Delhi High Court Restores Ban on Triple-Drug Diabetes Pills, Flags Safety Risks

The dispute centers on fixed-dose combinations that pack three anti-diabetic medicines—Glimepiride, Pioglitazone and metformin—into a single pill. While each of these drugs is individually approved, their combination in one tablet was challenged for lacking scientific justification and posing potential safety risks.

While such pills are commonly promoted as a more convenient alternative to taking multiple medicines, the Delhi High Court’s division bench observed that medical experts have consistently cautioned against so-called “irrational” fixed dose combinations that lack sound scientific backing or carry concealed safety risks.

Dr Anoop Misra, Chairman of Fortis C-DOC Hospital for Diabetes and Allied Sciences, stated that combining three anti-diabetic drugs in a single formulation cannot be considered rational therapy. He explained that each medicine has distinct pharmacological properties and side-effect profiles, and should ideally be prescribed individually so that adverse reactions can be identified early.

According to him, separate dosing also allows physicians to tailor treatment based on a patient’s blood sugar levels. In contrast, escalating a triple-drug combination automatically raises the dose of all three medicines at once, which could be unsafe. “The only advantage is convenience,” Dr Misra noted, adding that he does not prescribe such fixed dose combinations.

Although the three drugs lower blood sugar through different mechanisms, an excess of any one of them can trigger adverse effects, he cautioned, as reported by The Print.

Acting on safety concerns, the central government issued two notifications on September 7, 2018, prohibiting the manufacture and sale of these triple-drug diabetes combinations.

The central government first acted against these combinations in September 2018, following recommendations from a sub-committee of the Drugs Technical Advisory Board (DTAB). The panel, constituted under Supreme Court directions, examined whether the combinations involved risk to humans, lacked therapeutic value, or included ingredients without justification.

After reviewing nearly 395 scientific publications, the committee concluded that the triple-drug combinations posed two major concerns. First, the simultaneous use of all three drugs increased the risk of hypoglycaemia, or dangerously low blood sugar. Second, manufacturers had failed to produce clinical data demonstrating that the drugs were safe as a combined formulation, relying instead on the safety profile of the individual components. The panel also noted that such combinations are not approved by major international regulators.

In February 2019, a single-judge bench of the Delhi High Court quashed the government notifications banning the drugs, terming the move arbitrary.

The judge reasoned that since the individual medicines were approved and featured in standard diabetes treatment guidelines, their combination could not be presumed unsafe. The court also gave weight to patient convenience, observing that taking one pill instead of three reduced pill burden.

This order effectively allowed the drugs to continue in the market and sent the matter back to the DTAB for reconsideration.

In the meantime, the central government and AIDAN moved a division bench to contest the single-judge bench’s decision.

The latest ruling decisively rejects that approach. The division bench held that it was legally and scientifically incorrect to assume that drugs behave the same way in combination as they do individually.

Under the Drugs and Cosmetics Act, such combinations qualify as new drugs, placing a statutory obligation on manufacturers to prove their safety and efficacy—an obligation they failed to discharge.

Crucially, the court clarified the scope of Section 26A of the Drugs Act, stating that the government does not need to wait for actual injury before stepping in. The law permits preventive action based on potential or foreseeable risk.

The court held that the approach adopted by the single-judge bench was “fundamentally flawed”, the Print reported.

The bench also cautioned against judicial overreach, observing that judges are “institutionally ill-equipped” to evaluate complex scientific data or decide appropriate drug dosages. By reassessing expert conclusions on its own, the single-judge bench had exceeded the permissible limits of judicial review.

The court held,

“It cannot be presumed, as a matter of law or science, that individual drug components would behave, interact, or manifest identical safety profiles when administered in combination… Such a presumption is antithetical to the regulatory framework,”

The division bench rejected the “convenience” rationale that had influenced the single-judge bench, holding that although a single pill may be easier for patients to take, “convenience cannot supplant considerations of safety”.

In conclusion, the high court upheld the appeal filed by the central government and AIDAN, overturned the 2019 judgment, and reinstated the ban on the manufacture, sale and distribution of the triple-drug combinations with immediate effect.