Statutory interpretation of Section 26A: prior consultation with the Drugs Technical Advisory Board is not mandatory, but bans were sent for expert review.

Section 26A of the Drugs and Cosmetics Act, 1940 confers a distinct power on the Central Government to regulate, restrict or prohibit a drug or cosmetic when satisfied on relevant material that public interest requires action, and the provision does not import a mandatory prior consultation requirement with the Drugs Technical Advisory Board. Because the statute expressly requires consultation in other provisions but omits it here, the court refused to read such a condition into Section 26A. On the challenged fixed dose combinations, the bans were not finally left untouched: the affected products were directed to be re-examined by the expert body or its sub-committee, with stakeholder hearing and fresh consideration by the Central Government, while limited category-specific relief was granted for identified products.

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Issues: (i) Whether prior consultation with the Drugs Technical Advisory Board was a mandatory condition precedent to the exercise of power under Section 26A of the Drugs and Cosmetics Act, 1940. (ii) Whether, on the peculiar facts, the notifications banning the fixed dose combinations should be sustained, modified, or reconsidered by the competent expert body, and what relief followed for the categories of drugs specifically identified by the Court.

Issue (i): Whether prior consultation with the Drugs Technical Advisory Board was a mandatory condition precedent to the exercise of power under Section 26A of the Drugs and Cosmetics Act, 1940.

Analysis: Section 26A confers an additional power on the Central Government to regulate, restrict, or prohibit manufacture, sale, or distribution of a drug or cosmetic if it is satisfied on relevant material that the statutory grounds are made out and that action is necessary or expedient in public interest. The provision is materially distinct from other provisions in the Act where consultation with the Board is expressly required. The omission of any reference to consultation with the Board in Section 26A was treated as deliberate, especially because the same amendment that introduced Section 26A also amended other provisions to refer expressly to the Board. The Court held that the language of Section 26A is clear and does not permit the addition of a mandatory consultation requirement by reading words into the provision. Reliance on stray sentences in earlier cases was held insufficient to establish a binding rule that Board consultation is obligatory in every Section 26A case.

Conclusion: Prior consultation with the Drugs Technical Advisory Board is not mandatory for the exercise of power under Section 26A.

Issue (ii): Whether, on the peculiar facts, the notifications banning the fixed dose combinations should be sustained, modified, or reconsidered by the competent expert body, and what relief followed for the categories of drugs specifically identified by the Court.

Analysis: Although the High Court judgment was set aside on the consultation issue, the Court considered the factual backdrop of the bans already imposed and the extent of expert examination that had occurred. To avoid further litigation and to ensure a deeper review, the Court directed that the affected fixed dose combinations be re-examined by the Drugs Technical Advisory Board or a sub-committee constituted by it, with hearing to the affected parties and other stakeholders, and with a report to be placed before the Central Government for fresh consideration. The Court also distinguished the pre-1988 products and the cases involving alleged prior approval by the drug controller, and made separate directions for them. In the transferred Madras matters, the Court accepted the expert report and disposed of those petitions accordingly.

Conclusion: The impugned judgment was set aside, the matter was remitted for expert reconsideration in the manner directed, the notifications concerning the pre-1988 products were set aside, and the transferred Madras matters were disposed of in terms of the accepted expert report.

Final Conclusion: The Central Government's power under Section 26A was upheld as exercisable without compulsory prior consultation with the Drugs Technical Advisory Board, but the challenged bans were subjected to further expert review and limited category-specific relief was granted.

Ratio Decidendi: Where a statute confers a power in clear terms and expressly requires consultation in some provisions but omits it in another, the court will not read in a mandatory consultation requirement unless the text or context unmistakably compels that result; the statutory authority's satisfaction must instead rest on relevant material and public interest.

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