UMass Expert, International Team Sound Alarm on Diabetes Drugs in India

AMHERST — India has one of the highest rates of type 2 diabetes in the world, and there is now “growing national and international concern” about the drug regulatory system there, which allows use of a drug treatment that has not been shown effective or safe, say researchers at UMass Amherst and the U.K.’s Newcastle University in a paper published in the British Medical Journal.

In what they believe is the first study of its kind, lead author Valerie Evans, now a biostatistician at UMass Amherst’s School of Public Health and Health Sciences, with legal advisor Peter Roderick and senior author Allyson Pollock, now at Newcastle, used World Health Organization guidelines for approving metformin fixed-dose combinations (FDC) to assess the efficacy and safety of those top-selling diabetes drugs in India.

Evans, who did this work while at the University of Edinburgh with senior author Pollock, noted that “this work is relevant to an active case in the courts in India. We are in the six-month review window ordered by India’s Supreme Court right now.”

FDCs combine two or more drugs in a fixed ratio into a single-dose form, usually a tablet or capsule, which is appropriate for some conditions. FDCs can make medications more convenient and less costly for patients. However, no national or international treatment guidelines recommend use of FDCs for type 2 diabetes because individual monitoring and adjustment of blood sugar is so important in the disease, the authors say.

Multi-national corporations manufacture all five of India’s 500 top-selling FDCs for diabetes, they add, and Pollock, who is director of the Institute of Health and Society at Newcastle University, explained that “the lack of good trial evidence for these five top-selling metformin combination medicines for treatment of type 2 diabetes is of deep concern.”

Evans points out that India’s pharmaceutical companies are drug distributors for the world, “so if there’s a problem it can go everywhere,” she said. “You hope that the regulatory systems in the consumer countries can filter out problems, but that’s not always the case. 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.”