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Shoddy Safety/Effectiveness Evidence Behind India’s Top Selling Diabetes Drug Combos: Newcastle University Study

The evidence on which India’s top-selling drug combinations for diabetes have been approved for sale is shoddy, with the requisite trial data falling well short of the international standards set by the World Health Organization (WHO), finds the first study of its kind by Newcastle University, UK and published in the British Medical Journal Global Health.

So, poor is the data that, not only could the health of patients with type 2 diabetes be potentially put at risk, but they also call into question the role of the multinational corporations behind the manufacture of these drug combos, says senior author Allyson Pollock.

India is often referred to as ‘the diabetes capital of the world’, with 60 million of its population affected by type 2 disease. Two-thirds of all diabetes drugs sold in India are what is known as fixed-dose combinations, or FDCs for short, often containing metformin and one other drug.

The widespread use of FDCs runs counter to national and international guidelines which don’t recommend their use for treating type 2 diabetes, because of the need for constant monitoring and adjustment of drug doses to maintain adequate blood glucose control.

Amid mounting national and international concerns about the …

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