The safety of some of India’s top-selling type 2 diabetes drugs has prompted international concern among researchers.
India has one of the highest rates of type 2 diabetes in the world, so researchers assessed the efficacy and safety of the top-selling drugs being used to treat the condition.
Study teams from the University of Massachusetts Amherst School of Public Health and Health Sciences in the US and Newcastle University in the UK used World Health Organization (WHO) guidelines to assess the efficacy of drugs which include a combination of metformin and one or more other drugs.
Known as fixed-dose combinations (FDCs), normally taken in tablet form, the drugs were developed to help make taking medication more convenient as they combine two or more drugs in a fixed ratio into a single dose form. The top five best-selling FDCs available in India are made by large multinational companies.
The study findings are relevant to a current court trial which is ongoing in India. In 2016, India’s government banned 344 unapproved FDCs which either did not have any clinical support or were found to not be safe to use.
However, the decision was later overturned by the state-level Delhi High Court later that year. The government appealed the decision and the Drugs Technical Advisory Board was given six months to reconsider the banned drugs.
Senior author Allyson Pollock from Newcastle University said: “The lack of good trial evidence for these five top-selling metformin combination medicines for treatment of type 2 diabetes is of deep concern.
“We want the medicines that doctors prescribe for their patients to be safe and effective and for that to be supported by sound evidence and by properly conducted, transparent clinical trials.”
Those involved in the research want the Central Drugs Standard Control Organisatio, who regulate all the drugs in India, to go public with the evidence for approving the FDCs which are currently being used to provide “confidence in their efficacy and safety”.
The researchers concluded: “Our examination exposes serious deficiencies in the evidence base for metformin FDCs for type 2 diabetes and raises questions about the role of multinational corporations in manufacturing these for sale and use.”
The report has been published in the British Medical Journal (BMJ).

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