions. The fact that the product in which the drug was used was not itself a medicament did not, by itself, take the drug outside the notification. Ethopabate was found to be a coccidiostat used for treating coccidiosis in birds, and therefore a therapeutic ingredient. The notification did not require the resulting formulation to conform to pharmacopoeial standards. The reasoning was consistent with the principle that a bulk drug may be capable of use either by itself or as an ingredient in a formulation.

Conclusion: The appellant was entitled to the benefit of Notification No. 31/88 in respect of ethopabate, and the denial of exemption was unsustainable.

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