Delhi HC Restores Diabetes Drug Ban, Broadens Govt Regulatory Power
Overview
Delhi High Court has reinstated a ban on two fixed-dose combination (FDC) diabetes medications, ruling the government can prohibit drugs based on potential risk, not just proven harm. The decision strengthens regulatory authority under the Drugs and Cosmetics Act and impacts pharmaceutical manufacturers.
Stocks Mentioned
Court Reinstates Ban on Diabetes FDCs
The Delhi High Court recently reinstated a ban on two fixed-dose combination (FDC) medicines used to treat Type II Diabetes Mellitus. The government had previously issued notifications in 2018 to prohibit the manufacture and sale of these FDCs, which combine Glimepiride, Pioglitazone, and Metformin in specific dosages.
Upholding Government Authority
A Division Bench of Justices Anil Kshetarpal and Harish Vaidyanathan Shankar declared that the Central government acted within its powers to prohibit these FDC drugs in the interest of public health. This ruling overturned a single-judge order that had previously quashed the government's notifications.
Precautionary Principle Applied
The Court clarified that the government is not required to prove actual harm to human beings before banning a drug under Section 26A of the Drugs and Cosmetics Act, 1940. Instead, a ban can be imposed if there is a likelihood that the drug poses a risk to human health. The legislative intent is precautionary, focusing on potential or foreseeable risks rather than only demonstrable injury.
