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Informist, Wednesday, Jan. 14, 2026

--HC OKs ban on fixed-dose combinations to cure type-II diabetes mellitus

--CONTEXT: HC order on govt plea against Lupin, Eris Lifesciences, others

NEW DELHI – Delhi High Court has upheld a ban by the government on two fixed-dose combinations used for the treatment of type-II diabetes mellitus, and ruled against Lupin Ltd., Eris Lifesciences Ltd., Micro Labs Ltd., and Intas Pharmaceuticals Ltd. A division bench of Justice Anil Kshetarpal and Justice Harish Vaidyanathan Shankar set aside a single judge's 2019 order that had ruled in favour of the pharmaceutical companies and nullified the government's ban.

Section 26A of the Drugs and Cosmetics Act, 1940, expressly empowers the central government to prohibit a drug that contains ingredients in quantities for which there exists no therapeutic justification, the division bench observed. The statutory framework does not mandate the establishment of actual or demonstrable harm in every case; the absence of therapeutic justification, when assessed in the light of expert opinion and overarching public health considerations, by itself constitutes a sufficient statutory trigger for regulatory intervention, the bench observed.

In 2018, the government had banned these fixed dose combinations on the grounds that these involved risk to human beings and lacked adequate safety justification. The ban was based on the Drug Technical Advisory Board sub committee's recommendation to the government. The sub-committee recommended prohibition on the grounds that one of the fixed dose combinations might involve risk of hypoglycemia and that no safety data pertaining to it was available. Further, availability of multiple strengths on one of the single fixed dosage combination could lead to medication errors, said the sub-committee.

The sub-committee, an expert body constituted after directions of the Supreme Court, comprised specialists drawn from diverse disciplines that had co-opted additional experts. It examined a vast body of scientific material and engaged in extensive deliberations prior to formulating its recommendations, said the division bench. Once an expert body recorded its conclusions on matters of safety and risk, it was not open to the single judge bench to substitute such expert assessment with judicial reasoning grounded "on assumptions other than the expert material," said the division bench. In matters of drug regulation, where expert bodies have identified specific risks associated with particular formulations, it is impermissible for the court to dilute those concerns on the basis of broad generalization unsupported by technical material, the division bench observed.

The government had argued that the two fixed dose combinations were not supported by any dedicated clinical trial data, safety data, or scientific evidence validating their usage, dosage, or risk profile as combinations, and that the absence of such data was a determining factor weighed by the expert body while recommending prohibition. The ban on these fixed dose combinations was clearly warranted with public health being an integral and inseparable facet of public interest, said the government. Where the use of such fixed dose combinations was found to be likely involving risk to human beings, coupled with the absence of supporting clinical data and the lack of clear therapeutic justification, the central government was justified in treating such formulations as inherently injurious to public health, it added.

At 1400 IST, the shares of Lupin were at INR 2,205 on the National Stock Exchange, up 1.2%. Shares of Eris Lifesciences were down 0.3% at INR 1,462.30.  End

IST, or Indian Standard Time, is five-and-a-half hours ahead of GMT

Reported by Surya Tripathi

Edited by Nishant Maher

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