India bans 344 combination drugs


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.


Related Content

Indian U-turn on diabetes drug ban

16 August 2013 News and Analysis

news image

Suspension of cheap and popular medicine reversed but will now come with new safety warnings

Another drug suspension overturned in India

6 September 2013 News and Analysis

news image

Safety concerns put sales of antidepressant Deanxit on ice until firms petitioned a high court

Most Commented

Sweet tear sensor could ease pain of diabetes

29 June 2016 Research

news image

New non-invasive sensor could check blood glucose levels using tears

The next generation

24 June 2016 Premium contentFeature

news image

Elinor Hughes catches up with some of the latest materials and processes in photovoltaics research