Exemption for drug formulation in hydrochloride salt form upheld where the active ingredient remained covered by the notification.

Exemption under Notification No. 122/86-C.E. was held to extend to a medicinal formulation containing the specified drug as its hydrochloride salt, because the active ingredient remained present in the formulation. Prior Tribunal decisions were applied to treat salt or ester form as not defeating exemption where the specified ingredient was otherwise covered, and the later amendment and trade notice were treated as clarificatory support for that interpretation. On that basis, the denial of exemption was not sustainable and the appellant was entitled to the notification benefit.

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Issues: Whether the benefit of Notification No. 122/86-C.E. dated 01.03.1986 was available to a formulation containing the specified drug in the form of its hydrochloride salt.

Analysis: The exemption notification was applied in the light of prior Tribunal decisions holding that where the specified ingredient is present as the active ingredient in a medicinal formulation, the benefit of exemption is not denied merely because it appears in a salt or ester form. The later amendment and trade notice were treated as supporting the view that the notification was intended to cover such formulations and that the amendment was clarificatory in nature.

Conclusion: The appellant was entitled to the exemption under Notification No. 122/86-C.E. and the denial of benefit was not sustainable.

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