Drug ban on fixed dose corticosteroid combinations upheld as a valid public-health restriction on trade.

The Supreme Court of India considered whether a notification banning fixed dose combinations of corticosteroids with other drugs for internal use was valid under Section 26-A of the Drugs & Cosmetics Act and whether it unreasonably restricted trade under Article 19(1)(g). The Court relied on repeated expert examination by medical and regulatory bodies, which found the combinations irrational, difficult to titrate safely, and potentially harmful. It treated the ban as a public-health measure supported by expert material and found that lesser measures, such as warnings, would not adequately address the risk. The notification was upheld as a valid exercise of statutory power and a reasonable restriction on trade.

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Issues: (i) Whether the notification prohibiting fixed dose combinations of corticosteroids with any other drug for internal use was validly issued under Section 26-A of the Drugs & Cosmetics Act, 1940. (ii) Whether the prohibition imposed an unreasonable restriction on the petitioners' right to carry on trade under Article 19(1)(g) of the Constitution of India.

Issue (i): Whether the notification prohibiting fixed dose combinations of corticosteroids with any other drug for internal use was validly issued under Section 26-A of the Drugs & Cosmetics Act, 1940.

Analysis: The statutory power under Section 26-A permits prohibition where the Central Government is satisfied, on the basis of expert advice, that a drug is likely to involve risk, lacks therapeutic value, or has no therapeutic justification. The record showed repeated examination by the DCC, the expert committees, and the Board, all of which ultimately concluded that fixed dose combinations of corticosteroids with other drugs for internal use were irrational and potentially harmful, particularly because the dosage could not be properly titrated and the daily steroid dose could exceed safe limits. The material placed by the manufacturers did not displace those expert findings.

Conclusion: The notification was held to be a valid exercise of power under Section 26-A.

Issue (ii): Whether the prohibition imposed an unreasonable restriction on the petitioners' right to carry on trade under Article 19(1)(g) of the Constitution of India.

Analysis: In testing the restriction, the Court applied the settled standard of reasonableness, balancing the nature of the right, the object of the restriction, the extent of the harm sought to be prevented, and the adequacy of less drastic measures. Given the expert findings of therapeutic irrationality and harmful potential, and the public conditions noted by the Court, a mere warning label or lesser restriction was found inadequate to protect public health. The prohibition was therefore treated as a justified public-interest measure rather than an excessive restraint on trade.

Conclusion: The restriction was held not to violate Article 19(1)(g).

Final Conclusion: The challenge to the ban failed, and the impugned notification was upheld; the parties were left only with liberty to place fresh material before the Board for reconsideration within the time directed.

Ratio Decidendi: Where the Central Government, acting on expert medical advice under Section 26-A, records that a drug combination is irrational or harmful and lacking therapeutic justification, a prohibition imposed in the public interest will ordinarily be upheld as a reasonable restriction on trade unless shown to be arbitrary or unsupported by expert material.

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