Court restores ban on 2 FDC drugs for diabetes

A Division Bench of Justice Anil Kshetarpal and Justice Harish Vaidyanathan Shankar upheld the Central government’s 2018 notifications prohibiting the manufacture and sale of specific fixed-dose combinations containing Glimepiride, Pioglitazone and Metformin in varying strengths.

The formulations under the ban included Glimepiride 1 mg or 2 mg with Pioglitazone 15 mg and Metformin 850 mg, as well as combinations involving Glimepiride up to 3 mg with Pioglitazone 15 mg and Metformin 1000 mg.

The Bench set aside an earlier single-judge order that had quashed the government notifications, holding that the decision to interfere with the statutory process under the Drugs and Cosmetics Act, 1940 was legally unsustainable. The Union government had challenged that order, arguing that the ban was imposed following due procedure and expert evaluation, in the interest of public health.

Accepting the Centre’s position, the High Court ruled that the government had acted squarely within the powers conferred on it under Section 26A of the Drugs and Cosmetics Act. The provision allows the Central government to prohibit the manufacture, sale or distribution of a drug if it is satisfied that the drug is likely to involve a risk to human beings or that it lacks therapeutic justification.

In a crucial clarification, the Court rejected the notion that an actual injury or proven harm must be established before such a ban can be imposed. The Bench underlined that Section 26A embodies a precautionary principle, designed to avert harm rather than merely respond to it after the fact.

The Court observed that the statutory standard does not demand proof of demonstrable injury to patients. What matters is whether continued use of the drug carries a foreseeable or potential risk to human health. The focus, the judges said, is not on waiting for adverse outcomes to surface, but on assessing the likelihood of risk based on available material and expert inputs.