Many top-selling diabetes drugs in India unsafe for patients: experts

news
08 March 2018

A team of international experts say that many of the top-selling diabetes drugs in the country may not be safe for patients.

They point out that India's drug regulatory system allows the use of drugs that have not been found effective or safe.

On the basis of the World Health Organisation (WHO) guidelines for approval of metformin fixed-dose combinations (FDC) to assess the efficacy and safety of the top-selling diabetes drugs in India, the study's authors pointed out that in March 2016, the Indian government banned over 300 unapproved FDCs that had no 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 it was overturned by the Delhi High Court in December 2016.

It was later appealed to the Supreme Court by the government and in December 2017 the country's apex court gave the Drugs Technical Advisory Board six months to consider the banned drugs.

"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 researchers said in their current paper.

They have called on 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".

For their study, published in the British Medical Journal, the researchers used World Health Organisation (WHO) guidelines for approving metformin fixed-dose combinations (FDC) to assess the efficacy and safety of those top-selling diabetes drugs in India.

They pointed out that the March 2016 ban included different doses of three of the five top-selling metformin FDCs.

''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 researchers said in their current paper.





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