Pharmaceutical excipients preserve excise exemption when therapeutically inert and non-interfering, while delayed alternative-remedy objections fail.
Patent or proprietary medicines remain eligible for exemption under Notification No. 116/69 where additional ingredients are only pharmaceutical necessities, are therapeutically inert, and do not interfere with the scheduled ingredient's therapeutic or prophylactic activity. Amezole Tablets satisfied these conditions because their additional ingredients operated only as excipients and not as antacids. The exemption claim therefore succeeded, and the excise orders were set aside with consequential relief. Although an alternative statutory remedy existed, writ relief was not refused because the petition had long been entertained and proceeded to merits hearing.
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.