Therapeutically inert excipients preserve excise exemption for patent medicines under the exemption notification.

A patent or proprietary medicine remained within Notification No. 116/69 where the added ingredients were only pharmaceutical necessities, were therapeutically inert, and did not interfere with the therapeutic activity of the scheduled ingredient. On that basis, Amezole Tablets were treated as eligible for exemption because the extra ingredients functioned merely as excipients. The note also reflects that the existence of an alternate statutory remedy did not bar writ relief under Article 226 where the petition had already been entertained long earlier and heard on merits. The duty exemption claim was accordingly allowed and the excise orders were set aside with consequential relief.

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Issues: (i) Whether Amezole Tablets were eligible for exemption under Notification No. 116/69 despite containing ingredients not specified in the Schedule, and (ii) whether the availability of an alternate statutory remedy should preclude exercise of jurisdiction under Article 226 of the Constitution of India.

Issue (i): Whether Amezole Tablets were eligible for exemption under Notification No. 116/69 despite containing ingredients not specified in the Schedule.

Analysis: The exemption under Notification No. 116/69, issued under Rule 8(1) of the Central Excise Rules, 1944, extended to patent or proprietary medicines containing scheduled ingredients, subject to the proviso that any additional ingredients must be pharmaceutical necessities such as diluents, disintegrating agents, lubricants, buffering agents, stabilisers or preservatives, and must be therapeutically inert without interfering with the therapeutic or prophylactic activity of the scheduled ingredient. Applying the earlier reasoning on a similar formulation, the Court found that the extra ingredients in Amezole Tablets were used in such small quantities that they functioned only as excipients and did not operate as antacids or interfere with the therapeutic activity of Metronidazole.

Conclusion: Amezole Tablets were entitled to exemption under Notification No. 116/69, in favour of the assessee.

Issue (ii): Whether the availability of an alternate statutory remedy should preclude exercise of jurisdiction under Article 226 of the Constitution of India.

Analysis: Although an alternate statutory remedy existed, the petition had been entertained long earlier and had proceeded to a hearing on merits. In these circumstances, the Court declined to refuse relief on the ground of alternative remedy at such a late stage.

Conclusion: The writ petition was not rejected on the ground of alternate remedy, in favour of the assessee.

Final Conclusion: The duty exemption claim succeeded and the impugned excise orders were set aside, with consequential relief granted to the petitioners.

Ratio Decidendi: For an exemption notification of this kind, additional ingredients do not take the medicine outside the exemption if they are merely pharmaceutical necessities, are therapeutically inert, and do not interfere with the therapeutic or prophylactic activity of the scheduled ingredient.

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