Therapeutic ingredient excludes drug formulation from exemption where notification is limited to specified additive-based formulations.

Exemption under the cited notifications was confined to specified formulations and did not extend to a product containing pyrazinamide as a therapeutic ingredient. A formulation with a therapeutic agent could not be treated as a qualifying additive-based formulation for the purpose of the exemption. The benefit was therefore unavailable to Coxina-3, and the assessee's claim to exemption failed.

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Issues: Whether the medicine Coxina-3, containing rifampicin, isoniazid and pyrazinamide, was eligible for exemption under Notification Nos. 29/88, 30/88 and 141/89.

Analysis: The notifications extended exemption only to specified formulations. The formulation in question contained pyrazinamide, which is a therapeutic ingredient and not merely an inert or permissible additive. A formulation containing a therapeutic agent could not be brought within the scope of the notification intended for formulations of rifampicin and isoniazid, nor could it be treated as a qualifying formulation under the other notifications relied upon.

Conclusion: The exemption under the notifications was not available to Coxina-3, and the benefit had been wrongly granted.

Final Conclusion: The appeal was allowed and the assessee's claim to exemption under the cited notifications failed.

Ratio Decidendi: Where a notification restricts exemption to specified formulations and permits only non-therapeutic additives, the presence of a therapeutic ingredient takes the product outside the exemption.

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