Delhi HC restores ban on diabetes FDC drugs; proof of harm not needed

The Delhi High Court reinstated the Centre's 2018 ban on certain diabetes fixed-dose combination drugs, ruling that the law allows action based on potential health risks

The Delhi High Court has restored the prohibition on two fixed-dose combination (FDC) drugs prescribed for Type-II diabetes, overturning a previous single-judge’s order and ruling that the Centre acted within its statutory mandate to safeguard public health while imposing the ban.

 

The ban dates back to twin notifications issued by the Centre in 2018, which prohibited the manufacture and sale of formulations combining glimepiride, pioglitazone, and metformin in specified strengths. Those notifications had earlier been set aside by a single judge, prompting an appeal by the Union government.

 

Allowing the appeal, a Division Bench comprising Justice Anil Kshetarpal and Justice Harish Vaidyanathan Shankar held that the single-judge decision improperly interfered with the statutory scheme under the Drugs and Cosmetics Act, 1940. The Bench restored the ban, finding no infirmity in the Centre’s exercise of power.

   

The court further clarified the scope of Section 26A of the Act, holding that the government is not required to demonstrate actual or proven harm before prohibiting a drug. It is sufficient, if there is a reasonable likelihood that continued use of the medicine could pose a risk to human health, the Bench said.

 

Emphasising the precautionary character of the provision, the court noted that the statutory threshold focuses on potential or foreseeable danger rather than demonstrable injury, underscoring that public health protection permits regulatory intervention at the stage of risk itself.

 

“We are of the considered opinion that the statutory standard prescribed under Section 26A of the Drugs Act does not require the establishment of actual or proven harm to human beings. The legislative intent underlying the provision is clearly precautionary in nature and is satisfied once it is shown that the use of a drug is likely to involve risk to human health. The focus of the inquiry, therefore, is not on demonstrable injury but on the potential or foreseeable risk arising from continued use of the drug,” the court observed.