Licence conditions cannot impose a product-wise ceiling on restricted medicinal preparations without statutory authority.

The Medicinal and Toilet Preparations (Excise Duties) Act and Rules permit manufacture of restricted medicinal preparations only under licence and subject to prescribed conditions, but they do not authorise a product-wise 10% ceiling on any single restricted preparation under an L-1 licence. Rule 84(2) allows the licensing authority to assess and, where necessary, reduce or refix the quantity of alcohol required by a manufacturer, while Rules 86 and 142 operate only within prescribed conditions and supplemental instructions. Rule 91(ix) requires disclosure of proposed preparations, but not a quantitative cap on one product. The 10% restriction, imposed to support the prohibition programme and prevent misuse, was therefore invalid for want of statutory authority.

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Issues: Whether the 10% ceiling imposed on the manufacture of any single restricted medicinal preparation under the L-1 licence was authorised by the Act and Rules.

Analysis: The licensing scheme under Section 6 of the Medicinal and Toilet Preparations (Excise Duties) Act permits production only under licence and subject to restrictions and conditions prescribed by the Rules. Rule 84(2) empowers the licensing authority to satisfy itself about the quantity of alcohol required by a manufacturer and to reduce or refix that quantity where necessary, while Rules 86 and 142 operate only within the limits of prescribed conditions and supplemental instructions. Rule 91(ix) requires disclosure of the preparations proposed to be manufactured, but it does not authorise a quantitative ceiling on any single restricted product. The impugned 10% restriction was imposed to further the prohibition programme and to prevent alleged misuse, yet no rule or statutory provision confers power to impose such a product-wise ceiling on manufacture.

Conclusion: The 10% ceiling on manufacture of any single restricted preparation was not authorised by the Act or the Rules and was invalid.

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