Indian endocrinologists start debate on diabetes drug

BMJ 2015; 351 doi: (Published 29 September 2015) Cite this as: BMJ 2015;351:h5160
  1. Ganapati Mudur
  1. 1New Delhi

Two endocrinologists in India have started a debate over whether an Indian drug company launched and is marketing a drug to treat diabetes and dyslipidaemia without adequate safety and efficacy data.

In a commentary published in the Lancet Diabetes and Endocrinology last week, Anoop Misra and Atul Luthra, from the Fortis Centre of Excellence for Diabetes, Metabolic Diseases, and Endocrinology in New Delhi, listed saroglitazar among at least three drugs that were being promoted by drug companies and prescribed by doctors even though “available data are entirely inadequate to show the efficacy and safety of these three drugs.”1

Saroglitazar, marketed as Lipaglyn by Zydus Cadila, was approved after two studies of up to 24 weeks of follow-up with …

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