Manufacturers appeal to courts to allow continued sales of products the government deems risky

India has banned 344 fixed dose combination (FDC) drugs, including several antibiotics and analgesic (such as codeine-containing cough syrups), as they ‘involve risk to humans’ and safer alternatives are available.

The banned medicines, which combine several active ingredients in a single formulation, are listed in a government gazette notification dated 10 March. The ban came into effect immediately. According to the notification, the government’s expert advisory panel found the drugs had ‘no therapeutic justification.’ The ban is aimed at curbing the misuse of such medicines.

India is flooded with hundreds of FDC formulations that contain banned, restricted or never-approved drugs. This is due to inconsistent enforcement of laws between state and central regulators. In 2014, India set up a committee to review more than 6000 combinations that had entered the market based only on state regulators’ approval.

Several manufacturers of affected products, including Pfizer, Abbott, Macleods Pharma and Glenmark Pharmaceuticals have appealed to the courts and received interim injunctions.

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