Experts call for action on diabetes medicines in India

March 6, 2018 by Valerie Evans, University of Massachusetts Amherst
Valerie Evans at UMass Amherst, with others in England, used World Health Organization guidelines for approving metformin fixed-dose combinations (FDC) to assess the efficacy and safety of top-selling diabetes drugs in India. They call for a government ban on their use to be reinstated. Credit: UMass 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 the University of Massachusetts Amherst and the U.K.'s Newcastle University in a paper published today 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, says "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.

Multinational 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, says, "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 says. "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."

The authors point out that in March 2016, the government of India banned 344 unapproved FDCs that lacked clinical support or that were found to be potentially harmful. The ban included different doses of three of the five top-selling metformin FDCs. But the ban was overturned by the state-level Delhi High Court in December 2016. When the government later appealed this to the Supreme Court, it gave the country's Drugs Technical Advisory Board six months to consider the banned drugs.

In their current paper, Pollock and colleagues state, "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." They urge India's regulatory agency, the Central Drugs Standard Control Organization, to make public its evidence for approving the FDCs now in use, to provide "confidence in their efficacy and safety."

Further, Evans and colleagues say if that evidence does not extend beyond the clinical trials they reviewed, "those FDCs should be banned immediately." Pollock urges, "The Government's 2016 ban on FDCs should be reinstated and a review of FDCs mandated by the Indian Parliament."

For this work, the researchers searched the published literature, clinical trial registries and other data on the use of metformin FDCs in adults with type 2 in India. Evans says this work grew out of a larger project supported by the European Commission's FP7 and led by Pollock that is looking at seven pharmaceuticals, one of which is metformin, and tracing them from production to consumption in India, South Africa and Uganda.

Explore further: Multinational companies continue to produce unregulated antibiotics in India

More information: Adequacy of clinical trial evidence of metformin fixed-dose combinations for the treatment of type 2 diabetes mellitus in India, British Medical Journal (2018). gh.bmj.com/lookup/doi/10.1136/bmjgh-2016-000263

Related Stories

Multinational companies continue to produce unregulated antibiotics in India

February 5, 2018
Millions of unapproved antibiotics are being sold in India, according to a new study by researchers at Queen Mary University of London and Newcastle University.

Lack of essential and affordable medicines in India revealed

January 25, 2018
Research has revealed the shocking lack of access to essential medicines in India, despite thousands being approved in an attempt to generate wider availability.

Tackling the rising sale of unapproved antibiotics in India

October 10, 2017
Indian government needs to do more to tackle rising sale of unapproved antibiotics, according to an analysis by researchers at Newcastle University and Queen Mary University of London.

Many fixed-dose drug combinations in India lack central regulatory approval

May 12, 2015
Fixed-dose drug combinations (FDCs) which have not received central regulatory approval are sold in substantial numbers in India—despite concerns over the safety and efficacy of these combinations—according to new research ...

Fixed-dose combinations of drugs versus single-drug formulations for treating pulmonary tuberculosis

May 20, 2016
A research team from Spain has prepared a Cochrane systematic review that explores the efficacy, safety, and adherence to fixed-dose combinations (FDCs) of drugs versus single-drug formulations to treat people who are newly ...

No link found for metformin or statins and ovarian cancer

February 27, 2018
(HealthDay)—In women with type 2 diabetes, no evidence was found of an association between the use of metformin or statins and the incidence of ovarian cancer, according to a study published online Feb. 7 in BJOG: An International ...

Recommended for you

Cardiovascular disease related to type 2 diabetes can be reduced significantly

August 16, 2018
Properly composed treatment and refraining from cigarette consumption can significantly reduce the risk of cardiovascular disease resulting from type 2 diabetes, according to a study published in the New England Journal of ...

Using mushrooms as a prebiotic may help improve glucose regulation

August 16, 2018
Eating white button mushrooms can create subtle shifts in the microbial community in the gut, which could improve the regulation of glucose in the liver, according to a team of researchers. They also suggest that better understanding ...

Blood test may identify gestational diabetes risk in first trimester

August 16, 2018
A blood test conducted as early as the 10th week of pregnancy may help identify women at risk for gestational diabetes, a pregnancy-related condition that poses potentially serious health risks for mothers and infants, according ...

Weight gain after smoking cessation linked to increased short-term diabetes risk

August 15, 2018
People who gain weight after they quit smoking may face a temporary increase in the risk of developing type 2 diabetes, with the risk directly proportional to the weight gain, according to a new study from Harvard T.H. Chan ...

Evening preference, lack of sleep associated with higher BMI in people with prediabetes

August 15, 2018
People with prediabetes who go to bed later, eat meals later and are more active and alert later in the day—those who have an "evening preference"—have higher body mass indices compared with people with prediabetes who ...

Healthy fat cells uncouple obesity from diabetes

August 14, 2018
About 422 million people around the world, including more than 30 million Americans, have diabetes. Approximately ninety percent of them have type 2 diabetes. People with this condition cannot effectively use insulin, a hormone ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.