Bulk drug exemption applied to Solvent Ether used in anaesthetic formulation for surgical treatment purposes.

Solvent Ether conforming to Indian Pharmacopoeial standards was treated as a "bulk drug" because it was used as an ingredient in anaesthetic ether and therefore within the exemption for bulk drugs, medicines and drug intermediates. The decisive point was that an anaesthetic used in surgery is used in the treatment of disease: surgery itself was regarded as treatment, and an anaesthetic employed for that purpose was not excluded merely because it lacked independent therapeutic or prophylactic properties. Duty exemption under Notification No. 104/82, as amended by Notification No. 197/82, was accordingly available.

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Issues: Whether Solvent Ether conforming to Indian Pharmacopoeial standards and used in the manufacture of anaesthetic ether qualified as a "bulk drug" eligible for exemption under Notification No. 104/82 as amended by Notification No. 197/82.

Analysis: The notification exempted bulk drugs, medicines and drug intermediates, and defined "bulk drugs" as chemical, biological or plant products conforming to pharmacopoeial standards and used for diagnosis, treatment, mitigation or prevention of diseases in human beings or animals, and used as such or as an ingredient in any formulation. Solvent Ether satisfied the requirement of conforming to pharmacopoeial standards and was used as an ingredient in the formulation of anaesthetic ether. The decisive question was whether an anaesthetic used in surgical procedures could be regarded as used for the treatment of diseases. The reasoning accepted that surgery is itself a form of treatment, and that an anaesthetic employed in such treatment is used for treatment of diseases even though it may not itself possess therapeutic or prophylactic properties.

Conclusion: Solvent Ether was held eligible for duty exemption under Notification No. 104/82 as amended by Notification No. 197/82.

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