Section 26A prohibition needs relevant material; ban on corticosteroid-bronchodilator combination failed for lack of demonstrated statutory satisfaction.

Section 26A of the Drugs and Cosmetics Act permits prohibition of a drug only where the Central Government's satisfaction is founded on relevant material showing risk, lack of therapeutic value, or absence of therapeutic justification, and where prohibition is necessary in public interest. The ban on the fixed dose combination of corticosteroids with bronchodilators for internal use was found unsustainable because the record did not show that the required material, such as medical literature, clinical data, or other reliable information, had been placed before and considered by the Board before recommendation of the ban. The earlier governmental view that the combination was beneficial for bronchial asthma reinforced the absence of a demonstrated basis for the change in stance.

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Issues: Whether the notification banning the fixed dose combination of corticosteroids with bronchodilators for internal use was sustainable under Section 26A of the Drugs and Cosmetics Act, 1940 in the absence of demonstrated relevant material before the Government.

Analysis: Section 26A permits prohibition only when the Central Government is satisfied, on relevant material, that a drug is likely to involve risk, lacks therapeutic value, or contains ingredients without therapeutic justification, and that prohibition is necessary in public interest. The challenge succeeded because the record did not show that material of the kind required by the provision, such as medical literature, clinical data, or other reliable information, had been placed before and considered by the Board before the ban was recommended. The earlier governmental view that the combination was beneficial for bronchial asthma, together with the absence of any shown basis for the changed stance, indicated that the statutory satisfaction was not demonstrably founded on relevant material.

Conclusion: The ban was held unsustainable for want of shown relevant material supporting the statutory satisfaction under Section 26A, and interim relief was warranted.

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