A team of international experts has said that many of the top-selling diabetes drugs in India may not be safe for patients.
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, researchers have said.
According to the experts, India’s drug regulatory system allows the use of a treatment that has not been found effective or safe.
Using WHO guidelines for approving metformin fixed-dose combinations (FDC) to assess the efficacy and safety of those top-selling diabetes drugs in India, the study’s authors pointed out that in March 2016, the Indian government banned more than 300 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.
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.
The researchers are urging India’s regulatory drug agency, the Central Drugs Standard Control Organisation, to make public its evidence for approving the FDCs now in use, to provide “confidence in their efficacy and safety”.