Study reveals “concerning” low standards of type 2 diabetes drugs in India

pharmafile | March 7, 2018 | News story | Research and Development India, diabetes, pharma, regulatory, type 2 diabetes 

In what they believe is the first study of its kind, a team of researchers at the University of Massachusetts Amherst and Newcastle University have revealed that India’s regulatory system, particularly for type 2 diabetes treatments, allows the use of drugs which have not been proven safe or effective, falling well behind standards set by the World Health Organization.

India boasts one of the highest rates of type 2 diabetes in the world, which only serves to reinforce the team’s assertion that the current climate in the country is a cause for, “growing national and international concern”.

In the study, the team assessed the efficacy and safety of the top-selling diabetes drugs in India by referring to WHO guidelines for approving metformin fixed-dose combinations (FDC) by examining published literature, clinical trial registries and other data on the use of the drugs in adult type 2 diabetes patients. While these fixed ratio drug combos can prove more convenient and less expensive for patients, there are currently no national or international guidelines recommending FDCs for the treatment of type 2 diabetes; according to the researchers, this is due to the fact that individual blood sugar monitoring and adjustment is crucial for effective treatment of the condition.

Senior author Allyson Pollock noted that the nation’s top five best-selling FDC’s for type 2 diabetes are all manufactured by multinational corporations, adding: “The lack of good trial evidence for these five top-selling metformin combination medicines for treatment of type 2 diabetes is of deep concern.”

Lead author Valerie Evans pointed out that these low standards are particularly troubling given India’s position as a pharmaceutical manufacturer and distributor to the wider world, “so if there’s a problem it can go everywhere”.

“You hope that the regulatory systems in the consumer countries can filter out problems, but that’s not always the case,” she remarked. “We feel that people really need to know about this. 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.”

Even more troubling, the study points out, is the fact that, while the Indian Government banned 344 unapproved and potentially harmful FDCs lacking clinical evidence in March 2016, this decision was overturned by the state-level Delhi High Court in December that same year.

“Those FDCs should be banned immediately,” argued Pollock. “The Government’s 2016 ban on FDCs should be reinstated and a review of FDCs mandated by the Indian Parliament.”

The team’s paper states: “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 team are now calling for Indian regulator the Central Drugs Standard Control Organization to publicise its evidence for approving currently-used FDCs in order to provide “confidence in their efficacy and safety.”

Matt Fellows

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