Metronidazole exemption construed broadly for medicinal formulation where the active ingredient remained present despite ester form.

Idometrin Suspension containing metronidazole benzoate and di-iodohydroxyquinoline was treated as covered by the exemption for patent and proprietary medicines containing metronidazole under Notification No. 116/69-CE. The benzoate ester was regarded only as a formulation used to improve palatability for children, while the active ingredient remained metronidazole; the ester form did not negate the presence of the specified ingredient. A narrow construction that would defeat the exemption's object was rejected, and the product was held entitled to the exemption.

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Issues: Whether Idometrin Suspension containing metronidazole benzoate, along with di-iodohydroxyquinoline, was entitled to exemption under Notification No. 116/69-CE.

Analysis: The notification exempted patent and proprietary medicines containing specified ingredients, including metronidazole. The disputed product contained the benzoate ester of metronidazole, used to make the preparation palatable to children. The active ingredient remained metronidazole, and the ester form did not alter the substantive presence of the specified ingredient. The notification was construed in light of its object of granting exemption to medicines containing the specified ingredients, and a narrow construction that would defeat that purpose was rejected.

Conclusion: The product was held entitled to the exemption under Notification No. 116/69-CE, and the appeal was dismissed.

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